Kornimate/medical-research-clean huggingface dataset:
screening for depression and anxiety in pregnant and postpartum women: evaluating prevalence, risk factors, and the stepped screening protocol in a care pathway

Conditions: Depression, Postpartum; Puerperal Disorders; Depression During Pregnancy; Anxiety; Anxiety Disorder/Anxiety State; Stress, Psychological; Risk Factors

Summary: having a baby is a major life event, and for some women, it can increase the risk of developing mental health issues. a recent survey in the uk found that one in five women experience mental health problems during pregnancy or after giving birth. unfortunately, many of these problems go unnoticed without regular check-ups, and only one in ten women receive the support they need. regular mental health screenings can help detect these problems early, ensuring women receive the right care and support. the study at uz gent aims to improve how depression and anxiety are detected in pregnant and postpartum women by using a perinatal screening protocol. this protocol involves screening women for psychosocial risks around the 16th week of pregnancy, which is done by a midwife. further screenings take place during the second trimester (around 20 weeks) and again six weeks after birth, using questionnaires to assess for depression and anxiety (whooley, epds, gad-2, gad-7). if the assessment of risk factors or the screening for depression and anxiety is positive, further assessment and treatment are offered at the women\&#39;s clinic. a positive screening may lead to a recommendation for a diagnostic interview, such as a semi-structured interview (m.i.n.i.), with a psychiatrist, general practitioner, or psychologist to assess for possible depression or anxiety disorders. if needed, appropriate treatment will be provided. the study will explore how common depression and anxiety are during and after pregnancy, what factors increase the risk, and whether the screening process improves early detection and treatment. the ultimate goal is to help more women get the mental health support they need during this critical time.


Eligibility criteria:
inclusion criteria: * pregnant women aged ≥ 18 years, receiving regular care follow-up in a university hospital exclusion criteria: * non-dutch speakers were excluded. additionally, no data were collected from women in the vulnerable care pathway, which provides psychosocial support to those facing barriers in employment, income, housing, education, and healthcare. this group includes teenage mothers (under 18), women with intellectual disabilities, new immigrants, refugees, homeless women, and those with severe psychiatric or addiction issues referred by their psychiatrist or gp.
efficacy of manipulative treatment for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: hypothesis: manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of cts. study design: two-groups randomized single-blind interventional study.

background: carpal tunnel syndrome (cts) is the most common compressive neuropathy in the upper limb. it considerably impairs patient's quality of life and generates important social consequences due to the lost of productivity and the cost of treatments. both surgical and conservative treatment are utilized for cts management. manipulative treatment is a conservative, non-drug and cheap management option which can be proposed, but by now, treatment guidelines and reviews do not recommend it due to lack of evidence to assess his efficacy. hypothesis: manipulative treatment can relieve patients of discomfort and dysfunction and then be utilized as a cheap conservative management of cts. study design: two-groups randomized single-blind interventional study. methods: sixty-six patients reporting cts symptoms that are confirmed by clinical exam and nerve conduction studies will be included. participants will be randomized in two arms, one receiving manipulative treatment and one receiving simulated manipulative treatment (1/week for 4 weeks). the main outcome measures will be the dash questionnaire, the boston carpal tunnel syndrome questionnaire, patient estimate on visual analog scale for pain and the euroqol-5d scale. all outcomes measures will be administrated to participants before the first manipulation, after the last session (4 weeks) and 12 weeks after the baseline measure.

Eligibility criteria:
inclusion criteria: * symptoms of canal tunnel syndrome (cts) : pain, numbness, paresthesia, diminished grip strength * electromyography confirming cts exclusion criteria: * previous surgical procedure for cts in the same wrist * possible secondary cts : hypothyroidism, diabetes mellitus, pregnancy, rheumatologic diseases, neck or shoulder complaints, * hand and wrist pathological conditions as previous disease, intervention, traumatism, anatomic abnormalities in shape or size.
a prospective study of prophylactic gastrostomy in head and neck cancer patients undergoing chemoradiotherapy

Conditions: Carcinoma, Squamous Cell of Head and Neck

Summary: the purpose of the study is to determine whether prophylactic gastrostomy leads to less treatment interruption and provide better quality of life in head and neck cancer patients receiving chemoradiotherapy.

nutritional status is one of the essential factor to determine outcome of chemoradiotherapy in head and neck cancer patients. almost all these patients develop mucositis during the treatment, which usually leads to treatment interruptions and affects the efficacy of the treatment. prophylactic gastrostomy has been accepted for these patients with improvement of quality of life. however, there is no prospective study confirming superiority of such treatment. the investigators enrolled head and neck cancer patients who had the plan of chemoradiotherapy. the patients will be informed about both treatment arms and will decide the arm that they preferred. the treatment interruptions, body weight and nutritional status will be assessed every 2 weeks during treatment period.

Eligibility criteria:
inclusion criteria: * pathologically confirmed of head and neck cancer * plan to have chemoradiotherapy session * performance status of 0-2 exclusion criteria: * contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor * body mass index less than 16 kg/m2
the rett syndrome global registry

Conditions: Rett Syndrome

Summary: the rett global registry is a fully remote, global, caregiver-reported registry to collect information about caring for a loved one with rett syndrome. in addition, caregivers have the ability to track and graph their loved one's symptoms and care strategies over time, store information for central access, and opt-in to complete medical record consolidation and summary. qualified researchers and therapeutic developers may request access to de-identified aggregate information to further rett research, or assist with clinical development planning to facilitate and expedite more effective clinical trials.

the rett syndrome global registry is a fully remote, global, caregiver-reported registry intended to meet the needs of caregivers, clinicians and researchers, and therapeutic developers with the goal to increase our understanding of this rare disorder, support better outcomes for those with rett syndrome, and facilitate improved therapeutic development. the rett global registry allows families to provide data about their experience with rett syndrome to improve their loved one's care while contributing to research. participants may opt in to track and graph symptoms and care strategies over time to support day-to-day care. participants may also access aggregate data to see similarities and differences in care strategies and consolidate their personal information in a central location. participants may opt-in to complete medical record consolidation and summary that is centrally accessible, able to be shared with care providers, and utilized for research. the registry database is designed and maintained to clinical trial standards and supports research and therapeutic development while meeting or exceeding federal privacy and confidentiality requirements. these datasets including caregiver-reported rett syndrome progression, quality of life, at home day-to-day data, and consolidated medical records from office visits or hospital stays, provides unique and previously unused sources of information important for improving our understanding of rett syndrome, allow additional avenues of research, and support therapeutic development. specifically, the registry is intended to assist with clinical development planning, trial design, trial endpoints, and regulatory filings.

Eligibility criteria:
inclusion criteria: 1. parent/caregiver must be willing and able to provide written informed consent electronically prior to entering data into the registry. 2. rett individuals of any age, living or deceased, must have a diagnosis of rett syndrome and/or have a mutation in mecp2. exclusion criteria: 1. individuals who have a genetic mutation that is inconsistent with rett syndrome or who have a different disorder. 2. individuals with mecp2 duplication syndrome

Keywords: mecp2 registry rsrt
enhanced recovery after surgery in extremity sarcoma

Conditions: Sarcoma

Summary: the purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (eras) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.

specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. primary endpoints collected with be short-term patient reported outcomes (pain scores \[promis\] and \[qor-15\]), limb function scores \[msts\], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).

Eligibility criteria:
inclusion criteria: * any patient at vanderbilt university medical center treated with surgical excision of a suspected extremity sarcoma * adult patients \>17 years of age * patients of all preoperative opioid status (naïve or dependent) exclusion criteria: * patients treated non-operatively * non-english speaking patients

Keywords: enhanced recovery after surgery
u01-biomarkers for noninvasive and early detection of pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.

this is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue, normal tissue. biospecimens collected through this protocol will be shared with collaborators in the pancreatic cancer detection consortium to support projects funded through an nih u01 grant. participants will be enrolled when they present for clinically indicated surgical procedures for their possible tumor or pancreas resection or cyst resection, or at a clinically indicated follow-up appointment after their procedure. this protocol supports this effort by providing investigators with access to a wide variety of pancreatic tissues and biospecimens for translational studies in pancreatic cancer. this protocol covers the collection of clinical data and biospecimens (blood; malignant, benign, or precancerous pancreatic tumor; and adjacent normal tissues) from patients with, or suspected to have, pancreatic cancer. additionally, saliva and cyst fluid, may be collected in the future from patients with pancreatic cysts. these will be shared with the pancreatic cancer detection consortium for further analysis.

Eligibility criteria:
inclusion criteria: * males or females ≥ 18 years of age who have been diagnosed with pancreatic cancer (pdac), pancreatic neoplasms (pns - ipmms, panins and mcns), pancreatitis and diabetes or no disease/healthy. * individuals undergoing or have previously undergone a diagnostic procedure (i.e. eus or ercp) evaluation or surgery. * willingness and ability to donate biospecimens for the purpose of research. * subjects must have had diagnostic procedure or surgery after september 1, 2017. exclusion criteria: * individuals under 18 years of age. * inability to donate biospecimens. * females pregnant or lactating.
stress radiography for pelvic ring injuries

Conditions: Pelvic Fracture

Summary: the primary aim of this investigation is to prospectively and clinically validate a novel, reproducible method of quantitative application of compressive stress to a lc1 pelvic ring injury of indeterminate stability for the purpose of assessing quantitative pelvic ring displacement.

patients will receive a diagnostic intervention with multiple x-rays. these x-rays will be taken as different levels of force are applied to the pelvis. this will be used to determine instability as an indication for surgical intervention to stabilize the pelvic ring.

Eligibility criteria:
inclusion criteria: * age \> 18 years * acute emergency department admission or transfer to los angeles county + usc medical center * presentation within 3 weeks of injury * blunt or blast mechanism of traumatic injury * lateral compression pelvic ring injury with unilateral incomplete disruption of the posterior arch (ota/ao 61b1.1/2.2; young burgess lc1) on radiographs and/or computed tomography scan of the pelvis obtained per routine care * lc1 pelvic ring injuries occurring in isolation are virtually never associated with hemodynamic instability or critical patient condition * stress examination of lc1 pelvic ring injury is standard of care * patient must speak either english or spanish exclusion criteria: * volume expanding pelvic ring injury (young-burgess apc-2 and 3, lc-3, vertical shear, and combined mechanism of injury (cmi) (tile b and c patterns; ota codes 61-b and 61-c). * volume expanding pelvic ring injury injuries represent the types of pelvic ring disruption responsible for pelvic hemorrhage and hypotension and are correlate with patient hemodynamic instability as well as critical injuries * volume expanding pelvic ring injury injuries warrant stabilization with circumferential pelvic compression. * patients with volume expanding pelvic ring injury are not clinically appropriate for this study. * hemodynamic instability or hypotension angioembolization (ae), preperitoneal pelvic packing (ppp), or resuscitative endovascular balloon occlusion of the aorta (reboa) to obtain or maintain hemodynamic stability * bladder, vaginal, rectal, colonic, or other abdominal or pelvic organ injury precluding safe application of circumferential pelvic compression device * patient likely to have severe problems with maintaining follow- up due to at least one of the following: * patient has been diagnosed with a severe psychiatric condition * patient is intellectually challenged without adequate family support * patient lives outside the hospital's catchment area * follow-up is planned at another medical center * patients who are prisoners or homeless

Keywords: pelvic binder pelvic ring injury pelvic instability stress radiography
patient-centered dosage of levothyroxine

Conditions: Hypothyroidism; Thyroid Cancer; Thyroid

Summary: levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. because dosage adjustment normally takes several months, the investigators have developed a decision support tool (dst) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. in this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. the use of dst to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. the effect of dst use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.


Eligibility criteria:
inclusion criteria: * total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at norwegian hospitals exclusion criteria: * anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy

Keywords: decision support tool patient-centered dosage thyroidectomy levothyroxine
effect of a gait retraining intervention and a minimalist footwear transition on foot-ankle strength, running economy and injury in endurance runners.

Conditions: Running; Wounds and Injuries; Oxygen Consumption

Summary: the main aim is to determine whether a gait retraining intervention will improve the strength of the foot-ankle muscle, the running economy and reduce the injury incidence in a one-year follow-up study. the secondary aim is to seek whether a minimal foot-ankle strength is necessary to reduce the risk to sustain to a running-related-injury to transit toward a forefoot strike pattern or toward a minimalist footwear for an endurance runner. participants will be assessed at baseline, at 2 month follow-up, at 6 month follow-up and at 12 month follow-up. assessment will be composed by questionnaires, a foot screening, maximal voluntary isometric strength of foot-ankle muscle with hand held dynamometer. then, participants will run on a treadmill at self-paced and at 10 km/h with to measure their running economy and their footstrike pattern. in function of their distribution, participants will receive either nothing (control group) or minimalist footwear or a training to modify their footstrike pattern toward a more forefoot strike.


Eligibility criteria:
inclusion criteria: * run 15 km per week since minimum 6 month exclusion criteria: * no running related injuries in the last 3 month before the participation. * have never worn minimalist footwear (minimalist index superior to 70%) * have never modified their footstrike pattern

Keywords: gait retraining performance injuries
phase 1 to investigate the safety, tolerability, and efficacy of gcc2005 in patients with r/r nk and t-cell malignancies

Conditions: Lymphoma, T-Cell

Summary: this is a phase 1 (a and b), first in human (fih), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of gcc2005 in the treatment of patients with relapsed/refractory (r/r) nk or t-cell malignancies who have received at least two prior lines of therapy.

the purpose of the study is to assess the safety, tolerability, and preliminary efficacy of gcc2005 in treatment of patients with relapsed or refractory nk cell and t-cell malignancies expressing cd5. phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of patients and to provide a safety profile of gcc2005 in target patient population. phase 1b of the study is planned to conduct dose optimization to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d).

Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory cd5+ nk and t-cell originated malignancies (per who classification 2017). * patients with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the investigator. * according to the lugano classification, patients having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown. * patient has a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) performance status. * patients who satisfy the criteria defined in the protocol. * contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: * has t-all/t-lbl or ctcl. * patient with cns lymphoma or any involvement of the cns. * patient who had a prior history of another malignancy over the last 3 years. * patients who have used hematopoietic growth factor therapy within 14 days prior to screening. * patients who have had prior car-t or car-nk therapies. * presence of uncontrolled fungal, bacterial, viral infection or other infection requiring iv antimicrobials for management * patients with previous allogenic organ transplantation * patients with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency. * patients with acute gvhd ≥ grade 3 or extensive chronic gvhd within 2 weeks of lymphodepletion. * patients with known active hepatitis b or c * patients with presence of grade 2 or greater toxicity from the previous treatment.
gene testing in patients with colon cancer

Conditions: Colorectal Cancer

Summary: rationale: analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer. purpose: clinical trial to study the genes of patients treated with chemotherapy for colon cancer.

objectives: * determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on calgb protocol 8896. * determine the prognostic and predictive values for response to this therapy in these patients.

Eligibility criteria:
disease characteristics: * patients who received chemotherapy for colon cancer as part of calgb protocol 8896 * underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor * surgical specimen blocks available, including tumor tissue and normal tissue

Keywords: stage iii colon cancer adenocarcinoma of the colon
real-world study of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: this is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of niraparib as first-line maintenance treatment for chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.

in this study, 300 patients will be enrolled. eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. patients will be treated with niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. the primary endpoint is treatment pattern of niraparib as first-line maintenance treatment for ovarian cancer patients. the second endpoints include ae, pfs and quality of life.

Eligibility criteria:
inclusion criteria: * women aged 18 years or older * histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma * having received one line of platinum-based chemotherapy, and clinically cr or pr to this line of chemotherapy * understand the protocol, and written informed consent before any study-related procedure exclusion criteria: * participating in other clinical trials at the same time * having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators * having other malignant tumors (other than breast cancer with brca mutation) * pregnancy or breast feeding, or planning a pregnancy during the study * unable to visit on time * patients who are allergic to the study drug or drug components