cyrilzakka/clinical-trials huggingface dataset:
TAP vs. ESP Block for Gynecological Post Operative Pain

The goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. The main questions it aims to answer are:

* What are the numerical post-operative pain scores in these two groups?
* Is there any significant difference in the numerical post-operative pain scores between subjects who underwent TAP block and subjects who underwent ESP block?
* What are the differences in the time needed for additional morphine in these two groups?
* Is there any significant differences in the time needed for additional morphine between subjects who underwent TAP block and subjects who underwent ESP block?


Eligibility Criteria:
Inclusion Criteria:

* Subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy.
* Subjects with physical status based on the American Society of Anesthesiologists (ASA) in categories I-II
* Subjects who are willing to sign informed consent form.

Exclusion Criteria:

* The patient has a history of allergies to local anesthetic drugs used for TAP blockade or ESP blockade and is allergic to morphine.
* Patients who have skin infections at the injection site.
* Patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking.
* Patients with a history of chronic pain treatment obtained from history taking.
* Patients with impaired kidney function (Ureum \>39 mg/dL; Creatinine \>1.3 mg/dL) and liver (SGOT \>37 U/L; SGPT \>59 U/L), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an EKG examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination.
* The patient is pregnant as determined by history taking.
* Patients who are illiterate as obtained from history taking.
* The patient was uncooperative during examination.
A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

1. Patients with following criteria :

   * BMI ≥ 30 kg/m2 or
   * 27 kg/m2 ≤ BMI \< 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease)
2. A person who have failed at least once to weight control using diet and exercise therapy before screening visit.

Exclusion Criteria:

1. A person whose weight change exceeds 5kg within 3 months prior to screening visit.
2. Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
3. Administration of hypoglycemic agents.
4. Administration of medicines inducing weight gain.
5. Prader-Willi Syndrome or MC4R deficiency.
6. Cushing's Syndrome.
7. Administration of medicines for weight management.
8. A person who has a history of surgery(including device-based therapy) related to obesity or who has a plan during the clinical trial period.
9. Administration of Steroids for the systemic use.
10. Clinically significant gastric emptying abnormalities.
11. History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
12. History of acute or chronic pancreatitis.
13. A person who has the following clinical laboratory test results :

    * TSH \< 0.4 mIU/L or TSH \> 6 mIU/L
    * Calcitonin \> 100 ng/L
    * Amylase or Lipase \> 3 x UNL
14. Severe liver disease (AST or AST \> 3 x UNL or Total bilirubin \> 1.5 x UNL).
15. Severe renal disease ( eGFR \< 30mL/min/1.73m 2 ).
16. QTc \> 450 ms.
17. Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt.
18. PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness.
19. History of alcohol addiction or drug abuse.
20. History of malignant tumors.
21. History of severe heart disease or severe neurovascular disease.
22. Hypersensitivity to investigational products or multi-drug allergy.
23. Positive to pregnancy test, nursing mother, intention on pregnancy.
24. Considered by investigator as not appropriate to participate in the clinical study with other reason.
A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People

NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).

This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body.

Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle.

The study will last for about 17 - 21 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.5 and 29.9 kg/m\^2 (both inclusive)
* Body weight between 60.0 to 100.0 kg (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis
* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
* Factor VIII activity greater than or equal to150% at screening
* Any of the thrombophilia markers listed below:

  * Protein C, protein S or antithrombin below the lower normal laboratory range
  * Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening
Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel

The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

In this study, there is no experimental treatment, or experimental care.

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
* Patient with bitherapy are eligible only if the taxane is the first infusion.
* All type of tumor.
* Age\>18 years old.
* Signed written informed consent.

Exclusion Criteria:

* Patient under 18.
* Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
* Patient deprived of liberty.
A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain

A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* 20≤ Age ≤ 70
* Diagnosed with Type I or Type II diabetes
* HbA1c ≤ 11%
* Patients with diabetic neuropathic pain for at least 3 months
* Patients corresponding to average pain level of 4 points or mor for 24 hours evaluated with 11-point Likert scale

Exclusion Criteria:

* Neuropathic pain due to other causes
* Another stronger pain other than neuropathic pain
* Abnormality in blood pressure, weight
* Positive reaction in HIV, HBV or HCV
* A medical history of mental illness within 6 months
* The grade of BDI(Beck Depression Inventory) exceeds 21 points
* History of drug/alcohol abuse
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants

The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures similar to the capsule formulation over the dose range that may be used in future clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet formulation of branebrutinib in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants, of any race, as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations at screening or at check-in
* Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
* Participant is afebrile (febrile is defined as ≥ 38°C or ≥100.4°F), with systolic blood pressure ≥ 90 and ≤ 160 mm Hg, diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at screening

Exclusion Criteria:

* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
* History of acute or chronic bacterial, fungal, or viral infection necessitating treatment or inpatient admission within the 3 months prior to screening, or active/symptomatic infection at the time of screening

Other protocol-defined inclusion/exclusion criteria apply
Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD+ B-ALL

This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  1. All subjects or legal representatives must sign a voluntary letter of consent approved by the IRB in person prior to the commencement of any screening procedure;
  2. Patients diagnosed with B-ALL according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);
  3. There is no gender limitation, age 18-65 (upper limit not included);
  4. Disease status ≥CR2 with bone marrow flow cytometry MRD≥0.1%.
  5. Patients with Ph+ R/R ALL who failed after 2-line TKI treatment, were intolerant to TKI treatment or were not suitable for TKI treatment;
  6. The expected survival time is ≥12 weeks;
  7. ECOG score 0-1;
  8. Had good organic function during screening
  9. CD19 was still expressed on leukemia cells in bone marrow, peripheral blood or biopsy tissue by flow cytometry, results within one month prior to informed consent are acceptable (after the last treatment).

Exclusion Criteria:

1. Allergic to preconditioning measures.
2. Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma,basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
3. Uncontrollable bacterial, fungal and viral infection during screening.
4. Patients had pulmonary embolism within 3 months prior to enrollment.
5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
6. Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
7. \< 100 days after hematopoietic stem cell transplantation.
8. Active HBV or HCV or HIV or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenufovir, etc, and supervisory the relative indication during the treatment.
9. Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
10. Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
11. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
12. Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
13. Any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study.
The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain

Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.

Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific low back pain
* Must be pain at least 3 months

Exclusion Criteria:

* History of any lumbar spine surgery
* Presence of neurological deficit
* Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training.
* The presence of persistent severe pain
* Pain below the knee
* Severe/progressive scoliosis
* Spinal stenosis
* Spondylolisthesis
* Cancer
* Diabetes
* Metabolic syndrome
* Inflammatory, infectious or tumoral disease of the vertebra
Far Infrared Radiation Treatment of Dementia and Other Mental Illness

This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness.

Dementia is the progressive decline in cognitive function due to damage or disease in the brain beyond what might be expected from normal aging. Particularly affected areas include memory, attention, language, and problem solving. Especially in the later stages of the condition, affected persons may be disoriented in place and in person (not knowing who they are).

The prevalence of dementia is rising as the global life expectancy is rising. Particularly in Western countries, there is increasing concern about the economic impact that dementia will have in future, older populaces.

It is a disease that is strongly associated with age; 1% of those aged 60-65, 6% of those aged 75-79, and 45% of those aged 95 or older suffer from the disease.

We are postulating that the use of far infrared radiation on the central nervous system, the endocrine system and the viscera will have a positive effect on treating dementia and other neurological illnesses.

Eligibility Criteria:
Inclusion Criteria:

* Persons age 2 or older, with dementia, Alzheimer's, Huntington's disease, Parkinson's disease, Down's syndrome, multiple sclerosis or stroke

Exclusion Criteria:

* Persons with severe mental illness that are confined to mental hospitals etc., as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM)
Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects

A Single Dose Study of GBR 900 in Healthy Volunteers.

This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
2. Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
3. Subjects who are otherwise healthy and free from clinically significant illness or disease as determined by medical history, vital signs, physical examinations, and other tests performed by the investigator.

Exclusion Criteria:

1. Subjects with a history of neuropathy or otherwise present with risk factors for neurological toxicity like chronic alcoholism or clinically significant neurological (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.
2. Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
3. Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
4. Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
5. Subjects with a current and/or recent history of arthralgia or a history of fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.
6. Any evidence of organ dysfunction or any clinically significant deviation from the normal in history, physical or neurological determinations or investigations or has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study.
Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias

proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. during the current study, we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure.

two groups of infants diagnosed with proximal hypospadias will be allocated in two groups. group A will include cases of who will be operated upon using hybrid Duckett urethroplasty. group B will include patients who will be operated upon using modified duckett urethroplasty.

recruitment in either group will be done using sealed envelop method. in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis. the tube will be secured in place however, no proximal anastomosis with the meatus. the anastomosis will be scheduled six months later. In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session. the primary out come will be completion of the procedure and restoration of the urethral continuity. secondary out come will the cosmetic appearance

Eligibility Criteria:
Inclusion Criteria:

* all infants and children with proximal hypospadias

Exclusion Criteria:

* disorders of sex developments
* previous penile surgery
* circumcised children
* crippled penis
* refusal of the plan of the management by the care givers
Influence of Motor Proteins on Muscle Atrophy in Cancer Patients

The aim of the study is to investigate the effect of exercise in form of whole-body electromyostimulation (WB-EMS) on early tumor-induced muscular dysfunction. It is anticipated to gain detailed knowledge about composition and metabolism of skeletal muscle cells, and single muscle fiber functionality. To determine key factors leading to impaired force generation and thus decreased muscle strength in cancer patients who are suspected to develop or already show early signs of tumor cachexia is crucial for the establishment of effective cancer treatment. Comparative analysis of skeletal muscle biopsies taken from the abdomen of patients during indicated surgeries will be conducted. The patients will be allocated to the following study groups: a) Study group 1: Patients without cancer, b) Study group 2: Patients with solid tumors who did not perform physical training and c) Study group 3: Patients with solid tumors who executed physical training in form of WB-EMS. The investigation can help to understand skeletal muscle physiology under exercise and to get a better insight into the effects of physical training on early-stage muscle atrophy, both on cellular and molecular level. Initially, it is planned to identify the inflammation and nutrition status of the patients, and to determine skeletal muscle strength. It is anticipated to explore muscle protein composition, particularly myosin to actin ratio and their interaction. Biochemical analysis and the examination of the cellular ultra-structure should enhance the knowledge about the key mechanisms controlling the contractile apparatus of single muscle fibers in order to determine the quality of muscle force. Taken together, these investigations will help to better understand muscle atrophy in advanced cancer patients, and might support the development of targeted anti-cachectic therapies, that can be applied already in early phases of the tumor disease to significantly improve the patients' prognosis and their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Solid pancreatic, colorectal, esophageal, gastric and liver tumors under oncological treatment
* Karnofsky performance index between 50 and 100
* Loss of body weight (≥ 2 % and \< 5 %, weight before the illness and at study entry)
* Distinct decrease in muscle force
* Indication for surgery proximal to the M. rectus abdominis
* Intervention Group must have an at least 8-week waiting period until the surgery (to conduct WB-EMS)

Exclusion Criteria:

* Participation in other nutrition or exercise intervention studies
* Study-independent exercise more than once a week
* Ingestion of anabolic or dietary supplements
* Occurrence of heavy cardio-vascular events
* Epilepsy and other severe neurological disorders
* Skin lesions in the area of the electrodes
* Conductive materials or electronical implants in the body (that do not allow electromyostimulation)
* Pregnancy
* Chronic diseases (e.g. HIV or Hepatitis C/D/E)
* Rejection of a muscle biopsy