cyrilzakka/clinical-trials huggingface dataset:
The Influence of Laterality on the Performance of Healthy Women in Selected Standardized Tests

The aim of the research study is to find out how the results of healthy women aged 20-24 years (inclusive) differ in the Nine Peg Test, the Purdue Pegboard Test and the Box and Block Test, depending on the laterality of the research participants and the order of the performed subtests of the investigated tests. In this way, it will be preliminarily determined whether it is necessary to create normative data separately for right-handed and left-handed people for the tests.

Research participants will be tested in one meeting after giving informed consent, answering a few short questions regarding health status and filling out a short questionnaire using the Czech extended version of the manual for all three standardized tests, and always according to a predetermined order. Intentionally, all research participants with a dominant right upper limb will be tested as if they were left-handed, and vice versa.

The results of the research participants tested in this way will be compared with the results of women from the same age category who have already been properly tested as part of an ongoing research study entitled: "Establishing Czech Norms of Selected Standardized Tests".

Eligibility Criteria:
Inclusion Criteria:

* Czech language as a mother tongue
* age from 20 to 24 years (inclusive)
* female

Exclusion Criteria:

* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty

This study is a prospective validation study of a new hip and knee replacement-specific questionnaire that can be used to predict postoperative complications. The purpose of this study is to confirm the validity of a new hip and knee scoring system to be used as a clinical tool to predict potential complication rates in patients undergoing total hip or knee replacement surgery. This scoring system aims to stratify patients into specific risk categories based a standardized calculated score. Patients will be evaluated on health risk factors and severity of disease on radiographic imaging prior to surgery, associated to higher complication rates following surgery. The hopeful anticipated result of this study is a prospective validation of the scoring system with both statistical and clinical significance in predicting postoperative complication rates in patients with moderate to high health risk,

This stratification system may prove meaningful by allowing these patients, especially those classified as High-Risk, to be incorporated into more appropriate healthcare bundle payment systems that account for their higher financial demands. Furthermore, the stratification may allow for preoperative counseling and a shift towards non-operative management, or surgeon-patient conversations regarding the need to modify a portion of their objective risks prior to surgical intervention. Predictive risk models such as the one presented in the current study will be essential tools as the number of total hip arthroplasty procedures performed each year continue to increase and both the numbers of procedures and associated complications impose a significant cost on the U.S. healthcare system.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be male or female of any race.
2. Patients much be age greater than 18 years old.
3. Patients undergoing a primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) by participating surgeons at this institution.

Exclusion Criteria:

1. Patients with history of native joint infection or active periprosthetic infection according to Musculoskeletal Infection Society (MSIS) Criteria.
2. Patients requiring removal of hardware during their primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).
3. Patients requiring use of revision THA or TKA components (stems, augments).
4. Patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol
Personalized Spine Study Group Registry

As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.

The registry will follow the patient during their standard of care visits. At each visit, the patient will answer questions about themselves and also fill out patient reported outcome sheets. Spinopelvic measurements will be obtained on the x-rays taken. This registry is observational only, and there is no driving hypothesis for data collection. Some broad topics of discussion are:

1. Outcomes of patients sagittal profile through the pre-operative, plan and post-operative events
2. Effectiveness of rod in conjunction with other surgical implants by measurements of fusion assessment and sagittal alignment
3. Outcomes of patients in subgroups as defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables
4. Rod curvature maintenance over the follow-up period
5. Understand the post-operative risks and complications from the pre-operative condition

Eligibility Criteria:
Inclusion Criteria:

* Patient has been/ will be operated and instrumented with PSR from Medicrea
* Patient able to complete a self- administered questionnaires
* Patient able to consent or assent

Exclusion Criteria:

* Patient unable to sign an informed consent form
* Patient unable to complete a self-administered questionnaire
* Patient is pregnant or planning on becoming pregnant during the duration of their study participation
* Patient is older than 85
* Patient is younger than 10
Study of Patient Outcomes 5 Years After Partial Knee Replacement

The study seeks to evaluate the condition of patients 5 years after having undergone partial knee replacement for localized osteoarthritis of the knee. Participating patients will voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after surgery. The aims of the study are to describe the survivorship of the prostheses and the clinical results of patients, and to elucidate and describe the natural history disease of the untreated knee joint compartments after a partial replacement. Patients who were operated by the principal investigator 5 years previously will be invited to participate. The study is observational in nature; there is no element of experimentation or test of an intervention.


Eligibility Criteria:
Inclusion Criteria:

* All individuals who have undergone unicondylar knee replacement of a single tibio-femoral compartment using iBalance prosthesis (Arthrex, Inc, Lakeland Florida) under the care of the principal investigator between December, 2006 and December, 2008 will be invited to participate in the study.

Exclusion Criteria:

* There are no restrictions to inclusion in the study based on surgical or medical criteria; however, individuals who are pregnant, incarcerated, less than 18 years of age, or unable to give valid informed consent on their own behalf will be excluded from the study.
A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity

The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.


Eligibility Criteria:
Inclusion Criteria:

grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools.

Exclusion Criteria:

Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP) resistance mutations postpartum in women who received a single dose of nevirapine during labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV.

A single nevirapine dose to the mother, with or without a dose to the child, in addition to oral ZDV prophylaxis starting from 28 weeks gestation has been proven to be highly effective in reducing further mother-to-child HIV transmission (PMTCT).

However, post exposure nevirapine resistance mutations are observed in the mother's viral population. These mutations detectable very early after exposure tend to disappear over time.

Nevertheless, they may be associated with decrease in efficacy of non-nucleoside reverse transcriptase inhibitor (NNRTI) containing regimens subsequently given to the women for their own health.

Therefore, there is a need for research to prevent selection of resistance in the first place or to overcome the resistance in subsequent treatment of the infected mother or infant.

Nevirapine plasma levels above IC50 have been detected in women exposed to a single 200 mg dose of nevirapine in a significant number of women during the third week postpartum.

We hypothesize that giving ZDV+ddI to women exposed to nevirapine for one month as soon as possible after exposure may prevent the selection of nevirapine resistance mutations.

Eligibility Criteria:
Inclusion Criteria:

* Meet all pre-entry criteria;
* Consent to participate and to be followed for the duration of the study;
* Present the following laboratory values within 14 days prior to inclusion:

  * Hemoglobin \> 8.0 mg/dl
  * Absolute neutrophil count \> 1000 cells/mm3
  * Platelets \> 100,000 cells/mm3
  * Serum creatinine \< 1.5 mg/dl (women with a serum creatinine \> 1.5 mg/dl must have a measured eight-hour urine creatinine clearance \> 70 ml/min)
  * SGPT less than 10 times the upper limit of normal
  * Amylase less than 150/L IU (this upper limit may change slightly depending on the normal range at the hospital laboratory).

Exclusion Criteria:

* Evidence of pre-existing fetal anomalies incompatible with life;
* Known hypersensitivity to any benzodiazepine or to NVP;
* Receipt of antiretroviral agent other than ZDV;
* Receipt of non-allowed concomitant treatment or contraindication to ddI
* Concurrent participation in another clinical trial;
* Women with a CD4 count \<200/µL or history of oral candidiasis if they are not receiving pneumocystis carinii pneumonia (PCP) prophylaxis
* Any other contra-indicated drugs during ZDV+ddI treatment for the mother as well as the child (Contra-indicated drugs such as gancyclovir, isoniazid, linezolid, ethambutol, rifabutin, cidofovir are not allowed during the ZDV ddI treatment after delivery in order to prevent pharmacological interactions or overlapping toxicities.)
Dual Acupoints Stimulation Alleviates Pulmonary Complication

Stimulation at acupoints could be of beneficial effects during the perioperative period. In this study the investigators tend to verify the effect of dual acupoints stimulation on pulmonary complications after abdominal surgery in aged patients.

Postoperative pulmonary complications contributes to the high morbidity of aged patients. The incidence could be as high as 30\~50% in those undergoing abdominal surgery. Stimulation at acupoints have been to alleviate inflammatory response,improve pain management and decrease consumption of opioids, indicating a beneficial effect on pulmonary complications. In this study the investigators tend to verify the effect of dual acupoints stimulation on pulmonary complications after abdominal surgery in aged patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consented
* Scheduled for elective abdominal surgery under general anesthesia
* Age \>=65 yrs

Exclusion Criteria:

* Patients with contraindications to transcutaneous electrical stimulation
* Patients with difficulty in communication that may confuse follow-up
* emergent surgeries
* Patients with pneumonia or needed ventilation before surgery
* Patients with history of pulmonary surgery
* Scheduled surgery involves thoracic manipulations
* Patients who attended clinical studies in the last 3 months
Contingency Management to Promote Smoking Abstinence in Cancer Patients

This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. smoking 1 or more combustible tobacco products per day
3. diagnosed with or suspicion of any type of operable cancer

Exclusion Criteria:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia
2. non-English speaking
3. use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc)
4. pregnant women
Factorial Trial Testing Guided Thinking Tasks to Optimize a Physical Activity Intervention

The objective of this study is to optimize a novel, audio-recorded physical activity intervention that is scalable. Using principles of the Multiphase Optimization Strategy (MOST) framework, a full factorial study will test the unique and combined effects of different intervention components to identify which combination of components is optimal for increasing physical activity and mechanisms by which the components are or are not effective. This information will inform decisions about an optimal intervention package that is effective, efficient, and minimizes participant burden.

Eligible participants who provide informed consent will be enrolled in a 6-week study. At the baseline session, participants will be randomized to listen to a brief audio-recording of different guided thinking tasks. The audio-recordings are based on combinations of four different intervention components that will be tested in a 2 (positive affect imagery vs. neutral) x 2 (episodic future thinking vs. recent thinking) x 2 (action planning: yes, no) x 2 (dose: high vs. low) factorial trial. Participants will also complete a 30-minute brisk walking session on a treadmill. Participants will return for weekly visits in which they again listen to their assigned audio-recording and complete a 30-minute brisk walking session.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-64
* Not currently meeting physical activity guidelines (\<150 minutes/week of self-reported moderate-to-vigorous physical activity)
* Capable of providing informed consent
* Access to a smartphone with active data plan
* Willing to attend all study visits and comply with the protocol
* Conversant in English

Exclusion Criteria:

* BMI \> 40
* orthopedic problems that would limit physical activity
* self-reported coronary artery disease, stroke, COPD, chronic bronchitis, emphysema, diabetes
Feasibility Study to Evaluate the Role of a Novel Device in Childbirth

Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality.

Swabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina.

The common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention.

As the name suggests, a 'never event' should never happen in the first place. Never. Unfortunately, this is not the case. Incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice.

never-event incidents involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?


Eligibility Criteria:
Inclusion Criteria:

* Midwifery lead and consultant lead patient older than 18 years.
* Consented to participation after an informed choice.

Exclusion Criteria:

• Under 18 years of age

Antenatal (before labour):

* Patients who have a high risk of expected/unexpected maternal, fetal or neonatal deterioration such that during birth, the focus of attention would be towards safe patient care and observation required for using the swab-counter device system would not be possible such as :
* Patients who are seriously unwell and require high dependency care.
* Maternal cardiac conditions
* Severe pre-eclampsia
* Fetal anomalies where neonatal deterioration is expected (These will be relatively rare conditions where the doctor/midwife would decide to not recruit the patient)

Intrapartum and postpartum factors:

* Patient having an emergency Caesarean section instead of a vaginal birth due to maternal or fetal indication.
* Eclampsia (seizure/fitting in labour or after delivery)
* Maternal cardiac conditions requiring high dependency care
* Severe sepsis requiring high dependency care
* Fetal anomalies where neonatal deterioration is expected
Study and Treatment of Post Lyme Disease (STOP-LD)

The purpose of this study is to see how well antibiotics work in reducing chronic fatigue symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a common symptom of Lyme Disease. When fatigue does not improve after treatment, patients are considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients appears to be related to the initial infection which causes Lyme Disease. It is believed, but not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in PLS patients.

You will be assigned randomly (like tossing a coin) to receive either antibiotics or a placebo (sugar pill). Neither you nor your doctor will know which you are receiving. You will learn to give yourself the injection, and you will remain on your study drug for 28 days. A home health care nurse will visit you twice a week to check the injection site, and at weeks 1 and 3 the nurse will draw blood for laboratory tests. At months 1 and 6, you will be examined to see if you have fewer chronic fatigue symptoms after the antibiotics. This will include a fatigue questionnaire, a test of your mental processing speed, and a test of your cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

You may be eligible for this study if you:

* Are between 18 and 65 years of age.
* Are a resident of Long Island or greater NY metropolitan area.
* Are fluent in English.
* Have a history of Lyme Disease.
* Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study.
* Have severe fatigue.
* Are not pregnant or planning to be pregnant.

Exclusion Criteria:

You will not be eligible for this study if you:

* Have or have had major medical, neurologic, or psychiatric disorder.
* Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease.
* Have had Fibromyalgia Syndrome.
* Have a history of sleep apnea, narcolepsy, or other serious sleep disorder.
* Have a learning disability.
* Have had head trauma requiring hospitalization.
* Have symptomatic gallbladder disease.
* Are anemic.
* Abuse alcohol or illicit drugs.
* Have been treated with another antimicrobial agent for Lyme Disease within 6 months of study.
* Need to be receiving systemic steroid therapy during drug administration and follow-up.
* Have used benzodiazepines within 1 month of study entry.
* Are allergic to Beta lactams (a class of antibiotics).
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 2 years to 5 years of age
2. Available parent or legal guardian capable of giving informed consent for participation.
3. Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005).

Exclusion Criteria:

1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
2. Known history of a medical condition known to affect brain function.
3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
4. Known history of very low birthweight (\<1500 grams)