Kornimate/medical-research-clean huggingface dataset:
spenopalatine ganglion block for treatment of post-dural puncture headaches

Conditions: Postdural Puncture Headache

Summary: postdural puncture headache (pdph) is a severe, debilitating complication of dural puncture that can arise from insertion of an epidural or spinal needle for labour analgesia. presently, the conservative treatment options for pdph have limited effectiveness and the gold standard treatment for pdph, an epidural blood patch, is an invasive intervention with the potential for serious complications. there is a growing number of case reports and retrospective studies that suggest a sphenopalatine ganglion block (spgb) with local anesthetic may offer an effective, safe, and easy-to-administer treatment option for pdph in postpartum patients. we aim to conduct a feasibility study to assess whether a randomized controlled trial is feasible comparing whether early intervention spgb with the option for repeat, patient self-administered spgbs versus current standard conservative management can reduce the severity and duration of pdph pain and improve patient functional status.


Eligibility criteria:
inclusion criteria: * age 18-45 * confirmed pdph as per ichd-3 diagnostic criteria exclusion criteria: * american society of anesthesiologists (asa) class 4 and above * history of chronic headaches or migraines requiring prescription medication * known nasal septal deformity or abnormality * known allergy to amide anesthetics * intrathecal catheters * patients who received ebp on the initial presentation with pdph who declined a trial of conservative management * postpartum complication delaying maternal discharge
expanded access program of palopegteriparatide in patients with hypoparathyroidism

Conditions: Hypoparathyroidism

Summary: to provide palopegteriparatide (transcon pth), an investigational parathyroid hormone (pth) replacement therapy in an expanded access setting for adult patients with hypoparathyroidism who have previously received pth-treatment, who meet the eligibility criteria for this protocol as described below and have a clear unmet medical need that cannot be adequately treated by a commercial product or a clinical trial.

this is an expanded access program for eligible participants who previously received pth treatment and who are ineligible for an ongoing transcon pth clinical trial. the treating physician/investigator contacts ascendis pharma when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program. participants will start with a fixed dose of study drug and will be individually and progressively titrated to an optimal dose based on serum calcium levels, followed by an individualized dosing period until palopegteriparatide is commercially available to the participant. for patients taking conventional therapy with calcium and or active forms of vitamin d, these therapies will be reduced in dose and/or discontinued during titration of palopegteriparatide.

Eligibility criteria:
inclusion criteria: * diagnosis of hypoparathyroidism. * patients with previous pth-treatment experience. * serum albumin-adjusted calcium level ≥7.8 mg/dl and 25(oh) vitamin d in the normal range within 2 weeks before first dose. * body mass index (bmi) 17 - 40 kg/m2. * be willing and able to give written informed consent by signing an institutional review board (irb)-approved informed consent form (icf). exclusion criteria: * diagnosis of pseudohypoparathyroidism. * currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of day 1. * severe renal impairment (estimated glomerular filtration rate \<30 ml/min/1.73m2). * increased risk for osteosarcoma, such as those with paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton * active malignancy within past 2 years excluding successfully resected thyroid carcinoma and non-melanoma skin cancer. * severe or decompensated cardiac disease within 26 weeks, including but not limited to class iv or stage d heart failure, unstable angina, myocardial infarction or uncontrolled arrhythmias. * pregnant or lactating females, or females intending to become pregnant. * known allergy and/or sensitivity to palopegteriparatide or its excipients or prior pth therapy.

Keywords: hypoparathyroidism parathyroid hormone transcon pth pth(1-34) expanded access
cosmetic and functional outcomes after breast conserving surgery

Conditions: Breast Cancer

Summary: the initial aesthetic and functional conditions are recorded with the help of the breast cancer treatment outcome scale (bctos),an international validated questionnaire, and the breast cancer conservative treatment - cosmetic results (bcct.core) validated computer software, allowing for comparison. determination of the initial quality of life is measured with the european organisation of research and treatment of cancer - quality of life questionnaire number c30-br23 (eortc qol c30-br23). patients then undergo surgical treatment according to institutional protocols. following conventional marking of the orientation of the specimen, it is measured by an analytical scale. histological examination of the specimen will record the largest diameters, and parameters of the lymph nodes, according to the institutional protocol. on the 4th week following surgery, assuming that wound healing is completed, patients' data are again recorded in bctos, bcct.core and eortc qol c30-br23. a third set of data are gained after completion of adjuvant radiotherapy, on the 8th postoperative month. magnetic resonance imaging is performed to assess the volume of the contralateral breast. tumor - breast volume ratio is calculated, and matched up with cosmetic results in each quadrant, threshold value in the quadrants, above of which it is not advisable to perform conventional breast conserving surgery due to poor outcomes.


Eligibility criteria:
inclusion criteria: * early breast cancer * unilateral tumor * tumor size is less than 3 cm exclusion criteria: * age over 70 * malignant invasive tumor in the past * pregnancy * previous surgical treatment of the breast or axilla * central breast tumor sizing \<3 cm * a need for mastectomy * tumor size \>3 cm measured by mammography or physical examination * surgical excisions resulting in positive margins * surgical or radiotherapeutic complication

Keywords: early unilateral breast cancer
study of ny-eso-1 iscomatrix® in patients with high-risk, resected melanoma

Conditions: Melanoma

Summary: the purpose of this trial is to assess whether treatment with ny-eso-1 iscomatrix® vaccine improves outcomes for people with malignant melanoma which has been removed, but is at high risk of relapse.

ny-eso-1 protein is an immune target found in many cancers including melanoma. iscomatrix® adjuvant enhances immune responses. this trial compares ny-eso-1 iscomatrix® vaccine with iscomatrix® adjuvant alone to assess whether treatment with ny-eso-1 iscomatrix® vaccine improves outcomes for participants with malignant melanoma which has been removed, but is at high risk of recurrence. eligible participants are randomly allocated to a treatment arm. treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months). participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. off study, their own doctor will follow them for melanoma recurrence and survival.

Eligibility criteria:
inclusion criteria: * histologically proven malignant melanoma. * tumor expression of ny-eso-1 antigen by immunohistochemistry. * fully resected ajcc stage iic, iiib, iiic or iv melanoma. * within six months of surgery for melanoma. * full recovery from surgery. * no immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (previous adjuvant therapy accepted providing patient relapsed and resected after this.) * age 18 years or older. * able to give written informed consent. * vital laboratory parameters within normal range, or protocol specified ranges. exclusion criteria: * other serious or significant illnesses. * resected cerebral metastases. * ocular melanoma. * other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ. * using immunosuppressive drugs. * anticoagulation. * known hiv positivity. * chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs). * not available for immunological and clinical follow-up assessments. * participation in prior clinical trial involving an investigational agent within last 4 weeks. * previous isolated limb perfusion (ilp). * pregnancy or breastfeeding. * refusal or inability to use effective means of contraception for women of childbearing potential. * mental impairment that may compromise ability to give informed consent and to comply with study requirements.

Keywords: phase ii randomized controlled trial double-blind cancer vaccine ny-eso-1 protein, human iscomatrix®, immunological adjuvant
comparison of crinone 8% intravaginal gel and im progesterone supplementation for in vitro fertilization (ivf)

Conditions: Infertility

Summary: the goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (ivf).

the aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (ivf-et) cycle are not different with respect to the administration of progesterone (crinone 8%, intravaginal gel versus intramuscular progesterone).

Eligibility criteria:
inclusion criteria: * women of reproductive age (21-39) with infertility who are appropriate candidates for ivf/et and have an fsh \< 15 miu/ml * women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of luteal lupron/fsh or luteal lupron fsh/hmg. exclusion criteria: * women who have had more than 3 previous ivf/et cycles

Keywords: infertility in vitro fertilization embryo transfer crinone intramuscular progesterone progesterone support
the effect of exposure to an informative video on maternal anxiety

Conditions: Anxiety; Labor Pain; Patient Satisfaction

Summary: stress and anxiety during childbirth have negative consequence on both mother and fetus. previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. the present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.

a randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction

Eligibility criteria:
inclusion criteria: above 18 years of age nulliparus women informed consent reads and understand hebrew \>37 weeks of gestation exclusion criteria: refuse to participate contraindications for vaginal delivery
evaluation of atomoxetine for cocaine dependence: a pilot trial

Conditions: Substance Abuse

Summary: this placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (strattera®) for the treatment of cocaine dependence. cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. contingency management procedures will be used to reinforce attendance and compliance with study procedures. primary outcome measures will include urinalysis data assessing cocaine use.


Eligibility criteria:
inclusion criteria: * seeking treatment for cocaine dependence * must have used cocaine in the past 30 days exclusion criteria: * physical dependence on any drug requiring medical management * any major medical or psychiatric disorder that would be contraindicated for participation * cardiovascular disease * seizures or significant head injuries * currently taking atomoxetine * pregnant or breast-feeding

Keywords: cocaine dependence stimulants
comparison of anterior chest compression assist and abdominal thrust assist technique copd

Conditions: COPD

Summary: a total 34 patients will be taken. 2 groups will be created to apply intervention. after signing consent form, 17 patients in group a will be given abdominal thrust assist technique and 17 patients in group b will be given anterior chest compression technique.

patient is instructed to take in a deep breath and hold it. then, just as the patient is instructed to cough, the therapist applies a quick push up and in under the diaphragm with the heel of the hand. in anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it. after the patient takes a maximal breath, the therapist pushes down to help the patient cough. the greatest force is applied through the lower chest during expulsion. a total 34 patients will be taken. 2 groups will be created to apply intervention. after signing consent form, 17 patients in group a will be given abdominal thrust assist technique and 17 patients in group b will be given anterior chest compression technique. baseline treatment given to both groups will include percussion and tapping. the data collected will then be analyzed using ibm spss version 25.

Eligibility criteria:
inclusion criteria: * uncontrolled tachycardia * unconscious patients * in neuro-compromised patients with cognitive dysfunction * recent esophageal surgery * acute abdominal distension -recent broncho-pleural fistula - pulmonary embolism, pneumothorax hemothorax * unstable head and neck fracture exclusion criteria: * breathlessness, cough and sputum scale (bcss) * modified borg dyspnea scale * peak flow meter * pulse oximeter
comparing weaning of nasal continuous positive airway pressure (cpap) from preterm infants

Conditions: Respiratory Distress Syndrome

Summary: to compare the 2 methods of weaning of nasal continuous positive airway pressure (cpap) in premature babies born between 26 and 32 weeks

to study the weight and the post menstrual age (pma) at the time of ncpap wean utilizing the method of sudden wean as compared to gradual wean. methods: a prospective randomized trial was conducted comparing sudden weaning with gradual weaning from ncpap in neonates with gestational age between 26 and 32 weeks. the patients were randomized to one of the two methods of weaning from ncpap and their success was compared

Eligibility criteria:
inclusion criteria: * all neonates born 26 to 32 weeks of gestational age exclusion criteria: * those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia

Keywords: weaning ncpap preterm sudden wean gradual pressure off wean
deep brain stimulation in patients with dystonia

Conditions: Dystonia

Summary: the purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (dbs) of the subthalamic nucleus (stn)for primary dystonia.

dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. it is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (gpi) and the subthalamic nucleus (stn). deep brain stimulation (dbs) has been shown to be an effective treatment in patients with medically refractory dystonia and is currently approved for both the gpi and stn targets under a humanitarian device exemption (hde) for use in segmental and generalized primary dystonia as well as focal cervical dystonia. gpi dbs appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently gpi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. dbs of the stn has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. stn dbs for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as gpi dbs, but without unwanted stimulation-induced motor effects. objectives of this study are to evaluate the safety and efficacy of stn dbs for dystonia. up to twenty-five patients will be screened, consented, and enrolled in this study. all patients will undergo bilateral stn dbs for dystonia. participants will be evaluated pre- and postoperatively with standard dystonia rating scale toronto western spasmodic torticollis rating scale (twstrs), and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects and will be logged for safety monitoring. this pilot study will provide preliminary open label efficacy outcomes for stn dbs in the treatment of primary dystonia and will help determine if this target should be compared to gpi dbs in a larger double-blind trial.

Eligibility criteria:
inclusion criteria: * refractory primary dystonia diagnosed by a movement disorders neurologist * severe functional impairment despite optimal medical management, including failed botulinum toxin therapy * age 7-80 years (ucsf patients) and 18-80 (va patients) exclusion criteria: * patients considered at high risk for elective neurosurgery because of co-morbid conditions * brain mri showing extensive brain atrophy or small vessel ischemic disease * pregnancy * inability to tolerate awake microelectrode-guided neurosurgery * inability to follow up with post-operative study visits * inability to speak or read english * patients with a score of 4.5 or lower on the bfmdrs movement scale * patients with secondary dystonia

Keywords: blepharospasm deep brain stimulation cervical dystonia cranial dystonia generalized dystonia subthalamic nucleus dbs
a study to investigate acute respiratory virus infections in participants at high risk for severe illness

Conditions: Acute Respiratory Viral Infection

Summary: the purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.


Eligibility criteria:
inclusion criteria: * must sign an informed consent form (icf) indicating understanding the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study * participants at high risk for severe respiratory infections due to their immune-suppressive status and who fit in one or more of the following categories: a) participants with hematologic malignancy (hm) including, but not limited to, acute myeloid leukemia (aml), myelodysplastic syndrome (mds), acute lymphoblastic leukemia (all), multiple myeloma (mm): i) newly diagnosed, within 6 months of treatment initiation; including anticipation of cytotoxic and immunomodulatory therapy such as chimeric antigen receptor t (car-t) ii) hematologic relapse within 6 months from anticipating treatment initiation for relapse iii) participants with a history of hm who have maintained the immunosuppressive status in the opinion of the investigator and after consultation with the sponsor (that is, study responsible physician or scientists) b) participants with a history of hm who have received hematopoietic cell transplant (hct) within 1 year for autologous recipients or within 3 years for allogeneic recipients. c) participants with a non-hm who have received hct within 1 year for autologous recipients or within 3 years for allogeneic recipients. this can include, but is not limited to, participants who have received hct due to lymphoproliferative disorders, solid tumors, primary immunodeficiency, bone marrow failure syndromes, hemoglobinopathies, sickle cell disease, or autoimmune disorders. d) participants who have developed chronic graft vs host disease (gvhd) after hct and are currently on immunosuppressive therapy * must be able to read, understand, and complete questionnaires * must be willing and able to connect current electronic health records from one or more providers exclusion criteria: * has a clinical condition other than those specified in inclusion criterion 3 which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments (for example, asthma and allergies) * is, in the opinion of the investigator, unlikely to adhere to the requirements of the study or is unlikely to complete the full course of observation * cannot communicate reliably with the investigator * has moderate-severe allergies that add complexity to the assessment of acute respiratory infection (ari) episode * is currently enrolled in an interventional study that could interfere with the assessment of respiratory viral dynamics
analysis of gut microbiota in patients with brain metastasis of non-small cell lung cancer treated by pembrolizumab combined with chemotherapy

Conditions: Gut Microbiota; NSCLC; Pembrolizumab; Chemotherapy

Summary: analysis of gut microbiota in patients with brain metastasis of non-small cell lung cancer treated by pembrolizumab combined with chemotherapy


Eligibility criteria:
inclusion criteria: - non-small cell lung cancer patients with less than brain metastases patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-pd-1 / l1 treatment patients who have not received intracranial local treatment before exclusion criteria: - patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds patients with hemorrhage in intracranial metastasis
adaptive pet study

Conditions: Head and Neck Cancers; Lung and Esophagus Cancers; Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers

Summary: the purpose of this study is to determine the benefit of using positron emission tomography (pet) in addition to the standard (computed tomography) ct to plan radiation therapy for cancer treatment. the information from the pet-ct may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. presently the use of pet scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.


Eligibility criteria:
inclusion criteria: * pathologically (histologically or cytologically) proven diagnosis of carcinoma * patients with local or regional nodal disease are eligible. * zubrod performance status 0, 1, or 2. * age ≥ 18 * negative serum pregnancy test for women of child bearing potential * patient must sign study-specific informed consent prior to study entry. exclusion criteria: * no gross disease visible on imaging at the start of radiotherapy * contraindication to pet * complete response by pet achieved with pre-radiation therapy treatment (surgery or chemotherapy) * breast feeding