cyrilzakka/clinical-trials huggingface dataset:
Muscle Energy Technique of Lower Limb Muscles in Forward Head Posture

The aim of this randomized controlled trial is to find the effect of muscle energy technique of muscles involved in lower limb superficial backline (hamstring and Gastro-soleus) on improving craniovertebral angle and cervical proprioception and minimizing pain among patients with forward head posture

Forward head posture (FHP) is a common postural disorder (66%), occurring when the head is anterior to a vertical line passing through the center of gravity. This malalignment causes muscle weakness in deep cervical flexors and shortened opposing cervical extensor muscles. This posture increases lordosis in the lower cervical spine, leading to increased extension over upper, and flexion over the lower cervical spine. Abnormal postures can lead to headaches, myofascial pain syndrome, abnormal scapular movement, temporomandibular disorders, and limited cervical range of motion.

Muscles of the neck, back and lower limb are interconnected through myofascial called superficial backline. Prolonged forward head posture affects muscles and involved in superficial backline. So remote muscle stretching has a same effect on local neck muscles.

Muscle energy technique is a soft tissue technique designed to improve musculoskeletal function through stretching tight muscles and fascia, to reduce pain and improve circulation. MET is characterized by a patient-induced skeletal muscle contraction against physiotherapist resistance in a controlled direction and position. Pathological barrier of a muscle is located through joint positioning which is followed by active muscle contraction by the patient moving away from the resistance followed by relaxation of the muscle. A new pathological barrier is located through passive movement and process is repeated. The rationale for the use of these techniques is to identify the effects of MET of lower limb superficial backline muscles which are interconnected with cervical muscles through myofacial chain, on cervical pain ROM, craniovertebral angle , disability and cervical proprioception.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 35 years
* Both Genders
* Craniovertebral angle \<49.9 degrees
* History of neck pain \>3 months
* Patients with hamstring tightness(Inability to achieve greater than 160° of knee extension with hip at 90° of flexion)
* Patients with calf muscle tightness(The Taloche Sign (Maestro) If a patient with a tight gastrocnemius tries to stand on an inclined plane, it is immediately evident that it is impossible for the patient to be stable in this position)

Exclusion Criteria:

* Patient with recent injuries or surgeries in and around the neck region
* Vertigo
* radiating pain in upper limb
* spinal deformities
* malignancy in and around the neck region
* cervical instabilities
* fibromyalgia
* patients with any lower limb or lower back pathology(e.g arthritis)
CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

The purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, CATCH Healthy Smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children serving low-income, ethnically-diverse children,to determine the impact of CATCH Healthy Smiles on child behavioral, psychosocial, and environmental outcomes beginning in K through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.


Eligibility Criteria:
Inclusion Criteria:

For schools:

* greater than 75% of the children enrolled in the dree/reduced school lunch program.
* enrolling children in grade K in the 2021-2022 school year.
* agree to implement the CATCH Healthy Smiles program and agreed to participate in the measurements

For parent and child to participate in the measures:

* ability of the parent to speak and read in English or Spanish at the 4th grade level,
* child enrolled in the participating school in grade K in the 2021-2022 school year
* child ability to participate in the regular activities at the school

Exclusion Criteria:

-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT

This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.

Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.

Eligibility Criteria:
Inclusion Criteria:

* \> 24 weeks, viable pregnancy, singleton or twins

Exclusion Criteria:

* No consent
* Contraindication to oxytocin
* Antepartum fetal demise
* Intrapartum use of concentrated oxytocin
* Planned cesarean
* DIC or coagulopathy
Study of Testosterone vs Placebo in Testicular Cancer Survivors

The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.

The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.

This is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency.

70 subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent is signed. If a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Previous treatment for testicular cancer.
* No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).
* Free testosterone \< the age-adjusted median and \> -2 standard deviations (SD) from the age-adjusted median and LH \> 2 SD from the age-adjusted median.

Exclusion Criteria:

* Treatment with testosterone within the last 6 months.
* Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)\> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)\> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) \> 50%.
* Breast cancer.
* Symptomatic obstructive sleep apnoea syndrome
* Heart failure \> NYHA II.
* Uncontrolled hypertension: (Systolic blood pressure \> 160 mm Hg despite antihypertensive treatment, measured at two separate occasions)
* Inability to understand information about the trial
* Participation in any other clinical trial
* Allergy for the active substance or additives in Tostran or placebo.
* Known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

A multicenter, randomized, open-label clinical study with a concurrent control group to assess the effectiveness and safety of combined therapy with Isobide solution and Meniace tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease


Eligibility Criteria:
Inclusion Criteria:

* 20 - 80 years of age (in full)
* A definite Meniere's disease patient according to the diagnostic criteria of AAO-HNS (1995), who has had 2 or more episodes of rotary dizziness lasting more than 20 minutes within the last 3 months (12 weeks) and 1 or more episodes of hearing loss recorded by audiometry, and has tinnitus or ear fullness.
* For female subjects with the possibility of pregnancy during the study period, a subject whose urine pregnancy test result was negative at the time of the screening visit. A subject in menopause for at least one year, one who has no possibility to become pregnant through surgery, or one who effectively uses an acceptable contraceptive measure. A subject who definitely agreed to use an adequate contraceptive measure during the clinical study period.

Exclusion Criteria:

* A patient with the history of ear surgery
* A patient with the history of endolymphatic sac surgery
* A patient who used steroids or gentamycin in the eardrum within the last 6 months
* A patient to whom Isobide was administered within 3 months at the time of screening
* A patient who has an infection in the ear, paranasal sinuses or the upper airway system
* A patient who has a disease, other than Meniere's disease, that manifests as repetitive dizziness (e.g. Migrainous vertigo, vertebrobasilar transient ischemic attack, acoustic neuroma)
* A patient who has acute intracranial hematoma (If this drug is administered to a patient suspected of having an acute intracranial hematoma without checking for the existence of an intracranial hematoma, bleeding that had been stopped temporarily by brain pressure can occur again when intracranial pressure is reduced. Thus, eliminate the cause of bleeding and administer the drug after ensuring that there are no concerns of rebleeding)
* A patient with anuria (with urinary output of less than 100 mL/day)
* A severely dehydrated patient (loss of 10% or more of body weight)
* A patient with acute pulmonary edema
* A patient with severe heart failure (New York Heart Association class III or higher)
* A patient with an adrenal tumor
* A patient with pheochromocytoma
* A patient who is hypersensitive to the ingredients of the test and control drugs
* A patient with a hereditary disease such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* A woman who is pregnant or breastfeeding
* A patient who is deemed ineligible for this clinical study by the analyst
Effect of PBI-4050 on the Pharmacokinetics of Midazolam in Heathy Adult Subjects

This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of PBI-4050 combined with midazolam in healthy adult subjects.

This is a Phase 1, single-center, open-label, 2-period, fixed sequence study to investigate the effect of multiple doses of PBI-4050 on the PK of midazolam, a cytochrome P450 (CYP) 3A substrate, in healthy adult men and healthy women of non-childbearing potential (WONCBP), and to determine the safety and tolerability of PBI-4050, when co-administered with midazolam.

On Day 1 of Period 1, subjects will receive a single oral dose of midazolam followed by PK sampling of midazolam and its metabolite 1-hydroxymidazolam (1-OH-midazolam). In Period 2, subjects will receive multiple daily doses of PBI-4050 for 5 consecutive days (Day 1 to Day 5) with a single oral dose of midazolam co-administered on Day 5. PK sampling for midazolam and 1-OH-midazolam will be collected for 24 hours following dosing on Day 5. PK sampling for PBI-4050 and its major metabolite will be collected at pre-dose on Days 3, 4, and 5.

There will be a washout period of at least 2 days between midazolam dose in Period 1 and the first PBI-4050 dose in Period 2.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females (WONCBP only).
2. Age 18-65 years.
3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing.
4. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
5. Generally good health.
6. Males willing to use appropriate contraception.

Exclusion Criteria:

1. Significant medical history or physical findings.
2. History or presence of drug allergy or hypersensitivity to treatment ingredients.
3. Gastrointestinal surgery.
4. Pregnant or lactating.
5. Positive urine drug or alcohol screen.
6. Abnormal heart rate or blood pressure.
7. Prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety.

   • Receiving drugs known as significant inducers of CYP2C9, CYP3A4, CYP2C8 and/or CYP1A2 enzymes and/or P-glycoprotein, including St. John's Wort, for 28 days prior to the first dosing and throughout the study.
8. Has been on a diet incompatible with the on-study diet.
9. Recent blood donation or significant blood loss.
10. Recent blood received.
11. Participation in another clinical study within 30 days prior to the first.
Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms

The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.

The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensitivity , the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.

Since January 2000, date of the first double hand graft, six bilateral grafts of hands have been performed at the Hospices Civils de Lyon. This first study reported the feasibility of the graft. The functional results obtained after the double transplant have allowed patients to recover complete autonomy for everyday activities, at the price of an immunosuppressive treatment. We have found that these very good functional results are maintained over time and, for a certain number of patients, to return to work which is a factor of social integration.

The rate of medical complications (metabolic, infectious, oncological), essentially related to the immunosuppressive treatment, is not greater to that found for other types of graft, but are considered as a limiting factor for the development of this strategy. These results are confirmed by international experience that is of the same order. Only a few rare cases of re-amputation have been reported in patients for whom the immunosuppressive treatment was discontinued or following vascular thrombosis.

A new study is required to continue this evaluation and to compare double graft to prostheses in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The results of this study will allow the placement of these strategies in the management of patients with double amputation of the hands and forearms.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria common to the 2 groups of patients (allograft group and protheses group):

* Adult aged 18 to 60 years
* Double amputated of both forearms

Transplant eligibility criteria (for allograft group)

* Minimum interval between amputation and graft of three months (no maximal delay)
* Absence of previous psychiatric history contraindicating the graft and psychological maturity, according to two psychiatrists who have evaluated the patient
* No previous history of malignant tumor in remission for less than 5 years
* American Society of Anesthesiology (ASA) score ≤ 2
* New York Heart Association (NYHA) grade ≥ 1
* Creatinine clearance ≥ 60 ml/min/1.73m²
* Absence of badly controlled sever hypertension

Exclusion Criteria:

* Mono amputated patients
* Malignant tumor or previous history of malignant tumor for which the risk of recurrence at 5 years is greater than 5%
Internal Limiting Membrane and Macular Hole

Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings in closed holes.

A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.

Surgeries are performed under local or general anesthesia, pars plana vitrectomy with internal limiting membrane peeling, fluid gas exchange and face down position.

Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory.

Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. Both samples from same patient will follow the protocol available at dx.doi.org/10.17504/protocols.io.qjiduke.

Image acquisition Six electron-micrographs will be acquired for each fragment, using a Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of interest will be randomly selected, and acquisition of 15,000x magnification images.

Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody (anti-glial fibrillary acidic protein), to detect this protein in glial cells.

Results:

Only successful macular hole closure will be considered, BCVA will be compared before and after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with and without enriched medium.

Eligibility Criteria:
Inclusion Criteria:

* All macular holes were staged based on recent OCT based classification and only full thickness macular hole, grade 2 to 4 IMH are considered for study.

Exclusion Criteria:

* Excluding criteria are maculopathy other than IMH, surgeries of recurrence of IMH, other retinal diseases, or an axial length greater than 26.0 mm. Mean follow-up will be at least 12 months after surgery.
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients \>18 years old
* Positive PCR COVID-19 testing
* CT evidence of interstitial opacity
* Oxygen saturation \<90% on room air
* pO2 = 55-70.

Exclusion Criteria:

* Increased oxygen requirements
* Hemodynamic instability (MAP\<65)
* Bradycardia (HR\<50)
* History of seizure disorder
* Pneumothorax
* GFR\<30
* Hemodialysis
* Refractory anxiety/claustrophobia
* Current pregnancy
* Uncorrectable hypoglycemia
Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.

This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.

Eligibility Criteria:
Inclusion Criteria:

* Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
* Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
* Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
* Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
* Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.

Other protocol-defined exclusion criteria may apply.
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification \[POP-Q\] system)9,
* with or without anterior vaginal wall prolapse, and
* experiences symptoms of vaginal bulging with or without a previous hysterectomy
* being able to provide oral and written informed consent before entering the study.

Exclusion Criteria:

* previous cancer of any pelvic organ,
* systemic glucocorticoid treatment,
* insulin-treated diabetes,
* an inability to participate in study follow-up or to provide informed consent, or
* the need for any concomitant pelvic surgery.
A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment

To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.

The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* being 65 years and older
* having complaint of memory loss
* scoring ≤0.5 on Clinical Dementia Scale
* having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test

Exclusion Criteria:

* scoring \<24 on the Mini-Mental State Examination
* being able to ambulate independently for household distances
* having medical clearance
* having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months
* having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis
* being unwilling to be randomized