cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer

The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.

The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-70 years.
* male and female.
* signed the informed consent form.
* Diagnosis:Primary liver cancer diagnosed by imaging、cell and pathology report.
* Eastern Cooperative Oncology Group (ECOG) :0-2;life expectancy more than 3 months.
* Indication for TACE,no contraindication.
* First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
* At least 8 weeks after last biotherapy.
* Surgery：had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

* Chemotherapy is contraindicated.
* Have the primary disease can cause the neuropathy.
* A history of other malignant tumor in recent 5 years.
* Less than 6 months after last chemotherapy or radiotherapy.
* Less than 8 months after last.
* Cinobufacini allergy.
* Had received transplantation surgery ,less than 2 weeks after last major surgery.
* Other researchers think is not suitable for this clinical trail.
Engaging HIV Patients in Primary Care by Promoting Acceptance

Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public health concern because reduced commitment to care puts PLWHA at risk for illness progression, death, and transmission of HIV to others. This project will develop a novel treatment, brief acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a pathway to reducing engagement barriers. The clinical and public health impact of this project will be the development of a simple, low-cost, disseminable intervention that enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments that will prolong survival and improve quality of life. We hypothesize that individuals randomized to brief ABBT will showed increased longitudinal attendance of primary care appointments.


Eligibility Criteria:
Inclusion Criteria:

* new to the primary care clinic
* HIV+
* between 18 and 60 years old
* entering HIV care for the first time
* able to speak and read English sufficiently to be able to complete the study procedures
* have access to a telephone

Exclusion Criteria:

* psychiatrically or cognitively impaired
ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered

Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.

In any open surgery bleeding usually occurs. Surgeons try to stop the bleeding by using his/her usual surgical practice. These include, but are not limited to: suturing (stitches), ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). It is often necessary for surgeons to use an additional treatment to stop the bleeding. This may include the use of a hemostatic product (used to stop bleeding).

This Phase I study consists of a single arm evaluating the safety of ClotFoam as an adjunct to hemostasis. ClotFoam® is an investigational product-a gelatin-based hydrogel carrying a fibrin monomer-that has been designed for supportive treatment in general surgery for the improvement of hemostasis, where standard techniques are insufficient.

The evaluation will be conducted in 24 patients who are scheduled to undergo elective open surgery in which liver bleeding is encountered requiring control of mild-to- moderate bleeding where standard surgical techniques are expected to be ineffective and/or impractical. All subjects who meet eligibility criteria and who provide informed consent to participate will be assigned to ClotFoam topical treatment. Subjects who will be screened for eligibility to participate in this study will be those who are scheduled to with undergo an elective (non-emergency) hepatic wedge resection or anatomic resection (of 1 to 5 contiguous hepatic segments or a surgical procedure in which liver bleeding is encountered such as removal of the gall bladder (open), bile duct excision wherein an appropriate target bleeding site is identified.

Subjects undergoing living-related liver donation are also eligible. Participants will have post-operative follow ups at day 1,2,5, and 10 post-procedure, 2 weeks post procedure, and 12 weeks post-procedure. The follow up visits will consist of safety evaluations (physical exam, adverse event assessment, laboratory evaluations).

Eligibility Criteria:
Inclusion Criteria:

* Subject is expected to survive 6 months from the date of screening, If female and of child-bearing potential, subject has a negative serum pregnancy test prior to surgery and agrees to not breast feed her child (if applicable) for duration of study treatment and completion of study follow-up visits, If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

Exclusion Criteria:

* pregnant females
Plants Optimizing Development Study (PODS)

This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.

The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Child assent and parent/guardian consent
* Free of any food allergy
* 8-11 years of age
* Tanner scale score of ≤ 2
* 20/20 or corrected vision
* No antibiotic usage in the past 3 months
* ≤1 serving/d of soy food habitual consumption

Exclusion Criteria:

* Non-assent or consent by child assent and/or parent/guardian
* Presence of any food allergy
* Younger than 8 years or older than 11 years
* Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome)
* Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease
* Tanner scale score of \> 2
* Not 20/20 or uncorrected vision
* Antibiotic usage in the past 3 months
* \>1 serving/d of soy food habitual consumption
The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery

The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients (body weight\<10 kg)
* congenital heart diseases and scheduled for a repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital.

Exclusion Criteria:

* other systemic diseases
The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance

Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is designed to assess the efficacy of a newly developed product containing a mixture of these compounds. Specifically, the study will assess if the product is capable of increasing NO bioavailability and if this results in positive effects on exercise economy and intermittent exercise performance. These outcome measures have been chosen because they have previously been positively impacted by an increase in NO bioavailability.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants in self-reported good general health as assessed by the standard procedures described below and specifically meeting the following blood pressure (BP) and body mass index (BMI) ranges: systolic BP: 100-140 mmHg; diastolic BP: 60-90 mmHg; and BMI 18.5-30.
2. 18-40 years of age
3. Physically active. Determined by meeting the following criteria: completes vigorous physical activity (i.e. activities that take hard physical effort and make you breathe much harder than normal; e.g. heavy lifting, digging, aerobics, fast cycling, running etc) at least 2 x per week and moderate physical activities (i.e. activities that take moderate physical effort and make you breath somewhat harder than normal; for example: carrying light loads, cycling at a regular pace, playing doubles tennis) at least 3 x per week.
4. Understanding of the procedures to be undertaken as part of the study
5. Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
6. Informed, voluntary, written consent to participate in the study

Exclusion Criteria:

1. Known pulmonary, cardiovascular or metabolic disease
2. Food allergies including phenylketonurea (PKU)
3. Current regular use of any dietary supplement (excluding macronutrient based supplements) or previous use of any dietary supplement in the past 6 months that is known to have a lasting effect.
4. Blood donation within 3 months prior to the start of the study
5. Substance abuse within 2 years of the start of the study
6. Smoking
7. Any prescription and non-prescription medication which may impact saliva production (antidepressants, diuretics, analgesics, antihistamines, anti-hyper/hypo-tensives, anti-anxiety, appetite suppressants).
8. Current or previous use of phosphodiesterase 5 (PDE5) inhibitors.
9. Participation in another clinical trial within past 4 weeks.
10. Participation in another PepsiCo study within the past 6 months.
11. Highly trained or elite endurance athlete as determined by current or recent (within 3 months) participation in an endurance sport at international or national level.
12. Pregnancy
Renal Denervation Using Externally Focused Therapeutic Ultrasound

This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.

This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty patients who meet the eligibility criteria and have signed the informed consent form.

Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Average systolic blood pressure at least 160 mmHg
* Refractory, stable hypertension despite being treated with at least three hypertensive drugs
* Two functioning kidneys, defined as eGFR \>= 45 ml/min
* At least one renal artery on each side which is greater than 4 mm.

Exclusion Criteria:

* History of nephrectomy or hydronephrosis
* Renal stenosis \> 50%
* Renal stent
* Ambulatory blood pressure monitoring 24 hour average systolic blood pressure \<= 135 mmHg
* Kidney stones which are symptomatic and/or \> 1 cm
* History of abdominal surgery within the past 6 months
* Heterogeneities in the kidneys (cysts or tumors)
* Residual pyelonephritis
* History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last 6 months
* Hemodynamically significant valvular heart disease
* Implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI
* Body weight \> 150 kilograms
* Target treatment depth \> 14 cm from the skin line
* Pregnant, nursing or intends to become pregnant during the trial period
Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.

Intervention C - Daridorexant will assess the safety and efficacy of daridorexant in participants with PTSD.

Please see NCT05422612 for information on the S-21-02 Master Protocol.

The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information relevant to the daridorexant cohort.

Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the daridorexant cohort are then randomly assigned to receive either daridorexant or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period.

Parties interested in having their intervention considered for testing within the M-PACT should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV_8eTQKw6TNug4z42.

Eligibility Criteria:
Inclusion Criteria:

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).

1. History of narcolepsy.
2. History of any treatment with daridorexant.
An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies

This is a pilot study to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies

Older adults with hematologic malignancies receive more aggressive inpatient care at the end of life compared to patients with solid tumors. Advance care planning may promote early serious illness conversations for patients with hematologic malignancies, leading to less aggressive healthcare utilization at the end of life. This pilot aims to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years
* A diagnosis of hematologic malignancy \[including but not limited to acute leukemia, myeloid malignancies (e.g., atypical CML, MDS/MPN overlap syndromes, CMML), multiple myeloma, lymphoma, or any other hematologic malignancies based on the primary oncologist's judgment\]
* Able to provide informed consent
* Being managed in the inpatient setting
* English-speaking

Exclusion Criteria:

• None
Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation

The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.


Eligibility Criteria:
Inclusion Criteria:

* in need of bilateral sinus floor elevation
* residual alveolar ridge height 2-6mm
* residual alveolar ridge width \> 4mm

Exclusion Criteria:

* uncontrolled periodontal disease
* acute or chronic sinusitis
Partial Pulpotomy on Caries Free Human Teeth

The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.

This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries free premolar teeth from fifteen patients assigned for orthodontic extraction will be included. Participants including major eligibility criteria: Their parents need to sign an informed form, Patients shouldn't have any systematic complication, The teeth should be free of any symptom, caries and decalcification and should reveal a normal response to pulp sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on palpation or percussion should be present. Intervention: A class one cavity will be prepared and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal pulp will be removed. Then the exposure site will be covered using two pulpotomy agents: White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be extracted after radiographic and clinical examination to find any sign of swelling, abscess or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel defect formation. The underlying pulp will be assessed and graded according to the degree of inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our criteria are based on ISO 7405.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
* Their parents need to read and sign a fully informed form.
* They shouldn't have any systematic complication or take any medicine during the period of study.
* The teeth need to be free of any symptom, caries and decalcification
* They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
* The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion.
* On radiographic examination no apical lucency or PDL widening should be detected.

Exclusion Criteria:

* tooth crack
* tooth filling
* any caries
* hypocalcification
* The teeth showing apical lucency
* PDL widening on radiography
* sensitivity to cold, heat or bite
* The responses beyond the normal limits to pulp vitality testing
* Any medicine consumption