cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Electrical Stimulation in Lower Limb Amputees

Current lower limb prostheses support ambulation by absorbing and stabilizing positions during walking. Users of lower limb prostheses rely solely on sensory information provided by the contact between the socket and the residual limb. Restoring sensory feedback could potentially improve their quality of life and participation in daily activities. Despite a high incidence of lower limb amputations, there are few studies in the literature addressing the restoration of sensory feedback in lower limb amputees, particularly studies utilizing invasive techniques. In an effort to overcome these limitations, various non-invasive methods have been tested. Despite resulting benefits such as improved gait symmetry and stability, most non-invasive stimulation systems are non-somatotopic, failing to generate a sensation referred to the patient's missing limb. From the literature, Transcutaneous Electrical Nerve Stimulation (TENS) emerges as a very promising non-invasive and somatotopically-based sensory feedback approach, capable of inducing sensations referred to the amputees' phantom limb.

Therefore, the proposed study will involve the use of TENS as a means to stimulate sensitivity and prevent perceptual disturbances associated with the interruption of peripheral nerve structures occurring in individuals undergoing amputation. These disturbances, besides influencing the development of symptoms characterized by neuropathic pain, can impact prosthesis management.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 80 years;
2. unilateral transtibial amputation or transfemoral amputation at least two months prior the study;
3. stable clinical conditions;
4. skin integrity;
5. absence of cognitive deficits.

Exclusion Criteria:

1. bilateral amputation;
2. open wounds or sores on the residual limb;
3. cognitive deficits;
4. pregnancy;
5. presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps);
6. refusal to sign the informed consent.
A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)

The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.


Eligibility Criteria:
The main inclusion criteria include but are not limited to the following:

* Is in good health before randomization

Exclusion Criteria:

* Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination.
* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Infant Microbiota and Probiotic Intake Study

The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.

The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking women and their infants
* Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
* Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
* Plan to exclusively breastfeed their infants for at least 3 months
* Infants: 0-7 days old, delivered by C-section or vaginal delivery, born \>37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota

Exclusion Criteria:

* Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
* Infants who have taken antibiotics for more than 72 hours of life
* Infants who have consume formula feedings after day 7 of life
* Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
* Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
* Women who have had any breast surgery or injury within the past 5 years that would reduce the chance of successful exclusive breastfeeding
* Mothers who have a chronic metabolic disease or obesity
Cosopt Versus Xalacom

To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.


Eligibility Criteria:
Inclusion Criteria:

* adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
* at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
* the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
* visual acuity should be 6/60 or better in the study eye(s)

Exclusion Criteria:

* any anticipated change in systemic hypotensive therapy during the trial
* use of any corticosteroids by any route for more than two weeks during the study
* contraindications to study medicines
Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.

Methods: Randomized, single-blinded, controlled trial

Setting: Office practice of two academic otolaryngologists at a community hospital.

Primary Outcomes: Patient pain and discomfort, Optical quality

Secondary Outcomes: Physician and nursing staff satisfaction

Cost-analysis

Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy

Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy

Exclusion Criteria:

* Known sinonasal masses or nasal polyposis
* Unable to complete VAS surveys
* Significant septal deviation
* Unable to tolerate in-office flexible nasopharyngoscopy
* Patients who refuse consent
Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Head and neck cancer with xerostomia
* 6 months post radiation
* Willing to participate in this study

Exclusion Criteria:

* Sialolith or Sjogren's syndrome
* Uncontrolled cancer
* Using artificial saliva more than 2 weeks
* Taking Pilocarpine or cevimeline more than 2 weeks
* Allergic to cumin, ginger, xylitol, and glycerin
* History of other oral mucosal diseases
* Pregnancy and lactation
EPANOVA in Crohn's Disease, Study 1

The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject, age 17 or older; country-specific age limitations will be followed
2. Diagnosis of Crohn's disease confirmed by radiological studies or endoscopy or surgical pathology within 36 months prior to randomisation
3. In remission for at least 3 months, but no longer than 12 months; remission being defined as meeting both of the two conditions: (1) clinically in remission with a CDAI of less than 150 and (2) off steroids and/or immunosuppressants for at least 3 months, if remission had been induced with such medications

Exclusion Criteria:

1. Intolerance of omega-3 fatty acids or known allergy to fish or fish products
2. Ongoing CD therapy with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, tube feeding, defined formula diets or parenteral nutrition
3. In 3 months prior to randomisation received: systemic steroid therapy, azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products or preparations containing fish oil
4. In 12 months prior to randomisation received: biologicals e.g. enbrel, infliximab, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products
5. Chronic use of narcotics for pain control (opiates for diarrhoea are acceptable)
6. Documented short bowel syndrome, ostomy
7. Need for bowel surgery for CD, bowel obstruction or resection in past 3 months (a subject who had a bowel resection in the past must have had at least one relapse after the surgery)
8. Malignancy and/or clinically significant impairment in cardiac, liver or renal function, CNS, pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD
9. Known alcoholism or drug abuse
10. Any medical conditions which, in the investigator's opinion, may interfere with the evaluation of the trial medication
11. Any of the following laboratory abnormalities:

    * White blood count \< 3 x 109/L
    * Lymphocyte count \< 0.5 x 109/L
    * Haemoglobin \< 80 g/L
    * Platelet count \< 125 x 109/L or \> 800 x 109/L
    * ALT or AST \> 2.0 times the upper limit of normal
    * Alkaline Phosphatase \> 2.0 times the upper limit of normal
    * Serum Creatinine \> 1.5 times the upper limit of normal
Costovertebral Mobilization on Kyphotic Posture and Lung Function in Non-Smoker

Aim of this study is to find the effects of Costoverterbral Mobilization on Thoracic kyphosis and Lung function in non-smoker. A randomized control trial that will include total 44 participants.The first group will receive Costovertebral Mobilization along with conventional therapy and 2nd group will receive conventional therapy.Data collected will be analyzed through SPSS 25

Kyphosis is the curvature of the thoracic spine, formed by the shape of the vertebrae and the intervertebral discs and-in standing position-paraspinal muscle strength. Hyperkyphosis is usually associated with increased anteroposterior diameter of the thorax and a decrease in the distance between the xiphisternum and pubis and it is present when the kyphosis angle exceeds the normal ranges. This curve is concave anteriorly with a normal angle between 20˚ - 40˚.

The lungs are the foundational organs of the respiratory system,whose most basic function is to facilitate gas exchange from the environment into the bloodstream.The decline in lung function could be associated with hyperkyphosis, As the curvature of the thoracic spine increases and the posture becomes more hunched, the mobility of the rib cage could be limited and restrict the thoracic and lung expansions during inspiratory maneuver.

Different treatment strategies such as surgery, splinting, exercises and manual therapies such as massage, muscle energy technique, and passive joint mobilization have been used to treat hyperkyphosis. Costovertebral mobilization is a manual therapy technique, to improve the mobility and function of the joints between the ribs (costo) and the vertebrae (vertebral). This technique increases the range of motion of ribcage and spine, thus improve kyphosis posture and lung functions.

Eligibility Criteria:
Inclusion Criteria:

* Non smoker
* Age: 20-40 years
* Normal Body Mass Index 18.5 To 24.9
* Both female and male gender
* Decrease forced expiratory volume-one second/ forced vital capacity ratio greater than or equal to 70%
* Increase Thoracic kyphotic posture greater than or equal to 40˚

Exclusion Criteria:

* Any respiratory disease of the upper or lower respiratory tracts e.g. asthma, chronic bronchitis, COPD, emphysema etc. which could altered the optimal lung functioning.
* Previous history of rib fractures, dislocations, sprains of costochondral, costosternal and interchondral joints.
* Smokers
* Scheuermann Disease
* Primary and Secondary neoplastic lesions of the spine and/or ribs
* Obvious advanced spinal deformity e.g. kyphoscoliosis
* Infection e.g. tuberculosis
* Primary and secondary neoplastic lesions of the soft tissue structures of the chest
* Inflammation e.g. acute rheumatoid arthritis or ankylosing spondylitis
Comparative Effects of Myofascial Release and Dynamic Stretching on Flexibility Agility, Jump and Sprint in Athletes

The study will be a randomized clinical trial. Data was collected from the Pakistan sports board. All 44 Participants were randomly allotted into 2 groups via lottery method, with 22 participants in each group. 10 participants from cricket and volleyball each, 8 from wrestling, athletes, and football each. Participant informed consent was taken priory, and all information was given to them regarding their enrolment in the study. And taken them in confidence that their data was kept confidential and this study does not harm their health. Group A participants received the Myofascial release technique while group B received the dynamic stretching technique. Data were collected pre and post. The session was last for 3 weeks, and each week had 5 sessions. Statistical package for the social sciences will be used to analyze the results by using parametric test after confirming normality of data.

Myofascial treatment aims to stretch and relax the fascia, allowing musculoskeletal structures to move with relaxation and restore the affected individual functionality. This treatment is frequently known as myofascial release therapy. Other people may refer to it as 'myofascial trigger point treatment.

A dynamic warm-up, also known as dynamic stretching, involves using a muscle's force generation and the momentum of the body to increase the range of motion of a joint. A dynamic warm-up is frequently included in a specialized warm-up to make the body get ready for the loads that will be put throughout the game.

Myofascial Release and Dynamic Stretching are different techniques that can be used to Flexibility Agility, Jump and Sprint in the early phase which also lead to an increase in athlete's stability, coordination and build confidence in their performances and limit the incidence of injury.

The physical ability to move musculoskeletal through their full range of motion is known as flexibility. Stretching assists function, and posture, avoid poor body sequence, maintains muscle length, balance, and minimizes the risk of injury The sprint of 40-yard is utilized to evaluate speed, acceleration, and agility. The Agility T-Test is a famous test for assessing athletes' capacity to run forward, reverse, and lateral.

The Vertical leap assessment is used to test an athlete's lower limb strength. sit and reach test used for flexibility of athletes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15-35 years.
* No pain complaint
* Recreational activity

Exclusion Criteria:

* joint, meniscus, or ligament damage
* lower extremity surgical history
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.

Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).

Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.

The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years
2. Chronic Kidney Disease stage 5 receiving hemodialysis
3. Authorization (Consent) for Use/Disclosure of Data signed by the patient
4. Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program
5. Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL

Exclusion Criteria:

1. Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy
2. Any experimental drug within the period of 30 days before the inclusion into the program
3. Screening Ca x P \> 65 mg˄2/dL˄2
4. Screening normalized serum total calcium \> 10.2 mg/dL
5. Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy
BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis

The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel Vasculitis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older (male or female).
2. Granulomatosis with polyangiitis (GPA, or Wegener's granulomatosis) or microscopic polyangiitis (MPA) according to the definitions of the American College of Rheumatology and Chapel Hill Consensus Conference.
3. Active GPA or MPA disease at screening.
4. Positive for either PR3-ANCA or MPO-ANCA at screening.
5. Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline.
6. Clinical intention to prescribe MTX therapy for treatment of GPA or MPA.

Exclusion Criteria:

1. Diagnosed with Churg Strauss syndrome.
2. Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide.
3. Nursing or pregnant.
4. Active systemic infection or deep-space infection.
5. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
6. Liver disease.
7. History of documented anti-glomerular basement membrane (GBM) disease.
8. Malignancy within the past 5 years.
9. History of active tuberculosis (TB) or history of TB infection.
10. Anemia, neutropenia, or thrombocytopenia.
11. Serum creatinine level greater than 2.5 mg/dL.
12. Prior administration of a B-cell modulating therapy other than rituximab.
13. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
14. History of congenital immunodeficiency.
Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure

This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Liver damage remains a life-threatening syndrome. With the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. A bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. It may prolonger the expected survival time of acute liver failure patients. Direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. The investigators have already generated human induced hepatocytes (hiHeps) from fibroblasts by lentiviral expression of FOXA3, HNF1A, and HNF4A. hiHeps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome P450 enzyme activity and biliary drug clearance. hiHeps can restore the liver function and prolong survival. This study tends to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Eligibility Criteria:
Inclusion Criteria:

* Weight more than 45 kg;
* Age more than 18;
* Diagnosis of ALF;
* Subjects must not be listed for transplant at the time of Enrollment or, if listed, in the opinion of the Investigator are unlikely to be transplanted within 72 hours;

Exclusion Criteria:

* Acute clinical symptoms that are likely to result in death within 48 hours;
* Presence of sepsis or septic shock;
* Concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, AIDS, cancer;
* Portal hypertension;
* Liver dysfunction due to trauma;