cyrilzakka/clinical-trials huggingface dataset:
Plyometric and Eccentric Training in Improving the Strength, Stability and Ability of Women Soccer Players

Introduction. The high rate of recurrence and clinical involvement of muscle injuries in lower limbs, makes the hamstring musculature a very important structure in the development of athletes. Excentric movements, where eccentric force and flexibility are fundamental, and the quadriceps-hamstrings contraction cycle are risk factors for hamstring muscle injury.

Aim. ascertain the effectiveness of plyometric and excéntric exercises in the improvement of hamstring strength.

Study design. Randomized, prospective, multicenter, single-blind clinical study with athletes.

Methods. This study will be carried out with a sample of 40 women, federated players from 18 to 30 years old. They will be randomized into two groups: experimental (plyometric work and eccentric exercises) and control (eccentric exercises). The intervention will last 6 weeks in which, before each training, they will carry out the intervention, for 20 minutes, 3 days a week. An inter-judges piloting will be carried out. We will analyze the normality of the sample with the Kolmogorov-smirnov test and for the inferential analysis, we will use the t-student test of paired data to observe the difference between each evaluation in each study group, and the repeated measures ANOVA to calculate the effect intra and intergroup. Using Cohen's formula we will calculate the size of the effect.

Expected results. The eccentric work along with the plyometrics improves strength in hamstrings, jumping and stability.


Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 to 30 years old
* With 3 or less days of training a week
* Federate in the Community of Madrid (Spain)

Exclusion Criteria:

* Players who are injured and cannot do the job at the time of the study
* Soccer players who have had a hamstring injury in the last 6 months
* To practice another sport
* They are receiving physiotherapy treatment in the lower limb
* Not signing the informed consent document
Usefulness of Near-focus With Narrow-band Imaging

Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.


Eligibility Criteria:
Inclusion Criteria:

* Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)

Exclusion Criteria:

* fail to en bloc resection
Growth of Infants Fed New Starter Formula

The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.

Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.

The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full-term (\> 37 weeks gestation)
* Birth weight \> 2500 and \< 4500 g
* 14±3 days of age on enrollment
* Singleton birth
* Infant's mother has elected not to breastfeed prior to enrollment
* Has not received solid foods
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Congenital illness or malformation that may affect infant feeding and/or growth
* Significant prenatal and/or postnatal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Has received oral or intravenous antibiotic therapy in the last 7 days
* Has received probiotics in the last 7 days
* Currently participating in another clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and Female participants 18 to 75 years of age at time of consent.
2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.

   a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
4. Ability to keep accurate seizure diaries
5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

Key Exclusion Criteria:

1. History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
3. Resection neurosurgery for seizures \<4 months prior to the screening visit.
4. Radiosurgery performed \<2 years prior to the screening visit.
5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator
Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)

Several human genes affect how medications are metabolized by the body. It is believed that knowledge of variations of these genes can help health care providers better manage an anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems with bleeding or the development of blood clots. This study was designed to evaluate if genetic testing can improve warfarin initiation better than usual care.

This study was completed in 2008 and was published. Consult the citation link for more details.

Eligibility Criteria:
Inclusion Criteria:

* Participants were otherwise healthy adults (≥ 18 years of age) who were planning total hip or knee replacement or revision surgery at the University of Utah Hospital, and scheduled a pre-operative office visit at the University of Utah Orthopaedic Center.

Exclusion Criteria:

* Blood transfusion in previous two weeks
* Participant is already taking warfarin
* Pre-operative INR \> 4.0
* Pre-operative bilirubin \> 2.4 mg/dL
* Current active cancer diagnosis with ongoing treatment
* Concomitant medications known to exert a major interaction with warfarin such as septra, metronidazole, tramadol, amiodarone, ciprofloxacin, or cimetidine.
Anti-anxiety Biotics for Breast Cancer Survivors

Cancer survivors experience more rapid declines in health-related quality of life which include physical and psychological comorbidities, the latter of which may be subclinical and often overlooked by primary care providers. Recently, the gut-brain axis (GBA) has been identified as a therapeutic target to improve host health. The GBA is greatly influenced by the composition of the gut microbiome, as microbial metabolites directly influence the central nervous system. Thus, prebiotics, probiotics, and synbiotics (a combination of pre- and probiotics) have emerged as a possible approach to treating anxiety symptoms. Preclinical studies suggest efficacy of synbiotics, while pre- and probiotics have only been studied in isolation in humans.

This is a double-blind, placebo-controlled clinical trial in which female breast cancer survivors and/or their female relatives experiencing moderate to severe anxiety symptoms will be randomized to daily consumption of the synbiotic supplement or placebo. The previously validated Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptom severity at study screening and at each time point. The primary outcome of this study is feasibility, measured by accrual, adherence, retention, and adverse effects. Secondary outcomes relate to reduction of anxiety symptoms and other physiological changes. No study has investigated the mediating effects of gut microbiota and inflammatory markers on the ability of synbiotics to reduce anxiety symptoms. Thus, at each timepoint, phlebotomy will be conducted to determine serum levels of inflammatory cytokines and stool samples will be collected to determine alpha- and beta-diversity of the fecal microbiome as well as relative abundance of target genera. Hypothesis: this placebo-controlled study will be feasible and synbiotic treatment will result in a significant reduction in anxiety symptoms and inflammatory markers, which may be moderated by changes in the microbiome.


Eligibility Criteria:
Inclusion Criteria:

Female breast cancer survivors or female relatives of a breast cancer survivor who:

1. are 50 years of age or older
2. have completed primary treatment
3. currently experience clinical anxiety symptoms determined by the 7 item Generalized Anxiety Disorder screener (GAD-7; eligibility requires a total score of 5 or higher on the 21 point scale)
4. agree not to change dietary supplements throughout the course of the study
5. are willing to comply with daily supplement regimen
6. are able to speak and read English.

Exclusion Criteria:

1. use of any of the following drugs within the last 4 weeks (unless indefinitely prescribed): systemic antibiotics, corticosteroids, immunosuppressive agents, or commercial probiotics
2. changes in treatment for anxiety symptoms (i.e. initiation of Cognitive Behavior Therapy (CBT) within the last four weeks
3. current use (within 12 weeks) of anxiolytic medications.
Study's Care of Acute Pancreatitis at Saint-Etienne University Hospital.

Internal medicine units treat patients with undifferentiated or multisystem diseases, with a non-specific organ approach.

In some cases, patients with single-organ disease may be admitted to internal medicine wards. Acute pancreatitis is the most common gastrointestinal illness requiring acute admission to hospital. It is characterised by local and systemic inflammation of the pancreas corresponding to single-organ disease.

For patients with single-organ disease such as acute pancreatitis, it is not known whether admission to internal medicine is as effective as admission to a unit specialising in a specific organ, such as hepato-gastro-enterology.


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* primary diagnosis of acute pancreatitis in Internal Medicine and gastroenterology.

Exclusion Criteria:

-
Potential Improvements in the Pre-emergency Department Care for Cancer Patients

The goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ED). The main question it aims to answer are: Is there a potential relation between the lag-time and the ED length of stay (LOS) and the chance of admission. Participants will be asked to participate in a one-time interview, that focusses on the pre-admission process.

The goal of this single center prospective cross-sectional study is to identify the facilitators and barriers in the course of the disease that starts when symptoms first arise until patients with solid and hematologic malignancies arrive in the emergency department (ED). The main question it aims to answer are: Is there a potential relation between the lag-time and the emergency department length of stay and the chance of admission. Participants will be asked to participate in a one-time interview, that focusses on the pre-admission process. The interview focuses on several parts of the (pre-)admission process: The first part is regarding the timeline that led to an ED visit. The investigators will establish, when and which symptoms were first detected. The second part are regarding the number and type of health care workers that were contacted before visiting the ED. The third part will be about the actions that were taken before the ED visit.

Eligibility Criteria:
Inclusion criteria:

* Patients with solid or hematological malignancies and receiving systemic therapy or having received systemic therapy within the last 3 months.
* Presented at or admitted from the emergency department for the oncology, hematology, neuro- or lung-oncology clinical unit.
* Awake and conscious.
* Possible to answer questions within 48 hours after presentation at the emergency department (ED).

Exclusion Criteria:

* \<18 years old
* Only received a surgical intervention as cancer treatment
* Admitted to the ED for the surgical department
* Not willing or able to give written informed consent
Manual Therapy With Directed Vestibular Rehabilitation in Patients With Unilateral Peripheral Vestibular Hypofunction.

Randomized clinical trial with a control group that aims to evaluate the effects of a manual therapy protocol, together with a physical therapist-directed vestibular rehabilitation program, in patients with unilateral peripheral vestibular hypofunction. The intervention period will last approximately 4 weeks. Outcome measures will be collected at baseline, just after the intervention, as well as 1 and 6 months after the intervention.

Peripheral vestibular disorders are common in otorhinolaryngology practice. These patients often complain of vertigo and dizziness, as well as balance problems, causing an important impact on health-related quality of life. The objective of this study was to investigate the effects of manual therapy combined with physical therapist-directed vestibular rehabilitation in patients with unilateral peripheral vestibular hypofunction. The design of this study is a randomized controlled trial with two groups (experimental and control groups). The impact of dizziness on daily function and quality of life (Dizziness Handicap Inventory), the fear of falling and the balance confidence (Activities-specific Balance Confidence scale-16 items), postural control (stabilometric platform) as well as the intensity (visual analogue scale) and number of the vertiginous crisis will be determined. The intervention period will last four weeks. Participants of the experimental group will receive 4 sessions of manual therapy together with physical therapist-directed vestibular rehabilitation, while participants of the control group will receive home-based vestibular rehabilitation. Outcome measurements will take place at baseline, immediately after the intervention, one month and six months after the intervention. Within-group and between-group data will be analyzed and interpreted.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years with a clinical diagnosis of unilateral peripheral vestibular hypofunction confirmed by Video Head Impulse Test (\< 0.8), referring balance impairments, postural instability, gait instability, vertigo, dizziness or motion sensitivity, able to understand and complete e instructions, programs, and protocols of this project, and providing a signed informed consent.

Exclusion Criteria:

* Central nervous system, degenerative or cancer diseases, acute infection.
* Morphological/ functional alterations of the lower limbs, and/or morphological alteration of the cervical and/or suboccipital rachis.
* Conditions (i.e. neuromuscular disease or traumatism) that contraindicate the performance of the exercises and interventions of this study, as well as cognitive impairment that prevents the participants from understanding and completing the questionnaires and interventions.
* Positive results for the Klein test and the Rancurel test, or cerebrovascular alterations.
A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)

The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension

Exclusion Criteria:

* Uncontrolled medical conditions
* Subjects who wear contact lenses
* Subjects requiring chronic topical artificial tears, lubricants, and /or requiring any other chronic topical medications
Non-disabling Ischemic Cerebrovascular Event With Apathy

The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly increased. However, few previous studies have focused on affective impairment after transient ischemic attack (TIA) and minor stroke. Stroke survivors are often described as apathetic. Even though post-stroke apathy (PSA) affects one in three stroke patients,it has not hitherto received much attention. NICE-A is a prospective study aimed to explore the association between baseline apathy and probable incident stroke in a population-based sample of TIA and minor stroke adults.

Transient ischemic attack (TIA) and acute minor ischemic stroke, are common and may leave impermanent or mild neurological deficit, they are termed as non-disabling ischemic cerebrovascular disease (NICE). TIA and minor stroke exhibit the common substantial risk factors for early stroke recurrence and epidemiological characteristic, with approximately 10 to 20% of patients having a stroke within 3 months after the index event.

Previous studies has shown that post-stroke apathy (PSA) affects one in three stroke patients, which is consistently associated with a worse level of functional recovery, poorer overall health and poorer quality of life. However, still little is known about the development of TIA and minor stroke patients with apathy. Thus, it is imperative to find the relationships between baseline PSA and probable incident stroke in these patients.

NICE is an attractive researching area globally. According to the large quantities of NICE patients in China and the low standardized therapeutic rate, the awareness of TIA and minor stroke is largely insufficient. The purpose of the present NICE-A study is to establish the prevalence, predictors and evolution of symptoms of PSA in TIA and minor stroke patients during the first post-stroke year.

Eligibility Criteria:
Inclusion Criteria:

≥18 years old Onset of a minor stroke (National Institute of Health stroke scale, NIHSS≤3) and TIA elapsed time from last episode to registry \<1 month

Exclusion Criteria:

patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.

patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.

patients who received endovascular or thrombolytic therapy.
Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

The objective of this study is to evaluate whether use of TRMDU in addition to medication review leads to improved outcomes and reduced health care costs for patients when compared with medication review alone. The study will be conducted in patients assigned to Department of Defense (DOD) Warrior Transition Units (WTU's), similar DOD units, and VA polytrauma centers.

The military has been witnessing an increased number of patients with combat related impairments such as traumatic brain injury, post traumatic stress disorder and polytrauma which has lead to sub optimal medication self management. TRMDU is a medical device developed by INRange Systems Inc. that delivers medications and emits a sound alert to assist the patient. It can be used in a hospital, clinic, or residential setting. It can be remotely accessed by the health care professionals, and it allows physicians and other prescribers to remotely change scheduling or adjust prescriptions.

Use of TRMDU in hospital settings is expected to improve outcomes by improving medication self management, increasing adherence, reducing medication errors, and thereby associated costs. Further, it may contribute to overall improvement in a patient's psychological well-being and quality of life.

Eligibility Criteria:
Inclusion Criteria: Subjects must be

* At least 18 years of age
* Alert and oriented to person , place and time
* Primarily use English language for written and oral communication
* Have diagnosis of Traumatic Brain Injury(TBI) Multiple Traumatic Brain Injury (MTBI), Post Traumatic Stress Disorder (PTSD) or Polytrauma.
* Taking at least 4 chronic prescription medications
* Living in a participating WTU or enrolled in Tampa Veterans Administration polytrauma outpatient treatment facility at the time of enrollment
* Achieve a minimum score of 24 on Mini-Mental State Examination

Exclusion Criteria: If patients meet following criteria they are excluded from the study

* Disabilities preventing safe use of the TRMDU
* Projected life expectancy of less than 3 months