cyrilzakka/clinical-trials huggingface dataset:
Effects of Suspension Training on the Balance of Healthy Young Adults

Non-specific training through the use of devices in which the subject can be suspended is a technique that has aroused a growing interest in recent years. One of its advantages may be to enhance the balance, since it induces a high level of neuromuscular stimulation. Indeed, a suspension training suppose a high demand of the core musculature, require a high degree of postural control, precise response strategies , anticipatory capacity and muscular conditioning. However, current literature targeting healthy young adults and appraising the specifics effects of suspension training on balance is scarce or non-existent to the best of our knowledge. For this reason this interventional study will primarily assess the effects of suspension training on different balance components.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults aged between 18 and 30

Exclusion Criteria:

* Professional athlete
* Musculoskeletal injury in the last 6 months (i.e. sprain, bone fracture)
* Known balance disorders including vertigo, central or vestibular limitations
Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Ethanol exposure during pregnancy is associated with adverse perinatal outcomes resulting in high healthcare costs. Primary care centers whose attends low risk women will be randomized to apply a motivational intervention program to the mothers.

This is a cluster randomized simple masking controlled trial evaluating the effectiveness of repeated motivational interview (MI) during pregnancy on prevalence of ethanol intake together with offspring´s neurodevelopment.

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Eligibility Criteria:
Inclusion Criteria:

* Maternal age at recruitment \> 18 years
* Speak Spanish fluenty
* Women controlling their pregnancy in Baix Llobregat Center and Hospital Sant Joan de Déu, who will attend their delivery in Hospital Sant Joan de Déu and Parc Sanitari Sant Joan de Déu
* Viable singleton non- malformed fetus
* First trimestre of gestation

Exclusion Criteria:

* Multiple gestations
* Perinatal infections
* Fetal anomalies including chromosomal anormalities or structural malformations detected by ultrasound
* Premature rupture of membranes
* Uncontrolled or/and severe maternal chronic disease
* Language barriers
* Imposibility to obtain the sample (hair lenght below nine centimeters)
* Discolored hair
* Refusal to join the study
Management of Distal Ulna Fractures Using Hook Plate

The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures.

The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature distal ulna fracture with or without radius fracture.

Exclusion Criteria:

* Pathological fracture Skeletally immaturity Neurovascular problems
Gabapentin and Tizanidine for Insomnia in Chronic Pain

This is a double-blind, placebo-controlled, randomized, crossover trial aimed at assessing the effect of gabapentin and tizanidine, two pain medications, on insomnia in chronic pain patients.

Chronic pain and insomnia are highly prevalent conditions affecting 10-25% and 6-10% of the general population, respectively. Importantly, these two conditions frequently co-occur, with 50-80% of chronic pain patients reporting sleep disturbances. Identifying medication that alleviates pain and insomnia simultaneously may help reduce risks associated with polypharmacy, including drug-drug interactions.

In this double-blind, placebo-controlled, randomized, crossover trial, gabapentin and tizanidine, two drugs which are respectively commonly used to treat neuropathic and musculoskeletal pain, will be compared to each other and to placebo in their ability to alleviate insomnia in chronic pain patients.

In each week, patients will receive 3-night (Friday-Sunday) trials each of placebo, gabapentin or tizanidine in a randomized, double-blind order and will monitor their insomnia using the Athens Insomnia Scale (AIS) questionnaire (adapted to fit the time frame of this trial). The primary outcome consists of the difference in mean AIS scores between the 3 treatments at the primary time point, which is Monday of each week (after 3 nights of drug intake).

Patients will also monitor their sleepiness, pain relief and overall improvement as secondary variants using the Stanford Sleepiness Scale (SSS), Visual Analog Scale (VAS), and Patient's Global Impression of Change (PGIC) questionnaires respectively.

Scores on the Monday preceding the first treatment will serve as baseline and the period between treatments (i.e. Monday-Thursday nights) will serve as a 4-day washout period between treatments.

Our hypothesis is that gabapentin and tizanidine will both be more effective than placebo in alleviating insomnia in chronic pain patients but will not be different from one another.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 35
* Any ethnicity
* Must be able to communicate in English
* Must have access to email and be able to respond to REDCap questionnaires in English
* Has a chronic pain condition (≥ 3 months of pain)
* Reports sleep disturbance and scores ≥ 6 on AIS questionnaire
* Ability to provide informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Has diagnosis of chronic kidney disease
* Has known QT prolongation \>500 msec on prior EKG
* Inability to complete daily questionnaires
* Allergy to, or intolerance of, any of tizanidine or gabapentin
* Shift workers
* Anticipated travel across multiple time zones (jetlag) during the duration of the trial
* Circadian misalignment
* Prior syncope experience and/or fear of blood/needles (if a blood draw is required)
Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair

The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs.


Eligibility Criteria:
Inclusion Criteria:

* Study Participants: Only residents who have achieved mastery of the TEP training curriculum (in either arm) will be eligible for OR assessment
* Patients: All patients deemed fit by the staff supervising surgeon to undergo a TEP repair will be considered for this study.
Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study

To assess whether changes in electrical impedance - measured using an electrical impedance tomography (EIT) chest belt - can be used to derive changes in pulmonary artery pressure (PAP) in critically ill patients when compared to invasive gold-standard PAP measured using pulmonary artery catheter (PAC).


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18-year-old.
* Intubated patients in the ICU with clinical decision to monitor PAP and cardiac output using a PAC.

Exclusion criteria:

* Patients with implanted or external thoracic electronic devices (e.g., pacemaker) or thoracic metal implants.
* Known pregnancy or lactating patients.
* Open lung injuries or pneumothorax.
* Open wounds, drainages, burns or rashes of the upper thorax.
* Estimated thoracic perimeter smaller than 66 cm or larger than 134 cm.
* Known allergies to wound dressings or adhesives (e.g., gel electrodes)
An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity

The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.

Participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. As part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. At baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.

Eligibility Criteria:
Inclusion Criteria:

* at least 13 years of age
* engaged in mental health care
* evidence of either self-harm or suicidal urges or behavior in the past 3 months
* high levels of emotion-related impulsivity.

Exclusion Criteria:

* inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions,
* psychosis,
* not currently living in California,
* lack of access to a device to privately complete online modules.
Autologous Bone Marrow For Lower Extremity Ischemia Treating

The purpose of this study is to determine whether autologous bone marrow derived cells and isolated CD133+ fraction are effective in the treatment limb ischemia

The number of patients with low limb obliterating atherosclerosis steadily grows and compounds more than 20-25 % from all kinds of a cardiovascular pathology. At conservation of this tendency to 2020 the amputation percentage executed due to vessel diseases, can reach 45 %. Hemodynamics improvement in an extremity by surgery is possible at 40 - 70 % of patients even with the widespread and plural lesion of arteries, but results are not always satisfactory. The most actual is the problem of angiosurgical help to patients with distal forms of arterial occlusions, due to the difficulty or impossibility performing reconstructive interventions. In these cases the operations of an indirect revascularization referred on stimulation of a collateral blood flow are carried out. However, despite the reached successes, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. To date the most perspective methods of neoangiogenesis stimulation are a cellular therapy and gene-engineering technologies. Experimental researches on a model of local limb ischemia showed possibility of use of various cells for neoangiogenesis stimulation. A number of clinical researches at patients with obliterating limb diseases has shown efficacy of cellular therapy even at a critical ischemia. However randomized, the placebo-controlled researches based on principles of evidence based medicine while it is not enough for the convincing conclusions.

Eligibility Criteria:
Inclusion Criteria:

* an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)
* a painless walking distance of 10-50 m
* pulse absence on аа. dorsalis pedis, tibialis posterior, poplitea
* absence of a ischemia in a rest and necrotic changes
* mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance
* patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously
* heavy smokers

Exclusion Criteria:

* insulin depended diabetes
* myocardial infarction or a stroke within last year
* an idiopathic hypertensia III stage
* anaemia and other diseases of blood
* decompensation of the chronic diseases which are contraindications to any surgical operation
* HIV infection
* a virus hepatitis
* oncologic diseases
* chemotherapy in the anamnesis
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly

A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.

Eligibility Criteria:
Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women (elderly)
3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

1. Known to be allergic to constituents of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)

The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

Mardil Medical is developing an investigational device for functional mitral regurgitation intended to provide ventricular support with adjustable inflatable chambers to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation. In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular and ventricular changes that occur when strategically positioned external inflatable chambers are applied to the outside of the heart. Favorable benefits of circumferential reduction in ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and Geometric Changes using the Bladder on a Stick System (BOSS).

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Patient undergoing open chest cardiac surgery via sternotomy
* Signed informed consent by patient or legally authorized representative

Exclusion Criteria:

* Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior valve surgery, CABG, epicardial pacing leads, pericarditis, history of mantle radiation, or other procedure involving pericardial access)
Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

A randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Non-Syndromic infants with complete bilateral cleft lip and palate.
2. Both sexes.
3. Age range from 1-30 day

Exclusion Criteria:

1. Infants with systemic syndromes.
2. infants with unilateral cleft
3. infants whom parents refuse to consent.
Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

This is a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors. This study included 2 parts; a dose-escalation part and a dose expansion part.

This is consisted with dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist, or is not considered appropriate.
* Subjects with adverse events(AEs) excluding alopecia or Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) from prior therapy that have improved to Grade 1 or the baseline grade more than 14 days prior to the first administration of study drug.
* Subject with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 7 days prior to the first administration of ABL501

Exclusion Criteria:

* Subjects has received prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of ABL501 or who has recovered (i.e., =\<Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL501 administration.
* Subject has had prior chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives prior to the first administration of study drug or has not recovered (i.e., =\<Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL501 administration
* Subject discontinued from prior immunomodulatory therapy due to any intolerable immune-related AE(s) (irAEs) requiring systemic steroid treatment.
Double-blinded Trial of Household-based Chlorination in India

The proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. For more than a century, chlorine has be used to treat water in municipal systems in developed countries. Lack of infrastructure has prevented its use in lower-income settings. NaDCC is a tablet form of chlorine that has been used for more than 30 years in emergencies and has recently been approved for routine treatment of drinking water by the WHO and US Environmental Protection Agency. The placebo will consist of the food-grade ingredients in the effective tablet, without the chlorine. Study participants will be supplied with tablets (intervention or placebo) and instructed to use the same to treat their water daily. Monthly follow-up visits will assess diarrhoea morbidity and weight-for-age Z scores in \<5s. Chlorine residual and bacteriological quality of water stored in the home will be measured each month. The study will also assess the impact of the intervention on absenteeism from school and work and on health care expenditure for diarrhoea.


Eligibility Criteria:
Approximately 2000 households with children \<5 will be enrolled.

Inclusion Criteria:

* Households with at least one child\< 5
* Male and female head of household consent to participate
* Reside permanently in study area
Cranberry Juice for Preventing Bacteria in Urine During Pregnancy

The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).

Asymptomatic bacteriuria (ASB) infection, a condition in which a large number of bacteria are present in the urine, often precedes the development of symptomatic UTIs. UTIs are common among women and may create complications during pregnancy. By incorporating cranberry juice into their diets, pregnant women may be able to lower their risk for UTIs caused by ASB, and cranberry juice may also prevent preterm labor and birth. This study will determine the cranberry juice-containing regimen that will work best for preventing ASB in pregnant women.

For the duration of their pregnancy, participants in this study will be randomly assigned to one of three treatment arms: cranberry juice once a day, cranberry juice three times a day, or a placebo beverage three times a day. The level of bacteria in their urine will be measured at monthly study visits. Women who test positive for a UTI will receive oral antibiotic therapy. All women will be monitored throughout their pregnancies for UTIs and other related complications.

Eligibility Criteria:
Inclusion Criteria:

* Intrauterine pregnancy
* Mother and fetus in good health
* Mother pregnant for 16 weeks or less

Exclusion Criteria:

* Suspected nonviable or ectopic pregnancy
* Mother plans to terminate pregnancy
* Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start
* Significant underlying medical complications that may interfere with the study