cyrilzakka/clinical-trials huggingface dataset:
Effects of MET vs Mulligan MWM on Pain, Disability & Balance in Athletes With Ankle Sprain

Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve dynamic balance and to restrain athlete from disability due to chronic ankle sprain.

This study will be a randomized clinical trial,non probability convenience sampling technique will be used to collect the data. The sample size of athletes will be taken in this study to find the effect of post isometric relaxation and mulligan mobilization with movement in athletes.

Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve dynamic balance and to restrain athlete from disability due to chronic ankle sprain. As the effect of post isometric relaxation in comparison with Mulligan MWM has never been investigated in Athletes, the aim of this study is to investigate and compare the effect of these two techniques on athletes with chronic ankle sprain presented with pain, dynamic imbalance that leads to disability.

This study will be a randomized clinical trial and will be conducted in Pakistan sports board and Multan sports complex. The study will be completed within the time duration of six months. Non probability convenience sampling technique will be used to collect the data. The sample size of athletes will be taken in this study to find the effect of post isometric relaxation and mulligan mobilization with movement in athletes of PSB and MSC, aged 20-35 years, were allocated to both intervention group. The participants will be divided into two groups i-e, MET group and MWM group. MET group will receive post-isometric relaxation technique for gastrocnemius and soleus muscle. Patient will be in prone lying with the ankle out of the bed. 30% of the available strength will applied by the patient against unyielding resistance towards plantarflexion. The therapist will ensure that foot will not actually move and only a static muscle contraction apply and held for 20 seconds. This will be followed by 2-3 second of relaxation, and then the foot passively stretched to dorsiflexion up to the palpated barrier and/or tolerance to stretch. This will continue until no further gains achieved 2 sets of 5 repetitions a day for 3 days a week for 4 weeks. MWM group will receive inferior tibiofibular, talocrural, or cubometatarsal MWM 2-8 treatment sessions over 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of chronic ankle sprain (grade I or II) (3-4 months)
* Players have spent at least one year in sports

Exclusion Criteria:

* • Players undergone surgery or had an accident.

  * Any malignant or chronic disease
  * Players with the history of fracture in the same ankle
Effect of Allulose on Diet-induced Thermogenesis

The objective of this study is to investigate the dose-response effect of allulose on diet-induced thermogenesis, substrate oxidation, glycemic response, and subjective appetite in healthy normal weight adults.

A within-subject, repeated measures, randomized, repeated measures design will be used. Participants (n= 10, 5 males, 5 females) will consume, in a random order, one of three varying doses of test treatments (allulose (5g), allulose (10g) or allulose (20g)) on 3 separate days. After treatment consumption, energy expenditure measurements via indirect calorimetry will be collected in 30-min interval (30-min measurement, 30-min rest) for 3 hours. Blood glucose will be measured at baseline and continuously for 3 hours via the Dexcom G6 continuous glucose monitoring system. Subjective appetite (hunger, fullness, desire to eat, prospective food consumption) will be measured via visual analogue scales at baseline and at the end of each energy expenditure measurement interval over 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Participants (18 - 45 years) who are considered healthy, are non-smokers, and have a body mass index (BMI) between 20 and 24.9 kg/m2 \[World Health Organization classification of normal weight BMI\].

Exclusion Criteria:

* Participants who have a fasting plasma glucose \> 5.5 mmol/L indicative of impaired fasting glucose, previously diagnosed diabetes, known or uncertain pregnancy status at the screening visit, gastrointestinal disease, liver or kidney disease, have undergone a major medical or surgical event within the past 6 months, were or are on a diet, skip breakfast, smoke or have taken medication which would be a potential confounder with effects on metabolic and intake regulation.
* Those unable to complete the testing protocols or are intolerant or allergic to test-day ingredients.
OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of refractive surgery (including LASIK procedures)
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* Use any of the disallowed medications during the period indicated
* History of IOP increase as a result of steroid treatment
A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis

The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female, 16 years of age or older.
* Clinical diagnosis of moccasin type tinea pedis
* Microscopic evidence (positive KOH) of the presence of fungi
* Provided written informed consent/assent
* In general good health

Exclusion Criteria:

* Pregnant or lactating or planning to get pregnant while on the study
* Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris)
* Other skin disease which might interfere with the evaluation of tinea pedis
* History of diabetes mellitus or is immunocompromised
* Currently enrolled in an investigational drug or device study
* Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
Open vs Robotic Assisted Partial Nephrectomy

To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.

Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be the complete removal of the kidney, which is not examined in this trial.

Surgery will be randomized either to an open technique involving a large incision or the robotic assisted technique with a few small incisions (keyhole surgery). With robotic assisted surgery the movements of the surgeon are translated into the movement of the instruments.

It is not clear which of the two procedures, open or robotic assisted, has less complications. It is expected that these are different due to the different level of invasiveness and the level of direct access to the organ. This study aims to show that robotic assisted surgery results in less complications than open surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patient with a renal tumor that is a candidate for OPEN surgery and robotic assisted surgery (RAS) partial nephrectomy (PN)
* R.E.N.A.L. score ≥ 7
* eGFR ≥ 50 ml/min/1.73 m²
* Anticoagulation is accepted according to the surgeon's practice

Exclusion Criteria:

* Solitary kidney or functionally solitary kidney
* Prior surgery at the affected kidney excluding endoscopic kidney stone surgery
* Bilateral tumors
* Multiple renal tumors requiring excision
* Renal vein tumor thrombus
* Likely insufficient volume of remaining parenchyma after partial nephrectomy to maintain viable kidney remnant
* Metastatic disease with life expectancy of less than 1 year
* Pregnancy or suspected pregnancy
* Planned concomitant procedure
* Subject who is unable or unwilling to comply with the protocol requirements
* Subject considered to be from a vulnerable population according to IS0 14155:2011
Consumers' Preference for Sustainable Food

This study aims to test and compare the effectiveness of three priming interventions on consumers' selection of sustainable foods: priming with environmental benefits, health benefits and co-benefits (environment and health benefits).


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be aged 18 years or above
* Hong Kong residents
* Be able to read Chinese

Exclusion Criteria:

* Subjects who have vegan or vegetarian diets
* Subjects who have to follow special diets due to illnesses will be excluded.
Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of HSIL (CIN 2/3)

The study aimed to identify the clinical value of Magnetic Resonance Imaging examination (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)).

186 female patients with the HSIL(CIN2-3) were included in this study and followed up from the time of admission. All patients underwent colposcopy examination, MRI, SCC-Ag, loop electrosurgical excision procedure (LEEP), extrafascial hysterectomy, or radical hysterectomy. Pathological findings of the patient's tissues were used as the final diagnostic criteria. On the one hand, we compared the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI+SCC-Ag, LEEP of the menopausal group, and non-menopausal group. On the other hand, evaluating the accuracy of MRI combined with SCC-Ag examination in diagnosing HSIL(CIN2-3) by receiver-operating characteristic curve (ROC)．

Eligibility Criteria:
Inclusion Criteria:

* No previous history of cervical lesions
* TCT and HPV test results suspected cervical lesions
* Further colposcopy showed HSIL or CIN 2-3
* All selected patients underwent MRI, serological tests for SCC-Ag levels, LEEP, or radical hysterectomy

Exclusion Criteria:

* Patients with receiving cold knife conization
* Patients with skin squamous cell carcinoma or previous history of cancer
* Pregnant women
* Patients with serious heart, liver, kidney, blood system and autoimmune diseases
Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer

To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven breast cancer
* Surgical resection performed with clear margins (R0 resection)
* At least 1 histologically proven involved axillary node
* ER + or ER-
* Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
* Aged over 18 years, and more than 10-year life expectancy
* ECOG performance status 0-1
* Signed informed consent form prior to randomization

Exclusion Criteria:

* Bilateral breast cancer
* Inflammatory breast cancer
* Personal history of breast cancer
* Immunohistochemical only node involvement
* Intraductal breast cancer
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease
* Poor renal function (creatinin level \> 120 micromol/L), poor hepatic function (total bilirubin level \> 1 UNL), transaminases \> 2.5 UNL)
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/L or platelets \< 100 G/L; Hemoglobin \< 10 G/dL
* Poor contractile cardiac function (LVEF \< 50%)
* Coronary disease
* Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial
Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the Emergency Department

Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee

Dyspnea is associated with a variety of etiology whose diagnosis is challenging especially in elderly patients with unconventional symptoms. Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound. It has already demonstrated its ability to reduce diagnosis uncertainty in emergency patients with dyspnea. However, adequacy of diagnosis before and after thoracic ultrasound has not been investigated in such patients.

In this population, after clinical examination and use of any resource deemed necessary, the physician states its hypothesis in closed list. An emergency physician then realizes a thoracic ultrasound exam. An adjudication committee with all the patient's file will state the reference hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Acute onset dyspnea in patient over 74 years old consulting at the emergency department

Exclusion Criteria:

* Need for ICU
* Need for a mechanical ventilation
* Less than 24 hours hospital stay
* Inability to consent
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

The goal of this clinical trial is to learn if Atorvastatin 80 mg is effective to avoid functional right ventricular deterioration in patients affected by Arrhythmogenic Cardiomyopathy. It will also learn about the safety of Atorvastatin 80 mg in this type of patients. The main questions it aims to answer are:

1. Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?
2. Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?
3. What medical problems do participants have when taking Atorvastatin 80 mg?

Researchers will compare Atorvastatin 80 mg to a placebo (a look-alike substance that contains no drug) to see if the drug works to treat Arrhythmogenic Cardiomyopathy.

Participants will:

1. Take Atorvastatin 80 mg or a placebo every day for 18 months;
2. Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;
3. Make a phone call for safety check after 12, 15 and 19 months since the enrollment;
4. Fill out psychological questionnaires


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be at least 18 years of age, at the time of signing the informed consent
2. Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria

Exclusion Criteria:

1. Known hypersensitivity to atorvastatin or any of the excipients
2. Moderate or severe liver disease
3. Muscle disease
4. Left ventricular ejection fraction \<35%
5. Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.
6. Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
7. Hypercholesterolemic patients that require the use of lipid lowering drugs.
8. Heart transplantation
9. Estimated life expectancy of less than 2 years
10. Any other medical condition that, in the judgment of the investigator, places the patient at risk or makes the patient unreliable or limits the patient's ability to complete the study
11. Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol
12. Fusidic acid (drug for bacterial infections)
13. Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
14. Any other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants , PCSK9 inhibitors, Adenosine triphosphate-citrate lyase inhibitors , Fibrates, Omega-3 fatty acid ethyl esters
15. Drugs primary indicated as antioxidants
16. Enrollment in another clinical trial or past clinical trial in which an investigational drug was administered within 30 days of Visit 1 or within the 5 half-lives of the investigational drug, whichever is longer.
17. Pregnant or lactating women
18. Women of childbearing age who are not using adequate contraception
19. Known dependency on alcohol - drug abuse.
20. Contraindications to cardiac magnetic resonance
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers

This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females between 18 and 55 years of age, inclusive
* Body weight ≥ 55 kg and BMI within the range of 18 to 32 kg/m2, inclusive

Exclusion Criteria:

* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
* Positive drug or alcohol test at screening or prior to the first dose of study drug
Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)

The goal of this proposal is two-fold: (1) to further develop and validate a technology, magnetic resonance elastography (MRE), for quantitatively imaging mechanical properties and tension distribution in muscle and (2) to apply the technique for in vivo evaluation of patients with four common, and clinically significant muscle disorders (spasticity, disuse atrophy, myofascial pain and a metabolic myopathy). These studies will employ a magnetic resonance imaging sequence with synchronous motion-sensitizing gradients to map propagating shear waves in the muscle. The technique will assess the mechanical properties of the muscle and its tension distribution. Specifically, the study can be divided into three specific aims. Aim 1: Optimize MRE methods of acquisition and analysis for the assessment of muscle, including electromechanical drivers, data acquisition techniques, and methods for image analysis. Advanced techniques for very rapid MRE assessment of muscle will continue to be developed. Aim 2: Validate the MRE assessment of muscle properties and tension with phantom, ex-vivo muscle, and Finite Element Modeling (FEM) techniques. Finite Element Analysis will be performed by using both phantom and bovine muscles to better correlate MRE wave-length findings as function of muscle properties, tension and fiber architecture. Aim 3: Study In Vivo Normal and Abnormal Muscle. The MRE technique will be applied in vivo to provide elastographic images of abnormal muscle with known disorders. The patient groups chosen for study are each important in their own right, and furnish unique information across the spectrum of muscular disease and dysfunction. Groups to be studied include individuals with new onset of spasticity following an ischemic, hemispheric stroke, disuse atrophy as a result of immobilization, metabolic (hyperthyroid) myopathy and myofascial pain for trigger point identification. The overall hypothesis of this work is that will bring benefits to both basic research and clinical care.


Eligibility Criteria:
Inclusion Criteria:

Normals:

* Healthy individuals

Stroke:

* a first stroke (i.e., a unilateral, ischemic hemispheric stroke) within the previous one to two months, ability to cooperate and follow simple commands, and gastrocsoleous strength in the affected lower extremity of between trace and 50% of normal.

Immobilization:

* immobilized in a cast (typically 6 weeks) following sugical repair of a severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain

Myofascial Pain:

* history of pain in trapezius confirmed by clincal examination. The examiner will perform snapping palpation over the MFTP. If a localized, transient contraction is observed, the response is considered to be positive and the subject will be considered eligible for entry into the study.

Hyperthyroid Myopathy:

* clinical assessment in combination with a serum hormone profile of increased Free Thyroxine (FT4) and Triiodothyronine (T3) in the face of suppressed levels of Thyroid Stimulating Hormone (TSH).