Kornimate/medical-research-clean huggingface dataset:
zandelisib (me-401) in subjects with follicular lymphoma or marginal zone lymphoma after failure of two or more prior therapies (tidal)

Conditions: Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma

Summary: this is the study of the pi3kδ inhibitor zandelisib (me-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy

this is a global, multicenter open-label, single-arm, phase 2 study of the pi3kδ inhibitor zandelisib (me-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-cd20 antibody and chemotherapy with an alkylating agent or a purine analogue. approximately 180 subjects will be enrolled and treated with zandelisib (me-401) on the intermittent schedule.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis as defined in the world health organization (who) classification scheme 1. follicular lymphoma (fl) limited to grade 1,2 or 3a or 2. marginal zone lymphoma (mzl) including nodal, extranodal and splenic mzl * subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for fl or mzl * age ≥ 18 * at least one bi-dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by computed tomography (ct) scan as defined by the lugano classification * adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to fl per investigator assessment * qt-interval corrected according to fridericia's formula (qtcf) ≤ 450 milliseconds (msec); * left ventricular ejection fraction (lvef) ≥ 45% exclusion criteria: * histologically confirmed fl grade 3b transformation from fl to an aggressive lymphoma * known lymphomatous involvement of the central nervous system * uncontrolled clinically significant illness * ongoing or history of drug-induced pneumonitis * history of clinically significant cardiovascular abnormalities * history of clinically significant gi conditions * known history of, or active hiv infection
a trial of intravenous fluids during labor

Conditions: Ketosis

Summary: the purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.

this will be a multi-center, prospective, single-blind randomized trial of two types of iv fluids for maintenance hydration during labor. this study will be conducted at 4 sites: reading (reading hospital), allentown (lehigh valley), st. luke hospital and hershey (penn state college of medicine). it will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery. the primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. the primary outcome measure is the occurrence of a cesarean birth during the study period. the primary analysis will use an intent-to-treat approach to examine differences between the two iv fluid treatments in the proportion of deliveries requiring cesarean section.

Eligibility criteria:
inclusion criteria: 1. women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation. 2. these women will be in good health and candidates for vaginal delivery. exclusion criteria: 1. patients who are not candidates for vaginal delivery. this may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc. 2. patients presenting for induction of labor or requiring induction upon admission. 3. patients presenting for scheduled cesarean section. 4. patients with any form of diabetes or glucose dysregulation condition. 5. concurrent use of steroids. 6. patients presenting in active labor with advanced cervical dilation (≥ 6 cm). 7. subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site pi).

Keywords: d5lr glucose containing iv solution lr non glucose iv solution
alterations of gcf levels of sclerostin and dkk-1 in postmenopausal osteoporosis

Conditions: Osteoporosis, Postmenopausal; Periodontitis

Summary: symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone which supports the tooth. wnt way (wingless-type mmtv integration site family) plays a role in the regulation of bone homeostasis in periodontal disease-induced bone resorption. the wnt / β-catenin signal is controlled by physiological antagonists, including dickkopf released from osteocytes-associated protein 1 (dkk-1) and sclerostin (sost). thus, wnt inhibitors sost and dkk-1 affect bone mass changes. bisphosphonates used in osteoporous treatment are selective inhibitors of bone resorption. in the serum of postmenopausal osteoporotic women treated with bisphosphonate, short-term and decreased dkk-1 level during the treatment, and increased sost in the late period were reported. increased bone formation after bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with increased serum sost level. the aim of our study is to investigate the effect of bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition metabolism in periodontally healthy and periodontally diseased tooth regions and gingival health with the clinical data by investigating the sost and ddk-1 molecules that play role in bone destruction mechanism.

this study aims to reveal the effect of initial periodontal treatment together with bisphosphonate on sclerostin (sost) and dickkopf-related protein-1 (dkk-1) in gingival crevicular fluid (gcf) of patients with osteoporosis. clinical recordings and gcf were obtained from postmenopausal women; with chronic periodontitis and those using bisphosphonate (group a, n=12), with chronic periodontitis and otherwise healthy (group b, n=10), without chronic periodontitis and those using bisphosphonate (group c, n=11), systemically and periodontally healthy controls (group d, n=10) at the baseline. gcf sampling were recorded and repeated at the 6th and 12th months in group a, b and c. sost and dkk-1 values were measured by elisa.

Eligibility criteria:
inclusion criteria: * women with t scores less than -2.5 (groups a and c) * the periodontitis patients were selected based on the radiographical evidence of bone loss, presence of four or more sites with bleeding on probing (bop), ≥5 mm pocket depth (pd) and ≥6 mm clinical attachment loss (cal). * the clinically healthy control groups were selected on the basis of no radiographic bone loss or cal and pd≤3 mm. exclusion criteria: * any known systemic disease rather than osteoporosis * smoking * antibiotic therapy within the last 3 months * periodontal treatment in the last 6 months

Keywords: sclerostin dickkopf-related protein-1
the relationship between postoperative oxygenation and stop-bang questionnaire and 4-v tool

Conditions: Hypoxia; Bariatric Surgery

Summary: in our study, we aimed to investigate the relationship between stop-bang and 4-variable screening questionnaires in postoperative period in patients who underwent bariatric surgery.


Eligibility criteria:
inclusion criteria: * bmi\>40 * bariatric surgery patients exclusion criteria: * malignancy * patients who are unable to complete the questionnaire * patients who needs laparotomy

Keywords: stop-bang, bariatric surgery, obesity, hypoxia
the impact of a smartphone app on the quality of pediatric colonoscopy preparations

Conditions: Pediatric ALL

Summary: the investigators developed a smartphone app that guides pediatric patients and their families through colonoscopy prep in an attempt to see if an app could improve the colonoscopy process.

the investigators created a smartphone app designed for pediatric patients and their families that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite. the investigators designed a study to determine if this app will yield improved colonoscopy cleanouts, better patient understanding of the procedure, fewer calls to the gi service and more punctual arrival times to the endoscopy suite compared to patients who receive written instructions that do not actively interact with the patient before, during or after their colonoscopy prep.

Eligibility criteria:
inclusion criteria: - aged 5-18 years scheduled to undergo a diagnostic and/or therapeutic colonoscopy exclusion criteria: * patients who had undergone a colonoscopy within the past one year * patients admitted for a nasogastric (ng) cleanout * patients requiring colonoscopy preparation medication other than polyethylene glycol * patients with poor understanding of english.
koebner's phenomenon in psoriasis and lichen planus

Conditions: Kobner Phenomenon; Psoriasis; Lichen Planus

Summary: psoriasis and lichen planus often occur at mechanically irritated skin sites (e.g. tight clothing). the investigators would like to investigate this phenomenon in more detail in this study. for this purpose, the skin is specifically irritated at a small and cosmetically favorable site by tearing off scotch tape or rubbing with a wooden spatula. in order to be able to examine the inflammatory processes caused by the irritation more closely, a small skin sample and a skin swab are taken from the irritated area. this skin sample and the swab are repeated after three and fourteen days.


Eligibility criteria:
inclusion criteria: * dermatologist diagnosed psoriasis (group psoriasis), lichen planus (group lichen planus) or no skin disease (group healthy controls) * subject is capable of giving informed consent * signed informed consent exclusion criteria: * use of systemic immunosuppressive/immunmodulating agents in the last three months * use of topical anti-inflammatory treatment in the last 7 days in the area of sampling. * phototherapy in the last 4 weeks * active or recurrent serious bacterial, fungal or viral infection at the time of enrollment by patient history, including patients with human immunodeficiency virus (hiv) infection, hepatitis b and hepatitis c infection, active or untreated latent tuberculosis. * female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons.
single palatal temporary anchorage device for anterior open bite

Conditions: Anterior Openbite

Summary: participants are orthodontic patients with anterior open bite (aob) malocclusion. these patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal temporary anchorage device (tad) or orthodontic fixed appliances incorporating two buccal tads

participants will be recruited from those attending dundee dental hospital orthodontic department and those currently awaiting treatment. those that meet the inclusion and exclusion criteria will be invited to participate. after obtaining consent they will be allocated to receive one of the two interventions. the two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the orthodontic department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. in order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (see later for details). primary outcome is at the end of intrusion with tads after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction

Eligibility criteria:
inclusion criteria: * patients with aob of 1-6mm * aged between (12 and 40 years). * able to consent. * patient due to undergo orthodontic treatment with fixed orthodontic braces. exclusion criteria: * patient has previously had upper first permanent molar extraction. * patient with congenital cleft of lip and/or palate or any other craniofacial anomalies. * patient with bone disease or taking medications that affect the bone quality or nature. * patient with an active digit sucking habit. * pregnant or breastfeeding women

Keywords: orthodontics temporary anchorage device anterior open bite
eradication of h. pylori therapy individualized by the mutation of 23s rrna of h. pylori

Conditions: H. Pylori Infection

Summary: patients infected with h. pylori are treated with the individualized regimen which is based on the mutation of 23s rrna of h. pylori.

patients infected with h. pylori undergo the gastroscopy. during the gastroscopy, gastric mucus samples are collected, from which dna is extracted. the dna samples are subjected the full-auto snp analyzer and the from a to g mutation of 23s rrna of h. pylori at the positions of 2142 and 2143 is measured. when the mutation is detected, patients are diagnosed to be infected with clarithromycin-resistant strains of h. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + metronidazole 250 mg bid for 1 week. when the mutation is not detected, patients are considered to be infected with clarithromycin-sensitive strains of h. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + clarithromycin 200 mg bid for 1 week. the success or failure of eradication was determined based on the 13c-urea breath test performed 1 month after the therapy. the total eradication rates with this strategy was compared with that by the standard regimen in japan performed in the same period of the study.

Eligibility criteria:
inclusion criteria: * patients infected with h. pylori are invited to the study. * patients not allergic to the any of the drugs used for eradication of h. pylori. * patients who has agreed to participate to the study. exclusion criteria: * patients allergic to the any of the drugs used for eradication of h. pylori. * patients who do not agree to the study.

Keywords: eradication therapy mutation of 23s rrna of h. pylori personalized therapy
efficacy of corticosteroid injection into coracohumeral ligament in patients with adhesive capsulitis of the shoulder

Conditions: Direct Coracohumeral Ligament Steroid Injection

Summary: steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as rom, pain scale and stiffness of coracohumeral ligament under elastogram.

adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe pain and shoulder range of motion limitation. steroid injections are widely utilized to reduce inflammation and fibrosis. the thickening of the coracohumeral ligament was thought to play an important role in the pathogenesis of frozen shoulder, resulting in limited external rotation of the shoulder. while the elastogram of coracohumeral ligament will significantly increase stiffness under the shear-wave ultrasound (shear-wave elastography). therefore, in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as rom, pain scale and stiffness of coracohumeral ligament under elastogram. (the patient will not have additional risk of injection under ultrasound guidance)

Eligibility criteria:
a.inclusion criteria： 1. age 20-80 years old 2. unilateral shoulder pain more than 3 months 3. at least one shoulder rom limitation in three dimensions which decreased over 50% (abduction, flexion, external rotation) 4. visual analog scale more than 30 (total 100) 5. no fracture or subluxation or arthritis in shoulder xray. b.exclusion criteria： 1. history of shoulder or chest surgery 2. history of shoulder trauma in 2 recent years 3. ever receiving shoulder joint injection in recent 3 months 4. with cervical radiculopathy or any central cns disorders 5. with osteoarthritis or rheumatic arthritis of shoulder 6. diagnosed as rotator cuff tear, tendon calcification or bursitis 7. systemic diseases including diabetes or thyroid disorder 8. allergy history of steroid

Keywords: adhesive capsulitis
a bioequivalence study of two different peg-rhgh preparations

Conditions: Pediatric Growth Hormone Deficiency (PGHD)

Summary: the purpose of this study is to investigate whether peg-rhgh with new preparation is bioequivalent to peg-rhgh with present preparation.

the purpose of this study is to investigate whether peg-rhgh with new preparation is bioequivalent to peg-rhgh with present preparation.

Eligibility criteria:
inclusion criteria: * healthy male aged ≥18 years old and≤45 years old; * the body mass index (bmi): 19-26 kg/m2 (inclusive), and body weight ≥50 kg; * normal results of physical examination, vital signs, laboratory tests, 12 lead-ecg, chest x-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above. exclusion criteria: * subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; or a history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergy to two or more substances) * subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or suggest potential diseases, such as abnormal laboratory test results of liver and kidney function (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\] exceeding the upper limit of normal, or total bilirubin exceeding the upper limit of normal; or blood creatinine exceeding the upper limit of normal value); or other diseases (such as a history of mental illness) deemed unsuitable for participation in the trials by the investigators; * subjects with severe infection, severe trauma, or major surgery within 6 months prior to screening; * subjects who have received blood transfusions, had blood donors, or lost blood ≥400 ml within 3 months before screening; or plan to donate blood within 1 month of the end of the trial; * subjects who have positive results of human immunodeficiency virus antibodies (hiv-ab), or hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv-ab), or syphilis specific antibodies (tppa); * subjects who have participated in clinical trials for medication or medical device within 3 months prior to screening;etc.
acute exposure to high altitude on symptoms

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary hypertension (pah, cteph) to assess the acute response to high altitude (2500m above sea level) in altitude related symptoms

low altitude baseline measurements will be performed in zurich (460m asl) including echocardiography, right heart catheterization, 6mwt, pulmonary function test, clinical assessment and blood gas analysis. randomly assigned to the order of testing, the participants will be tested at low altitude (zurich, 470m) and high altitude (2500m). regularly during the exposure of approximately 5 hours, the participants will be asked to complete altitude related symptom questionnaires

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mpap ≥ 25 mmhg along with a pawp ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting pao2 ≤7.3 kpa corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, hape, etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: high altitude altitude related symptoms
monitor response to treatment in neuroblastoma using 3&apos;-deoxy-3&apos;-fluorothymidine- positron emission tomography (flt-pet)

Conditions: Neuroblastoma

Summary: the purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.

the purpose of this research study is to observe the changes within the tumor cells which may improve the understanding of how tumors grow and how they respond to various treatments. these changes will be compared with results of the physical examination and scans (ct and mri) that are done as part of clinical care. images will be made showing the distribution throughout the body of substances containing a small amount of radioactive material. this procedure is called a pet scan. the radioactive substances (tracer compound) in this study are \[f-18\] flt.

Eligibility criteria:
inclusion criteria: * all patients with neuroblastoma or suspected neuroblastoma seen at children's hospital of michigan (chm). patients need to be 2 years or older to be eligible for the initial study * patients must be 1 day to 21 years old, there is no gender limit. * diagnosis: all patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for objective 1. to be eligible for objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery * female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant * patients must be able to lie still for the tests, or have no contraindication for sedation * patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study * a total number of 40-50 patients will be included in the study exclusion criteria: * patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study * patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the objective 1 but excluded for objective 2.

Keywords: neuroblastoma