cyrilzakka/clinical-trials huggingface dataset:
Validation of a Spasticity Measurement Tool

The objective of this project is to investigate the validity of a handheld spasticity measurement tool against standard clinical measurements of spasticity. We propose the testing apparatus will accurately provide an equivalent clinical measure of spasticity while also providing a more precise estimation of spastic response in persons with stroke.

An ongoing conversation amongst clinicians exists on how to properly define, measure, and manage spasticity. The standard measurement tools are the Modified Ashworth Scale (MAS) and the Tardieu scale, although both of these lack reliability and specificity, causing variability between clinicians and a lack of accurate spasticity measurement. In addition, some have concerns about whether the MAS measures true spasticity at all. Due to this lack of trust in these scales, clinicians often use them as a communication tool to identify the presence of spasticity, rather than as reliable quantifiable outcome measurements.

The MAS and Tardieu function mainly on the principal of catch, a limb is moved slowly by a clinician through the available range of motion, and then quickly. Hyperactive muscles are sensitive to velocity dependent stretch and will activate a reflex if quickly perturbed. In both the MAS and Tardieu, the catch location is noted and translated into a score. In MAS the catch location is only noted in three distinct ranges; with the Tardieu Scale the catch angle is remembered by the clinician and recorded after the movement with a standard goniometer.

Here we will test a new handheld spasticity measurement tool MITSS (Modified Intelligent Tardieu Scale for Spasticity), which is essentially a 3-DOF digital goniometer, to quantify the catch angle as well as general forces at the joint.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Able to provide informed consent
* History of unilateral stroke

Exclusion Criteria:

* Orthopedic injuries or surgeries that would impact arm function
Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male Chinese and Japanese volunteers
2. Age between 20 and 45 years
3. BMI between 18.5 and 25 kg/m2 (Body Mass Index)
4. Known genotype as specified in the study protocol
5. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. Any deviation from healthy condition
ACT for High-risk Pregnancy

This study is designed to reduce the psychological distress of women with high-risk pregnancy. Women who express interest and are eligible will have the opportunity to participate in a 7-day acceptance therapy. This therapy is based on the theory that attempts to control internal states, thoughts and feelings can contribute to symptoms of depression, anxiety and/or stress. This study aims to educate women about how the willingness to experience uncomfortable pregnancy-related sensations and thoughts, rather than fighting them, can provide relief. The therapy is completed virtually, with the first therapy session done over video call with the therapist. Following, participants complete the remaining six days of therapy on their own using a work book. All women participating in the study will be asked to complete a series of self-report questionnaires before, during, and immediately following treatment, as well as twice postpartum. Participants will receive up to $60 and a work book for participation.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with a current high-risk pregnancy.
2. Patients must be willing to engage in brief Acceptance-Commitment Therapy
3. Patients must be English-speaking.
4. Ages 18 years or older.

Exclusion Criteria:

1. Active suicidal ideation or self-harm in the past year; any previous history of suicide attempts.
2. History of bipolar disorder, psychosis, mental retardation or organic brain damage.
3. Currently using substances (alcohol, nicotine, marijuana, etc.)
4. Actively participating in psychotherapy for emotional or psychological problems from another provider
Knowledge, Attitudes, and Practices Towards COVID-19 Among Health Care Professionals Among Healthcare Professionals

The aim of this study is to evaluate the knowledge level of healthcare professionals such as physicians, nurses, physiotherapists and nutritionist about published COVID-19 guidelines.

The listed healthcare workers are take part in the primary treatment of the Corona virus infected patients in hospitals. Therefore the knowledge of the world wide spreading Corona Virus and its effects for the human being is should be known for the effective treatment and for raising public awareness.


Eligibility Criteria:
Inclusion Criteria:

* Physicians, nurses, physiotherapists and other healthcare professionals with clinical practical experience
* Actively working in the hospitals and in any health institution

Exclusion Criteria:

* Employees outside the health area
* Health professionals who do not work in any health institution
* Employees who do not have a bachelor's degree
Immune Response to Hepatitis B Virus Booster Vaccination After 20-23 Years

This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine booster in healthy adults which received a full course of neonatal hepatitis B vaccination 20-23 years ago.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults 20-25 years old

Exclusion Criteria:

* Hepatitis B surface antigen (+)
* Hepatitis B core antibody (+)
* any history of liver disorders including hepatitis
* HIV Ag or Ab(+)
Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

The study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center.

On each of two treatment days, subjects will consume a standard high fat meal and then receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such that each subject receives both Treatment A and Treatment B over the 2 treatment days, randomized 1:1 to the treatment sequence AB or BA.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 30 and 85 years, inclusive.
* Have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
* Classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
* Stable on other non levodopa PD medications for at least 4 weeks prior to the Screening Visit.
* Subjects must have normal cognition as confirmed by a score of ≥ 25 on the Mini Mental State Examination (MMSE), performed in the ON state.
* Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%.
* Body Mass Index (BMI) between 18 - 32 kg/m2, inclusive.

Exclusion Criteria:

* Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit.
* Chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years.
* History of any cancer in the past 5 years with the exception of successfully treated basal cell carcinoma.
* Narrow angle glaucoma or a history of peptic ulcer disease less than 1 year prior to screening.
* Previous surgery for PD (including but not limited to deep brain stimulation or cell transplantation).
* Current use of nicotine patch or tobacco-containing products including cigarettes, electronic cigarettes, cigars, chewing tobacco, pipe tobacco or snuff or use within 4 weeks prior to the Screening Visit, or expected use during the study.
* Marijuana smoking within 4 weeks prior to the Screening Visit, or expected smoking/inhalation during the study.
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of radiation therapy following surgery in treating women who have early stage breast cancer.

OBJECTIVES:

* Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy.
* Arm II: Patients receive radiotherapy 5 times a fortnight (i.e., Monday/Wednesday/Friday/Tuesday/Thursday/Monday, etc.) for 13 fractions over 5 weeks for a total dose of 41.6 Gy.
* Arm III: Patients receive radiotherapy as in arm II for a total dose of 39 Gy. A breast boost is recommended in all arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.

Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.

Patients are followed annually for up to 20 years.

PROJECTED ACCRUAL: A total of 2,010 patients (670 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive unilateral breast cancer that is considered operable

  * T1-3, N0-1, M0 at presentation
* Complete macroscopic excision of tumor by breast conserving surgery or mastectomy
* No immediate breast reconstruction
* No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed
* Not enrolled on SECRAB or OSCAR trials
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

* Prior neoadjuvant, or primary medical, therapy allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor

Biologic therapy:

* Not specified

Chemotherapy:

* At least 2 weeks since prior cytotoxic agents
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa

The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product or planned use during the study period.
Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects

1. To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials
2. To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation
3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three 25mg tablets vs. one 75 mg tablet, current 1B formulation


Eligibility Criteria:
Inclusion Criteria:

1. Healthy HIV negative adult male volunteers
2. Age ≥18 and ≤ 60 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2
4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
7. Intake of drugs with a long half-life (\>24 hours) within at least one month prior to study drug administration and during the trial
8. Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
10. Current smoker
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse).
13. Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
14. Excessive physical activities (within one week prior to study drug administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator
16. Inability to comply with dietary regimen required by the protocol
17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive
Intervention for Monitoring of Salt Intake in Hypertensive Patients

Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for CVD-related mortality. From recent national survey, Thai people had consumed more than 9.1 g of salt per day, which was nearly two times above WHO reference level. Dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. To create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. This study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.

A randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (SBP\>130 mmHg) in Uthaithani. Participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). Trial was followed up for 12 weeks. The primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-70 years of age with hypertension
* Systolic blood pressure \> 130 mmHg
* Provided informed consent to participate in the study

Exclusion Criteria:

* Participants with end stage kidney disease
* History of adjust antihypertensive agents or diuretic within 2 weeks before enrollment
* Pregnant or breastfeeding women
* Adjustment of any antihypertensive agents during study period
* Participants with salt supplement
Enhanced Recovery After Surgery for Spine Fusion Surgeries in the Elderly

elderly patients in our hospital who received spinal fusion surgery after the year 2025 will receive ERAS treatment.


Eligibility Criteria:
Inclusion Criteria:

* elderly patients who received spinal fusion surgeries

Exclusion Criteria:

* patients who received non-fusion surgeries
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)

This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).

Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4.

Primary Objective:

To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions

To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15.

Eligibility Criteria:
Inclusion Criteria:

* Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
* Females of childbearing potential: negative urine pregnancy test
* Ability to provide informed consent
* Ability to collaborate with planned follow-up (transportation, compliance history, etc.)
* Use of contraception through the study exit visit (week 28)

Exclusion Criteria:

* Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ®
* Cluster of differentiation 4 (CD4) count \< 200 at the time of screening for eligibility.
* Unable to provide informed consent
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Pregnant females
* Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus);
* Women weighing less than 50 kg
A Primary Care Educational Intervention for Families of Overweight Children

The purpose of the research is to find out if an educational booklet is helpful to families with overweight children. The educational booklet contains information for parents about nutritious eating, physical activity, and strategies for healthy living.

The prevalence of overweight among children has at least doubled in the past 25 years. In the year 2004, 18.8% of children ages 6-11 were overweight. Being overweight as a child is clearly associated with adulthood obesity. In addition, complications once prevalent only in adults are now being seen in overweight children and adolescents. These include hypertension, hypercholesterolemia, and type II diabetes which are well known risk factors for cardiovascular disease. Obesity is also associated with low self-esteem among some groups of overweight adolescents.

Primary care providers are in a unique position to combat this epidemic. However, a recent survey found that only 12% of pediatricians felt highly effective in their ability to treat obesity. Furthermore, physicians reported that low self-efficacy in treating obesity was associated with a lack of patient educational materials. Few written resources for families of overweight children have been tested in the primary care setting. Much of the research on childhood overweight has been conducted in specialty obesity clinics where the resources and patient population may differ from those of primary care offices.

Kid STRIDE is an educational booklet designed for parents of overweight children. It includes information about nutrition, physical activity, and strategies for healthy living. It is hypothesized that the booklet will be distributed to and used by parents of children who are overweight or at risk for overweight. This study will analyze parents' perceptions of this booklet in order to improve its potential value. Information obtained from this pilot study will be used to prepare for a future study to determine the effectiveness of this intervention.

The purpose of this study is:

Aim 1 is to determine the distribution rate and uptake rate of an educational booklet for parents of children between the ages of 8 and 12 who are overweight.

Aim 2 is to describe parents' perceptions of the educational booklet.

Aim 3 is to assess the impact of the intervention on BMI as measured by change in BMI z-score.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index greater than or equal to the 95th percentile for age and gender
* Presenting to pediatrician for a health maintenance visit

Exclusion Criteria:

* Genetic conditions known to predispose to overweight
* Endocrine conditions associated with overweight
* Chronic steroid therapy
* Current enrollment in a professional weight management program
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion Criteria:

* Recurrent hernia
* Scrotal or bilateral hernia
* Previous lower abdominal surgery
* Unable to participate in follow up
* ASA more than 3
* Bleeding diathesis.