Kornimate/medical-research-clean huggingface dataset:
a pilot research project on outcome of trauma informed stabilization treatment (tist) for adults with complex trauma symptoms after childhood trauma, at the department of trauma treatment, modum bad, norway

Conditions: PTSD and Trauma-related Symptoms; PTSD

Summary: the purpose of the study is to examine the effects of residential group and individual trauma informed stabilization treatment (tist) for complex symptoms in adult survivors of childhood trauma in a naturalistic observational study.

adult survivors of childhood trauma have complex and diverse symptom profiles. the aim of the study is to examine the effects of thetrauma informed stabilization treatment (tist) model, developed by dr janina fisher, in adult survivors of childhood trauma. 32 patients will be recruited from referrals to an residential open door trauma clinic in norway, modum bad. patients will be admitted for in-patient pre-planned treatment over 11 weeks - consisting of individual therapy and group therapy using different modalities, all within the tist approach and framework. patients will be summoned for 6 day follow-up 8 months after treatment.

Eligibility criteria:
inclusion criteria: * adults ≥18 years * complex symptom presentations connected to childhood trauma * all patients will have undergone outpatient therapy with insufficient effect * most included patients will have a diagnosis of complex ptsd (diagnosed by m.i.n.i. and clinical evaluation) * patients may have diagnosis of unspecified dissociative disorder, personality disorders, depression and other comorbidity. exclusion criteria: * dissociative identitiy disorder * ongoing psychosis * ongoing drug addiction * very disturbed group function * ongoing life crisis * mental disability * acute suicidality * ongoing severe self harm * patients with complex dissociative disorders and patients eligible for exposure therapy will be referred to/prioritized for other treatment programmes.

Keywords: complex ptsd childhood trauma tist group treatment affect regulation mindfulness self compassion
a trial of ino-1001 in patients undergoing heart surgery that involves heart-lung bypass

Conditions: Heart Diseases; Postoperative Complications

Summary: the purpose of this study is to assess the safety of ino-1001, an intravenous parp (poly-\[adp ribose\] polymerase) inhibitor, in patients undergoing heart surgery. the study also measures whether ino-1001 reduces the side effects caused by heart-lung bypass machines.

heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery. studies have shown that parp inhibitors protect cells from damage due to lack of oxygen. heart-lung bypass during heart surgery can result in cells being deprived of oxygen. ino-1001 may be able to protect these cells and reduce complications following surgery. a total of 162 patients will be randomly assigned to either ino-1001 or placebo (sugar water). treatment will begin on the day of heart surgery and continue for 36 hours. a total of 4 doses of ino-1001 will be given. patients will be followed up until 30 days after surgery. the following information will be collected: symptoms, vital signs, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts. the information provided in this listing is disclosed solely to comply with regulatory requirements. the drug ino-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery * males and non-pregnant, non-lactating females exclusion criteria: * subjects will be required to undergo a full medical review in order to exclude serious medical or psychological illness prior to inclusion * history of a hypersensitivity reaction to more than three drugs or to mannitol * participation in any other investigational study within 30 days of the screening phase * known alcohol or drug abuse within the last year * treatment with certain restricted medications within a specified time prior to participation in the study

Keywords: cardiac surgery parp inhibitor parp inhibition bypass surgery cpb surgery cardiopulmonary bypass coronary revascularization cardiac valve replacement
monitoring pre-exposure prophylaxis for young adult women

Conditions: HIV/AIDS; Adherence

Summary: next generation real-time monitoring for prep adherence in young kenyan women

this protocol describes a longitudinal study of young kenyan women at high risk for hiv who will be offered hiv pre-exposure prophylaxis (prep) for up to two years. adherence will be monitored in all women with the next generation wisepill; half will be randomized to receive short message service (sms) reminders. the technical function, acceptability, cost, and validity of the next generation wisepill device coupled to sms reminders will be determined among this cohort of young kenyan women. additionally, sms will be used for longitudinal assessment of risk perception and its alignment with prep adherence.

Eligibility criteria:
inclusion criteria: * hiv-uninfected (as determined by kenya national testing algorithms) * wanting to start prep with an initial recommendation of 6 months of use * clinically safe to receive prep, in accordance with centers for disease control and prevention (cdc) guidelines: * creatinine clearance \>60 ml/min * not infected with hepatitis b * no other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study * sexually active (defined as vaginal or anal sex) within the last 3 months * at high risk for hiv infection based on a validated risk score of \>5 or being in an hiv serodiscordant relationship * not pregnant * owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it * ability to send a text message * intending to stay in the area for at least the next year * willing to use study criteria exclusion criteria: * unable to provide consent * breast-feeding (prepis not currently approved for use during breast-feeding) * concurrent participation in another research study that may influence adherence to prep and/or interfere with the procedures of this study.

Keywords: hiv/aids adherence women real time monitoring risk sms mhealth
chemo- and radiotherapy in epithelial vulvar cancer

Conditions: Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer

Summary: this retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy. application of chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore extended to relapsed disease.

all patients with primary squamous cell cancer of the vulva \> stage ia who were diagnosed and received treatment between 1998 and 2008 at the participating centres will be included in the study. furthermore patients with recurrent disease diagnosed and treated at the participating centres during the same time period can be included given that they not only underwent surgical excision for treatment. for centers with restricted resources for data entry an alternative study collective was defined: all patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment at the participating centres between 1998 and 2008 will be included in the study. this also includes node negative patients receiving radio/chemotherapy for other reasons. the participating centers themselves have to decide which study collective they are documenting, dependent on their available resources.

Eligibility criteria:
inclusion criteria: 1. patients with primary squamous cell vulvar cancer except stage ia disease regardless of the received treatment 2. patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision. 3. or alternatively, dependent on the decision of the participating center: -patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment regardless of nodal involvement. 4. patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008 5. women aged ≥ 18 years exclusion criteria: 1. patients with benign or precursor lesions (vin - vulvar intraepithelial neoplasia) of the vulva 2. patients with non-squamous neoplasia of the vulva (e.g. melanoma) 3. patients with verrucous vulvar cancer 4. patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment. 5. patients with secondary cancers if those interfered with the treatment of vulvar disease

Keywords: vulvar cancer radiotherapy chemotherapy
urine metabolites in the diagnosis of disease

Conditions: Colorectal Cancer; Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Crohn Disease; Celiac Disease

Summary: the goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (gi) diseases. this research study intends to enroll participants across a range of demographics and gi disease states including colorectal cancer, small intestinal bacterial overgrowth (sibo), crohn\&#39;s disease, and celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific gi disease. the main questions it aims to answer are: 1. does the platform identify a disease signal within each disease cohort, compared to normal controls? 2. how well does the test perform (e.g. sensitivity and specificity/false-positive rate)?


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age at time of enrollment. * able and willing to provide a one-time urine sample and comply with all study procedures for the study. * able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a hipaa medical release form. exclusion criteria: * known to be pregnant. * a medical condition which, in the opinion of the investigator and/or sponsor, should preclude enrollment in the study.
pelvic and acetabular fracture: a prospective observational study

Conditions: Pelvic Fracture; Acetabular Fracture; Pubic Rami Fracture

Summary: the purpose of this study is to understand the trajectory of function and self-reported outcomes of patients following pelvic and acetabular, treated both operatively and nonoperatively.

the goal of the study study is to prospectively capture data from patients following pelvic and acetabular fractures, treated both operatively and nonoperatively, in order to understand the trajectory of functional and self-reported outcomes as well as to answer critical questions about treatment. performance assessment data and patient-reported outcome measures utilizing the nih promis tool will be collected and analyzed for patients following pelvic or acetabular fracture, regardless of treatment.

Eligibility criteria:
inclusion criteria: * fracture of the pelvic ring * fracture of the acetabulum exclusion criteria: * patients unwilling to provide consent to participate.
long-term effects of hiv exposure and infection in children

Conditions: HIV Infections; HIV Seronegativity

Summary: as new drugs and vaccines are developed to prevent hiv disease progression and prolong survival of hiv infected patients, the short-term safety and effectiveness of these treatments are evaluated in research studies. however, the long-term effects, whether they are benefits or side effects, need to be studied as well. these long-term effects may have a greater impact on infants and children who are still growing and developing. the purpose of this study is to follow hiv-exposed and hiv infected infants, children, and adolescents who are seen at pediatric aids clinical trials group (pactg) study sites. these patients will be observed for long-term benefits or any late harmful effects of medications or vaccines.

the potential long-term benefits, toxicities, and other adverse outcomes of new anti-hiv therapies cannot be assessed within the time frame of most clinical trials. there is a need to better assess both positive and negative late outcomes and late treatment effects in growing children. this prospective, longitudinal study will evaluate the effects and their impact on children. children in this study will include patients who are hiv infected, were exposed to hiv or anti-hiv drugs prior to or at the time of their birth, or children of patients followed at pediatric aids clinical trial group (pactg) sites. children will have a study visit every 3 months through the first year of life. after age 1, children who are hiv infected will continue to have study visits every 3 months, while children who are hiv uninfected will have study visits once a year. study assessments will include complete physical exam, medical history, tanner staging, neurologic exam, growth and quality of life assessments, and laboratory tests such as hematology, chemistries, and urinalysis. not all assessments will be performed at each study visit. patients will be followed until age 24.

Eligibility criteria:
inclusion criteria * age 21 or younger (consent of parent or guardian required if under 18). * meet 1 of the following 3 requirements: 1) enrolled in a previous version of this study; 2) perinatally exposed to hiv, hiv vaccines, or antiretroviral treatment (must enroll before first birthday); 3) hiv infected infants, children, and adolescents (and their offspring) followed at pactg sites. exclusion criteria * unable to adhere to study visit schedules.

Keywords: acquired immunodeficiency syndrome aids-related complex
effects of brain training games on cognitive function and quality of life in mci

Conditions: Mild Cognitive Impairment

Summary: the study aims to determine the effects of brain training games on cognitive function and quality of life among older adults with mci.

the study aims to determine the effects of brain training games on cognitive function and quality of life among older adults with mci.this study will assess the efficacy of brain training games. lumosity on the cognitive function and quality of life among older adults with mci .beyond cognitive rehabilitation, this intervention holds promise as a cost-effective approach to delay, maintain, or even improve cognitive decline associated with the aging process.

Eligibility criteria:
inclusion criteria: * older adults of age \>50 years and above * both male and female * education level matriculation at least * mild cognitive impairment ( moca score of 18-25) * active independent individuals with normal hearing and normal or corrected-to-normal vision. exclusion criteria: * moderate to severe cognitive impairment * diagnosed case of dementia, depression or other mental issues. * current plans to move to another city.

Keywords: cognition aging quality of life brain training games
blood levels of ketamine in patients using topical application of 10% ketamine gel for neuropathic pain

Conditions: Neuropathic Pain.

Summary: the purpose of this research study is to measure how much, if any, ketamine is absorbed into the blood stream after ketamine gel is applied to the skin. the investigators expect that the topical administration will provide pain relief locally, at the site of pain, but not be absorbed into the bloodstream and thus not cause side effects. this research will help assess the safety of this drug by measuring the blood concentrations of the drug. ketamine is a general anesthetic drug but also has excellent pain relieving qualities. it has been used to relieve chronic pain by administering intravenously, by mouth, or as an injection beneath the skin. when given these ways ketamine can occasionally cause side effects like dizziness, nausea, nightmares, agitation, hallucinations. recently it has been used topically for patients with neuropathic pain in order to avoid the dizziness and nausea side effects. neuropathic pain can be partially caused by the misfiring of small nerve fibers close to the area of pain. by applying it on the skin, it is expected the drug can penetrate the skin and act directly on the small nerve fibers. the advantage is that less drug will get into the blood circulation. up to now, it has not been carefully studied how much of the drug appears in the circulation after application on the skin.


Eligibility criteria:
inclusion criteria: * patients with peripheral, focal neuropathic pain such as or complex regional pain syndrome following surgery, bony, soft tissue trauma or nerve trauma, associated with significant allodynia and hyperalgesia who score equal to or greater than 4 in the dn4 questionnaire. * duration of pain more than 3 months. * ability to speak english adequately to consent to and participate in the study exclusion criteria: * allergy to ketamine * severe medical illnesses like, e.g. unstable angina, tachyarryhthmias, renal or hepatic failure * history of psychosis. * patients who are already on oral ketamine treatment. * patients who are taking hiv antiretrovirals: (indinavir, nelfinavir, ritonavir saquinavir); antibiotics: (clairithromycin, itraconazole, ketoconazole, telithromycin,fluconazole, erythromycin); calcium channel blockers (verapamil, diltiazem),amiodarone, ciprofloxacin. (these drugs inhibit cyp 3a4 enzyme which metabolises ketamine)
study of trifarotene cream to assess risk of a trophic acne scar formation

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.


Eligibility criteria:
key inclusion criteria: * participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter \[cm\]): 1. investigator's global assessment (iga) score of 3 (moderate) or 4 (severe), with the same score on both sides of the face; and 2. a minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and 3. no more than 2 nodules (greater than or equal to \[\>=\] 1 cm in diameter) on the face; and 4. a minimum of 10 atrophic acne scars in total (\>2 mm) * participant with a symmetrical number of the following lesions/scars on the whole face: 1. inflammatory and non-inflammatory lesions; and 2. atrophic acne scars (minimum of 4 scars per half-face) * the participant is a female of non-childbearing potential * if a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris * other protocol defined inclusion criteria could apply key exclusion criteria: * participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment * participant with any acne cyst on the face or with more than 3 excoriated acne lesions * participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation * participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator * participant with known impaired hepatic or renal functions, based on medical history

Keywords: acne vulgaris trifarotene aklief® cd5789
efficacy of plyometrics to increase bone mass in men with osteopenia

Conditions: Osteopenia

Summary: this study will compare the ability of two types of long term (12 months) weight-bearing exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass of the total body, spine and hip in physically active men with osteopenia.

the overall goal of this project is to determine the efficacy of chronic (12 months) plyometric jump training exercise on bone mineral density (bmd) and markers of bone turnover in physically active males cyclists diagnosed with osteopenia below normal bone mineral density of the lumbar spine or hip.

Eligibility criteria:
inclusion criteria: * male * age 25-60 years * no symptoms of disease * currently participating in cycling activities an average of 4 hr/wk for the previous 24 months * osteopenia of the lumbar spine and/or hip (t score \ -2.5 ) exclusion criteria: * medications or supplements that affect bone metabolism or prevent exercise * previous or current medical condition affecting bone health * osteoporosis of the lumbar spine and/or hip (t score \> -1.0 or \< -2.5) * cardiovascular disease * metallic implants * current smoker * current regular participation in high-intensity resistance training and/or plyometrics
extension study assessing long term safety and efficacy of ionis-ttr rx in familial amyloid polyneuropathy (fap)

Conditions: FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary: this study evaluates the safety and tolerability of extended dosing with ionis-ttr rx in patients with familial amyloid polyneuropathy.

familial amyloid polyneuropathy (fap) is a rare, hereditary disease caused by mutations in the transthyretin (ttr) protein. ttr is made by the liver and secreted into the blood. ttr mutations cause it to misfold and deposit in multiple organs causing fap. ionis-ttr rx is an antisense drug that is designed to decrease the amount of mutant and normal ttr made by the liver. it is predicted that decreasing the amount of ttr protein will result in a decrease in the formation of ttr deposits, and thus slow or stop disease progression. this study evaluates the safety and tolerability of extended dosing with ionis-ttr rx in patients with familial amyloid polyneuropathy.

Eligibility criteria:
inclusion criteria: * satisfactory completion of dosing \& efficacy assessments in isis 420915-cs2 exclusion criteria: * any new condition or worsening of existing condition that could make the patient unsuitable for participation, or interfere with the patient participating in and/or completing the study

Keywords: fap familial amyloid polyneuropathy ttr transthyretin amyloidosis