Kornimate/medical-research-clean huggingface dataset:
a phase 3, bridging, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of subcutaneously administered bremelanotide in premenopausal women with hypoactive sexual desire disorder (with or without decreased arousal)

Conditions: Hypoactive Sexual Desire Disorder

Summary: the purpose of this study is to evaluate the efficacy and safety of subcutaneously administered bremelanotide in premenopausal women with hypoactive sexual desire disorder(with or without decreased arousal).


Eligibility criteria:
\[main inclusion criteria\] * has met diagnostic criteria for hsdd for at least 6 months * is willing and able to understand and comply with all study requirements * has a normal pelvic examination at screening \[main exclusion criteria\] * subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results * not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

Keywords: kd-bmt-301 bremelanotide
effects of intra-operative intra-articular cocktail injection in patella open reduction and internal fixation

Conditions: Patella Fracture

Summary: the objective of this study is to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients, by comparing post-operative pain relief and functional recovery among study subjects who received the injection and those who did not receive the injection. secondary objective is to demonstrate the health economic effects of intra-articular analgesics cocktail injection by reducing length of hospital stay and reducing bed-stay related complications.

this is a single-centre, double-blinded, randomised control trial that evaluates the efficacy of intra-articular analgesics cocktail injection in post-operative pain relief and functional recovery for fractured patella fixation patients. the recruited study subjects will be randomised to the two study groups respectively in a 1:1 randomisation ratio. patella is the largest sesamoid bone in the human body, it acts as the fulcrum of our knee extensor apparatus and is important during the gait cycle. patella fracture commonly occurs after a fall on a flexed knee. treatment can be conservative or surgical with open reduction and internal fixation. patients often experience significant pain around the knee post-operatively, limiting their walking ability and hindering their rehabilitation. as a result, total hospital stay will be prolonged, leading to hospital stay-related morbidity and additional healthcare economic burden. previous studies have shown that the use of an analgesic cocktail injection in arthroplasty cases can significantly reduce early postoperative pain and provide better early motion. the cocktail regime is as follows for a unilateral joint: ketoralac 15mg ropivacaine 1% 15ml 0.9% normal saline 35ml adrenaline 1:1000 0.5ml stacort-a triamcinolone acetonide 40mg total cocktail volume \~50ml after fracture fixation, patients in the intervention group will receive an intra-articular injection of the above analgesic cocktail, while patients in the control group will not receive an injection. herein this study, the investigators hope to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients.

Eligibility criteria:
inclusion criteria: * acute patella fracture requiring open reduction and internal fixation; * able to consent to surgery; * pre-morbid able to ambulate exclusion criteria: * open fracture; * polytrauma; * previous knee arthroplasty; * history of chronic pain, * insulin-dependent diabetes mellitus, or peptic ulcer disease; * chronic users of glucocorticoids, immunosuppressants, or immune-modulating agents, or of strong opioids (e.g.: morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine); * hepatitis b or c carrier; * renal impairment (creatinine \[cr\], \>200 mmol/l)

Keywords: intra-articular analgesic injection pain relief open reduction and internal fixation functional recovery rehabilitation range of motion post-operative recovery
study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail

Conditions: Pancreas Cancer; Fistula

Summary: randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. the "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface. trial evaluation will be a. the pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. x-amylase and x-protein as long as the patient has the external drain. b. co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Eligibility criteria:
inclusion criteria: * inclusion criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate. exclusion criteria: * the patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

Keywords: pancreas leakage fistula tail
effect of shoulder sling use on balance and mobility in subacute stroke patients

Conditions: Hemiplegia; Balance Disorders; Mobility Limitation; Shoulder Subluxation; Stroke

Summary: this study examines whether wearing a shoulder sling can improve balance and mobility in people who are recovering from a stroke. participants will perform simple movement and balance tests twice-once with the sling and once without. the goal is to find out if using the sling helps patients feel more stable and safe during walking and everyday activities.

this is a cross-over study designed to evaluate the impact of shoulder sling use on balance and functional mobility in patients recovering from stroke in the subacute phase. participants will be asked to complete three validated functional tests: the timed up and go (tug) test, the functional reach test (frt), and the modified four square step test (mfsst). each test will be performed twice, once with the shoulder sling and once without, in randomized order. the study aims to determine whether the sling provides measurable benefits in stability and performance during movement tasks. data will be collected in rehabilitation centers under the supervision of clinical researchers.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke in the subacute phase (up to 6 months post-onset) * hemiplegia affecting one upper limb * brunnstrom stage \< 4 for the affected upper limb * functional ambulation category (fac) score \> 3 * age between 40 and 80 years * ability to follow simple instructions * medically stable to participate in balance and mobility testing * signed informed consent exclusion criteria: * severe cognitive impairment (e.g. mmse \< 23) * visual or vestibular disorders affecting balance * significant orthopedic or musculoskeletal conditions of the lower limbs * uncontrolled cardiovascular or pulmonary disease * use of assistive devices that prevent sling application * severe aphasia interfering with understanding or communication * skin lesions or injuries at the shoulder region preventing sling use

Keywords: stroke hemiplegia mobility dynamic balance balance shoulder brace arm sling
hlx07(anti-egfr mab) in patients with advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of hlx07 administered as a single-agent by iv infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.


Eligibility criteria:
inclusion criteria: * volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (icf); * aged ≥ 18 years, ≤ 75 years; * patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy; * measurable disease according to recist version 1.1; * eastern cooperative oncology group (ecog) performance status 0 or 1; * expected survival 12 weeks; * adequate organ function; * for fertile female subjects, the pregnancy test must be negative within 7 days before the first dose; exclusion criteria: * prior anti-egfr (including egfr adc) monoclonal antibody therapy; * a history of other malignancies within two years, except for cured localized tumor; * participants with any prior allogeneic solid organ or bone marrow transplantations; * symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable); * uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; * active clinical severe infection;
combined occipital and supraorbital transcutaneous nerve stimulation for treatment of migraine

Conditions: Migraine

Summary: this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (neurolief device, relievion™).


Eligibility criteria:
inclusion criteria: 1. males and females ages of 18 to 65 years old. 2. history of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ichd (international classification of headache disorders)-iii beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction). 3. capable to corporate with the study protocol and to sign an informed consent. exclusion criteria: 1. patients having received botox treatment in the head region in the prior 4 months. 2. patients having received supraorbital or occipital nerve blocks in the prior 4 months. 3. history of medication overuse headache. 4. patients using opioid medication. 5. allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation). 6. implanted metal or electrical devices in the head (not including dental implants). 7. patient having had a previous experience with the relievion™ device. 8. patients who have concomitant epilepsy. 9. history of neurosurgical interventions. 10. patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps. 11. history of drug abuse or alcoholism. 12. participation in current clinical study or participated in a clinical study within 3 months prior to this study. 13. skin lesion or inflammation at the region of the stimulating electrodes. 14. personality or somatoform disorder. 15. pregnancy or lactation. 16. women with child bearing potential without medically acceptable method of contraception. 17. history of cerebrovascular event. 18. subjects with recent brain or facial trauma (occurred less than 3 months prior to this study). 19. patients using cannabis 20. patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
effect of pentoxifylline on tight junctions (tjs) of intestinal mucosa in patients with irritable bowel syndrome(ibs)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with ibs.

disruption of the intestinal epithelial barrier is part of the pathophysiology of ibs favoring immune activation present in the mucosa of these patients and the development of symptoms in ibs. to evaluate the effect of treatment with pentoxifylline (ptx) in patients with ibs related to clinical response and modulation of the components of the epithelial barrier at the level of intestinal mucosa.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old * most of the patient with ibs will be chose between the patients who go to digestive system ambulatory external medical office from our center. * be studied and with clinical monitoring al least 6 months before be included. * fulfill with roma iii criteria for ibs (gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to modification francis scale exclusion criteria: * 2 weeks before colon biopsia, any patient cann´t take salicylates, nsaid, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea. * 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive * 6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy. * pentoxifilina alergic reactions * pregnants * grave kidney failure * grave hepatic failure * menthal or legal disability to sign the consent

Keywords: pentoxifylline tight junction signalling intestinal epithelial barrier irritable bowel syndrome
alemtuzumab in treating patients with waldenstrom's macroglobulinemia

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: this phase ii trial is studying how well alemtuzumab works in treating patients with waldenstrom's macroglobulinemia.

objectives: * determine the objective response in patients with waldenstrom's macroglobulinemia treated with alemtuzumab. * determine the time to treatment failure in patients treated with this drug. * determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive alemtuzumab iv over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. patients with a complete response undergo observation. patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12. patients are followed every 6 months for 2 years. projected accrual: a total of 13-27 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma) * immunoglobulin (ig) m, igg, and iga paraprotein * measurable monoclonal paraprotein * failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab) * cd52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry patient characteristics: age * over 18 performance status * ecog 0-2 life expectancy * at least 6 months hematopoietic * absolute neutrophil count ≥ 500/mm\^3 * platelet count ≥ 25,000/mm\^3 hepatic * sgot ≤ 2.5 times upper limit of normal (uln) * bilirubin ≤ 2.5 times uln renal * creatinine ≤ 2.5 mg/dl (\> 2.5 mg/dl allowed if due to disease) other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective double-method contraception during and for 6 months after study participation * no serious comorbid disease * no uncontrolled bacterial, fungal, or viral infection * no other active malignancy prior concurrent therapy: biologic therapy * see disease characteristics * no prior alemtuzumab * more than 3 months since other prior monoclonal antibody therapy chemotherapy * see disease characteristics * more than 21 days since prior chemotherapy endocrine therapy * more than 21 days since prior steroid therapy radiotherapy * more than 21 days since prior radiotherapy surgery * not specified

Keywords: waldenström macroglobulinemia
psychological flexibility and effectiveness of psychotherapy

Conditions: Adjustment Disorder

Summary: the objectives of the current research is to evaluate whether psychological flexibility influences psychotherapy outcomes in patients with adjustment disorder and depression. if indeed this is the case, we would be able to identify risk factors for low adjustment- such as low psychological flexibility, and develop psychotherapy that would try to enhance this ability.

subjects will be recruited from the psychiatric daycare center at the tel-aviv souraski medical center, serving the broader tel-aviv municipal area. referrals to the department will be screened for eligibility to participate in the study according to the study's inclusion and exclusion criteria. inclusion criteria would be adjustment disorder as the referral cause, age ranging from 20 to 65 years old and hebrew speaking. patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded. all participants will sign a written informed consent. the diagnosis of adjustment disorder will be conﬁrmed by an open clinical interview followed by a structured clinical interview for dsm-iv scid-iv (shalev et al. 1994; first et al. 1995). before starting the psychotherapy treatment, the patients will fill a psychological flexibility questionnaire (pfq) and well-being questionnaire (mhi), in order to evaluate their psychological flexibility and well-being baseline. at the end of the psychotherapy treatment, they will fill the questionnaires again. also, their therapists will evaluate the patients' levels of adjustment disorder or depression before and after the therapy.

Eligibility criteria:
inclusion criteria: adjustment disorder as the referral cause, age ranging from 20 to 65 years old and hebrew speaking. the diagnosis of adjustment disorder will be conﬁrmed by an open clinical interview followed by a structured clinical interview for dsm-iv scid-iv (shalev et al. 1994; first et al. 1995). exclusion criteria: patients with major depression, a psychotic disorder, alcohol or drug dependence will be excluded.
the role of natural orifice specimen extraction surgery (noses) in treating right-sided colon cancer

Conditions: Colon Cancer

Summary: the purpose of this study is to investigate the short-term and long-term outcomes between natural orifice specimen extraction surgery (noses) and totally laparoscopic right hemicolectomy (tlrh). the hypothesis is that noses could achieve good short-term and oncological outcomes for right colon cancer patients.

this study is a retrospective clinical study. we reviewed collected data from all patients who underwent laparoscopic curative resection for stage i-iii right-sided colon cancer between january 2018 and january 2023. a total of consecutive 115 patients who underwent laparoscopic resection with transvaginal or transrectal specimen extraction were identified as the noses group. to establish a comparative cohort, 234 patients who underwent totally laparoscopic right hemicolectomy (tlrh) during the same period were selected. the purpose of this study is to investigate the short-term and long-term outcomes between noses and tlrh. the hypothesis is that noses could promote postoperative recovery, reduce incision-related complications with comaprable long-term oncological outcomes when compared with tlrh.

Eligibility criteria:
inclusion criteria: 1. biopsy proven colon carcinoma; 2. imaging diagnosis of t1-3 colon cancer; 3. the tumor located in the cecum, ascending colon, or colonic hepatic flexure; 4. written informed consent; exclusion criteria: 1. complete intestinal obstruction; 2. hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment); 3. significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation; 4. pregnancy or breastfeeding; 5. alcohol abuse or drug addiction; 6. concurrent uncontrolled medical condition;

Keywords: colon cancer totallly laparoscopic right hemicolectomy natural orifice specimen extraction surgery
telehealth coaching for families of children with autism

Conditions: Autism Spectrum Disorders

Summary: the purpose of this study is to investigate the efficacy of a 12 week telehealth intervention for families of children with autism spectrum disorders under the age of 6 years on child participation and parent efficacy.

autism spectrum disorders (asd) are increasingly being diagnosed in children, creating a pressing need for effective and cost-efficient models of early intervention (ei) services. many ei systems are struggling to meet the needs of the increasing number of families of children with asd. in rural areas, there is a shortage of ei therapists, and the distances to reach families results in an inefficient use of professional time and research shows that rural families of children with asd receive fewer ei services, which has detrimental effects on children's developmental trajectories. if occupational therapy interventions for young children with asd utilize innovative methods of service delivery in rural areas, investigators can increase the number of families that receive services thereby positively influencing child and family outcomes. therefore, investigators propose to test the acceptability, cost-effectiveness, and efficacy of a 12 week telehealth intervention for families of young children with asd.

Eligibility criteria:
inclusion criteria: * family with a child up to 72 months old with a diagnosis of asd and primarily spoke english in the home. exclusion criteria: * child has significant visual or hearing impairments or has a known genetic condition associated with autism (e.g., fragile x syndrome).

Keywords: telehealth