Kornimate/medical-research-clean huggingface dataset:
pre-operative immuno-modulatory sbrt (poims trial): a pilot trial in early stage nsclc

Conditions: Non-small Cell Lung Cancer

Summary: the current proposal is structured as a pilot trial to evaluate the impact of non-ablative sbrt (800 cgy x 3 fractions) as an immunomodulatory mechanism in patients with early stage nsclc who are surgical candidates. tumor, normal tissue and blood specimens will be analyzed for immunomodulatory changes including phenotypic changes in tumor cell surface marker expression, tumor and normal tissue microenvironment and gene expression profiles, serum/blood immune profile changes, and circulating tumor cell immunophenotypic and gene expression alterations. published literature showed that cytotoxic doses of xrt may not elicit a clinically meaningful alteration in the immune profile. further, studies using an animal model have concluded a fractionated regimen induces a greater abscopal effect than single dose radiation. furthermore, research has shown a regimen of 800 cgy x 3 fractions yielded the most significant changes in the immune profile compared to 2000 cgy x 1 or 600 cgy x 5. the immune response within the tumor milieu is a complex dynamic process with an interplay among lymphocyte subsets, antigen presenting cells/dendritic cells, macrophages, and tumor cells. the interactions between the various components is orchestrated by a variety of extracellular and intracellular signaling pathways involving ligand and cell surface expression, cytokine release, and activation or inhibition of a variety of t cell subsets. in order to comprehensively define the immunomodulatory effect of three fractions of 800 cgy on the primary tumor, the investigators will analyze the following: tumor cell surface phenotype, tumor microenvironment immune profile and gene expression profile, t cell repertoire changes in tumor tissue and peripheral blood, and circulating tumor cell phenotype and gene expression profiles. each of these components has been shown to be impacted by radiation in either a cell culture or animal model systems. by characterizing, quantitating and defining these changes related to three fractions of 800 cgy, it will directly provide important insights to inform rational uses of xrt and immunotherapy in the future.


Eligibility criteria:
inclusion criteria: * stage i-ii nsclc * adequate diagnostic biopsy tissue to allow pre-sbrt tumor analysis * candidate for oncologic surgery (lobectomy or sub lobar resection) for the lung cancer * lesion located peripherally, ≥ 2 cm from bronchial margin, and 1 cm from visceral pleura, with location deemed acceptable by cardio-thoracic surgeon for resection. * adequate pulmonary function test results exclusion criteria: * prior history of lung/chest wall surgery * prior chest radiation * prior immunotherapy * history of autoimmune disease * currently using immunosuppressive drugs

Keywords: non-small cell lung cancer sbrt
observational study of b-cell non hodgkin lymphomas (nhl) associated with hepatitis c virus (hcv)

Conditions: Chronic Hepatitis C

Summary: an prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and non hodgkin lymphomas. the characteristics , evolution and treatment of diseases will be observed from the study.

main objectives are: * description of the clinical and histological characteristics, treatment and evolution of these nhl. * study their physiopathology by immunological, virologic and molecular studies. the study included prospective or retrospective patients with b- cell non-hodgkin lymphomas (nhl) associated with chronic hepatitis c. the patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments. the enrolment period is 6 years and the total study lasts 8 years. * "prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years. * "retropective patients" are followed all the years during 2 or 5 years. at each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies. the enrollment is estimated at 140 patients.

Eligibility criteria:
inclusion criteria: * patients with evolving nhl whatever its histological type * at diagnosis or relapse or failure previous treatments stopped over 3 months * patients with hcv infection with positive quantitative viral load * 18 years or more of age * life expectancy greater than 6 months * signed and informed consent * benefit from social security exclusion criteria: * active uncontrolled infection (out hepatitis c) * hiv (human immunodeficiency virus) infection * severe psychiatric history

Keywords: b-cell non hodgkin lymphomas hepatitis c
exploring the effects of a baduanjin program on the symptoms of constipation in patients with schizophrenia spectrum

Conditions: Randomized Controlled Trial

Summary: patients with schizophrenia spectrum have been suffering from constipation due to long-term use of psychotropic medications and changes in physical activity and eating habits caused by diseases. aim this study was to examine the effectiveness of baduanjin program in improving the symptoms of intestinal peristalsis and constipation in patients with psychosis. method:a randomized controlled trial was conducted in tow psychiatric centers in northern taiwan.the experimental group was provided with an 8- session baduanjin program for 24 weeks (1 hour, thrice times per week), while the control group received routine care.

this study was conducted in two psychiatric center. residents in one of psychiatric center were allowed to walk for 20 min after dinner every day, and each unit residents rare active. in this study, patients on the schizophrenia spectrum were invited to receive screening for constipation syndrome. a total of 275 patients agreed to undergo the screening. in total of 112 patients satisfied the inclusion criteria, and 58 patients consented to participate in the experiment. each participant was assigned one number from 1 to 112 by the first author. the second author enrolled participants. they were randomized to either baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 3. patients in the experimental group (eg) participated in the baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 hour after dinner between 6 and 7 pm; the entire program continued for 24 weeks. the control group (cg) received routine care. the outcome indicators for this intervention program involved the risk factors for constipation, constipation symptoms, and intestinal peristalsis.

Eligibility criteria:
inclusion criteria: * comply with the diagnosis of the spectrum. * have the willingness to participate in the study and could read, communicate and cooperate with the completion of the consent form and questionnaire. * the age is 20 to 64 years old. * no need for any assistance in walking, and the gait is stable. * appeared more than 2 times in the past month for more than 3 consecutive days without resolving or routine use of laxatives exclusion criteria: * diagnosis is organic brain disease, alcohol and substance abuse. * there have been problems with gastrointestinal bleeding or lesions. * have a history of extensive abdominal surgery or gastrointestinal surgery. * there are medical considerations and medical expenses reduction activities.

Keywords: baduanjin program constipation intestinal peristalsis schizophrenia spectrum
the role of cobamamide supplements in malnourished patients

Conditions: Malnutrition

Summary: the trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.


Eligibility criteria:
inclusion criteria: * 18 - 70 years old * diagnosis of malnutrition based on 2019 glim criteria * participant agree to join the trial by signing infomed consent. exclusion criteria: * malignancy (ecog iv) and bowel obstruction * patients who unable to tolerate oral intake and in total parenteral nutrition * bowel disorder that caused severe malabsorbtion * patients who refuse to join the trial
comparison of the accuracy and reliability of amh, fsh and afc in predicting ovarian response

Conditions: Infertility

Summary: serum bio-markers have different prediction values for ovarian response during ovarian stimulation in-vitro fertilization


Eligibility criteria:
inclusion criteria: * age ≤ 45 years at the time of fsh starting * bmi \< 25 kg/m2, * first ivf attempt * receiving gnrh-antagonist protocol * had oocyte retrieval exclusion criteria: * had ovarian stimulation or ovulation induction within 2 months prior to the study * pcos * had ovarian tumor or endometrioma * hyperprolactinemia * thyroid hormone disorders * pituitary failure * had other medical situations such as liver failure, renal failure, heart disease, diabetes, depression * had ivm

Keywords: in-vitro fertilization ovarian stimulation
home-based arm and hand exercise program for stroke: a multisite trial

Conditions: Stroke

Summary: the goal of this multisite clinal trial is to evaluate the implementation of the home-based graded repetitive arm supplementary program (grasp) at rehabilitation clinics across several hospitals. the main questions it aims to answer is: • the efficacy of the home-based grasp program relative to the conventional occupational therapy intervention on improving health outcomes, including ue motor function, daily function, quality of life, and motor control strategies. stroke participants will be randomly assigned to either the home-based grasp group or the conventional occupational therapy home program group. each group will undergo an 4 to 6-week intervention (3 sessions/week) with evaluations conducted before, immediately after, and 3 months post-trial, assessing clinical and kinematic measures. interviews and surveys will be conducted to gain insights into the perspectives of patients regarding the implementation of the home-based grasp program.


Eligibility criteria:
inclusion criteria: * are aged 20 years or older * have upper extremity hemiparesis due to the first-ever stroke * have some voluntary movement in the affected ue * are able to follow 2-step instructions exclusion criteria: * orthopedic conditions affecting the arm/hand or other neurological conditions * severe pain that prevents movement in the affected arm and hand * unstable medical status
association between laparoscopic removal of endometriomas and anti-mullerian hormone levels

Conditions: Endometriosis; Ovarian Reserve

Summary: laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. however there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. available evidence on the topic are contradictory and employed research methodology are diverse. there is need for an adequately powered research with proper methodology to assess actual effects of surgery.


Eligibility criteria:
inclusion criteria: * women with endometrioma cyst(s) * women of age under 35 years old * women without any previous ovarian surgery exclusion criteria: * combined oral contraceptive or long term gnrh (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment * having another cystic lesion besides endometrioma * need for extensive bipolar coagulation during surgery * any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound * postoperative pathology excluding endometrioma

Keywords: endometrioma laparoscopy anti-mullerian hormone ovarian reserve
a randomised controlled trial of family mediated exercises (fame) following stroke

Conditions: Weakness; Balance

Summary: the aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. the first group or the experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. the second group or the control group will receive routine therapy with no additional formal input from their family members. a secondary aim of the project is to evaluate the impact of the fame programme on the person with stroke and the individual (s) assisting in the delivery of exercises.

participants with primary stroke eligible for inclusion to the study at 2 weeks post stroke will be randomised into either a 'control' group that will receive routine therapy or an 'experimental' group that will receive routine therapy and additional 'family mediated exercise therapy. training will be provided to the nominated family member (s)/friends of participants in the 'intervention' group on a weekly basis by the research physiotherapist (r1). family members/friends will be requested to keep an exercise diary on a daily basis to document completion of exercises. the trial will continue for eight weeks with an expectation that at least 1200 additional minutes of fame therapy will be delivered over this time period. each fame session is expected to last 35-40 minutes. exercises will include repetitive sit to stand exercises with an emphasis on improving symmetry, weight bearing exercises during standing, bridging, straight leg raises, quadriceps strengthening exercises, active/active assisted range of movement exercises for the lower limb and walking. outcome will be assessed by a blinded outcome assessor (r2) on entry to the study, at eight weeks (post-intervention) and again three months post-intervention (follow-up) in addition, a semi-structured interview will be carried out with a random sample of the participants and their family member (s)/friends to gain a more qualitative insight into the impact of the programme on those involved. this interview will be completed by a person unknown to the participant. (r3)

Eligibility criteria:
inclusion criteria: * diagnosis of first unilateral stroke * patients who score between 3.2 and 5.2 on the orpington prognostic scale * patients participating in a physiotherapy programme * patients willing to give informed written consent * patients with family willing to participate in their assigned physiotherapy intervention programme exclusion criteria: * hemiplegia of a non-vascular origin * discharged from hospital less than two weeks following stroke * pre-existing neurological disorder * any lower limb orthopaedic condition that may limit exercise capacity * aphasia * cognitive impairment * not willing to give written consent

Keywords: exercise frequency duration
clinical trial to evaluate of efficacy and safety of ginsengberry concentrate on fatigue.

Conditions: Fatigue

Summary: the investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.

previous studies have indicated that ginseng root may have the ability to improve fatigue. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ginsengberry concentrate on improvement of fatigue in adults; the safety of the compound are also evaluate. the investigators examine fss(fatigue severity scale), cis, lactate, ammonia, exercise test at baseline, as well as after 4 and 8 weeks of intervention. 88 adults were administered either ginsengberry concentrate or a placebo each day for 8 weeks.

Eligibility criteria:
inclusion criteria: - cis \> 76 points exclusion criteria: * a person who feels tired due to surgical operation within 6 months. * drug/alcoholic hepatitis, cirrhosis, and fatty liver * anorexia or bulimia * a person on night duty, shift work, or heavy redundancy * a person who is unable to perform an exercise load test * a person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue. * a person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue. * a person who continues to exercise regularly within three months of visiting * immunosuppressants, sleep-inducing drugs, antidepressants, sleeping pills, and antihistamines
the clinical application of mcces in examination of human colon

Conditions: Abdominal Pain; Diarrhea; Hematochezia

Summary: this study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.

colorectal cancer (crc) is the second leading cause of cancer-related deaths in the western world. the screening tests include flexible sigmoidoscopy, optical colonoscopy (oc), double-contrast barium enema , or ct colonography . such screening can reduce crc incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .colon capsule endoscopy(cce) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by chongqing jinshan science \& technology. while screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. however, there's little data report on this colon capsule robot system in clinical application. the investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.

Eligibility criteria:
inclusion criteria: * patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or * patients who volunteer to the colonoscopy screening. exclusion criteria: * dysphagia or swallowing disorder, * congestive heart failure, * renal insufficiency, * prior major abdominal surgery of the gastrointestinal tract, * known or suspected bowel obstruction, * presence of a cardiac pacemaker or other implanted electromedical devices, * allergy or contraindication to the medications used in the study.

Keywords: colon capsule magnetic maneuverability colonoscopy
lesinurad and febuxostat combination extension study in gout

Conditions: Gout

Summary: this study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

this is a phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in study rdea594-304.

Eligibility criteria:
inclusion criteria: * subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. * subject completed the double-blind treatment period in study rdea594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the month 12 visit. * subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication. exclusion criteria: * subject has any medical or psychological condition, which in the opinion of the investigator and/or the medical monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Keywords: gout
matuzumab treatment with epirubicin, cisplatin and capecitabine (ecx) in esophago-gastric cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: the purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ecx chemotherapy, with ecx chemotherapy. participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.


Eligibility criteria:
inclusion criteria: * histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus * metastatic disease * immunohistological evidence of epidermal growth factor receptor (egfr) expression from archived tissues * eastern cooperative oncology group performance status (ecog ps) 0-1 * at least 1 measurable lesion (modified world health organization criteria) exclusion criteria: * previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (\>) 12 months prior to study treatment * radiotherapy or major surgery within 4 weeks prior to treatment * brain metastases * peripheral neuropathy or ototoxicity greater than or equal to (\>/=) grade 2 (national cancer institute common terminology criteria for adverse events version 3 \[ncictc v3\]) * abnormal electrocardiogram (ecg)

Keywords: esophagus gastric adenocarcinoma egfr matuzumab emd 72000 randomized epirubicin cisplatin capecitabine metastatic esophago-gastric cancer
low back pain among care-seeking families in general practice

Conditions: Low Back Pain

Summary: background low back pain (lbp) is the largest cause of years lived with disability worldwide and often associated with low quality of life, inability to work and low physical activity levels. in danish general practice, lbp accounts for nearly 10% of all yearly consultations, making it the number one reason for consulting a general practitioner in denmark. an increase in care-seeking children and adolescents with lbp in general practice is seen in the pre-teen-age-years. at present, no study has investigated on the natural prognosis of lbp among care-seeking adolescents in general practice. furthermore, the potential impact of patient and parent-related factors on prognosis remains unknown. the aims of the study are to 1) investigate the natural prognosis of lbp and 2) identify patient and parent-related factors which my influence prognosis. methods adolescents aged 8 to 19 years consulting their general practitioner due to lbp will be invited to participate in this prospective cohort study. one parent of each patient will be invited to be a part of the parallel cohort. online questionnaires will be used to collect data on patient characterises, pain intensity, pain frequency, medication, health-related quality of life, physical activity and illness perception at baseline and at the one-year follow-up. data on pain intensity and parent-related worries will be collected through biweekly text messages. lbp will be assessed by latent class analysis. discussion this study will be the first to uncover the natural prognosis of lbp within a young, care-seeking population in general practice and to investigate if factors related to the patient or parents influence prognosis.


Eligibility criteria:
inclusion criteria: for adolescents in the primary cohort: * age between 8 and 19 * experiencing low back pain for parents in the parallel cohort: - parent or legal guardian of included adolescents exclusion criteria: - not providing informed consent.

Keywords: low back pain adolescent parent prognosis general practice