cyrilzakka/clinical-trials huggingface dataset:
Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma

To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18-yo
* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
* ECOG 0-3
* Histology reviewed by reference pathologist
* Lesion can be assessed
* Can tolerate radiotherapy and Anlotinib
* Agree contraception.
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

Exclusion Criteria:

* No gross tumor post-resection in other center.
* Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
* Benign histology
* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
* STS can be cured by extensive operation alone.
* Previous irradiation to the same area
* Radiological evidence of distant metastases
* Other contraindications, can't tolerate operation or other treatment needed in this study.
* Neoadjuvant chemotherapy given or planned.
Hair2Go Label Comprehension and Usability Study

The purpose of this study is to test label comprehension and usability of the hair removal device in 60 male and female participants. The study population will represent the US demographic distribution of skin types and will include varying levels of literacy.

This will be a single-visit study consisting of two phases: Phase I - assessing label comprehension and Phase II - usability. For Phase I, subjects will be asked to review the outer packaging of the mē device. Each subject will be taken through an interview which will evaluate messages on the external product labeling regarding product use and self-selection criteria. Subjects, who are not self-excluders and/or contraindicated for use of the device will continue with Phase II of the study. This usability phase will consist of watching the instructional DVD, reading the User Guide and then performing a skin sensitivity test. Subjects will be expected to self-administer the hair removal treatment in a simulated home-use environment under observation of the study personnel. The users will have a telephone in the room and may call a phone number and request assistance while performing the treatment, simulating the toll-free hotline that will be available to consumers in commercial use.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, between 18 and 65 years of age.
2. Able to read and understand the written consent form.
3. Willing to sign informed consent.
4. Able to read and speak English.
5. Willing and able to participate in the study procedures.

Exclusion Criteria:

1. The participant or anyone in their household is currently employed by a marketing research department or company, an advertising agency or public relations firm, a pharmaceutical company, a healthcare device manufacturer, a cosmetic or personal care company.
2. The participant is currently employed at a salon, day spa or beauty school/college as a stylist, barber, esthetician or beauty instructor.
3. The respondent has ever been trained or employed as a healthcare professional.
4. The participant normally wears corrective lenses, contacts or glasses to read and does not bring them with him/her to the study site.
5. The participant has participated in any market research study, product label study or clinical trial in the past thirty (30) days.
6. Non-English speakers.
Men's Prostate Awareness Church Training

The objective of the Prostate Cancer Education in African American Churches project is to develop and evaluate a spiritually-based educational intervention for Informed Decision Making (IDM) for prostate cancer screening to be delivered to African American men in church settings.

The specific aims of the project are to 1) develop, and 2) test the efficacy of a spiritually-based cancer communication intervention to increase IDM for prostate cancer screening among African American men in church settings, and including women as supportive "health partners".

A randomized controlled trial is utilized, in which churches will be randomized to: 1) male-only educational groups; and 2) co-educational groups where women supportive "health partners" are invited to attend with the men in dyads, and then break out into men's and women's discussion groups. These two approaches are compared through use of cluster randomized design to determine whether the addition of the women health partner increases the intervention efficacy in the study outcome of informed decision making for prostate cancer screening.

Eligibility Criteria:
Inclusion Criteria:

Male Study Participants

* African American Men church attending men
* 40-69 years of age Advisory Panel

  * Knowledgeable about the community where the intervention is implemented, adults ages 21+, review materials and provide input for intervention development and program implementation Pastors
  * Willing to conduct the intervention at church
  * Support the program
  * Designate two individuals to serve as community health advisors
  * Identify a ministry in the church which will champion the project Community Health Advisors
  * attend a 6 hour training and 1 hour certification
  * assist in recruitment of study participants
  * recruit up to 24 men
  * recruit up to 24 females to attend sessions with men in 10 Health Partner Churches
  * prepare and conduct the 4 part workshop series
  * serve as liaisons between the project and study team Workshop Participants
  * self-identified, African American men (40-69), Health Partners --over 18 years of age, able to complete self-administered paper-and-pencil surveys

Exclusion Criteria:

* Workshop participants with a history of prostate cancer, do not meet the age criteria
A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia

A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

X(T) groups were as follows:

1. near and distance exodeviation angles greater than 5 prism degrees (PD) and alternate cover tests and X(T) diagnosis by an experienced doctor;
2. between 5 and 30 years old;
3. 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
4. absence of other ocular disorders or other systemic diseases.

Normal group were as follows:

1. between 5 and 30 years old;
2. 0.0 or better logMAR BCVA;
3. near and distance exodeviation angles less than 5 PD and alternate cover tests; and
4. no history of any ocular pathology or systemic disease.

Exclusion Criteria:

X(T) groups were as follows:

1. near and distance exodeviation angles less than 5 prism degrees (PD)
2. younger than 5 or older than 30 years old;
3. less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
4. has other ocular disorders or other systemic diseases.

Normal group were as follows:

1. younger than 5 or older than 30 years old;
2. less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
3. near and distance exodeviation angles more than 5 PD and alternate cover tests;
4. has history of any ocular pathology or systemic disease.
Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease

Gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their movements to the rhythms. In this study, auditory stimuli will be constituted by Tango musical pieces, which tempo is modified to adapt to patients' walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance and may also improve Health-Related Quality of Life. This will be a randomized, blind, controlled clinical trial to further assess RAS efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Clinically definitive or probable PD diagnosis
* Gait disorders (MDS-UPDRS #2.12 =1)
* Patients that can be reasonably expected to remain in ON-state during training sessions.

Exclusion Criteria:

* Previous use of RAS or kinesiology
* MMSE \>= 24
* BDI \>= 17
* Patients having undergone PD surgical treatments.
* Patients with auditory or visual handicaps
Manual Diaphragm Release in Cleaning Laborer

This study intended to examine the effect of manual diaphragm release on pulmonary function, chest wall mobility, and functional ability in female occupational cleaners with respiratory hazards.

Cleaning chores have been linked to exposure to various chemical agents that have the potential to cause harmful effects on both the respiratory system and cardiovascular markers, many cleaning products and disinfectants contain ingredients that can act as airway irritants. One of the physical therapy procedures that is used to manage chest disorders is manual diaphragm release which aims to lengthen the diaphragm musculature whereas encouraging better and more proficient contraction.

Eligibility Criteria:
Inclusion Criteria:

* Female occupational cleaners.
* Age between 35 and 45.
* Had work-related respiratory hazards.
* Clinically stable.
* No exacerbation in the previous 6 weeks.
* Working in an occupation with respiratory hazards for at least 2 years.
* Mild to moderate air way obstruction.
* Willingness to participate in this study and provide a consent form.

Exclusion Criteria:

* Other cardiopulmonary diseases.
* Body mass index \> 30 kg/ m2.
* Previous thoracic or abdominal surgery.
* Smokers and users of tobacco in any form (chewing, snuffing or water pipe).
* Systemic conditions (e.g., diabetes mellitus, hypertension).
* Sever airway obstructions.
* Inability to perform the required exercises.
* Inability to attend the scheduled sessions.
Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk

This study aims to investigate the safety and efficacy of individual nutrition support for treating hepatitis b virus(HBV) related acute-on-chronic liver failure patients at nutrition risk

The aims of the randomized-controlled trial are to test the hypothesis that in medical inpatients with HBV related ACLF at risk for undernutrition defined by the nutritional risk score (NRS 2002), tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a effective strategy to prevent mortality, morbidity and functional decline.

Sixty patients with HBV related ACLF will be enrolled in this study. The participants are divided into trial Patients in the trail group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, others) based on a predefined nutritional strategy.In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated within first 3days ( oral supplements, parenteral nutrition) if targets are not met (at least 75% of targets).

Eligibility Criteria:
Inclusion Criteria:

1. Age from 20 to 60 years old;
2. Clinical diagnosis of chronic hepatitis b virus infection(positive hepatitis b surface antigen or positive hepatitis b virus DNA \>0.5 year
3. serum total bilirubin level ≥12 mg/dl
4. prothrombin time international ratio ≥1.5
5. NRS≥ 3points
6. COSSH-ACLF IIs \<8.4 points

Exclusion Criteria:

1. Other active liver disease;
2. Hepatocellular carcinoma or other malignancy, HIV, Chronic kidney disease(CKD), diabetes, thyroid disease, cardiopulmonary disease, neuromuscular diseases, serious psychiatric disease;
3. Acute cholecystitis, acute pancreatitis, biliary obstruction, short bowel syndrome, intestinal obstruction, inflammatory bowel disease;
4. Severe complications or other organ failure including sever infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal failure(AGI III-IV);
5. Pregnancy, BMI\<18.5 or BMI ≥28，organ transplantation, bed-ridden;
6. Unable to ingest oral nutrition, contraindication against parenteral nutrition
7. Admitted with enteral or parenteral nutrition in the last week
8. expected hospital length of stay\<3 days，.expected residence in Guangdong Province length of live\< 90 days
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects

* Objective:

  * A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.
* Study Design:

  * Randomized,single-dose,2-way crossover.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old.
* Subject had no clinically significant abnormal lab values at the screening evaluation.
* Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative.
* Acceptable screening of ECG.
* Female subject's pregnancy test at screening is negative.
* Subject had no evidence of underlying disease at the pre-entry physical examination.
* Subject has given written consent to participate.
* Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study.
* Agreed to undergo at least a 14-day pre-dose washout.
* Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception:

  1. Condom and topical spermicide
  2. Condom and diaphragm
  3. Intra-uterine device (I.U.D)
  4. Complete abstinence.
* Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

Exclusion Criteria:

* History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months.
* History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
* History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
* History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure.
* Subject is pregnant or lactating.
* History of drug hyper sensitivity.
* Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study.
* Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products.
Does Ultraviolet Irradiation Reduce Platelet Reactivity and Improve Coronary Microvascular Function in Man?

Endothelium derived nitric oxide (NO) regulates vascular tone and blood pressure in man. NO also inhibits platelet aggregation and mediates a variety of beneficial anti-inflammatory and repair mechanisms. NO may also be a mediator in the release of the endogenous fibrinolytic factor, tissue-plasminogen activating factor (t-PA) from the endothelium.1 Via these actions it plays a very important role in protection of the vasculature from atherothrombosis and clinical sequelae such as myocardial infarction and stroke.

Visible and ultraviolet (UV) light relax vascular smooth muscles by producing NO in a phenomenon known as photorelaxation.2 The investigators have demonstrated significant stores of pre-formed, bound NO and other nitrosospecies in human skin, which are rapidly released upon exposure to UVA.3 The investigators have demonstrated recently that serum nitrite and nitroso-species are increased after standing in a UVA phototherapy cabinet and that local UVA exposure is associated with increased forearm arterial blood flow that is independent of skin temperature. The investigators have also demonstrated a fall in mean arterial blood pressure in subjects exposed UVA.

Cardiovascular morbidity and the prevalence of hypertension vary with latitude. The investigators hypothesise that some of this geographical variation may be explained by a diminished sunlight/UVA exposure with attendant negative effects upon NO bio-availability.4 To further examine the potential beneficial effects of UVA exposure we will examine the effects of whole-body UVA upon platelet activation and upon myocardial/coronary arterial flow reserve. The investigators will correlate these measures with systemic nitrate, nitrite and nitroso-species content in healthy volunteers.

HYPOTHESES

1. UVA irradiation enhances coronary flow reserve in healthy volunteers.
2. UVA irradiation suppresses platelet activation in healthy volunteers.
3. UVA irradiation enhances the release of endogenous fibrinolytic factors in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged between 18-45 years (inclusive).

Exclusion Criteria:

* Inability to provide informed consent
* Co-existent systemic disease (including any history of asthma, reactive airways disease or hypertension)
* Contraindication to UVA treatment
* Any history of cardiac conduction abnormality (including bundle branch block or atrial fibrillation)
* Smoker
* Current intake of aspirin, other non-steroid anti-inflammatory medications or any regular medication.
* Recent infective/inflammatory condition
* Echocardiographic evidence of left ventricular hypertrophy (left ventricular septal diameter \>1.2 cm in diastole), systolic dysfunction or significant valvular stenosis or regurgitation.
Mometasone Furoate Nasal Spray in Italian Children

Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about its effects in European children with SAR. Thus this study addressed this unmet need.

Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about its effects in European children with SAR. Thus this study addressed this unmet need.

Methods MFNS was compared to isotonic saline. Both treatments were prescribed one spray per nostril, twice a day, per 3 weeks. Nasal cytology, total symptom score (TSS), visual analogic scale concerning the parental perception of symptom severity, and the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) were assessed at baseline, after 7 and 21 days, and one month after discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were: age range 4-12 years, SAR diagnosis, Total Symptoms Score (TSS) ≥ 6, and written informed consent of both parents or legal guardians.

Exclusion Criteria:

* Exclusion criteria were: perennial AR, rhinitis due to other causes, concomitant acute or chronic rhinosinusitis, nasal polyps, asthma comorbidity, current use of topical or systemic corticosteroids, antihistamines, antileukotrienes, inadequate washout of them, nasal anatomic defect, respiratory infections in the last two weeks, participation in other clinical studies in the previous month, documented hypersensitivity to the study product or its excipients, and trip planned outside of the study area.
Thinking in Speech for Children With Autism

This study examines a cognitive therapy for autistic children, Thinking in Speech. Thinking in Speech helps children with autism independently cope with everyday events that cause stress, by developing their ability to use "inner speech".

The purpose of this study is to examine the effectiveness of Thinking in Speech (TiS) in teaching children to identify when they are experiencing a problem and learn to ask for help appropriately.

Participants. Participants will be 20 verbal children, aged 7-11, who have been diagnosed with autism or related neurocognitive disorders. Therapists will be experienced and certified speech-language pathologists (SLPs) who will be trained to use TiS For this grant, investigators will develop a standardized training program that can be administered to community SLPs. Training will consist of background reading and discussions, analysis of past therapy sessions, and practice sessions with individualized feedback provided by a trainer. Training will focus on developing the child's ability to ask for help. Asking for help requires a complex combinations of executive functions and being able to adopt the perspective of another person. Training sessions will be recorded for use in further training development and enhancements. A five-week training program is anticipated.

Procedure: Both training and therapy will be delivered remotely. The therapists will plan to conduct sixteen 30-minute remote therapy sessions over 8 weeks - the actual time frame will depend on the health and scheduling demands of the therapists and children. All TiS sessions will be video-recorded. Children will be randomly assigned to either receive therapy immediately or to be placed on a 10-week wait-list after which they will receive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Verbal language ability as reported by the caregiver
* Ages 7-11
* Prior autism or related neurocognitive diagnosis
* Child proficient in English
* Caregiver proficient in English
* Residing in Pennsylvania
* Access to internet at home

Exclusion Criteria:

* History of major child mental illness (e.g., bipolar, schizophrenia, psychosis)
* Child visual and/or hearing impairment that interferes with his/her ability to participate in therapy