Kornimate/medical-research-clean huggingface dataset:
clinical trial of the tqb2930 injection in patients with advanced cancers

Conditions: Advanced Cancers

Summary: tqb2930 is an anti-her2 (human epidermal growth factor receptor 2) bispecific antibody that can simultaneously bind two epitopes of her2, leading to a dual her2 signal blockage. this is a phase i study to evaluate the safety, tolerability and effectiveness of tqb2930 injection in subjects with advanced malignancies.


Eligibility criteria:
inclusion criteria: * 1 evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * 2 male or female patient 18 to 75 years of age, an eastern cooperative oncology group (ecog) performance status of 0 to 1, and life expectancy ≥12 weeks; * 3 histologically or cytologically confirmed, locally advanced tumors, priority will be given to subjects with her2 positive solid tumor; * 4 malignant tumor that failed from standard treatment or had no standard treatment; * 5 according to the recist 1.1 standard, patient with at least one evaluable lesion; * 6 the main organs function well; * 7 male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug. exclusion criteria: * 1 concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years; * 2 history of uncontrolled intercurrent illness; * 3 major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose; * 4 patients with known symptomatic brain metastases; * 5 receiving any other investigational agent within 4 weeks before first dose; * 6 unstable or serious concurrent medical conditions, as assessed by the investigators, that would substantially increase the risk-benefit ratio of participating in the study.
a phase i clinical trial to evaluate lit-00814 tablets in patients with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: this study is a multi-center, open, dose-increasing and dose-expanding phase i clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of lit-00814 tablets with different doses in china, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of lit-00814 tablets. this study includes two parts: ia phase (i.e. dose escalation) and ib phase (i.e. dose expansion).


Eligibility criteria:
inclusion criteria: 1. the subject or legal representative shall voluntarily sign the informed consent approved by the ethics committee before starting any screening procedure. 2. male or female, age ≥18 years old. 3. unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology. 4. subjects with relapsed and/or metastatic advanced solid tumors who have failed or have no standard treatment at present, or who are unable to accept standard treatment. 5. at least one target lesion. 6. ecog score 0\~1. 7. subjects must have sufficient organ function. 8. agree to use effective contraceptive measures within 3 months (about 90 days) from the signing of informed consent to the last administration of the study drug. exclusion criteria: 1. the toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration; 2. known or symptomatic active central nervous system (cns) metastasis or cancerous meningitis in the screening period; 3. patients who have undergone surgery within 28 days before the first administration and have not recovered yet; 4. suffering from uncontrolled or clinically significant cardiovascular diseases; 5. other malignant tumors occurred within 3 years before the first administration; 6. patients with active chronic hepatitis b, or patients with active hepatitis c, or patients with human immunodeficiency virus (hiv-ab positive) or syphilis infection; 7. there are circumstances that affect the subjects' compliance with the research plan; 8. other circumstances that the researcher thinks are not suitable for participating in this clinical study.
role of mirtazapine in ameliorating sleep disordered breathing

Conditions: Spinal Cord Injuries; Sleep Disordered Breathing

Summary: the purpose of this study is to look at the effect of using mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (sci) and non-injured persons during sleep. during this part of the study participants will be asked to take mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). the drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the mirtazapine/placebo pill has on the way the body responds during sleep.

randomized placebo controlled cross-over study. each subject will be studied on two separate occasions: (1) mirtazapine vs. placebo for one week; the participants will be blinded to whether they are taking mirtazapine or placebo. after the one week treatment a sleep study will be repeated. mirtazapine will be given at 15 mg dose before bed-time. (2) cross over medication for one week will be followed by a second sleep study.

Eligibility criteria:
inclusion criteria: * adults with sci (\>6months after spinal cord injury) at the t6 level/above * non-injured adults exclusion criteria: * pregnant and lactating females * heart failure, vascular disease, or stroke * advanced chronic obstructive pulmonary disease (copd), liver disease, and chronic kidney disease * bmi \>38 kg/m2 * mechanical ventilation dependence
we project: 2.0 grassroots wellness coaching (phase 2)

Conditions: Obesity

Summary: african american adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. the treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. the purpose of this research study is to find out about the feasibility and acceptability of using house chats (hc) as a model for a weight loss program in a real-world, community-based setting.

the pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. two wards will be randomly assigned to either intervention or a delayed intervention control. a total of 10 hcl will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward). hcl will recruit members of their social network (n=80, \>18 years of age) to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the hcl's homes. the primary goal is to understand the feasibility and acceptability of this novel approach to intervention delivery, and as such, process data on recruitment, training, fidelity of intervention delivery, and satisfaction with the sessions will be collected on a weekly basis. in addition, in-person assessment visits will take place at 0, 12 weeks (post-treatment) and 24 weeks (follow up) to determine the preliminary effectiveness of this intervention to promote positive changes on behavioral risk factors (physical activity and diet) and adiposity (weight and waist circumference). satisfaction will be assessed in-person at 12 weeks (post-treatment) via surveys and an exit interview. in addition, the investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with hcl and focus groups with participants) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.

Eligibility criteria:
inclusion criteria: * 18 or older * resident of petersburg, va exclusion criteria: * dx of type 1 diabetes mellitus * current treatment for cancer * medical conditions that may increase risk for participating in unsupervised * hospitalization for depression or other psychiatric disorder within the past 12 months * uncontrolled psychotic disorder or bipolar disorder * currently pregnant or lactating or planning to become pregnant within the study period * current involvement in a weight loss program or current use of weight loss medication * inability to speak and read english * planning to move from the petersburg area within the study period

Keywords: cardiometabolic disease
overactive bladder (oab) voiding diary and urodynamics correlation study

Conditions: Overactive Bladder

Summary: this is a prospective cohort study study with the primary aim of identifying the strongest correlating parameters between voiding diaries and uds studies most predictive for each type of urologic condition. investigators will focus on oab related conditions, as these are symptoms


Eligibility criteria:
inclusion criteria: * completing a bladder diary * undergoing vuds exclusion criteria: * have a urinary tract infection * neurogenic bladder * history of pelvic irradiation * prolapse alone without luts * pregnant * incarcerated * hospital employee * unable to give consent
an open study to investigate the safety and efficacy of optivate® in haemophilia a patients undergoing surgery.

Conditions: Haemophilia A

Summary: the main objective of the study is to investigate the safety and efficacy of optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with haemophilia a undergoing surgery.


Eligibility criteria:
inclusion criteria: * diagnosed with haemophilia a, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a fviii concentrate. exclusion criteria: -
gut microbiota is associated with autoimmune thyroid disease

Conditions: Gut Microbiota

Summary: autoimmune thyroid disease (aitd), which includes hashimoto's thyroiditis (ht) and grave's disease (gd), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. investigators systematically performed a comparative analysis of the gut microbiota in aitd patients and healthy controls.

autoimmune thyroid disease (aitd), which includes hashimoto's thyroiditis (ht) and grave's disease (gd), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. these two diseases are clinically diverse because in ht, t cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas gd is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (tshr) leading to hyperthyroidism (2,163-165). however, these diseases still share several immunological features，and the disease may progress from one state to another as the autoimmune process evolves. many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. investigators systematically performed a comparative analysis of the gut microbiota in aitd patients and healthy controls.

Eligibility criteria:
inclusion criteria: * aged 18 to 65 years * male or female gender * euthyroidism (normal ft3, ft4, and tsh plasma levels without hormonal therapy) exclusion criteria: * pregnancy * lactation * cigarette smoking * alcohol addiction * hypertension * diabetes mellitus * lipid dysregulation * bmi \> 27 * recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, proton pump inhibitors, insulin sensitizers or chinese herbal medicine * known history of disease with an autoimmune component such as ms, rheumatoid arthritis, ibs, and ibd * history of malignancy or any gastrointestinal tract surgery (e.g., gastrectomy, bariatric surgery, colectomy, ileectomy, cholecystectomy or appendectomy).

Keywords: gut microbiota hashimoto thyroiditis graves' disease methimazole levothyroxine sodium 16s rrna gene metabonomics
effects of dark chocolate on the risk factors of cardiovascular diseases

Conditions: Cardiovascular Diseases

Summary: cardiovascular disease (cvd) is the number one cause of death in the us. epidemiologic evidence supports that antioxidant-rich diets promote health and attenuate or delay the onset of cvd. cocoa and chocolate products have among the highest antioxidant concentrations compared to other antioxidant food sources. the objective of this study is to examine the effects of regular dark chocolate, bloomed dark chocolate, and white chocolate on cardiovascular health markers.


Eligibility criteria:
inclusion criteria: * generally healthy subjects exclusion criteria: * smoker * pregnant woman * lactose intolerance * required dietary supplement use * required medication of metabolic disorders * allergy to cacao
potential injury incidents at the fifa world cup qatar 2022

Conditions: Injury;Sports

Summary: this is an exploratory observational study. video footage is used to review all 64 matches in the football tournament. all players actions are registered using the fifa football language, such as, pass completed, clearance, etc. potential injury incidents are registered, and for each incident the injury location, contact type, player reaction, velocity, location, game reaction, referee reaction, medical staff on pitch, and outcome (e.g. substitution) are also registered.

video footage is used to review all 64 matches in the fifa world cup qatar 2022. all players actions are registered using the fifa football language, such as, pass completed, clearance, etc.(https://www.fifatrainingcentre.com/en/resources-tools/football-language/index.php) potential injury incidents are registered, and for each incident the injury location, contact type, player reaction, velocity, location, game reaction, referee reaction, medical staff on pitch, and outcome (e.g. substitution) are also registered. simple descriptive statistics are used to create overviews of the outcomes described above, including comparisons between actions which do or do not lead to potential injury incidents. a secondary analysis may be performed including injury diagnoses, if players consent as part of another study on injury surveillance allowing video analysis of their injuries. no a priori sample size calculation was performed, as all potential injury incidents are included.

Eligibility criteria:
inclusion criteria: * all participating football players at the fifa world cup qatar 2022. exclusion criteria: * none
perioperative intravesical instilation of hypertonic saline following bladder tumor resection

Conditions: TCC

Summary: hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.


Eligibility criteria:
inclusion criteria: 1. patients of 18 years or older able to sign informed consent 2. a previous diagnosis of low grade bladder cancer 3. a pyelographic imaging examination (ctu, mru, ivp, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion 4. serum creatinine levels ≤ 2.0 mg/dl 5. serum sodium levels \<146 mg/ml 6. current bladder tumor diagnosed by endoscopy or imaging in the last 3 months 7. patient is candidate for turbt exclusion criteria: 1. previous history of high grade bladder cancer including carcinoma in situ 2. presence of upper urinary tract tumor on imaging 3. renal failure with serum creatinine \>2.0 mg/dl prior to inclusion 4. hypernatremia \>146 mg/dl prior to inclusion 5. contra-indication to undergo turbt
improving patient outcomes through the implementation of an ibd biologic care pathway

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Summary: inflammatory bowel disease (ibd) includes a group of chronic inflammatory conditions of the gastrointestinal system and is composed of crohn's disease and ulcerative colitis. as an immune-mediated disease, ibd treatment options include the use of biologic medicines including anti-tumor necrosis alpha factor (also called anti-tnfs) medication. despite biologic medicines being an important part of ibd management, there is inconsistency in the way these medications are used. implementation of evidence-based, standardized biologic care pathways (bcp) can improve treatment related outcomes. previous research has shown that using a clinical care pathway, such as a bcp, is a feasible method to support clinical decision making and may improve disease-related outcomes for patients. the researchers propose a prospective study to determine how well a bcp can be incorporated into clinical practice, improve patient health outcomes, and reduce healthcare system redundancies. also, the impact of a bcp on outcomes for patients treated with the help of a standardized bcp compared to those in patients treated without the use of a bcp will be studied. the results of this study will inform how best to incorporate evidence-based bcps into real-world practice and support the wide-spread adoption of bcps in clinical practice.


Eligibility criteria:
inclusion criteria: * greater than or equal to age 18 * starting an anti tnf biologic therapy or biosimilar exclusion criteria: * high-grade, symptomatic fibrostenotic strictures * perforating complications * intraabdominal or perianal abscesses * active infection, * known malignancy * any contraindication to biologic therapy

Keywords: ibd biologics care pathway
ptsd, aud, and interpersonal conflict: within-person associations

Conditions: Stress Disorders, Post-Traumatic; Alcoholism

Summary: the present study seeks to increase understanding of alcohol use disorder (aud) and posttraumatic stress disorder (ptsd) among veterans, an important public health concern. we will study the effects of regulatory deficits and sleep disturbance on the dynamic course of ptsd and aud. the study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, aud symptoms, and ptsd symptoms in the real world.


Eligibility criteria:
inclusion criteria: * oif/oef/ond veterans * at risk for ptsd (i.e., pcl-5 ≥33) and/or aud (i.e., audit ≥ 7 (women) ≥ 8 (men)) exclusion criteria: * psychosis or severe alcohol use disorder that contraindicates participation (based on interview) * active suicidal or homicidal ideation that contraindicates participation (based on interview) * \[exclusion criteria removed 6/2022\] - severe risk for sleep apnea (a positive score in three categories of the berlin questionnaire), or reported treatment for sleep apnea
study of magrolimab (hu5f9-g4) in combination with cetuximab in participants with solid tumors and advanced colorectal cancer

Conditions: Solid Tumor; Colorectal Cancer

Summary: the primary objectives of this study are: (phase 1b) to investigate the safety and tolerability and to determine the recommended phase 2 dose (rp2d) for magrolimab in combination with cetuximab; and (phase 2) to evaluate overall response rate (orr) of magrolimab in combination with cetuximab in participants with kirsten rat sarcoma 2 viral oncogene homolog (kras) mutant and kras wild-type colorectal cancer (crc).


Eligibility criteria:
key inclusion criteria: * histological diagnosis * phase 1b only: advanced solid malignancy with an emphasis on colorectal cancer (crc), head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available. * phase 2: * kras mutant crc: advanced kras mutant crc who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy * kras wild-type crc: advanced kras wild type crc who have progressed or are ineligible for fluoropyrimidine, irinotecan, and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-epidermal growth factor receptor (egfr) antibody, such as cetuximab, panitumumab or others. * adequate performance status and hematological, liver, and kidney function * phase 2 only: willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy key exclusion criteria: * active brain metastases * prior treatment with cluster of differentiation 47 (cd47) or signal regulatory protein alpha (sirpα) targeting agents. * phase 2 only: second malignancy within the last 3 years. * known active or chronic hepatitis b or c infection or human immunodeficiency virus (hiv) * pregnancy or active breastfeeding note: other protocol defined inclusion/exclusion criteria may apply.
pain relief for thrombosed external haemorrhoids

Conditions: Thrombosed External Hemorrhoid

Summary: thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. they are associated with swelling and intense pain. this study evaluated the efficacy and safety of an intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed external haemorrhoids

background: thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. they are associated with swelling and intense pain. internal sphincter hypertonicity plays a role in the aetiology of the pain. this study evaluated the efficacy and safety of an intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed external haemorrhoids. methods: thirty patients with thrombosed external haemorrhoids who refused surgical operation were randomized into two groups. patients received an intrasphincteric injection of either 0·6 ml saline or 0·6 ml of a solution containing 30 units botulinum toxin. anorectal manometry was performed before treatment and 5 days afterwards.results: after 5 days of treatment, the maximum resting pressure fell in both groups, but was significantly lower in the botulinum toxin group (p = 0·004). pain intensity was significantly reduced within 24 h of botulinum toxin treatment (p \< 0·001), but only after 1 week in the placebo group (p = 0·019). conclusion: a single injection of botulinum toxin into the anal sphincter seems to be effective in rapidly controlling the pain associated with thrombosed external haemorrhoids, and could represent an effective conservative treatment for this •condition.

Eligibility criteria:
inclusion criteria: * thrombosed external haemorrhoids disease * patients that refused surgery for fear of procedure related pain. exclusion criteria : * previous anal surgery * third- and fourth-degree haemorrhoids * anal fissure * anal fistula * presumed or confirmed pregnancy.

Keywords: botulinum toxin thrombosed external haemorrhoids pain