Kornimate/medical-research-clean huggingface dataset:
a clinical pharmacological study of mt-3921 in subjects with htlv-1 associated myelopathy (ham)

Conditions: HTLV-1-Associated Myelopathy (HAM)

Summary: the purposes of this study is to assess the safety, tolerability, and pharmacokinetics of mt-3921 in subjects with human t-cell leukemia virus type 1 (htlv-1)-associated myelopathy(ham). subjects meeting eligibility criteria will enter the 6-month double-blind period. subjects will be randomized in a 2:1 ratio to receive mt-3921 or placebo in a double blind manner.


Eligibility criteria:
inclusion criteria: additional screening criteria check may apply for qualification: * subjects aged 20 years or older on the day of consent * subjects with a confirmed diagnosis of ham according to the diagnostic algorithm of practical guideline for ham 2019 on the day of consent * subjects with an osame's motor disability score (omds) of ≥4 and ≤6 at screening and on the first day of the treatment period (predose) * subjects with no change in omds for at least 3 months before the day of consent * subjects with a csf concentration neopterin of ≥6 pmol/ml at screening * subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to ≤10 mg/day of prednisolone for at least 3 months before the day of consent exclusion criteria: additional screening criteria check may apply for qualification: * subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products * subjects exhibiting or with a history of malignant tumor. * subjects with adult t-cell leukemia/lymphoma (atl) or those with positive htlv-1 clonality test (southern blot) at screening and suspected of having atl * subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament * subjects with psychiatric disorders, epileptic seizures, or dementia. * subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the columbia suicide rating scale (c-ssrs) at screening and/or on the first day of the treatment period (predose) * subjects exhibiting or with a history of hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) infection. * subjects with the novel coronavirus disease 2019 (covid-19) * subjects with severe illness * male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product * female subjects who are pregnant, lactating, or may be pregnant * subjects who have received anti-repulsive guidance molecule (rgm) a antibody containing this investigational medical product * subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent
irt and cbt in sexual assault victims with ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: sexual assault victims (sav) have an elevated risk of developing posttraumatic stress disorder (ptsd). trauma-focused cognitive-behavioural therapy (cbt) is an effective first-line treatment for this pathology. however, although sleep disturbances are a common complaint in sav with ptsd, trauma-focused cbt does not directly address this symptom. posttraumatic nightmares are widespread among sav. trauma-related sleep disturbances are associated with significant impairment in general functioning and quality of life (mental and physical health), and contribute to the maintenance of ptsd symptoms. this study evaluates the efficacy of sequential nightmare therapy (imagery rehearsal therapy; irt) and trauma-focused cbt, in comparison to cbt alone. forty-two sav suffering from ptsd and sleep difficulties were recruited and randomly assigned to the experimental (irt+cbt) or control condition (waiting period followed by cbt alone). participants were administered a clinical interview and a series of questionnaires assessing ptsd symptoms, general functioning and quality of life.


Eligibility criteria:
inclusion criteria: * over 18 years of age; * able to understand and speak french; * history of unwanted sexual experience; * ptsd diagnosis according to dsm-iv-tr; * sleep complaints, as established by pittsburgh sleep quality index score ≥ 5 and a mean of one or more nm per week for at least one month; * if psychotropic medication was used, (antidepressant, antianxiety, antipsychotic or hypnotic medication) stable for a minimum of three months; * available for in-person assessments and therapy sessions. exclusion criteria: * past or present psychotic episode, bipolar disorder or organic mental disorder (e.g. dementia); * substance use disorder; * sleep apnea diagnosis; * use of prazosine to treat nightmares; * presently in treatment for psychological difficulties; * significant suicidal thoughts requiring immediate intervention.
effects of mtor inhibition with sirolimus (rapa) in patients with covid-19 to moderate the progression of ards

Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Respiratory Failure; Sars-CoV2

Summary: this study assesses the clinical effectiveness of mammalian target of rapamycin (mtor) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ali/ards) in participants infected with mild to moderate covid-19 virus.

this is a single center, double-blind, placebo-controlled, randomized clinical trial in which each participant, after admission to hospital with a diagnosis of mild to moderate covid-19 infection, will be administered either a dose of rapamycin or the placebo daily. each subject will receive the assigned treatment until hospital discharge or death. evaluations will be performed at the beginning of the clinical trial and then daily up to 4 weeks.

Eligibility criteria:
inclusion criteria: 1. over 60 years of age clinically judged to require hospitalization 2. sars-cov2 infection documented by positive rt-pcr nasopharyngeal swab 3. mild to moderate clinical status defined as clinical symptoms with or without pneumonia on imaging, with or without fever who are judged to require hospital admission 1. elevated ferritin 2. lymphopenia 3. bilateral opacities on chest x-ray 4. low pro-calcitonin 5. clinical signs suggestive of symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea or moderate illness with covid-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (spo2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute. exclusion criteria: 1. known or suspected allergy to rapa 2. high pro-calcitonin 3. sars-cov2 documented by negative rt-pcr nasopharyngeal swab 4. treatment with contraindicated concomitant medications: currently receiving immunosuppressants, including steroids, prior to enrollment, or with immunomodulators or immunosuppressant drugs, including but not limited to inter leukin (il)-6 inhibitors, tumor necrosis factor (tnf) inhibitors, anti-il-1 agents and janus kinase (jak) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 5. currently receiving immunosuppressants, including steroids, prior to enrollment 6. serious underlying disease including but not limited to cardiac, pulmonary, renal, hepatic (bilirubin \>1.5x upper normal limit (uln) or aspartate aminotransferase (ast)\>uln but bilirubin ≤ uln), endocrine (diabetes) or psychiatric disorders judged to be at risk in participating by the inpatient attending physician or team 7. suspected or confirmed history of alcohol or substance abuse disorder 8. having participated in other drug trials in the past month 9. deemed otherwise unsuitable for the study by researchers 10. clinically judged to not require hospital admission

Keywords: covid-19
alpers huttenlocher natural history study

Conditions: Alpers Huttenlocher Syndrome

Summary: this is a natural history study of alpers huttenlocher syndrome. patients will be followed over time to assess clinical symptoms for the purpose of expanding knowledge of this disorder in the medical community.

the study team will conduct outpatient visits to the medical center on a 6 month basis, or as patients are able. the patients or their caregivers will complete medical and symptom questionnaires.

Eligibility criteria:
inclusion criteria: * all individuals of any age with confirmed alpers huttenlocher syndrome (ahs) or siblings of confirmed ahs patients are eligible to participate. ahs requires the presence of polymerase gamma 1 (polg) pathological mutations, either homozygous or compound heterozygote mutations, and the presence of epilepsy and either, developmental regression or hepatopathy. if polg mutations are not demonstrated, ahs requires the presence of refractory seizures, developmental regression, and hepatopathy as well as two or more other clinical and laboratory findings including elevated cerebrospinal fluid (csf) protein, neuroimaging showing lactate peaks, reduced n-acetyl aspartate with hyperintensities on t2/flair in the thalamus and posterior head regions, optic atrophy/cortical blindness, quantitative mtdna reduction (\>30% ) in muscle and/or liver, non-specific electron transport chain (etc) enzyme deficiencies. * all patients must agree to participate in the north american mitochondrial disease consortium (namdc) clinical registry exclusion criteria: * patient does not have confirmed ahs and is not the sibling of a patient with confirmed ahs * not willing to participate in the namdc clinical registry
to evaluate patient preference of movantik and polyethylene glycol 3350 for opioid induced constipation

Conditions: Opioid Induced Constipation

Summary: the purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (movantik) or with polyethylene glycol 3350.

this study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. the study will assess the overall patient preference movantik versus polyethylene glycol 3350 for the treatment of their opioid-induced constipation. this study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by bowel function index. patient's bowel movement diary will also be collected during the study.

Eligibility criteria:
inclusion criteria: * male or female between the ages of ≥18 and \<85 years * self-reported active symptoms of oic (opioid induced constipation) based on components of the rome iv criteria at screening. patients should have at least 2 of the following: * \<3 sbms (spontaneous bowel movements) per week * straining \>25% of defecations * sensation of incomplete evacuation \>25% of defecations * lumpy or hard stools \>25% of defecations * sensation of anorectal obstruction/blockage \>25% of defecations * confirmed oic by bfi (bowel function index) ≥30 * stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies * willingness to stop all laxatives and other bowel regimens other than specified rescue medication exclusion criteria: * pain related to cancer or has a history of cancer within 5 years * current constipation or chronic constipation not caused by or related to use of opioids * history of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement * evidence of significant gi structural abnormalities, acute or chronic gi conditions that could post risk to the patient or confound the study results * recent surgery that may affect gi motility or increase risk for bowel obstruction or perforation * severe hepatic impairment * moderate or severe renal impairment * condition that may affect the permeability of blood-brain barrier * concomitantly using strong or moderate cyp3a4 inhibitors and strong cyp3a4 inducers * any other significant and/or progressive medical, surgical, psychiatric, or mental health condition or any significant laboratory findings that could increase the risk of participation in the study or affect the interpretation of study data as determined by the investigator

Keywords: opioid induced constipation, constipation, laxative, bowel movement, movantik, naloxegol
the efficacy of intravenous iron for the treatment of anemia in cancer patients

Conditions: Cancer; Anemia

Summary: * multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple. * currently, treatment options available for anemia in cancer patients include red blood cell (rbc) transfusion, erythropoietin stimulating agent (esa), and iron supplementation, accompanying considerable pros and cons for each treatment. * previous studies have demonstrated benefit when treating with iv iron in combination with esa and, more recently, evidence is emerging to suggest a role for iv iron alone. * in this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.


Eligibility criteria:
inclusion criteria: * subjects who diagnosed with solid cancer or lymphoma * subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment * anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent" * subjects whose hb level is 8.0-10.5g/dl, or who experienced a drop of hb by 2g/dl or more during anti-cancer treatment exclusion criteria: * subjects who received iron (oral or iv), esa, dialysis within 4 weeks before enrollment * subjects with uncontrolled infection * subjects with ongoing bleeding * deteriorated organ function * poor performance state (ecog 3-4) * subjects whose disease involves bone marrow * ferritin \> 800 ng/ml and transferrin saturation(tsat) ≥ 50%
improving the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma

Conditions: Lung Adenocarcinoma, Stage I

Summary: the goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. the main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. the multi-modal information of participants will be collected retrospectively.


Eligibility criteria:
inclusion criteria: ct examination within 3 months before surgery patients with operable clinical stage i lung cancer no previous treatment in the lungs or any other organ ≥ 20 years and ≤ 80 years old tumor less than 3cm in diameter on thin-slice (0.625-1 mm) ct images lung adenocarcinoma confirmed by surgical resection and histopathological diagnosis exclusion criteria: marked artifacts on ct images history of preoperative treatment incomplete clinical information or dicom images history of other malignant tumors lung cancer associated with cystic airspaces

Keywords: multi-modal information lung adenocarcinoma intraoperative diagnosis invasiveness
promoting hpv vaccination among young adults in texas

Conditions: Human Papillomavirus Infection

Summary: this clinical trial studies how to improve the human papillomavirus (hpv) vaccination rate in young adults in texas. this trial aims to learn more about how researchers and health care providers can increase hpv vaccination among college students.

primary objectives: i. to determine the impact of addressing individual and system levels of influence on hpv vaccination initiation and completion rates. ii. to gain insight into mechanisms of the intervention's efficacy, individual differences, and implementation of the intervention using mixed methods. outline: participants are randomized to 1 of 6 groups. group i: participants receive standard centers for disease control and prevention (cdc) information about hpv vaccination. group ii: participants receive video narratives about hpv vaccination. group iii: participants receive written narratives about hpv vaccination. group iv: participants receive enhanced access to vaccination and standard cdc information about hpv vaccination. group v: participants receive enhanced access to vaccination and video narratives about hpv vaccination. group vi: participants receive enhanced access to vaccination and written narratives about hpv vaccination. after completion of study, participants are followed up at 3 and 9 months.

Eligibility criteria:
inclusion criteria: * age 18-26 years. this criterion is based on the cdc recommendation of vaccination up to 26 years of age and the fact that individuals 18 years and older can consent by themselves for on-site vaccination * ability to read and understand english * self-identification as not yet having received any hpv vaccine injections. self-identification is justified because it is safe to be vaccinated again, which could happen if a previously vaccinated person forgets their vaccination. furthermore, in a person previously vaccinated with an older version of the vaccine, which targeted fewer hpv types, receiving the newer version would be advantageous and not cause any harm. alternatives to self-identification, such as obtaining medical records from doctors' offices, would be very challenging for young adults, especially for those who do not remember when and where they might have received vaccination * access to a smart phone, tablet or computer that is connected to the internet * current enrollment in one of the participating schools with an anticipated continuous enrollment of at least 9 months exclusion criteria: * being pregnant * having a life-threatening allergy to any component of the hpv vaccine
forces on teeth during videolaryngoscopy

Conditions: Tooth Injuries; Intubation Complication

Summary: in this randomized crossover trial the investigators test whether three different brands of videolaryngoscopes (vls) exhibit reduced forces on both upper and lower teeth, and compare them with a classic macintosh laryngoscope blade.

during endotracheal intubation the anesthesiologist uses a laryngoscope blade to distract the tongue to achieve the best view of the glottis opening, thereby avoiding using the maxillary incisors as a fulcrum to lever the soft tissues upwards. using the maxillary incisors as a fulcrum may otherwise result in dental trauma. it is obvious that contact with teeth and - even worse - the incidence of accidental dental trauma, is directly related to the difficulty of the intubation. indirect videolaryngoscopy has proven advantageous over direct laryngoscopy using a classic macintosh blade, for improved viewing of the glottis, with subsequent more successful intubations, and a shorter effective airway time both in patients with normal and difficult airways. previously, it has been demonstrated that the forces exerted by the anesthesiologist on the patient's maxillary incisors are reduced when using a vls, compared with a classic macintosh laryngoscope. however, only one type of vls (v-mac®, karl storz, tuttlingen, germany) was used or only forces applied to upper teeth were being registered.

Eligibility criteria:
inclusion criteria: * informed patient consent * asa i -iii * age \> 18 years * elective surgery, other than head and/or throat surgery * pre-operative mallampati i -iii * fasted (≥6 hours) exclusion criteria: * no informed patient consent * asa ≥ iv * age \< 18 year * emergency surgery, surgery of head and/of throat * locoregional anaesthesia * pre-operative mallampati iv * fasted \< 6 hours * pre-operative expected difficult airway * no teeth, bad dentition * dental crowns and/or fixed partial denture

Keywords: videolaryngoscopy forces teeth
evaluation of the performance of y-strut® medical device to strengthen pre-fractural tumour-induced lesions at the level of the proximal femur

Conditions: Pathological Fracture of Hip; Bone Metastases

Summary: hippon 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a y-strut® medical device implanted to prevent a high risk of impending pathological fracture. the primary objective of this study is to evaluate the performance of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation. a total of 100 patients from france will be enrolled (until november 2018) and followed up to 24 months.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * patient with information form signed to participate in the study; * patient presenting a cancer with bone metastases at the level of the proximal femur and having a y-strut® medical device implanted; * patient able to complete a questionnaire. exclusion criteria: * patient who refuse to participate to this study; * patient already enrolled in a clinical study, excluding his participation to hippon100.

Keywords: osteosynthesis prophylactic consolidation proximal femur
prognostic value of ptco2 in patients with covid-19

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: five percent of patients with covid-19 progressed to respiratory failure and required icu admission, such patients often have abnormal oxygen tolerance. however, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of covid-19.

five percent of patients with covid-19 progressed to respiratory failure and required icu admission. attention should be paid to patients over 65 years of age who have severe underlying diseases (cancer, respiratory diseases, cardiovascular and cerebrovascular diseases, chronic renal failure, autoimmune deficiency diseases, etc.) and have not completed the whole course of vaccine, and such patients often have abnormal oxygen tolerance, that is, a significant decrease in skin finger pulse oxygen saturation (spo2) can occur after daily activities. basal spo2 at admission is often associated with prognosis, but it is difficult to differentiate prognosis from responsiveness to treatment by changes in spo2 after oxygen therapy is administered clinically. however, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of covid-19.

Eligibility criteria:
inclusion criteria: * age: 18-80 years, male or female; patients with covid-9 pneumonia (typical imaging features of covid-19 pneumonia) (oxygen saturation ≤ 93% during air or arterial partial pressure of oxygen (pao2)/oxygen concentration (fio2) ≤ 300 mmhg at rest)； exclusion criteria: * pregnant or lactating women; patients who refuse to undergo transcutaneous tissue oxygen pressure monitoring; clinicians believe that patients are not appropriate; patients undergoing ecmo.

Keywords: ards respiratory failure covid-19