cyrilzakka/clinical-trials huggingface dataset:
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma

This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell leukemia/lymphoma (r/r ATL).


Eligibility Criteria:
Inclusion Criteria:

* Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen
* Aged ≥20 years or older at the time of signing the informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
* At least 1 evaluable lesion
* Participants who have defined laboratory criteria
* Life expectancy ≥ 3 months

Exclusion Criteria:

* A presence of central nervous system involvement at the time of screening tests
* Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina
* ≥ Grade 3 neuropathy
* QT interval corrected using Fridericia's method (QTcF) \>470 ms
* Has an uncontrolled infection
* Participants who use corticosteroids over 10 mg/day
* Receipt of allogeneic hematopoietic stem cell transplantation
* History of, or concurrent, malignant tumors
Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classification I-II
* 18.5≤BMI≤28
* Patients who receiving breast and thyroid surgery and requiring general anesthesia and receive PCIA
* Voluntarily and be able to understand and sign the informed consent form

Exclusion Criteria:

* Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history
* History of allergy to opioids
* Patients with a history or family history of epilepsy that has not been controlled by treatment
* Sedatives and antidepressants were used 24 hours before surgery
* Failure to cooperate with the study for any reason or in the opinion of the investigator
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora

The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.

In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders. The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions. A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function. While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks. Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function. Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear. More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function. Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* First and second year undergraduate students in Sun Yat-sen University.
* BMI≥22 kg/m\^2.
* Keeping weight stable for 3 months prior to study start (weight fluctuation \<5kg).
* Having the time and volunteering to receive the interventions.

Exclusion Criteria:

* Currently engaged in other weight-loss studies.
* With high blood pressure, diabetes or other cardiovascular diseases.
* With secondary obesity induced by medicine or other diseases.
* Contraindication to exercise.
Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy

This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* 60\~80 yr
* American Society of Anesthesiologists physical status 1 or 2
* scheduled for elective robotic assisted radical prostatectomy

Exclusion Criteria:

* heavy smoker
* severe respiratory or cardiac disease
* hepatic or renal function impairment
* neurologic disease
* BMI \> 31kg/m2
Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture.

Methods: Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The primary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure.


Eligibility Criteria:
Inclusion Criteria:

* meet the diagnostic criteria according to the NIH CP/CPPS consensus: discomfort or pain in the pelvic region for at least 3 months in the previous 6 months
* 18-50 years
* NIH-CPSI total score ≥15

Exclusion Criteria:

* Urologic disease
* Residual urine volume ≥100 milliliter (mL)
* Qmax ≤15mL/s
* Use 5-alpha reductase inhibitor, alpha-blockers, antibiotics or any other prostatitis-specific medication during previous 1 month
* Diseases that influence urologic symptoms are multiple sclerosis, multiple system atrophy, stroke, Alzheimer disease, Parkinson's disease, spinal cord injury, cauda equina injury, and sexually transmitted disease
* Any acute disease or severe disease requiring treatment
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.

This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum
* Local curative approach
* Normal continence preoperatively
* Non-IBD-associated carcinoma
* Possible sphincter salvage
* Signed informed consent

Exclusion Criteria:

* Non-curative approaches
* Emergency surgery in cases of tumor perforation, abscess, sepsis
* Proximal rectal carcinoma (\> 12 cm from anocutaneous line)
* Lack of informed consent
* Age \<18 years
* Inclusion in other trials with interference of endpoints
* Life expectancy less than 24 months (as estimated by the treating physicians)
* Pregnancy
* Immunosuppression
Radiomics of Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.


Eligibility Criteria:
Inclusion Criteria:（a）healthy subject of same ages;(b)without injury to head and diseases of the nervous system; (c)without family history of mental disorders; (d)without other somatic illness.

Exclusion Criteria:

-
Effectiveness and Cost-effectiveness of vCST and Online Dementia Carer Support

A multicentre single-blind cluster randomised trial to evaluate the effectiveness and cost-effectiveness of virtually delivered versus in-person cognitive stimulation therapy (CST) and carer support in people living with dementia and carers

This is a multicentre, single-blind cluster randomised trial with an aim to evaluate the effectiveness and cost-effectiveness of virtual delivery of CST and carer support in comparison with in-person CST and carer support in Hong Kong Chinese. A total of 156 dyads of people living with dementia and carers will be randomly assigned to one of the four groups: (A) vCST (7 weeks) followed by in-person carer support programme (6 months); (B) in-person CST (7 weeks) followed by in-person carer support programme (6 months); (C) vCST (7 weeks) followed by online carer support programme (6 months); and (D) in-person CST (7 weeks) followed by online carer support programme (6 months). The investigators will measure outcomes at baseline, 7 weeks, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* having a clinical diagnosis of mild to moderate dementia;
* having a family carer;
* living in the community in Hong Kong;
* able to communicate and understand communication;
* able to see and hear well enough to participate in a meaningful assessment;
* the person with dementia and/or his/her carer can provide informed consent

Exclusion Criteria:

* unable to communicate;
* unable to participate in intervention due to significant hearing or visual impairment, or other physical or psychiatric conditions
Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth

This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.

Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.

Materials and Methods:

o Study design:

The present study is a randomized control trial (RCT).

* Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
* Study procedure:

  * Study population includes healthy children (n=118) aged between 4-5 years diagnosed with white spot lesions.
  * Oral examination at baseline to record dmft and caries risk using the Caries-risk Assessment Tool (CAT) based on American Academy of Pediatric Dentistry (AAPD) guidelines will be carried out, patients will be classified as: low, moderate or high risk
  * Quantitative assessment of early caries lesions will be carried out using QLF.
  * Children will be randomly allocated into three groups:

Group 1: children will brush their teeth with CPP-ACP twice daily.

Group 2: children will brush their teeth with fluoridated toothpaste twice daily.

Group 3: children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

The researcher will do the morning application at school, the evening application will be done at home with help of the parent. The researcher will give oral hygiene and brushing instructions to the parents and also diet advice. An oral hygiene chart will be given to monitor twice-daily tooth brushing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy 4-5 years old children, with primary dentition, and early white spot lesions

Exclusion Criteria:

* Lack of cooperation in the oral examination.
* Allergies to milk protein.
* Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
* Medically compromised patient.
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

Obesity is a serious global public health issue. Many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. Clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc.

TCI378 (Lactobacillus plantarum TCI378) is a probiotic extracted from Korean kimchi, and TCI507 (Lactobacillus plantarum TCI507) is a probiotic extracted from the oranges peels. These two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. Therefore, we want to evaluate whether the probiotics TCI308 and TCI507 have effects on reduction of body weight.


Eligibility Criteria:
Inclusion Criteria:

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
2. For those with BMI ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30%
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history).

Exclusion Criteria:

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. Those who had undergone major surgery or bariatric surgery (according to medical history).
3. Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history).
Treatment of the Hypertensive Leg Ulcers by PRF Application

Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established.

We want to study the efficacy of PRF applications on the pains related to those ulcers.

PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation.

PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot.

The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.

2 to 8 PRF (depending on the ulcer surface), applied on painful hypertensive leg ulcer, and covered by a dressing for 4 days.

Afterwards, dressings are made in a classical way. If needed (persistence of important pain), the PRF application can be repeated after 7 days.

Eligibility Criteria:
Inclusion Criteria:

* hypertensive leg ulcer
* important pain (\>= 5/10)

Exclusion Criteria:

* significant venous deficiency
* significant arterial deficiency
* other leg ulcers
* any active diseases such as infection, neoplasia, auto-immune disease
The Effects Of Cervical Mobilization

The aim of this study is to examine the effects of cervical mobilization on balance and gait parameters in stroke individuals.

Twenty-four stroke individuals aged 30-65 years, with a mini mental test score of 24 and above, and with a maximum score of 3 according to the modified rankin scale, were included in this study. Individuals were randomly divided into 2 groups as study (Bobath approach and cervical mobilization n=12) and control group (Bobath approach n=12).

Demographic data, gait parameters, balance parameters and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Portable computerized kinesthetic balance device (SportKAT 550) and photometer, respectivelyThe evaluations were performed 2 times before and after the treatment.

The aim of this study is to examine the effects of cervical mobilization on balance and gait parameters in stroke individuals.

Twenty-four stroke individuals aged 30-65 years, with a mini mental test score of 24 and above, and with a maximum score of 3 according to the modified rankin scale, were included in this study. Individuals were randomly divided into 2 groups as study (Bobath approach and cervical mobilization n=12) and control group (Bobath approach n=12).

Demographic data, gait parameters, balance parameters and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Portable computerized kinesthetic balance device (SportKAT 550) and photometer, respectivelyThe evaluations were performed 2 times before and after the treatment.

In addition to the 1 hour Bobath treatment, the study group received 15 minutes of cervical region joint and soft tissue mobilizations 3 times per week along 4 weeks. The control group was treated with Bobath 3 days per week along 4 weeks and each session was 75 minutes.

Eligibility Criteria:
Inclusion Criteria:

Individuals diagnosed with stroke beetwen 30-70 ages had hemiparetik lezion

Exclusion Criteria:

Having previously diagnosed orthopedic diseases related to the spine

* Acute or chronic infections (including HIV)
* Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis)
* Have a history of whiplash or cervical surgery
* Having diseases that cause balance weakness (spinal cord damage, cerebellar ataxia, Parkinson's disease)
* Having another neurological disease
* Having a vision problem
* Receiving another treatment that will affect balance and walking
* Having a vision problem
* Receiving another treatment that will affect balance and walking
Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer

This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.

Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.

In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

* 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging
* sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).
* indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.
* using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.
* ICG can be visualized with a fluorescence imaging system
* confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients who receive neoadjuvant chemotherapy
* cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
* ECOG Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years

Exclusion Criteria:

* history of breast cancer
* early stage breast cancer
* history of excisional or incisional biopsy or axillary dissection
* inflammatory breast carcinoma
* cN3 on tumor lymphnode metastasis classification(TNM)
* history of hormone therapy or targeted therapy
* stage 4 breast cancer
* pregnancy