cyrilzakka/clinical-trials huggingface dataset:
Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia

There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose

The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.

The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.

Exclusion Criteria:

* Patients who are:
* Unable to cooperate.
* Patients who have allergy to any of the study drugs.
* Patients who are on opioids.
* Local infection at the site of injection or systemic infection.
* Patients with coagulation disorders or on anticoagulation therapy Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder
* Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
Donafenib Plus Sintilimab for Advanced HCC

This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).

This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC.

30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer \[BCLC\] stage C, or China liver cancer staging \[CNLC\] IIIa/IIIb) will be enrolled in the study.

Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle.

Part 2: patients will receive donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.

Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically
* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
* Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included
* At least one measurable lesion
* Child-Pugh score ≤7
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ and hematologic function
* Life expectancy of at least 3 months

Exclusion Criteria:

* Diffuse HCC
* Macrovascular invasion involving the main trunk or inferior vena cava
* Central nervous system metastasis
* History of malignancy other than HCC
* Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment
* Uncontrolled ascites
* History of hepatic encephalopathy
* Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC
* History of organ and cell transplantation
* Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab
* Autoimmune disease or immune deficiency
* Severe organ (heart, kidney) dysfunction
Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.


Eligibility Criteria:
Inclusion Criteria:

* To qualify for the study a subject must:

  1. Be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  2. Have participated in and completed both studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
  3. Be willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

* Subjects will be ineligible for participation in this study if the subject:

  1. Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202.
  2. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
  3. Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study.

     1. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision).
     2. Any investigational treatment for EFP/cellulite.
     3. Endermologie® or similar treatments.
     4. Massage therapy.
     5. Creams (eg, Celluvera™, TriLastin®).
  4. Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.
AVANCE-Houston FRAMEWorks Program Evaluation

AVANCE-Houston seeks to understand whether a standard or compressed schedule format for delivering the Survival Skills for Healthy Families curriculum better meets the needs of low-income adults to improve skill retention and, ultimately, to promote better outcomes for healthy family relationships and economic stability.

AVANCE-Houston's FRAMEWorks (Family, Relationship, and Marriage Education Works) Project seeks to promote healthy family relationships and economic stability by providing the Survival Skills for Healthy Families (SSHF) curriculum to cohorts of low-income adults. Developed by Family Wellness Associates, SSHF is an evidence-based curriculum delivered through a series of workshops that focus on communication skills, conflict resolution, knowledge of the benefits of marriage, stress and anger management, parenting skills, financial literacy, job and career advancement, and relationship skills to improve family and economic stability. In the past, AVANCE has offered two curriculum delivery models: recurring weekly workshops (standard schedule format) and intensive weekend retreats (compressed schedule format). Each model meets the needs of the target population in different ways, and participants consider factors such as childcare, work/school schedules, weekend availability, and geographic location when choosing their preferred model.

The key goal of this descriptive evaluation is to assess the extent that attitudes and behaviors related to parenting, partner relationships, and financial and job readiness change after participation in the SSHF curriculum. Though the program offers support services and economic stability resources, our analysis will only include outcome changes based on surveys taken at program enrollment, program completion, and one-year post-enrollment. Additionally, a secondary analysis will focus on the ancillary question of whether differences in outcomes exist between in-person and virtual format group participants, and subgroup analyses will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older)
* Reside in Harris County (Houston area), TX

Exclusion Criteria:

* Minor (under the age of 18)
* Reside outside of Harris County (Houston area), TX
Validation of New Type Radiopaque Marker in the Evaluation of Colonic Transit Time

The goal of this clinical trial is to learn if the local made colonic transit capsule can be use to diagnose slow transit constipation. The main questions it aims to answer are:

* Does the local made colonic transit capsule correlate with the standard colonic capsule in the diagnosis of slow transit constipation?
* Does the number of remained radiopaque marker similar between the two test after five days of ingestion?

Researchers will compare the local made colonic capsule with the standard Sitzmark colonic capsule to see the correlation.

Participants will:

* Take both local made colonic capsule and Sitzmark colonic capsule at the same time.
* Obtain abdominal x-ray 5 days after capsule ingestion.
* Keep a diary of their symptoms and medication used during investigation.

The accurate diagnosis of constipation subtype is crucial especially in patients refractory to treatment. The current methods are expensive and not widely available. Thus, the investigators design the clinical study to evaluate the correlation and diagnostic accuracy of local made colonic transit capsule (Siriraj gastrointestinal transit capsule) compare with standard colonic capsule.

The patients with constipation and healthy volunteers will be enrolled. Participants will be asked to take both Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule. The two capsules have different shape of radiopaque marker. The abdominal x-ray will be taken 5 days later. The number of radiopaque marker left will be counted separately between the two type of markers. Slow transit constipation is defined with retained more than 20% of radiopaque marker at 5 days after ingestion. Primary outcome is the correlation in the diagnosis of slow transit constipation and number of remained radiopaque markers between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule and the secondary outcome is the diagnostic performance of Siriraj gastrointestinal transit capsule in detecting slow transit constipation with Sitzmark colonic capsule as standard reference.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with normal bowel habit not meet the criteria for functional constipation and irritable bowel syndrome with constipation according to Rome IV criteria
* Participants with constipation according to Rome IV criteria

Exclusion Criteria:

* Previous abdominal surgery
* Participants at risk for intestinal obstruction such as endometriosis, history of intra-abdominal infection
* Receive medication which affect colonic transit such as opioids
* Pregnancy
Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Normal glucose tolerance
* Age \> 18 years
* BMI \> 40 or \> 35 if combined with hypertension or obstructive sleep apnoea
* Caucasian
* Normal hemoglobinaemia
* Signed informed consent

Exclusion Criteria:

* Major psychiatric disorder
* Alcohol or drug abuse
* Major hearth or pulmonary disease
* Previous major abdominal disease (e.g. peritonitis, large hernia)
* Pregnancy/lactation
* Treatment with GLP-1 analogs
Functional Change With MMS

Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.


Eligibility Criteria:
Inclusion Criteria

* Subject (healthy volunteer) has read and signed the study written informed consent form.
* Male or female ≥ 22 years and ≤65 years of age.
* Subject has not had weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine during the course of the study.
* Subject has a BMI ≤ 30 as determined at screening.
* Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
* Subject agrees to refrain from any new abdominal muscle training exercises of the treatment area during the course of the study.

Exclusion Criteria

* Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has had an intrauterine contraceptive device inserted or removed within the past month.
* Subject has a bleeding disorder or hemorrhagic condition
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.
* Subject has metal or electronic implants in or adjacent to the treatment area
* Subject has an abdominal hernia.
* Subject has pulmonary insufficiency.
* Subject has a cardiac disorder.
* Subject has a malignant tumor.
* Subject has been diagnosed with a seizure disorder such as epilepsy.
* Subject currently has a fever.
* Subject is diagnosed with Grave's disease.
* Subject has a growth plate in the treatment area
* Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase

The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.


Eligibility Criteria:
Inclusion Criteria:

* Is overweight or obese but otherwise generally healthy who interested in losing weight
* BMI of 25 to 35 kg/m2
* Waist/hip ratio of 0.9 or more for male and 0.85 for female.

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* cardiovascular disease (other than mild, controlled hypertension or dislidemia)
* On a weight-loss program within six months
Effects of Hallux Valgus Deformity on Rear Foot Position, Pain, Function, and Quality of Life in Women

To investigate relationship between HV deformity and position of rearfoot joints, and its effects on the quality of life, pain, and related functional status in women with bilateral hallux valgus (HV).

To investigate relationship between HV deformity and position of rearfoot joints, and its effects on the quality of life, pain, and related functional status in women with bilateral hallux valgus (HV). Study included 27 right-dominant women. Demographic data, HV angle, weight-bearing and non-weight-bearing subtalar pronation (SP), and navicular height were recorded. Visual Analog Scale, Foot Function Index (FFI), and the American Orthopaedic Foot and Ankle Society (AOFAS) MTP-IP along with AOFAS Mid foot (MF) Scales, and SF-36 were used. HV angle, weight-bearing SP, and pain intensity of the left foot were higher. HV angle of left foot was correlated with all sub-sections of FFI, pain parameter of AOFAS MTP-IP, and pain and total score of AOFAS-MF Scale ). HV angle of left foot was correlated with physical role, pain, and social function sub-domains of SF-36. Right HV angles were correlated with right foot pain and non-weight-bearing SP.Increasing HV angle and pathomechanical changes in rear foot were correlated. Besides, although all participants were right-dominant, their left foot problems were more highlighted.

Eligibility Criteria:
Inclusion Criteria:Inclusion criteria were as follows:

* Women in an age range of 18-55 years,
* Having bilateral deformity with right-dominance,
* First MTP angle of \> 15° as radiologically determined by the referring physician,
* Deformity intensity \> 2 based on the Manchester scale,
* Muscle forces on ankle and foot \> 4
* Having no systemic disease that affects foot biomechanics with no history of surgery,
* Having no neurological problems,
* Having no cognitive, mental, or psychological problems.

Exclusion Criteria:

-
Oral Hygiene in Patients With Orthodontic Fixed Appliances

The study aims to compare the efficacy of the use of different methods of teeth cleaning on the oral hygiene in patients with orthodontic fixed appliance

Subjects were randomized into four groups, the first group will receive manual tooth brush with super floss, the second group will receive electric tooth brush with super floss, the third group will receive manual tooth brush with water dental flosser and the fourth group will receive electric tooth brush with water flosser.

Eligibility Criteria:
Inclusion Criteria:

1. participants with fixed orthodontic appliance.
2. participants age 14 years and above and didn't have mental of physical disabilities.
3. participants willing to comply with given oral hygiene instructions.

Exclusion Criteria:

1. patients with mental retardation.
2. patients with systematic diseases.
Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis

This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

1. The guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse reactions that may occur during the study, is willing to complete the follow-up as required, and voluntarily signs the informed consent form before the start of the study.
2. The child's age is 6 months or older but no more than 2 years old (including the critical value) at the time of signing the informed consent, and the gender is not specified.
3. Positive viral detection in nasopharyngeal swab.
4. Presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in the lungs; with or without chest imaging showing signs of hyperinflation, patchy infiltrates, localized atelectasis, and peribronchitis.
5. The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
6. The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (the appearance of symptoms and signs related to RSV bronchiolitis does not exceed 72 hours from the signing of the informed consent, including but not limited to: tachypnea, wheezing, hypoxemia, dyspnea, fever).
7. No use of other antiviral drugs or immunomodulators within 3 weeks before randomization.

Exclusion Criteria:

1. Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing.
2. Presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.
3. Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases.
4. Having epilepsy or other disorders of central nervous system function.
5. The investigator's comprehensive judgment suspects a concurrent bacterial infection.
6. Clinical diagnosis of myocarditis or suspected myocarditis (diagnostic criteria see Appendix 2: Diagnostic Recommendations for Myocarditis in Children).
7. Known or suspected allergy to interferon or excipients.
8. Participation in other interventional clinical trials within 3 months prior to screening, or planning to participate in other clinical trials during the study period. (9) A history of pneumonia in the past 3 months.

(10) Other conditions deemed unsuitable for inclusion by the investigator.
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years Patients that give their inform consent

Exclusion Criteria:

* Pregnant women Diabetic patients Treated with statins for the year prior to study inclusion Patients with contraindications listed in fluvastatin prescribing information

Other protocol-defined in and exclusion criteria may apply
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

Probiotics have been proved to shorten duration of diarrhea in children; whether they are cost-effective is less clear. We'd like to validate the use of Infloran, a proprietary probiotic sold in Thailand, in terms of its cost-effectiveness compared to standard diarrhea care in our hospital setting.

Eligibility Criteria:
Inclusion Criteria:

* Children 3 months to 6 years of age
* Hospitalized due to acute diarrhea

Exclusion Criteria:

* History of probiotic treatment in this episode of illness
* History of use of other anti-diarrheal medications
* Chronic gastrointestinal disease(s)
* Severe dehydration
* Severe systemic disease(s)