Kornimate/medical-research-clean huggingface dataset:
evaluation for young children with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: collaborative early management of children under 30 months with autism spectrum disorder and their families in an ambulatory child psychiatry unit.

early intervention in autism spectrum disorder (asd) is now considered a priority. an approach that targets both child disorders and parental distress, and supports the skills of parents, is desirable. yet there is no early intervention by the asd involving parents and targeting both child functioning and parenting skills specifically. our objective is to evaluate quantitatively and qualitatively the collaborative family support system for asd "coquille". this scheme combines the development of a personalized care project based on parents' priorities, an intensive single-family parent-child follow-up and a group of multi-family therapy , over a total period of 6 months. our main hypothesis is the significant decrease in behavioral disorders of children, evaluated by cars, following the coquille device. our secondary hypotheses concern the evolution of parental dimensions following the device (sense of coherence, parental skills, parental stress, coping strategies and social support). we assume that these dimensions will change as a result of the scheme, and that they will be maintained in the medium term, six months after coquille. a semi-structured interview will qualitatively explore the dimensions related to family resources, before and after the follow-up and in the medium term. this will also allow the mother to collect experience of the device.

Eligibility criteria:
inclusion criteria for the mother and the child: * age 18 years and over * french language spoken and written by the parent * free and informed consent form , initialled and signed by the parent * child under 30 months of age at time of inclusion, diagnosed with autism spectrum disorder * total cars score greater than or equal to 30 * free and informed consent form, initialled and signed by legal representatives exclusion criteria for the mother only: * any acute, somatic or psychiatric clinical condition of the mother not compatible with therapeutic intervention. * current engagement in an interventional research protocol * mother under protection of justice, guardianship or enhanced curatorship * mother no longer having parental authority

Keywords: autism spectrum disorder - coquille device
electro-massage in subjects with subacromial pain syndrome

Conditions: Subacromial Pain Syndrome

Summary: objectives: establishing and validating an electrotherapy procedure with interferential current (ifc) application using electro-massage on patients who have undergone acromioplasty surgery. to evaluate the possible decrease in pain perception and improvement of functionality following surgical intervention. design: randomized, single blind clinical trial. subjects: 18-patients, aged 18 to 65, with a similar distribution of male and female participants methods: 10-patients will be enrolled in the experimental group and 8 patients as the control group. both groups of patients will undergo six physiotherapy sessions (three times a week). the experimental group will undergo a treatment consisting of electro-massage with constant voltage (cv) ifc bipolar application, 4000 hz carrier current and 100 hz amplitude modulated frequency (amf). two 48 cm2 electrodes will be used. session length with electrotherapy will be approximately ten minutes.


Eligibility criteria:
inclusion criteria: * patients having undergone acromioplasty surgery in the three months prior to the first day of physiotherapy treatment exclusion criteria: * value equal to or less than 45 in personal psychological apprehension scale, showing any absolute contraindication for physiotherapy or electrotherapy treatment, fear or apprehension for electrotherapy application, not signing informed consent, showing alterations in local level sensitivity (cervical-scapulohumeral complex), showing bone fracture associated with scs, having been applied local infiltration with corticoids following surgery and having started physiotherapy treatment before signing informed consent.
two different tactile stimulus methods

Conditions: Pain

Summary: this study was conducted to evaluate the effects of the shotblocker and palm stimulator, developed by researchers for reducing pain during intramuscular (im) injections in children.

objectives: this study was conducted to evaluate the effects of the shotblocker and palm stimulator, developed by researchers for reducing pain during intramuscular (im) injections in children. design: the study was conducted via a randomized controlled design. setting: the study population consisted of children in the seven to 10 age group admitted to the emergency department of a public hospital (kahta state hospital) between february 2019 and july 2019 and who received an im injection as part of the medical treatment. interventions: the study data were collected from the children, who were divided into palm stimulator, shotblocker, and control groups. main outcome measures: the children's pre-procedure fear levels were evaluated using the children's fear scale (cfs), and their pain levels during the procedure were evaluated using the facial pain scale-revised (fps-r). the children also reported injection-related pain levels using the visual analog scale (vas).

Eligibility criteria:
inclusion criteria: children who * had no diagnosed physical or mental disability or chronic illness; * had no communication problems; * received single injection, * required ampicillin + sulbactam group of antibiotics for standardization; and * received ventrogluteal muscle injection during the study. exclusion criteria: * parents who were unable to collaborate in the fear and pain evaluation, * overweight or underweight children (under the third or above the 97th percentile), * children with any incision or scar tissue in the injection area, * children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history

Keywords: pain management child nursing practice intramuscular injection
phase 2 randomized, double-blind, placebo-controlled, parallel group trial of linaclotide administered to patients with opioid-induced constipation receiving chronic opioid treatment for non-cancer pain

Conditions: Opioid-Induced Constipation

Summary: the purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (oic), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. this study included up to a 4-week screening period, and a 2 to 3-week pretreatment period. patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. this 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of oic.


Eligibility criteria:
inclusion criteria: * patient has chronic non-cancer pain that has been present for a minimum of 3 months * patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks * patient meets protocol criteria for opioid-induced constipation (oic): \< 3 spontaneous bowel movements (sbms) per week and reports one of the following symptoms for at least 4 weeks: 1. straining during \> 25% of bms 2. lumpy or hard stools during \> 25% of bms 3. sensation of incomplete evacuation during \> 25% of bms * patient meets the colonoscopy requirements defined by the american gastroenterological association guidelines * patient has successfully completed protocol procedures (with no clinically significant findings) * patient is compliant with interactive voice response system (ivrs) for daily diary reporting * patient has a total of \< 6 sbms in ivrs during the 14 days before and up to the time of randomization * patient has adequate relief and well-controlled pain with current dose of opioid exclusion criteria: * patient has been using opioids for abdominal pain * patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment * patient has symptoms of or been diagnosed with irritable bowel syndrome (ibs) prior to initiation of opioid treatment * patient has a history of loose or watery stools for \> 25% of bms during the 3 months before the screening in the absence of laxatives, suppositories, or enemas * patient has a structural abnormality of the gastrointestinal (gi) tract or a disease or condition that can affect gi motility * patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Keywords: opioid-induced constipation linaclotide linzess
prostate-specific membrane antigen antibody-drug conjugate in subjects with prostate cancer

Conditions: Prostate Cancer

Summary: prostate-specific membrane antigen antibody-drug conjugate (psma adc) 1301 is an open-label, dose-escalation phase 1 study of psma adc administered iv in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. for all subjects, psma adc will be administered in four repeating cycles.


Eligibility criteria:
inclusion criteria: 1. a diagnosis of progressive, castration-resistant, metastatic prostate cancer. 2. prior chemotherapy regimens, one of which contains taxane. 3. eastern cooperative oncology group status of 0 or 1 exclusion criteria: 1. clinically significant cardiac disease or severe debilitation pulmonary disease 2. evidence of an active infection requiring ongoing antibiotic therapy 3. any prior treatment with any other therapy targeting psma 4. history of drug and/or alcohol abuse
functional results of soft palate free flap reconstruction

Conditions: Oropharyngeal Cancer; Palate Free Flap Reconstruction

Summary: the oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. the removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. the main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation. the treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. surgery is often kept for relapses, because it is considered to lead to important sequelae. however, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important. recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. in addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity. it is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction. there is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.


Eligibility criteria:
inclusion criteria: * patients with oropharyngeal tumor who had surgical management with removal of all or part of the soft palate and free flap reconstruction, and at least 12 month after the end of external radiotherapy treatment * patients over 18 years old exclusion criteria: * patients protected by law (guardianship, curatorship and under judicial protection) * patients who expressed their opposition to participate to the study * patients who do not speak french (incompatible with reading, understanding and filling out the questionnaires) * patients participating in interventional research (excluding physiological studies and interventional research with minimal risks and constraints that do not interfere with the primary endpoint analysis)
clinical performance of advanced self- adhesivee resin composite hybrid restorations.

Conditions: Caries Class II; Caries,Dental

Summary: clinical performance according to modified usphs criteria of advanced self-adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.


Eligibility criteria:
inclusion criteria: * patients with carious proximal cavities in molars * good oral hygiene. * presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. exclusion criteria: * teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. * severe periodontal problems.

Keywords: self-adhesive resin composite hybrid restorations posterior resin composite surefil one
strides for life i: increasing physical activity in stage 1 lung cancer patients

Conditions: Lung Cancer

Summary: this randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational control group results in improved function at 6-months.

this is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small cell lung cancer patients, whether induction of positive affect vs. an educational control group, results in improved function as assessed by the 6-minute walk test. our primary outcome will be a within-patient change in the 6-minute walk test at 6 months.

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer (stage 1) exclusion criteria: 1. cognitive impairment 2. inability to walk 3. \< 12 month anticipated survival 4. enrollment in other behavioral programs 5. lack of medical approval to participate 6. substance/alcohol dependence or participation in a substance abuse treatment program within 12 months 7. major psychiatric illness.

Keywords: physical activity non-small lung cancer positive affect
physical activity level and insomnia

Conditions: Primary Dysmenorrhea

Summary: this study aims to investigate the relationship between physical activity levels and insomnia in females with primary dysmenorrhea.

this study will be designed as a case-control study, conducted on 150 females recruited from el_nassr hospital in helwan, cairo, egypt and from social media. patients will be divided into two equal groups: group a(75 patients complain from pd according to walidd score)\& group b(75 patients don't complain from pd according to walidd score). all data and information of each female in this study, including name, age, address, weight, height, and menstrual history, will be recorded in a recording data sheet. walidd score will be used to assess pd symptoms, insomnia severity index will be used to assess insomnia, international physical activity questionnaire (short-form)\& six-minute walk test will be used to assess physical activity levels. inclusion criteria: 1)patient ages will be ranged between 18-25 years old, 2)they do not receive any drugs, 3)being a virgin. participants will be excluded if they 1) using hormonal contraception (such as oral contraceptives and injections), 2)taking any medications, 3)history of chronic disease, 4)having any psychiatric or gynecological problems (such as pco, amenorrhea, women who suffered from menopause). the subject, who missed for any of assessment session, would be withdraw form the research.

Eligibility criteria:
inclusion criteria: 1. patient ages will be ranged between 18-25 years old. 2. they do not receive any drugs. 3. being a virgin . exclusion criteria: 1. using hormonal contraception (such as oral contraceptives and injections). 2. taking any medications. 3. history of chronic disease. 4. having any psychiatric or gynecological problems (such as pco, amenorrhea, women who suffered from menopause).

Keywords: physical activity level insomnia
robotic vs. laparoscopic distal pancreatectomy for pancreatic cancer

Conditions: Pancreatic Tumor

Summary: the present randomized controlled trial evaluates the incidence of r1 resections in patients undergoing robotic distal pancreatectomy compared to the laparoscopic technique.

surgical resection the only potentially curative therapeutic approach in patients with pancreatic cancer. among the clinicopathologic factors that are associated with long-term survival, a complete (i.e. r0) tumor resection is of utmost significance. numerous reports have already demonstrated detection of tumor cells at the resection margin on microscopic examination (i.e. r1 resection) is associated with poor long-term survival. however, studies using a standardized pathological work-up of operative specimen from patients with pancreatic cancer revealed that most pancreatic resections are r1 resections. innovative surgical techniques that reduce the incidence of r1 resections may provide a promising approach to improve the outcome of patients with pancreatic cancer. for patients requiring a distal pancreatectomy, a laparoscopic pancreatic resection is increasingly performed, as it may enhance postoperative recovery without compromising oncological safety compared to the open approach. however, laparoscopic technique does not affect the proportion of patients with complete (r0) resections. furthermore, the inability to control major vasculature frequently results in conversion to the open approach. the vast majority of r1 margins are located at the retroperitoneal dissection surface. due to technical limitations, the open and the laparoscopic technique may not further reduce the incidence of positive resection margins at this location. the 3d visualization provided by the robotic approach together with improved dexterity of the surgeon are likely to enable a meticulous dissection at the posterior dissection margin. this may result in a significant reduction of patients with positive resection margins. however, to date there has been no randomized controlled trial that compared the robotic to the laparoscopic technique. as health-care interventions need to prove efficacy and safety in well-designed randomized controlled trials, the present randomized controlled trial was designed to test, if robotic distal pancreatectomy increases the incidence of patients with complete (r0) tumor resection for pancreatic cancer. secondary endpoints include oncological parameters such as the number of harvested lymph nodes and factors of perioperative outcome such as perioperative complications (clavien-dindo classification), pancreatic fistula, in-hospital mortality, blood loss and conversion rates.

Eligibility criteria:
inclusion criteria: * suspected malignant disease of the pancreas scheduled for distal pancreatectomy * patient eligible for laparoscopic resection * ≥ 18 years of age * written informed consent exclusion criteria: * planned multi-visceral and/or vascular resection * evidence of distant metastases * expected lack of compliance
p4ace trial for persons with chronic knee pain

Conditions: Knee Osteoarthritis

Summary: the goal of this single-blind, cross-over clinical trial is to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (oa). in this cross-over trial, participants will perform two types of walking on a treadmill. intermittent walking will involve 3 blocks of 10 minutes with 2 blocks of 5-minute rest (sitting on a chair) in-between. continuous walking will involve resting for 10 minutes (sitting in a chair) before walking on the treadmill for 1 continuous block of 30 minutes.

the study objectives are to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (oa). the investigators hypothesize that continuous walking will result in greater increases in clinical pain and mechanistic pain sensitivity than intermittent walking. physical activity (pa) has been recommended as the first-line management strategy for people with chronic knee pain. walking is an accessible, low-cost, joint-friendly form of pa and is widely advocated for older adults with knee complaints. however, movement-evoked pain is a commonly cited barrier for pa engagement. on one hand, a bout of pa may produce short-term analgesia and reduce pain. on the other hand, excessive or prolonged pa may exacerbate symptoms and lead to avoidance/fear of subsequent pa. besides the total pa volume, how it is accumulated could also impact joint health. it is biomechanically plausible that shorter and frequent activities are more beneficial to articular tissues than longer and infrequent activities. compared to intermittent loading, prolonged continuous loading had a detrimental effect on the biomechanical functions of articular cartilage in a bovine model. findings of this study will provide insight on the relations between patterns of pa and pain profiles.

Eligibility criteria:
inclusion criteria: * men or women aged 45-75 years * bmi ≤ 35 kg/m2 * frequent movement-related knee pain (knee pain on more than half the days of the past month) * no morning stiffness or morning stiffness lasting \< 30-min * self-reported unilateral or bilateral knee pain of ≥ 3 and ≤ 7 on a 0-10 numeric pain rating scale (nprs) * knee pain duration ≥ 12 months * physically able to walk unassisted on a treadmill at ≥ 4 km/hour for 30 minutes * own a smart phone * willing and able to wear an activity monitor and answer electronic survey questions delivered via a smart phone over a 10-day period. exclusion criteria: * intra-articular steroid injections in the previous 3 months * intra-articular hyaluronic acid injection in the previous 6 months * any arthroscopic or surgical knee procedures (e.g., partial meniscectomy) in the past 12 months * lumbar radiculopathy * neurological, vestibular, or visual dysfunction affecting walking balance and mobility * plan for total knee arthroplasty in the next 12 months
study of weight loss using gastric stimulation in obese patients

Conditions: Obesity; Morbid Obesity

Summary: the purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.

the purpose of this study was to evaluate efficacy and safety of the igs system in a population of patients with a bmi between 35 and 55 kg/m2. shape was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the igs system.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age at time of screening * bmi of 35 to 55 kg/m2 at time of screening * patients with a reported history of five years of obesity (bmi \> 30 kg/m2) exclusion criteria: * patients who are excluded by the screening algorithm * patients scoring 29 or higher on the binge eating scale questionnaire * patients taking any weight loss medication or other drugs that can affect body weight

Keywords: obesity morbid obesity shape igs implantable gastric stimulator