cyrilzakka/clinical-trials huggingface dataset:
The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees

The purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance, heart rate and fit during sit to stands.

Initial Visit:

1. Informed consent
2. HIPAA
3. Foot Inspection
4. Review expectations
5. Take measurements
6. Casting

Second Visit: Fitting and adjusting accordingly.

* One person will conduct all the measurements, casting, check sockets, etc. to evade inconsistencies in data collection.
* Begin conducting practice runs on Balance Master at LLU-East Campus.

Third, Fourth and Fifth Visit: Testing (5-10-minute rest period in between each test) \*Testing will be video recorded for re-assessment of subjects\*

1. Five times sit-to-stand test (5XSTS).
2. Activities-Specific Balance Confidence (ABC-16) scale
3. Balance Master:

   Weight Bearing Squat (WBS) Unilateral Stance (US) Sensory Organization Test (SOT) modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Limits of Stability (LOS)
4. A Polar H10 heart rate monitor will be worn while subjects perform each of the various tests.

Eligibility Criteria:
Inclusion Criteria:

Male and Female below knee amputees (bi-lateral or unilateral)

* 18-70 years of age
* K1-K3 (K-levels/activity levels)

  * K1=patient has the ability or potential to use a prosthesis for transfers or walking on level surfaces at a fixed speed (typical limited or unlimited household ambulator).
  * K2=patient has the ability or potential for walking with the ability to traverse most low-level environmental barriers such as curbs, stairs, or uneven surfaces (typical community ambulator).
  * K3=patient has the ability or potential for walking with variable speed. Has the ability to traverse most environmental barriers and may have vocational, exercise, or recreational activities that demand prosthetic use beyond simple locomotion.
* Those who wear a prosthesis daily for the purpose of walking
* Able to get in and out of a chair
* Prosthetic foot that has the same functional components as the subject's current one

Exclusion Criteria:

Amputation at birth

* Foot amputation at ankle
* Uncontrolled edema in leg compartments
* Compromised skin of the residual limb
* Patients that are 3 months or less post-amputation
A Study of LAM-003 in Patients With Acute Myeloid Leukemia

A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia

This clinical trial is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of LAM-003 across a range of LAM-003 dose levels when administered to subjects with previously treated relapsed or refractory cute Myeloid Leukemia (AML).

Subjects will self-administer oral LAM-003 either once or twice per day as long as they are safely benefitting from therapy. Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of LAM-003 using a standard 3+3 dose-escalation design. Based on the pattern of dose-limiting toxicities observed in the first 4 weeks of therapy, escalation will proceed to define a recommended LAM-003 dosing regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women of age ≥18 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
3. Presence of measurable AML that has progressed during or relapsed after prior therapy
4. All acute toxic effects of any prior antitumor therapy resolved to Grade 1.
5. Adequate hepatic profile.
6. Adequate renal function.
7. Adequate coagulation profile.
8. Negative antiviral serology for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
9. For female subjects of childbearing potential, a negative serum pregnancy test.
10. For both male and female subjects, willingness to use adequate contraception.
11. Willingness and ability of the subject to comply with study activities.
12. Evidence of a personally signed informed consent document.

Exclusion Criteria:

1. Leukemic blast cell count \>50 × 10\^9/L before the start of study therapy and despite the use hydroxyurea, cytarabine, and/or cyclophosphamide.
2. Presence of known central nervous system (CNS) leukemia.
3. Presence of another major cancer.
4. Ongoing Grade \>1 proliferative or nonproliferative retinopathy.
5. Significant cardiovascular disease or ECG abnormalities.
6. Significant gastrointestinal disease
7. Uncontrolled ongoing infection.
8. Pregnancy or breastfeeding.
9. Major surgery within 4 weeks before the start of study therapy.
10. Subject was a candidate for hematopoietic stem cell transplantation (HSCT).
11. Ongoing severe graft-versus-house disease (GVHD) with Grade ≥2 serum bilirubin, Grade ≥3 skin involvement, or Grade ≥3 diarrhea at the start of study therapy.
12. Prior solid organ transplantation.
13. Ongoing immunosuppressive therapy other than corticosteroids.
14. Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.
15. Use of a drug known to prolong the cardiac QT interval.
16. Concurrent participation in another therapeutic or imaging clinical trial.
17. Presence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.
Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph node dissection. After completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes in non-small cell lung cancer patients undergoing definitive surgical resection.


Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years. Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%, see Appendix A).

Life expectancy of greater than 3 months

Patients be able to undergo VATS resection as defined below:

* Preoperative Forced Expiratory Volume at one second ≥ 40% predicted
* OR
* Post-operative predicted Forced Expiratory Volume at one second ≥ 0.8 l
* Hg ≥ 8.0
* No evidence of coronary ischemia on stress evaluation Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with surgery for a prior ipsilateral lung cancer

Patients with known brain metastases

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. (Patients with HIV are not excluded from this study)
The Body's Response to Food Intake in Trained, Older Adults

The purpose of this research study is to determine the effects of food supplements and strength training on appetite, the amount of energy expended, and body composition.


Eligibility Criteria:
Inclusion Criteria:

All subjects must meet the following eligibility criteria:

* Age range: 60 years and older
* Body mass index between 20-29 kg/m2
* Weight stable (\< 2 kg weight change within last 6 months)
* Non-smoking
* Constant habitual activity patterns within last 3 months
* Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose \<110 mg/dl)
* Not taking medications known to influence appetite or metabolism
* Non-diabetic
* Confirmation of acceptability of eating the study test foods (solids and fluids)

Trained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:

* Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
* Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)

Sedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:

* Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)
* Active fitness level (≤ 2, 30-minute aerobic exercise sessions/week)

Exclusion Criteria:

All subjects will be excluded based on the following exclusionary criteria:

* Age: \<60 years
* Body mass index: outside of the 20-29 kg/m2 range
* Gained or lost \> 4.5 kg within the last 6 months
* Smoker (currently or within the last year)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
* Clinically diagnosed as diabetic
* Study foods are found to be unacceptable for consumption by the subject
* Clinically diagnosed osteoporosis

Trained subjects will be excluded based on the following exclusionary criteria:

* Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)

Sedentary subjects will be excluded based on the following exclusionary criteria:

* Performed resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Perform \> 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Acute Physiological Effects of Electronic Sigarette vs Cigarette Smoking

Because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known toxins found in conventional cigarette smoke.However e-Cigarettes with low dose of tobacco were found to have immediate adverse physiologic effects after short-term use that are similar to some of the effects seen with tobacco smoking.

In this study we wanted to assess the short-time effect of one e-cigarette with no tobacco vs a "traditional" cigarette.

10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.

On day 1 the subjects will be asked to smoke either the e-cigarette or a "traditional" one for 5 minutes. On day 2 the subject will be ask to smoke for 5 minutes the other kind of cigarette.

Exhaled Nitric Oxide will be measured in a sitting position with a nose clip using an analyzer equipped with a software program. The patient will be instructed to inhale as deeply as possible to total lung capacity through a filter mouthpiece and consecutively exhale at a mouth fl ow rate of 50 mL/s for 10 s. Three consecutive trials will be performed with a 30-s interval.

Dynamic Lung Volumes: Flows and lung volumes will be measured in the sitting position, a spirometry system (heated pneumotach, with the highest FEV 1 recorded in line with pulmonary guidelines. Spirometry will be measured according to the recommendations of the American Thoracic Society/European Respiratory Society task force guidelines. FEV 1, FVC, FEV 1 %, peak expiratory fl ow (PEF), and maximal expiratory fl ow (MEF) at 25%, 50%, and 75% of vital capacity will be measured. Each maneuver will be repeated for at least three technically acceptable forced expiratory fl ow curves.

Eligibility Criteria:
Inclusion Criteria:

* 10 no smoking healthy individuals
* 10 smoking (\>20 pack/yr) healthy individuals

Exclusion Criteria:

* pre-existing diseases
* FEV1/FVC ratio\<70%
The Osteosarcoma Biobank in Peking University People's Hospital

Osteosarcoma is very rare bone tumor. The investigator set up the biobank to ensure the patients has the chance to participate in future research

Samples of blood and other stored material such as slides,frozen tissues and so on .

Questionnaire information, including health history, growth and development, physical activity and family medical history information.

Eligibility Criteria:
Inclusion Criteria:

Proband Inclusion criteria: A diagnosis or suspected diagnosis of osteosarcoma

Exclusion Criteria:

non-asian pulmonary metastasis
iCBT for Depression - Standard Versus Condensed Treatment Material

Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. The investigators are not aware of any research that has investigated if slow readers, or persons with difficulty concentrating, can use the standard material or if they would benefit more from using an adapted version.

In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.

Patients will be recruited within Örebro County by referrals and self-referrals. The goal is to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks and all patients will be assessed for depression at an interview with a psychologist. There will also be interviews after treatment and one year after treatment. The most important outcome will be depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Fullfill criteria for diagnosis of major depression
* Being able to read and write Swedish
* Have access to the internet
* Being a resident in Örebro county

Exclusion Criteria:

* Severe depressive symptoms (\>34 on the MADRS-S)
* High risk for suicide
* Attending cognitive behavior therapy
* Psychosis
* Bipolar disorder
* Addiction to alcohol or illegal drugs
* A somatic or psychiatric condition that is a contraindication for iCBT or in some way debars iCBT, or have to be treated before depression
The Effect of Yoga on Barriers to Occupational Engagement in African American Breast Cancer Survivors

The purpose of this study was to determine if occupational therapy informed yoga could decrease barriers to occupational engagement in African American breast cancer survivors.

.

Breast cancer disproportionately affects African American women as illustrated by a 42% higher death rate and an 11% lower 5-year survival rate when compared to Caucasian women. Reasons for these disparities include biological and structural barriers to higher survival rates.

Regular physical activity and resistance training are recommended to support improved survivorship. To date, few efforts have targeted African American survivors who may experience greater survivorship challenges than Caucasians.

Yoga is a safe and effective means for breast cancer survivors to exercise and gain positive physical and psychosocial outcomes. Only two studies, 10 years apart, have provided evidence about the efficacy of yoga for African American breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* African American race
* Breast Cancer survivor
* No medical restrictions on activity

Exclusion Criteria:

* Race other than African American
* No history of breast cancer
* Medical restrictions on activity
Effects of Frailty, Sarcopenia and Muscle Wasting on Outcomes of Patients in the Surgical Intensive Care Unit

The primary aim of the study is to evaluate consequences of frailty in critically ill patients. We hypothesize that a higher frailty index (based on published questionnaires) predicts a longer surgical intensive care unit and hospital length of stay, less ventilator-free days and a higher likelihood of an adverse discharge disposition.

Our secondary aim is to identify muscle-size derived variables that can be used to predict frailty. We hypothesize that a low skeletal muscle mass measured by ultrasound can be used to quantify frailty, and to also predict the outcome of SICU patients, expressed as longer stay in the surgical intensive care unit and longer stay in the hospital, less ventilator-free days and a higher likelihood of an adverse discharge disposition.

Our third aim is to examine potential triggers of muscle wasting in critically ill patients. Muscle wasting will be assessed by repetitive ultrasound measurements of muscle mass. We hypothesize that a significant decrease in skeletal muscle mass predicts longer stay at the surgical intensive care unit and longer hospital length of stay, less ventilator-free days and adverse discharge disposition.

Frailty is defined as status of decreased physiological reserve which leads to a higher vulnerability to stressors. It is associated with a higher risk of morbidity and mortality. Within the geriatric population, frailty is common and a known predictor of adverse outcomes. The usefulness of a frailty assessment as an outcome measure in critically ill patients of all ages needs to be evaluated. This study evaluates whether frailty has an effect on outcome of critically ill patients.

Muscle weakness predicts outcome of ICU patients but is hard to determine in the ICU since the measurement is volition dependent. Muscle mass correlates with muscle weakness and can be assessed objectively. This study evaluates the consequences of reduced muscle mass or sarcopenia on the outcome of critically ill patients.

In addition, muscle wasting in the ICU may predict persistent functional disability. This study aims to examine muscle wasting of critically ill patients on the surgical ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the SICU (within 72 hours of admission)
* Age over 18 years
* Stay on the SICU for at least 24 hours

Exclusion Criteria:

* Ongoing discussions about goals of care
* Motor component of Glasgow Coma Scale \<5
* Unstable fractures
* Preexisting paralysis
* Pregnancy
* Absence of both lower limbs
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression

This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has signed an informed consent form prior to any study-specific procedures being performed
2. Subject is an ambulatory female at least 18 years of age
3. Subject agrees to adhere to the study requirements
4. Subject agrees not to be the primary caregiver of any dependents during the infusion
5. Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
6. Subject has a current diagnosis of PPD, as assessed by the Investigator

Exclusion Criteria:

1. Subject has end stage renal disease
2. Subject has a known allergy to progesterone or allopregnanolone
Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units

Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.

This was a pilot study assessing the technique in this population. The study was conducted with 8 stable premature infants admitted in the Neonatal Intensive Care Unit (ICU) from Hospital Luterano de Porto Alegre. Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p \< 0.001. The score in pain assessment scale was reduced from 5,38 ± 0.91 to 0.25 ± 0.46, p \< 0.001 after intervention. The study suggests that aquatic physical therapy could be a simple and effective method to reduce pain and stress in premature infants admitted in the neonatal ICU.

Eligibility Criteria:
Inclusion Criteria:

* premature infants with gestational age less than 36 weeks,
* clinically stable, showing behavioral abnormalities such as intolerance to the touch, excessive crying, showing signs of pain in accordance with the scale
* difficulty of NFCS leave the stage of crying and agitation for a period of deep sleep during a period of not less than 60 minutes.

Exclusion Criteria:

* premature medically unstable because of the difficulty of monitoring in liquid medium, with a change in temperature on mechanical ventilation who had an infectious process due to the exacerbation of it in hot water, and syndromic children with congenital facial deformities that impede the use of scale NFCS for evaluation.
Airway Clearance Study

The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
* Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 \>80% of PN, Non-smoker

Exclusion Criteria:

* COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
* Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,
Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases

Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from 18-90 years
* Written informed consent
* Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media

Exclusion Criteria:

* Pregnant or breast feeding women
* Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
* Inclusion in another clinical trial 30 days prior to inclusion
* Age \< 30years
* Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
* Known allergies to contrast CT or MRI contrast media
* Patients with an glomerular filtration rate of \< 60ml/min/1.73m2