Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of caldonirimab plus nimotuzumab for recurrent or metastatic cervical cancer

Conditions: Cervical Cancer

Summary: to evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer

caldonirimab, a pd-1/ctla-4 bispecific antibody, has shown promising efficacy and tolerable toxicity in the first-line treatment of recurrent or metastatic cervical cancer. in this study, patients with recurrent or metastatic cervical cancer, after failure of first-line platinum-containing chemotherapy or intolerance to chemotherapy, will be included in this study according to the prescribed criteria in the protocal. nimotuzumab 400 mg/time, intravenous injection, q2w, a total of 8 times; caldonirimab 6 mg/kg, q2w. assess objective response rate; disease control rate; duration of overall response and safety ( adverse event).

Eligibility criteria:
inclusion criteria: 1. age≥18 \& ≤80. 2. eastern cooperative oncology group (ecog) performance status of 0 or 2. 3. subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervix 4. patients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic setting 5. has at least one measurable lesion based on response evaluation criteria in solid tumors (recist) 1.1 assessed by investigator. 6. has adequate organ function. 7. life expectancy ≥3 months. exclusion criteria: 1. concurrent enrollment in another clinical study; 2. clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent; 3. had received caldonirimab or nimotuzumab before; 4. known history of testing positive for human immunodeficiency virus (hiv) or known active acquired immunodeficiency syndrome. 5. known active hepatitis b or c infections (known positive hepatitis b surface antigen \[hbsag\] result or positive hepatitis c virus \[hcv\] antibody with detectable hcv ribonucleic acid \[rna\] results). 6. patients with clinically significant cardio-cerebrovascular disease 7. known allergy or reaction to any component of the two drugs.

Keywords: cervical cancer caldonirimab nimotuzumab
effect of pre-medication in pain measures on office hysteroscopy

Conditions: Pain

Summary: will be perform a rct to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. patients will be alocate to oral sodic diclofenac, scopolamin or placebo. we will compare visual analog score of pain after the procedure. patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality. interventions group 1 (control) the patients will receive about 2 h prior to the procedure 2 placebo tablets. group 2 (diclofenac + scopolamine) the patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg. group 3 (diclofenac only). patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.

pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). acceptance of the procedure and assessed through the likert 5-point scale: 1) totally disagree; 2) disagree; 3) i do not agree or disagree; 4) i agree and 5) i totally agree.there will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope

Eligibility criteria:
inclusion criteria: 1. indication of intrauterine evaluation 2. abnormal uterine bleeding 3. post-menopause uterine bleeding 4. infertility 5. recurrent miscarriage exclusion criteria: 1. stenosis of the external cervical orifice, 2. pelvic inflammatory disease, 3. suspected gestation or pregnancy, 4. active bleeding at the time of examination 5. contraindication to the use of the study medication, diclofenac sodium and scopolamine,

Keywords: office hysteroscopy, pain measure
quarfloxin in patients with low to intermediate grade neuroendocrine carcinoma

Conditions: Neuroendocrine Tumors; Carcinoid Tumor

Summary: this is a phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. the purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. patients with neuroendocrine tumors associated with men1 syndrome are eligible. * measureable disease by recist * unresectable or metastatic disease * secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers * males and females 18 years of age or older. * zero to two prior cytotoxic chemotherapy regimens. * patients may be receiving concomitant octreotide sandostatin® * patients must have central iv access, or agree to the insertion of a central iv line. * all previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment. * acceptable liver function * acceptable renal function * acceptable hematologic status * ecog performance status ≤1. * anticipated survival of at least 6 months. * able to maintain a patient diary. * for men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment. * ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments. exclusion criteria: * poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma. * pregnant or nursing women. * severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise. * seizures not controlled by anticonvulsant therapy. * participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy. * patients with a second malignancy requiring active treatment. * active symptomatic bacterial, fungal, or viral infection including active hiv or viral hepatitis. * prior treatment with quarfloxin. * clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis. * patients who have exhibited allergic reactions to a similar structural compound or formulation. * any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.

Keywords: neuroendocrine carcinoid net men-1 islet cell
telephone intervention for pain study (tips)

Conditions: Chronic Pain; Multiple Sclerosis; Amputation; Spinal Cord Injury

Summary: treatments teaching people how to manage pain have been used to treat chronic pain in the general population. the purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. we are also interested in finding out if these treatments decrease a person's pain.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of acquired amputation (amp), multiple sclerosis (ms), or spinal cord injury (sci) confirmed by participants' primary care physicians * average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale; * pain is either worse or started since the onset of the disability; * pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months; * read, write and understand english; * must be able to communicate over the phone (i.e., must be verbal); * age 18 years or older. exclusion criteria: * cognitive impairment defined as one or more errors on the six-item screener (callahan et al., 2002). * current or previous participation in a psychological treatment for pain (obtained via self-report). * current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).
microbiological and epithelial evaluation related to the use of orthodontic thermoplastic device

Conditions: Malocclusion; Orthodontic Appliance Complication

Summary: thermoplastic devices are used in orthodontic treatment and consists of a series of nearly invisible, removable aligners. however, every device used in the mouth can change the buccal flora and increase the number of bacterias. this is a risk factor for enamel demineralization. the treatment can vary in time of use per day. the patient under orthodontic treatment has to use the device for 22 hour each day. when the period of retention comes, it is reduced to 8 hours. the investigators want to know if the concentration of bacterias in saliva and dental plaque will increase, and if the material can cause damage on gingiva.

the orthodontic thermoplastic devices became more affordable and with simple techniques, due to the technological advancement. the main advantage of this appliance is that it is nearly invisible, seen that patients do not want to show braces. others reasons for searching this kind of treatment is because it is removable. while eating, brushing the teeth or even in a important social event, there is the facility to remove the appliance. in the other hand this appliance, according to the american board association, does not finish the treatment as well as the conventional braces. another problem is that every device placed in the mouth is more plaque retentive, increasing the risk of enamel demineralization. also, this device disrupts the normal flow of the saliva, preventing the buffering. this study will analyse the amount of streptococcus mutans and lactobacillus in the saliva and in the biofilm of the teeth and of the appliance, seeded in culture medium. another point, is check the prognosis of the gingival health owing to the contact with the device during the hole treatment.

Eligibility criteria:
inclusion criteria: * patients who have stabilized their growth between 16 and 40 * who have agreed to participate in the study if elected and to sign informed consent * residing in the metropolitan area of curitiba and have the opportunity to attend recall appointments exclusion criteria: * periodontal status deteriorated * missing teeth * cleft lip and palate * history of orthognathic surgery * history of dental or skeletal open bite * presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment

Keywords: removable orthodontic appliance; malocclusion streptococcus mutans lactobacillus epithelium
a study of paclitaxel with or without ramucirumab (imc-1211b) in metastatic gastric adenocarcinoma

Conditions: Gastric Cancer

Summary: this is a phase iii randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (imc-1211b) drug product (dp) compared to paclitaxel plus placebo.

the aim of this study is to determine if paclitaxel given together with ramucirumab (imc-1211b) as second line therapy will prolong overall survival (os) compared to paclitaxel alone. approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression. upon registration and completion of screening procedure and reviewing the inclusion and exclusion criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo. ramucirumab (imc-1211b) dp/placebo will be administered iv on days 1 and 15, paclitaxel will be administered iv on days 1, 8 and 15 of a 4 weekly cycle. participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Eligibility criteria:
inclusion criteria: * signed informed consent * histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma * metastatic disease or locally advanced, unresectable disease * disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline) * organs are functioning well (liver, kidney, blood) * good performance status eastern cooperative oncology group (ecog) performance status (ps) 0 to 1 exclusion criteria: * first line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline * previous systemic therapy with other anti-angiogenic drugs * uncontrolled high blood pressure * symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month * evidence of central nervous system (cns) metastasis at baseline

Keywords: metastatic adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma
canadian clinical evaluation of spiderflash arrhythmia detection in spiderflash™ device

Conditions: Arrhythmias, Cardiac

Summary: this clinical investigation is a prospective, non-randomized, multi-center pivotal trial. this trial aims to validate the automatic detection features provided by the external long-duration spiderflash-t™ event recorder coupled with its analyser eventscope™, and to assess the performances of the mode switch function provided by sorin group implantable cardioverter-defibrillators (icds). this trial is being performed first in order to demonstrate the ventricular tachycardia (vt)/ ventricular fibrillation (vf) sensitivity of the automatic vt/vf detection function of the eventscope™ software. patients will be implanted with an icd from sorin group, with parad+ arrhythmia detection enabled and mode switch (ms) algorithms activated in all patients. arrhythmic events will be documented over a period of 6 to 8 weeks for each patient.


Eligibility criteria:
inclusion criteria: patients already implanted with an ovatio dr or crt-d device may be included in the study if they presented with at least one clinical vt/vf event at the follow-up visit preceding the enrolment. icd or crt-d device upgrading or replacement are allowed but under the condition that existing bipolar rv sensing/pacing lead and/or defibrillation lead and/or lv pacing lead (where applicable) are not of poor or questionable integrity. patients with implanted pacemakers may be included in the study only if the pacemaker is to be explanted or otherwise disabled prior to implanting the icd or crt-d system, to avoid any potential pacemaker-icd interactions. patients must comply with all the following criteria in order to be included in the can-detect study: 1. patient is eligible for implantation of a dual-chamber icd or a crt-d device according to current available guidelines for primary or secondary icd indication . 2. a stable, optimal (as determined by the enrolling physician) drug regimen 3. scheduled for implant of an ovatio dr model 6550 or ovatio crt 6750 or an equivalent device from sorin group. 4. signed and dated informed consent. exclusion criteria: any patient complying with any of the following criteria cannot be included in the can-detect study: 1. any contraindication for standard cardiac pacing 2. any contraindication for icd therapy 3. permanent high-degree av block for patients planned for dual-chamber icd implant only. 4. permanent af for patients planned for dual-chamber icd implant only. 5. abdominal implantation site 6. acute myocarditis 7. mechanical tricuspid valve 8. heart transplant recipient 9. already participating in another clinical study 10. life expectancy less than 6 months 11. inability to understand the purpose of the study or refusal to cooperate 12. inability or refusal to provide informed consent 13. unavailability for scheduled follow-up at the implanting center 14. under guardianship 15. age of less than 18 years.

Keywords: cardiac event recorder sensitivity efficacy
emla topical anesthetic during scaling and root planing

Conditions: Local Anesthesia; Pain, Postoperative; Self-Perception

Summary: injectable anesthesics previous to subgingival scaling and root planing (srp) presents some disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening of adjacent tissues. this study will compare the intrapocket anesthetic effectiveness of a skin topical anesthesic emla with intrapocket 2% benzocaine, intrapocket placebo and injectable anaesthesia for srp in a split-mouth, double-blind, clinical trial study.

objective: the aim of this study was to compare the effect of a eutectic mixture containing 25 mg/g of lidocaine and 25 mg/g of prilocaine (emla®) with injectable 2% lidocaine, topical benzocaine, and 2% placebo for reducing pain during subgingival scaling and root planing (srp) procedures. methods: thirty-two patients were enrolled in this split-mouth, double-blind randomized clinical trial. patients were randomized to a sequence of four anesthetics: 25 mg/g lidocaine and 25 mg/g of 5% prilocaine (emla®), injectable 2% lidocaine, topical 2% benzocaine, or placebo. pain and discomfort were measured using a visual analogue scale (vas) and verbal scale (vs). patient satisfaction with anesthesia was also determined at the end of each treatment session.

Eligibility criteria:
inclusion criteria: * eligible individuals for the study were selected from those requiring srp with at least 2 experimental teeth in four of the six sextants. * each experimental teeth had to present ≥ 1 site with probing depth ≥ 5 mm associated with bp after treatment of gingivitis (without marginal bleeding). * furthermore, individual should present ≥ 18 years-old, have not ever done periodontal treatment and be able to understand verbal scale (vs) and visual analog scale (vas). exclusion criteria: * patients that related allergy history or sensitivity reaction to any used amide or ester anesthetics form, * who received anesthesia or sedation 12 hours before srp, * who presented ulcerated lesions or abscesses in the oral cavity, * who presented oral pathologies with immediate surgical, * who had prior abuse alcohol history, pregnant women, * who presented uncontrolled hypertension or * who had participated in a clinical trial of investigational drug before four months from the beginning of this study.

Keywords: local anesthesia pain measurement pain perception dental anesthesia root planing
evaluation of skin quality improvement

Conditions: Skin Quality

Summary: the purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue botox® cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars.

the purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue botox® cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars. the ability of hyperdilute botox® cosmetic to improve overall skin quality is likely optimized when it is injected uniformly in hyper-diluted small aliquots in order to "saturate" the dermis. we propose to prepare botox® cosmetic in a manner that is approximately 4 times more dilute compared to the typical botox® cosmetic preparation. a 4x4 centimeter area located in the mid-cheek adjacent to the nose will be injected with hyperdilute botox® cosmetic. botox® cosmetic is not fda-approved for this use. a maximum of 15 subjects will participate in this study, all of whom will receive injections of botox® cosmetic during the course of this study. this study is a randomized, placebo-controlled, and double-masked study. this means neither the study doctor nor participant know the experimental agent (e.g., 0.9% saline solution and hyperdiluted botox® cosmetic) injected on each side of the patients' faces. the study will last for a total of 75 days. evaluation of the study is based on the analysis of photographic images obtained during the study.

Eligibility criteria:
inclusion criteria: * ability to follow study instructions and likely to complete all required visits * written consent has been obtained * written authorization for "use and release of health and research study information" has been obtained * subjects who are fitzpatrick skin types ii-iv exclusion criteria: * subjects must be onabotulinum toxin type a naive; if subject has had onabotulinum toxin type a administered in the face in the previous 12 months they are excluded * subjects must be dermal filler naïve in the lateral canthal region and midface regions * subjects must be energy or light device naïve * subjects must have average or below-average lifetime sun exposure * subjects must be free of inflammatory skin disease(s)
double blind, randomized, 3 week inpatient study to evaluate the safety & efficacy of pf-02545920 compared with placebo

Conditions: Schizophrenia

Summary: to assess the efficacy and safety of an investigational compound pf-02545920 for the treatment of schizophrenia. pf-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.


Eligibility criteria:
inclusion criteria: 1. have a current diagnosis of schizophrenia. 2. increase in symptoms over the past 2-4 weeks. 3. willing to remain inpatients for the duration of the trial. exclusion criteria: 1. evidence or history of clinically significant medical problems. 2. females of childbearing potential. 3. a primary psychiatric diagnosis other than schizophrenia. 4. a diagnosis of substance abuse or dependence in the last 6 months.

Keywords: schizophrenia acute exacerbation and pf-02545920