Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lingzhi in patients with early parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine whether lingzhi (ganoderma), a widely used traditional chinese medicine is effective and safe in the treatment of parkinson's disease when combined use with l-dopa.

this study is to focus on the effects of lingzhi on non-motor symptoms of parkinson's diseases as the primary outcome and on delaying the disease progression using the delay start design as the secondary outcome measurement. two dosage groups and one placebo control group with total 360 subjects will be recruited. the treatment is one year.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent * age 30 years or older at time of diagnosis of parkinson's disease * have idiopathic parkinson's disease, defined as: * having at least 2 of the following 4 signs: resting tremor, bradykinesia, rigidity, or postural reflex impairment, at least one of which must be resting tremor or bradykinesia * no secondary or atypical parkinsonism * asymmetric features (current signs or history of asymmetric onset) * response to l-dopa, by patient self-report * parkinson's disease duration of no more than 5 years * receiving stable therapy of l-dopa/dci for at least 3 months; acceptable dose range: 250 mg - 1000 mg l-dopa/dci daily * hoehn and yahr stage \< 4 on stable l-dopa/dci treatment exclusion criteria: * have atypical parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases * have any other known medical or psychiatric condition that may compromise their participation in the study * have taken another investigational drug within 90 days of baseline * have a change in dosage of any other antiparkinsonian drug (eg, pramipexole, ropinirole, pergolide, bromocriptine, methylphenidate, anticholinergics, or amantadine) during the study or within 90 days prior to baseline * have received treatment with dopamine blocking agents (including neuroleptic agents, antiemetic agents), dopamine-depleting agents (including reserpine or tetrabenazine) within 90 days prior to baseline * do not consent to participate

Keywords: traditional chinese medicine lingzhi
depressive symptoms and emotion regulation following cognitive behavioral therapy

Conditions: Depression

Summary: this study investigates depressive symptoms and the use of emotion regulation strategies over the course of a two-year period in participants terminating outpatient cognitive behavioral therapy for depression. the main objective of the study is to examine if changes in the use of certain emotion regulation strategies (e.g. reappraisal, rumination) predict depression relapse or changes in depressive symptoms after the completion of outpatient cognitive behavioral therapy.


Eligibility criteria:
inclusion criteria: * age older than 18 years * regular termination of outpatient cognitive behavioral therapy for depression (or premature termination agreed upon by both the therapist and the patient because of symptom improvement after at least 12 sessions) * last therapy session not more than two weeks prior to enrollment * self-reported improvement in depressive symptoms as a result of cognitive behavioral therapy * possession of a smartphone (operating system: android or ios) with internet access * possession of a laptop/desktop computer with internet access * familiarity with apps and the internet * fluency in german language exclusion criteria: * premature termination of outpatient cognitive behavioral therapy (exception: termination agreed upon by both the therapist and the patient because of symptom improvement) * bdi-ii score ≥ 20 * acute substance use disorder (\< 3 months) * current or past psychotic disorder * current or past (hypo)manic episode * acute suicidality * severe neurological disorder/cerebral damage * severe physical/medical illness

Keywords: depression emotion regulation cognitive behavioral therapy ecological momentary assessment
efficacy at one year of combined injections of plasma rich in platelets and hyaluronic acid in knee osteoarthritis

Conditions: Knee Osteoarthritis; Hyaluronic Acid; Platelet Rich Plasma

Summary: the french society of rheumatology cannot rule on the value of intra-articular injections of prp due to the lack of hindsight and insufficient data. in fact, the injection protocols are very heterogeneous in terms of preparation method, the presence or not of leukocytes, the number of centrifugations, the volume injected, the ultrasound guidance, which makes it difficult to analyze the literature. the investigator objective is therefore to evaluate the effectiveness of combined injections of prp and hyaluronic acid.


Eligibility criteria:
inclusion criteria: * age : \> 18 years old * patients benefiting, in the context of knee osteoarthritis, from viscosupplementation alone or from two injections of prp, in combination with ha, at the amiens university hospital. exclusion criteria: * patient refusal to use the data * language barrier * age less than 18 years old.

Keywords: platelet rich plasma hyaluronic acid knee osteoarthritis
kinematic analysis in stroke patients using microsoft kinect and akira software: kinect-akira movement study

Conditions: Stroke

Summary: in this prospective, unicentric, case-control study, the main aim is to analyze joint movement and walking patterns in patients with acute stroke with a marker-free motion capture system. case group: stroke patients who fulfill the inclusion criteria are invited to participate in the study during admission. the evaluation consists of a workout designed by expert rehabilitation physicians and neurologists that is performed by the patient in front of the microsoft kinect camera. the custom-built software akira record the joint angles of body trunk and upper limbs during the workout. the kinematic data will be analyzed with a machine learning algorithm that classifies the participant according to the kinematic data in normal movement or impaired movement (with the degree of impairment) by age decade. control group: healthy participants (without neurological or osteomuscular diseases) matched by age and sex with cases 1:1. the correlation between kinematic and clinical scales (nihss) and functional scales (modified rankin scale) will be analyzed. a secondary objective will be to analyze the predictive value of the kinematic measurements with the functional outcome at three months


Eligibility criteria:
inclusion criteria: * acute stroke patients (within the first week of index stroke) * neurological deficit present at the moment of the evaluation. * informed consent signed. exclusion criteria: * clinical instability * aphasia or cognitive decline that prevents the understanding of the workout. * refuse to participate * previous neurological or osteomuscular conditions. * previous conditions with less than 3 months of expectancy of life.
assessment of suppression of cutaneous allergic responses and pruritis by topical minocycline

Conditions: Allergic Rhinitis; Asthma

Summary: adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). each site will be challenged with up to three known allergens, saline and histamine controls. mean wheal diameter after 20 minutes challenge will be determined. this is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.

adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). each site will be challenged with up to three known allergens, saline and histamine controls. mean wheal diameter after 20 minutes challenge will be determined. this is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours. in addition, itch assessment at each site will be done at baseline, 30 minutes, 60 minutes and 24 hours using vas and questionnaire.

Eligibility criteria:
inclusion criteria: * adult ( ages 18-75) outpatients with diagnosis of allergic rhinoconjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive. exclusion criteria: * subjects who are unable/unwilling to undergo cessation of oral antihistamines for five days prior to testing. * current use of oral steroids or other systemic immunosuppressants, including omalizumab (anti-ige therapy) and anti-il-5 therapy. * allergic asthmatics who have current uncontrolled asthma.
long term safety and efficacy of teriflunomide (hmr1726) in multiple sclerosis with relapses

Conditions: Multiple Sclerosis

Summary: the primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. the secondary objective is to assess the long-term efficacy.

subjects completing the hmr 1726d/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives; * subjects on teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide. * subjects on placebo are randomized to teriflunomide 7 mg or 14 mg. the total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows: * treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives, * post-washout follow-up: 4 weeks after last treatment intake.

Eligibility criteria:
inclusion criteria: * satisfactorily completion of hmr1726d/2001 study with respect to safety. * if female subject, non-childbearing potential or child bearing potential with adequate contraception. * consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment. * clinically definite multiple sclerosis (ms) as established on entry into hmr1726d/2001 study. * extended disability status score(edss) between 0 and 6 inclusively, when the subject entered hmr1726d/2001 study. * magnetic resonance imaging (mri) criteria must continue to support the diagnosis of clinically definite ms. * willingness to participate in a long-term safety and efficacy trial. exclusion criteria: * subject who did not complete hmr 1726d/2001 study for safety reasons. * subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease. * pregnancy. * breast-feeding. * wish to parent. * likelihood of requiring treatment during the study period with drugs not permitted. * disallowed therapies such asw immunomodulators, immunosuppressants. * recent history of drug or alcohol abuse. * liver function impairment. * abnormal mental conditions.

Keywords: multiple sclerosis relapsing remitting secondary progressive progressive relapsing
wound infiltration of liposomal bupivacaine v plain bupivacaine for post-op pain control in elective cesarean delivery

Conditions: Bupivacaine; Pain, Postoperative

Summary: randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.

participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (itm). exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, american society of anesthesiologist (asa) physical status class iii or higher (note: an asa i patient is defined as a normal healthy patient, an asa ii patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an asa iii or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment. a three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. after patients receive their spinal anesthetic and as the pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Eligibility criteria:
inclusion criteria: 1. asa i or ii women with uncomplicated singleton pregnancies 2. ≥37 weeks gestation 3. ≥18 years old presenting 4. presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (itm). 5. able to provide informed consent. exclusion criteria: 1. subject is not a candidate for a spinal anesthetic 2. subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc) 3. subject is on chronic opioids. 4. subject is an asa class iii or higher. 5. subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, 6. subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.

Keywords: cesarean delivery liposomal bupivacaine exparel bupivacaine wound infiltration
opioid induced hyperalgesia (oih) modulation with propranolol

Conditions: Hyperalgesia

Summary: opioid induced hyperalgesia (oih) is an entity than has been demonstrated in healthy volunteers and in animal models. is defined as an increase in the perception to painful stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli. the apparition of oih is also related to the exposure to opioids during surgery, depending of the dose, the time of exposition and the type of opioid. this condition can be modulated, specially in the perioperative context. it has been seen in healthy volunteers and in animal models, than the use of propranolol can modulate this phenomena, diminishing the postoperative requirements of analgesia. it is also unknown, the dose of propranolol required to modulate adequately oih. the objective of this work is to evaluate the efficacy of propranolol in the modulation of opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.

this is a randomized controlled study, comparing 2 interventions with a placebo. the interventions will be use of propranolol, at different doses, to achieve specific plasmatic concentrations. 80 patients will be required to find a difference of 20% in the primary outcome. the primary outcome to be measured is the postoperative use of opioids in the post anesthesic care unit. secondary outcomes, will be the amount of opioids used in the following 24 hours to the surgery, the time to the first dose of analgesia in the post anesthesic care unit, and the change in the pain thresholds, evaluated as pain by pressure and by tactile sensitivity, before and after surgery. also, as a secondary outcome, in a group than will not receive the study drug, we will evaluate the temporal changes in opioid induced hyperalgesia, by pain sensitivity measured in the postoperative hours 2, 4 and 24. 10 patients receiving placebo will be part of this additional measures.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective laparoscopic cholecystectomy * american society of anesthesiology score (asa) i-ii exclusion criteria: * medical history of cardiac disease * medical history of respiratory disease * regular use of beta blockers * known allergies to drugs used in the study * known history of illicit drugs use
arterial stiffness and atrial fibrillation

Conditions: Atrial Fibrillation

Summary: researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * all patients with persistent af, scheduled for electrical cardioversion exclusion criteria: * unable to provide informed consent. * patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion. * patients with prior carotid stents.
the use of acupuncture for the treatment of vulvar vestibulitis

Conditions: Vestibulodynia

Summary: randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

patients were randomized to five acupuncture sessions designed to treat pain in the vulvar area (study group), or five acupuncture sessions designed for tranquility (controls). participants and evaluating gynecologists were blinded to randomization. participants were examined clinically before treatment and one month after completion of assigned treatment; at both visits they completed the female sexual function index (fsfi) questionnaire. fsfi scores for pain during intercourse and total score were used to evaluate change. the examining gynecologist evaluated the degree of sensitivity to touch and the degree of local erythema. response to treatment was evaluated for each group before and after treatment, and for study group compared to the control group.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of vestibulodynia exclusion criteria: * pregnancy * patient who received other treatment for vestibulodynia in the month preceding.
mta/fs pulpotomy for vital primary incisors: a randomized controlled trial

Conditions: Dental Caries; Dental Pulp Exposure

Summary: to compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (mta/fs) pulpotomy and root canal therapy (rct) in carious vital primary maxillary incisors.

dental caries is the most common chronic disease in children. caries of the primary maxillary incisors is common in young children; often necessitating either extraction or pulp therapy. the premature loss of primary maxillary incisors can adversely affect a child's dental occlusion, ability to properly size food boluses for swallowing, speech articulation, facial esthetics and psychosocial development. pulp treatment of cariously exposed vital primary incisors may prevent premature tooth loss as well as eliminate pain. currently, there is a paucity of outcome investigations with regard to pulp therapy in primary incisors.

Eligibility criteria:
inclusion criteria: * children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure * reside in the gta at time of inclusion * english-speaking exclusion criteria: * history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility * incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications * non-restorable tooth

Keywords: pediatrics dental caries dental pulp exposure incisor
trap study: testosterone for androgen receptor polymorphism

Conditions: Fertility Disorders

Summary: to determine whether pretreatment with transdermal testosterone increases the number of cumulus-oocyte complexes (cocs) obtained after ovarian stimulation by more than 1.5 in patients with low ovarian reserve and androgen receptor polymorphism undergoing intracytoplasmic sperm injection (icsi).


Eligibility criteria:
inclusion criteria: * patients with low ovarian reserve according to bologna criteria: at least two of the following three: 1. age equal to or greater than 40 years. 2. previous cycle with less than 4 oocytes retrieved. 3. low ovarian reserve markers (antral follicle count \<5-7; amh \<0.5-1.1 ng). * carriers of androgen receptor polymorphism: between 22 and 24 cag repeats. * body mass index (bmi) less than 32. * indication for in vitro fertilization. * presence of both ovaries. * absence of ovarian cysts. * absence of endometriosis. * normal karyotype and fragile x study. * absence of severe male factor. * semen sample from ejaculate. * ability to comply with the study protocol. * to have given written consent. exclusion criteria: * non-compliance with instructions or non-formalization of informed consent. * concurrent participation in another study.

Keywords: ovarian stimulation; testosterone
reducing obesity in underserved postpartum african american women

Conditions: Obesity

Summary: in this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum african american (aa) adult women that can be integrated into a postpartum care model within a clinical setting.

the investigators proposal adapts the diabetes prevention program (dpp) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the dpp to address the needs of our aa population in several ways: 1) the reference materials and lesson handouts include information about the types of foods and cooking methods used by an aa culture (see other study documents); 2) topics are selected for group classes that are most appropriate for our participants such as hip hop or salsa dancing for physical activity. participants will be randomized during the early postpartum period to either usual care or intervention. usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the nutrition and weight management center. intervention participants will be assigned a birth sister for the postpartum period. they will also attend 8 weekly sessions for the weight loss program. all participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.

Eligibility criteria:
inclusion criteria: * pre-natal: 1. bmi greater than or equal to 25 2. ready to change (classified as answering yes to: are you seriously considering trying to lose weight to reach your goal in the next 6 months?) 3. english-speaking * post-partum: 1. live birth (based on medical record review) exclusion criteria: * pre-natal: 1. signs of moderate to severe depression based on the patient health questionnaire-9 (phq-9) 2. previous enrollment in the birth sister's program prior to the study * post-partum: 1. signs of moderate to severe post-partum depression based on the edinburgh postnatal depression scale (epds)

Keywords: pregnancy african american weight management program behavioral modifications