cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Effectiveness of a Novel Neck Training Device

Functional training focusing on dynamic, multiplanar eccentric loading of the neck's complex musculature may provide a unique training effect that may protect against neck injuries and mTBI. The purpose of this study is to test the efficacy and adherence of a 12-week TopSpin360 training regimen on important physiologic and performance outcome measures between an intervention group and a control group. The specific aims are 1) to compare differences in four physiologic neck measures and two TopSpin360 performance measures by group and gender, and 2) to evaluate program adherence.

The study will employ a randomized controlled clinical trial design with pre-and post-exposure testing and comparison of intervention and control groups. Inclusion criteria are active-duty men and women of any rank assigned to LRMC, ages 18-35, own a personal cellphone to download the TopSpin360 App (intervention group), able to attend the two times per week training, and have sufficient time on stations to complete the entire study including post-study measures. Exclusion criteria include any medical profile that prevents full participation in the ACFT, any chronic inner ear abnormalities or history of invasive neck procedures or any gross cervical abnormalities when examined by the staff physical therapist.

Study participants in both groups will be measured at baseline and study conclusion. The intervention will use the TopSpin360 device, and the control group will perform a physical therapist designed neck strengthening program. A certified athletic trainer or physical therapist will lead the intervention group for the 12-weeks duration. Data collected will include demographics, physiologic and performance measures, and program adherence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy active-duty service members of any military rank assigned to LRMC
* 18-35 years old
* assigned to Landstuhl Regional Medical Center
* own a personal cellphone to download the TopSpin360 App (intervention group)
* able to attend the two times per week training
* have sufficient time on station to complete entire study including post-study measures.

Exclusion Criteria:

* any medical profile that prevents full participation in the ACFT
* any chronic inner ear abnormalities (e.g., Meniere's disease or benign positional vertigo)
* history of invasive neck procedures (cortisone injections or neck surgery)
* any known cervical spine disorders (e.g., degenerative changes of the cervical spine) or gross cervical spine abnormalities when examined by the staff physical therapist
* non-US military personnel, i.e., German or Netherlands military personnel etc.
Investigation of Validity and Reliability of the Minnesota Manual Dexterity Test in Patients With Multiple Sclerosis

Many assessment tools have been developed and used to evaluate upper extremity functions in multiple sclerosis (MS) patients. While each test has its strengths and weaknesses, the most significant limitation of these tests is that only a limited number assess both hands simultaneously. On the other hand, most daily life activities require the coordinated use of both hands. In MS patients, bilateral impairments in hand functions can also be observed. Therefore, there is a need for bilateral assessment tools.

Unlike many other assessment tools, the Minnesota Manual Dexterity Test (MMDT) allows for simultaneous evaluation of both hands. In addition to manual dexterity, it also assesses hand-eye coordination and gross motor skills. The MMDT consists of five subtests: placing, turning, displacing, single-hand turning and placing, and two-hand turning and placing. The validity of the MMDT has also been examined in MS patients.

Our study aims to evaluate the reliability and validity of the MMDT in MS patients. The cutoff times that best distinguish individuals with MS from healthy individuals will also be examined. The study aims to systematically and thoroughly evaluate the MMDT, establish it as a valid and reliable method for MS patients, and provide a new perspective on assessing hand functions.

At baseline, the MMDT, EDSS, 9-hole peg test (9-HPT), ABILHAND survey, and Jebsen-Taylor Hand Function Test (JTHFT) will be applied to the MS group. The MMDT will be repeated seven days after the first application in MS. Healthy controls are going to perform only the MMDT.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years,
* Neurologist-diagnosed Multiple Sclerosis,
* Expanded Disability Status Scale (EDSS) score between 0-6.5
* No MS exacerbation within the last 3 months,
* Use of stable medication in the last 3 months.

Exclusion Criteria:

* Having any vision, hearing or perception problems that may affect the research results,
* Having an orthopedic problem that may affect manual skills in the upper extremity,
* Having a cardiovascular, pulmonary disorder
Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients

Abstract

Background:

It is documented that some patient education interventions, preferably with a behavioral component included, may improve pain, disability and moods Purpose of the study: the purpose of this study was to improve the quality of life and reduce pain in rheumatoid arthritis patients.

Methods:

Patients were allocated to a patient training intervention group and patient without training intervention group. Both groups received routine treatments while the patient training intervention group, in addition to the routine treatments received training booklets and participated in the training workshop. All the extracted data from the written questionnaire were collected and analyzed using SPSS software.

Results:

The improvement in the signs of recovery for physical and mood symptoms in the patient training intervention group were seen (p \< 0.05). The score of quality of life had significantly improved in the two groups (Mean difference was 9.31±3.03 and P\<0.003). This improvement was significantly higher in the patient training intervention group (P=0.008). After adjustment for education level, the score of quality of life in patient training intervention group had a higher improvement, but the difference between the two groups was not significant (P = 0.1).

Conclusions:

This study showed the important role of training and the patients' educational level on better treatments. The appropriate training in the patient could create a change in the treatment process and has a better effect on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* The only inclusion criterion was that the patient had RA as the main disease (with the same duration and severity of disease).

Exclusion Criteria:

* Patients were excluded if they had another disease.
Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

* patients with diabetes, HIV, cancer or other immunocompromised patients
* patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables
* pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment
* basic Military Trainees will also be excluded from participation
* patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded
* patients with sulfa allergy will be excluded.
Trial to Evaluate Erectile Function, Fertility and Sperm Count in Male Cyclists Compared to Age Matched Controls

Bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ED). Very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia.


Eligibility Criteria:
Inclusion Criteria:

* Males ages 20-35, with at least 2 years of bicycle riding, at least 2 hours a week.

Exclusion Criteria:

* History of prostatic surgery, testicular surgery, or single testis,
* Patients after chemotherapy,
* Patients receiving hormonal therapy,
* Patients receiving alpha blockers for any indication.
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Infection and inflammation is related to increased encephalopathy of prematurities.

Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with encephalopathy

Exclusion Criteria:

* refuse the participate in the trial
Spinal Sufentanil for Obstetric Analgesia

Background: This descriptive study was designed to evaluate effects and adverse effects of spinal sufentanil for relief of labor pain in primi- and multiparous women.

Methods: The retrospective study design was approved by the regional Human Research Ethics Review Board, Lund, Sweden (Dnr 2015/687). The investigators included 164 (82 primi- and 82 multiparous) obstetrical patients given 10 µg of intrathecal sufentanil for labor pain. Any maternal hypotension, third- or fourth-degree perineal tear, intrapartum Cesarean section, abnormal fetal heart rate, low Apgar score, use of neonatal intensive care, postdural puncture headache, epidural blood patch, and breastfeeding problem was recorded. Major outcome measures were maternal satisfaction with pain relief, and provision of supplementary analgesia.

A total sample size of 150 parturients had been calculated to enable differences of at least 20 % versus 5.0 % in proportions of obstetrical and neonatal problems between (equal numbers of) primi- and multiparous mothers to be statistically confirmed with 80 % power and 95 % probability.

Descriptive parametric data is reported as mean ± standard deviation (SD), and descriptive non-parametric data as median with interquartile range (IQR). Proportions are reported in percent with 95 % confidence interval (CI).

Parametric data was compared with two-tailed unpaired student's t-test, and non-parametric data with the Mann-Whitney U-test. Proportions were analyzed with two-tailed Fisher's exact test.

Probability (P) values at \< 0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

Intrathecal sufentanil for labor pain

Exclusion Criteria:

Demographic, obstetrical or neonatal data is missing
Acute Cognition and Exercise

The central hypothesis is that, while both groups will benefit from the exercise session, participants with obesity will exhibit greater gains in cognitive control, relative to healthy weight adults. Additionally, it is anticipated that the benefits of a single bout of exercise for cognitive control will be mediated by changes in exercise-induced myokines. These hypotheses will be tested by accomplishing three aims:

Aim 1: Elucidate the changes in cognitive control following an acute bout of exercise, relative to a sedentary condition, in persons with and without obesity.

Aim 2: To examine the effect of a single bout of exercise, relative to a sedentary condition, on myokines known to have neuroprotective effects i.e., BDNF and CTSB in both healthy weight and individuals with obesity.

Aim 3: To link changes in exercise-induced myokines (i.e., BDNF and CTSB) to changes in cognitive function, following a single bout of exercise.

18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order. A cognitive testing battery accompanied by an electroencephalogram (EEG) will be administered following each session. Blood samples will be collected prior to, during, and following each throughout each testing condition.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18 and 35
* No prior diagnosis of neurological disorders (e.g., autism spectrum disorder)
* No prior diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
* No physical disability that would preclude the participant from completing a VO2max test
* Corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
* Not pregnant
* BMI between 18.5 and 25.0 kg/m2, or BMI greater than 30.0 kg/m2
* Readiness for exercise (determined through PAR-Q)

Exclusion Criteria:

* \<18 years and \>35 years
* Diagnosis of neurological disorders (e.g., autism spectrum disorder)
* Diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
* Physical disability that would preclude the participant from completing a VO2max test
* Lack of corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
* Pregnancy
* BMI less than 18.5 kg/m2 or BMI greater than 25.0 but less than 30.0 kg/m2
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas

The aim of this study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens

This study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven primary thoracic esophageal squamous cell carcinoma
2. According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer
3. The subject has PD after first-line chemotherapy or radiation within a year
4. Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1
5. Can eat more than liquid diet; No signs before esophageal perforation
6. 18\~75 years
7. PS:0-1
8. Life expectancy of ≥ 3 months
9. ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
10. TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL
11. Ccr≤ UNL,Scr≥60 mL/min
12. Normal electrocardiogram (ecg), the body had no unheal wounds
13. Radiotherapy before within the scope of the normal dose and not affect subsequent treatment
14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions
15. Signed written informed consent

Exclusion Criteria:

1. Breast-feeding or pregnant women, no effective contraception if risk of conception exists
2. Chronic diarrhea, enteritis, intestine obstruction which are not under control
3. Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
4. A second primary tumor (except skin basal cell carcinoma)
5. The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
6. With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
7. With bleeding tendency
8. Has inherited bleeding evidence of physical or blood coagulation disorder
9. With clear chemotherapy drug allergy
10. Other researchers believe that patients should not participate in this testing
A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes.

The study will last about 13 weeks for each participant, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
* For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
* For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Key Exclusion Criteria

* Have undergone gastric bypass or bariatric surgery
* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
* For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
* Have any lifetime history of a suicide attempt
* Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
* Unwilling to comply with smoking and alcohol restrictions during the study
Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation

The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days

Exclusion Criteria:

* No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.
Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point is the pathologic response. Secondary end-points will be DFS and OS based upon standard of care surveillance. A pathologic complete response (pCR) will require no histologic evidence of residual malignant cells seen in the primary tumor area specimen or the lymph nodes. Standard of care surgery and radiation therapy will be undertaken.

Eligibility Criteria:
Inclusion Criteria:

* Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable)
* Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.)
* Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.)
* Absolute neutrophil count \> 1500 mm3 and platelet count \> 100,000 mm3
* Normal myocardial left ventricular function
* Serum creatinine \< 2.0 mg/dl
* Total bilirubin and AST \< 3X upper limits normal

Exclusion Criteria:

* Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol)
* Another active cancer present
* Medical contraindications to chemotherapy or surgery
* First trimester pregnancy
* Breast feeding
Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19

The mechanism of peripheral blood lymphocyte decline in COVID-19 patients is not yet clear. However, one theory demonstrated that in the whole progression of COVID-19, the extensive activation of poly-ADP-ribose polymerase (PARP) may reduce the cellular NAD+ and dampen the adaptive immune system. So investigators presume that replenishing the NAD+ using nicotinamide as the precursor may improve the lymphocyte counts and boost the adaptive immune system. As a result, the study using nicotinamide as a kind of supportive therapy provide further evidence of their efficiency and safety in treating lymphopenia in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* the patients diagnosed as the common or severe cases of COVID-19
* aged 18-85
* the absolute lymphocyte counts below the normal value (\<1.1-3.2×109/L)

Exclusion Criteria:

* the patients who are diagnosed as critically ill cases or participating in other clinical trials
* women who are pregnant or lactating
* ALT/AST \> 5 times upper limit of normal (ULN), neutrophils counts \< 0.5×109/L, platelets counts\< 50×109/L
* patients diagnosed with rheumatoid immune-related diseases
* patients who take long-term oral anti-rejection drugs or immunomodulatory drugs
* hypersensitive reaction to nicotinamide or any auxiliary materials
* patients with active tuberculosis or combined with bacterial and fungal infections
* patients undergoing organ transplant
* patients with mental disorders.