Kornimate/medical-research-clean huggingface dataset:
study of feasibility and safety of mdma-assisted group therapy for the treatment of ptsd in veterans

Conditions: PTSD

Summary: the goal of this clinical trial is to learn if mdma-assisted group therapy is safe and effective in in people with at least moderate ptsd. the main question it aims to answer is: do two sessions of open-label mdma-assisted group therapy reduce ptsd symptoms? participants will undergo non-drug preparatory therapy sessions before their mdma-assisted therapy sessions. after, they will undergo non-drug integrative therapy sessions.

to further assess the feasibility and safety of mdma-assisted group therapy for participants with at least moderate ptsd, the sponsor is conducting a phase 2, open-label, non-randomized, 3-cohort study. this novel treatment package consists of two once-monthly experimental sessions of therapy combined with a divided-dose of mdma (120 mg midomafetamine hcl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions. the primary outcome measure, the clinician administered ptsd scale (caps-5), evaluates changes in ptsd symptom severity and is assessed by a blinded centralized independent rater (ir) pool. the therapeutic approach will combine manualized mdma-assisted therapy for ptsd with group therapy components.

Eligibility criteria:
inclusion criteria: * are at least 18 years old. * are a u.s. military veteran * are fluent in speaking and reading the predominantly used or recognized language of the study site. * are able to swallow pills. * agree to have study visits recorded, including experimental sessions, outcome assessments, and non-drug psychotherapy sessions. * must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable. * must agree to inform the investigators within 48 hours of any medical conditions and procedures. * if able to become pregnant, must have a negative pregnancy test at study entry and prior to each experimental session, and must agree to use adequate contraception through 10 days after the last experimental session. * must not participate in any other interventional clinical trials during the duration of the study. * have a current ptsd diagnosis at the time of screening. exclusion criteria: * are not able to give adequate informed consent. * have uncontrolled hypertension. * have a marked baseline qtcf interval \>450 milliseconds \[ms\] demonstrated on repeated ecg assessments. * have a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long qt syndrome). * have evidence or history of significant medical disorders. * have symptomatic liver or biliary disease. * have history of hyponatremia or hyperthermia. * weigh less than 48 kilograms (kg). * are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control. * have an active illicit drug or prescription drug substance use disorder
oral care with propolis in pediatric oncology patients

Conditions: Oral Mucositis

Summary: according to the data from the world health organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. in chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. intact tissue cells are also affected by this cytotoxicity. mucositis develops in the patient, especially as a result of the mucosal cells being affected. mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. it is one of the most important side effects of both chemotherapy and radiotherapy. this study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple use of chemotherapeutic drugs.

according to the data from the world health organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. in chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. intact tissue cells are also affected by this cytotoxicity. mucositis develops in the patient, especially as a result of the mucosal cells being affected. mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. it is one of the most important side effects of both chemotherapy and radiotherapy. this study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple uses of chemotherapeutic drugs.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * receiving chemotherapy treatment for lymphoproliferative malignant disease (leukaemia, lymphoma) or other childhood solid tumour (such as central nervous system tumour, neuroblastoma, osteosarcoma, ewing sarcoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumours) * being between the ages of 2-18 (although there is no harm in using propolis, it is inconvenient for children under the age of 2 to use honey and its by-products due to botulism) * no development of oral mucositis * the child who does not smoke exclusion criteria: * the patient does not receive head and neck rt (increases the incidence of oral mucositis by 40%). * the patient is allergic to bee products. * exclusion criteria and practices in this case: * development of an allergic reaction to propolis (applied oral care protocol is stopped, removed from the sample) * starting rt * the child's need for mv support
trapezoidal flap vs. envelope flap in mandibular third molar extraction.

Conditions: Impacted Third Molar Tooth

Summary: the purpose of this study was to test the effectiveness of the envelope flap compared to trapezoidal flap in impacted mandibular third molar extractions.

a sample of 50 patients requiring mandibular third molar extraction was selected for the study. healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study. a total number of 52 consecutive cases of mandibular third molar surgical extractions were performed using either a trapezoidal flap or an envelope flap. the choice of the flap was randomized. the following parameters were recorded: probing pocket depth, clinical attachment level, bleeding on probing, full mouth plaque score, full mouth bleeding score, total time for the surgical intervention, age of the patient, type of inclusion, ostectomy. all the patients received a questionnaire to evaluate the post-intervention discomfort (swelling, pain, number of pain-killers, bleeding). periodontal parameters were checked at 6-month follow up.

Eligibility criteria:
inclusion criteria: * third molar impaction * mild symptoms of pericoronitis exclusion criteria: * systemic diseases * cigarettes smoking * history of irradiation therapy

Keywords: third molar surgery, periodontal probing depth , flap design
treatment with pirfenidone for covid-19 related severe ards

Conditions: Covid19; ARDS

Summary: a randomized, open label, two arm, pilot trial of pirfenidone 2,403 mg administered per nasogastric tube or orally as 801mg tid for 4 weeks in addition to standard of care (soc), compared to soc alone, in a population of covid-19 induced severe ards. patients will be randomized according to 1:1 ratio to one of the trial arms: pirfenidone (intervention arm) or soc (control arm).

the objective of the trial is to evaluate the safety and efficacy of treatment with pirfenidone vs soc in covid-19 induced severe acute respiratory distress syndrome (ards) requiring mechanical ventilation. following initial diagnosis of covid-19, severe ards patient will be admitted to a dedicated intensive care unit (icu) at soroka university medical center (day 0). upon admission, patients will be randomized according to 1:1 ratio to one of the trial arms and receive either pirfenidone 2,403mg administered through nasogastric tube as 801mg tid (intervention arm) plus soc or only soc treatment (control arm). patients' vital signs (temperature, blood pressure, pulse rate per minute, breath rate per minute, oxygen saturation) urine output, ventilation settings, and respiratory parameters will be monitored according to soc. symptom will be captured daily from patients as well as adverse events (aes) assessment and recording of the need for any supportive care during the period of icu admission.

Eligibility criteria:
inclusion criteria: * men and women between the ages 18-80 years * diagnosis of covid19 with severe ards (pao2/fio2 \<150mmhg) * admission to the icu and in need of mechanical ventilation * able to give informed consent according to local regulations. if the patient is unable to give written informed consent, the form will be read to them and their verbal consent will be documented. if the patient is sedated, an impartial icu physician will approve eligibility. exclusion criteria: * previous use of nintedanib or pirfenidone * administration of fluvoxamine 7 days prior to admission to icu * severe hepatic impairment (liver enzymes and bilirubin\>2 of normal upper limit, at day 0) or end stage liver disease * severe renal impairment (crcl \<30 ml/min) or end stage renal disease requiring dialysis * pregnancy * participation in any other clinical trial 30 days prior to enrollment

Keywords: covid-19 ards pirfenidone
changes of functional connectivity after rtms in depression

Conditions: Major Depression

Summary: in order to explore the effect of repetitive tms, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. we will use a double-blind, sham-controlled design. our target sample size is 60(30 patients will be treated by active rtms, the other 30 will be treated by sham rtms). we will apply 10-day course of 10 hz rtms on left dorsolateral prefrontal cortex of the subjects.

up to now, 24 patients with major depression and 6 normal controls are enrolled. twenty-three patients and 4 normal participants have taken 10 days rtms. one patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache. we scanned fmris(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rtms. all of participants have not reported side effects except mild headahe. there's been no seizure event up to now.

Eligibility criteria:
inclusion criteria: * dsm-iv major depressive episode * failure of at least 3 different kind of antidepressant exclusion criteria: * organic brain disorder * other diagnosis of dms-iv except nicotine dependence * history of seizure disorder
european multicentre study of human spinal cord injury

Conditions: Spinal Cord Injury

Summary: today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (sci). consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with sci. the aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. the establishment of combined clinical, functional and neurophysiological measures for a qualitative and quantitative assessment of spinal cord function in patients with sci at different stages during rehabilitation represents a basic requirement to monitor any significant effect of a new treatment. therefore, several european paraplegic centres involved in the rehabilitation of acute traumatic sci patients build up a close collaboration for standardised assessment. the aim is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and to bring new standardised assessment tools to the clinical setting.


Eligibility criteria:
inclusion criteria: * single event traumatic or ischemic para- or tetraplegia * first emsci assessment possible within the first 6 weeks after incidence * patient capable and willing of giving written informed consent exclusion criteria: * nontraumatic para- or tetraplegia (i.e. discusprolaps, tumor, av-malformation, myelitis) excl. single event ischemic incidences * pre-known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent * peripheral nerve lesions above the level of lesion (i.e. plexus brachialis impairment) * pre-known polyneuropathy * severe craniocerebral injury
effect of ziprasidone on glucose & plasma lipids in diabetes (ii) and schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the aim of the protocol is to study the effects of 320 mg/day of ziprasidone (geodon) on glucose and lipid metabolism of patients with both diabetes type ii (dm) and schizophrenia or schizoaffective disorder, after switching their antipsychotic medication/s from typical and/or atypical to ziprasidone monotherapy.

inpatients with dsm iv diagnosis of schizophrenia or schizoaffective disorder and dm ii will be enrolled after giving informed consent. participants may stay on their original ward at mpc, if their clinical care would be better served on their home ward because of patient programs and/or continuity of care reasons. patients recruited from other participating sites will be transferred to mpc research ward. there will be a screening phase (two weeks) on the prior antipsychotic regimen, a cross-titration phase (three week) and a ziprasidone phase (eight weeks; four time points). all medications, except for the antipsychotic agents, will be kept stable throughout the protocol. these medications may include anticholinergics, mood stabilizers and antidepressants. after the screening phase lasting two weeks, patients will enter the cross-titration phase lasting three week. the cross titration schedule will be changed in accordance with deutschman \& deutschman's 2005 recommendations. the current antipsychotic will be gradually decreased to zero and ziprasidone will be started at 40 mg bid po and raised up to 160 mg po bid during the cross-titration phase, according to clinical response and tolerance. after the cross-titration phase has concluded, the ziprasidone dose will range from 80 mg bid p.o. to 160 mg bid p.o. daily according to clinical response during the eight week treatment phase.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 65 years 2. dsm iv diagnosis of schizophrenia (all subtypes) or schizoaffective disorder 3. diabetes mellitus type ii treated with oral antidiabetic drugs or insulin 4. stable dose of antipsychotic regimen for previous one month. 5. stable dose of antidepressant regimen for previous one month. 6. stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month 7. signed informed consent 8. absence of significant cardiovascular pathology as demonstrated by ekg (qtc \< 450 millisec) 9. absence of severe medical conditions (except for dm) requiring frequent changes in medication. exclusion criteria: 1. dsm iv diagnosis other than schizophrenia or schizoaffective disorder 2. unstable epilepsy 3. acute, unstable or significant medical condition 4. suicidal or physically violent behavioral episodes in the previous month 5. current dsm iv diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks. 6. liver enzyme test values ≥ three times upper normal limit for ast, alt, ggt, and alkaline phosphatase; ≥ two times upper limit for ldh.

Keywords: schizophrenia schizoaffective disorder metabolic markers ziprasidone diabetes
study to evaluate the response rate to therapy with docetaxel and cisplatin in unresectable locally advanced squamous cell carcinoma of head and neck

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: primary objective: to evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer secondary objective: to assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

the treatment duration for each patient will be around six months. patients included in the study will be treated with induction regimen followed by chemo radiotherapy. within the induction period there are three cycles (docetaxel + cisplatin) every 21 days, with follow-up post-induction at day 21 after cycle three. this is followed by chemoradiotherapy consisting of radiotherapy for six weeks and cisplatin every week for four weeks. the post-consolidation follow up is at eight weeks after end of chemoradiotherapy.

Eligibility criteria:
inclusion criteria : * histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage iii-iv without evidence of distant metastases. * no prior chemotherapy or radiation therapy. * having at least one measurable lesion in one dimension. * age ≥18 and \<65 years with eastern cooperative oncology group ≤ 1. * adequate organ function: * adequate hematological function * adequate hepatic function * renal function within normal limits exclusion criteria: * peripheral neuropathy \> grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer). * being treated concomitantly with corticosteroids (except as pre-medication). * patients having another type of cancer. * previous chemotherapy or radiotherapy. * any previous definitive surgery for squamous cell carcinoma of head and neck. * severe weight loss (\> 20 % of body weight) in the preceding 3 months. * hearing loss (\> grade 2). * pregnancy (pregnancy test result for women of childbearing potential). * sexually active females with lack of adequate contraception. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
persistent pulmonary artery hypertension after valve replacement

Conditions: Persistent Severe PH After Valve Therapy

Summary: background: persistent severe pulmonary hypertension (ph) after mechanical valve replacement is a frequent finding in patients with severe valve-diseases. the reasons to develop ph are multifactorial and the prevalence of severe ph significantly worsens the patients´ outcome. aims: (i) to define the prevalence of ph in patients after valve replacement and (ii) to identify factors predicting persistent ph. methods: all patients which underwent valve replacement at our institution between the years 2008 -2010 will be screened retrospectively. those patients with pre- procedural proven ph by means of right-heart catheterization will receive prospective follow-up with echocardiography. diagnosis of persistent ph will be confirmed with right heart catheterization.


Eligibility criteria:
inclusion criteria: * proven pulmonary hypertension before valve replacement and informed consent for data acquisition exclusion criteria: * patients do not meet inclusion criteria

Keywords: valve replacement pulmonary hypertension long term follow up
foot reflexology in diabetic patients with neuropathic pain

Conditions: Diabetes Mellitus; Patient Engagement; Reflexology

Summary: this study was carried out to determine the effect of foot reflexology applied to diabetic patients with neuropathic pain on their quality of life, hope and pain levels. this research, which was designed as a randomized controlled and experimental study, was conducted between january 2022 and december 2022. it was determined that foot reflexology application increased the quality of life and hope level of diabetic patients with neuropathic pain and decreased the level of pain.

aim: this study was carried out to determine the effect of foot reflexology applied to diabetic patients with neuropathic pain on their quality of life, hope and pain levels. material and method: this research, which was designed as a randomized controlled and experimental study, was conducted between january 2022 and december 2022. the data of the study consisted of 102 diabetic patients with neuropathic pain, 51 of whom were experimental and 51 were controls. as data collection tools; patient information form, herth hope scale (hhi), four-question neuropathic pain questionnaire (dn4q), neuropathic pain impact on quality of life questionnaire (nepiqol), and visual analog scale (vas) were used. a total of 12 sessions of foot reflexology were applied to the patients in the experimental group, twice a week for 6 weeks. no intervention was performed on the patients in the control group.

Eligibility criteria:
inclusion criteria: * 18 years old and over * do not have any physical or mental illness that will prevent communication, * diabetic neuropathic pain \[with a total score of at least 4 and above according to the four-question neuropathic pain questionnaire (dn4q)\] * patients who can read, write and speak turkish exclusion criteria: * complications developing during reflexology practice, * not attending at least one of the practice sessions, * it was planned to exclude patients who wanted to leave at any stage of the study.

Keywords: reflexology diabetes mellitus neuropathic pain hope quality of life
eti during spinal trauma

Conditions: Intubation; Cardiac Arrest

Summary: the aim of this study was to compare time, success rates of different tracheal tubes (standard tube and etview vivasight sl) for intubation with an immobilized cervical spine in a standardized manikin model.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * minimum 1 year of work experience in emergency medicine * experienced emergency medicine personnel (physicians, nurses, paramedics) exclusion criteria: * not meet the above criteria * wrist or low back diseases
hepatic impairment study

Conditions: Liver Disease

Summary: this study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. subjects with varying degrees of liver function are being asked to participate in this study. study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.


Eligibility criteria:
inclusion criteria: * healthy subjects, child pugh a and child pugh b liver disease patients.

Keywords: liver disease