cyrilzakka/clinical-trials huggingface dataset:
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer

Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at time of study entry
2. Histologically documented diagnosis of unresectable stage III NSCLC;
3. Fully-informed written consent obtained from patients;
4. Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
5. Adequate bone marrow, liver and kidney function
6. Life expectancy of at least 3 months
7. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated
8. Histologic or cytologic confirmation of small cell lung cancer
9. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value

Exclusion Criteria:

1. Previous chemo-, immuno- or radiotherapy for NSCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women
Prevention and Treatment of Reperfusion Injury After Mechanical Thrombectomy in Acute Ischemic Stroke

Ischemic stroke accounts for 80% of all strokes and there is a lack of effective treatment options.Mechanical thrombectomy can significantly improve the vascular recanalization rate and reduce the disability rate of stroke, but the problem of reperfusion injury caused by vascular recanalization is more prominent than before.

The most common manifestation of reperfusion injury is postoperative hemorrhage transformation in the infarct area, which is caused by the inability of blood vessels to tolerate normal perfusion pressure after endothelial cell injury.Therefore, in addition to using necessary strategies to reduce the risk of bleeding before and during surgery, maintaining an appropriate and individualized perfusion pressure after surgery is also an important strategy to prevent and treat postoperative bleeding.

Lead a multicenter, randomized, controlled study looking at Individuation lowers blood pressure.( Drop systolic blood pressure to 90-110mmHg，Blood pressure not lower than 90/60 mm Hg，The reduced blood pressure was maintained for 48 hours). Influence of the incidence of hemorrhage transformation caused by reperfusion injury after mechanical thrombectomy and prognosis (modified Rankin Scale (mRS) score and proportion of patients with mRS≤2) at 48hours, 14 and 90 days after surgery.Thus, provide clinical evidence for blood pressure management strategy after mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute cerebral infarction with large vessel occlusion within 24 hours of onset .(internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery).
* 18 years≤age≤85 years.
* CT ruled out cerebral hemorrhage and subarachnoid hemorrhage.
* Informed consent signed by patient or legal representative.
* Successful vascular recanalization (defined as modified thrombolysis in cerebral infarction (mTICI)≥2b/3 for cerebral infarction with anterior bleeding).
* Degree of disease: 6 points≤NIHSS ≤19 points.

Exclusion Criteria:

* Preoperative or immediate postoperative CT showed active bleeding or was known to have significant bleeding tendency \[International Normalized Ratio(INR)\>3.0,Platelet count \<30×10 9/L.
* Severe heart, liver and kidney insufficiency.
* Blood glucose \<2.7mmol/L or \>22.2mmol/L.
* Severe hyperemia beyond medication control (\>180/105mm Hg).
* Patients with Alberta early stroke grading CT scores (ASPECT)\<6.
* Patients with a life expectancy of less than 90 days.
* Blood pressure is below 90/60 mm Hg.
* mRS≥3 points .
* pregnant women.
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup

Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
* Age 1 to 7 years
* Dexamethasone treatment indicated
* No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
* Have not received systemic corticosteroid for current episode prior to enrollment

Exclusion Criteria:

* Allergy to dexamethasone or apple sauce and pudding
* Unable to take medication orally
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy

This is an interventional (category 2), prospective, multicentric cohort study designed to demonstrate that the search, based on Circulating tumour DNA analysis, for a BRCA1/2 reversion mutation leading to restoration of its protein function enables early identification of disease progression in BRCA1/2 mutant patients treated as first-line maintenance with a PARP inhibitor (Olaparib alone or in combination with bevacizumab) for ovarian cancer.

For this study, a total of 9 blood samples will be taken from patients who will undergo a full 24-month treatment regimen.

Apart from the study procedure (blood sampling), all examinations carried out in this study, treatment with Olaparib (alone or combined with bevacizumab) and patient follow-up procedures will be carried out as part of routine care in accordance with the standard practices of each investigating site.

130 patients will take part in the study, and each patient will be followed for 24 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with an epithelial ovarian cancer.
2. Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previously confirmed and validated by an approved laboratory.
3. Patient due to start first-line maintenance treatment with Olaparib alone (PARP inhibitor) or in combination with bevacizumab.
4. Age ≥ 18 years at the time of signing the consent.
5. WHO ≤ 1.
6. Patient affiliated to a Social Security scheme in France.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria:

1. Other cancer under treatment.
2. Olaparib treatment already initiated.
3. Indication for treatment with a PARP inhibitor other than Olaparib.
4. Any pathology contraindicating the sample collection procedures required by the study.
5. Any psychological, family, geographical or sociological condition that makes it impossible to comply with medical monitoring and/or the procedures laid down in the study protocol.
6. Subjects deprived of their liberty or under legal protection.
Xanamem® in Adults with Major Depressive Disorder and Impaired Cognition (XanaCIDD)

Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).

This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female aged 18 to 75, inclusive.
* Positive MDD primary diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
* Persistent depressive symptoms as determined by a Hamilton Depression Rating Scale (HAM-D) ≥ 17 at Screening.
* Cognitive abilities on a coding test \> 0.5 standard deviations below expected.
* Self-reported subjective cognitive dysfunction.
* Currently or previously treated with a stable dose of a first- or second-line antidepressant that is approved for the treatment of depression (but not a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine). If on current treatment, dose must be stable for at least 6 weeks.
* Smokers are eligible if they are able to comfortably abstain from nicotine for 2 hours prior to scheduled cognitive assessments.
* Able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments.
* Must provide written informed consent to participate in the trial and be willing and able to comply with the requirements of the protocol and complete all trial visits.

Key Exclusion Criteria:

* Active suicidal ideation within the previous 3 months
* On a tricyclic antidepressant, monoamine oxidase inhibitor, esketamine, or vortioxetine.
* A history of clinically diagnosed dementia of any type
* Previous clinically significant systemic illness or infection, including test positive COVID-19, within the past 4 weeks prior to Screening
* Has a BMI or body weight that will interfere with participation in the trial
* Type I or Type II diabetes requiring insulin
* Clinically significant ECG abnormalities
* Participation in another clinical trial of a drug or device
* Trial participants who in the opinion of the Investigator exhibit physical, cognitive, or language impairments of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
* Positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibodies at Screening.
* Participants with a history of drug abuse or addiction in the past 2 years
* Current use of cannabis/marijuana, or tetrahydrocannabinol-containing medications.
OHRQoL and Accelerated Orthodontics With Micro-osteoperforations

OHRQoL assessment using OHIP-14 between sliding anterior retraction with self-ligating brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery patients who were assigned for pre-molar extraction and decompensation

Our patients are participants in a randomized clinical trial, an ongoing study about the effectiveness of micro-osteoperforations to accelerate tooth movement. The study sample consisted of 22 consecutive subjects - 12 females and 10 males - between the ages of 18 and 35, who were selected for ortho-surgical treatment and pre-molar extraction assigned for decompensation. The participants were randomly allocated to two groups: control (anterior retraction was performed using implant-assisted sliding mechanics with self-ligating brackets) and experimental (micro-osteoperforations were performed in the activation appointments for anterior retraction using implant-assisted sliding mechanics). For immediate and follow-up assessment of patients' perceptions, comparing regular orthodontic activation and activation with Accelerated Orthodontics, subjects were asked to complete an electronic questionnaire OHIP-14, to assess the participants' comfort level, experiences, and QoL impact.

Eligibility Criteria:
Inclusion Criteria:

* maxillomandibular discrepancy indicative for orthognathic surgery, no previous dental extractions, good oral and general health, non-smokers, and no use of systemic corticosteroids or biphosphonates

Exclusion Criteria:

* any tooth absence/previous tooth extraction
Nonvisual Foot Inspection for People With Visual Impairment

The purpose of this study was to find out whether a method of nonvisual foot inspection, using the senses of touch and smell, helps people with diabetes and visual impairment to find new foot problems when they are in early, easily-treated stages. All people in the study had regular foot inspections by podiatrists. The results include how people feel about the method, whether they actually did check their feet it, and whether the method helped them to discover foot problems themselves.

Data gathered over the course of 1 year:

* bimonthly phone calls to ask about foot care practices at home over the last week
* a baseline comprehensive foot evaluation and 4 additional comprehensive evaluations every 3 months

Qualitative data:

- Focus groups immediately after comprehensive diabetes self-management education, and 1 year later, to determine acceptability of foot care procedures and patient perceptions about effectiveness

Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* Diagnosed with diabetes (either type 1 or type 2)
* Having visual impairment

Exclusion Criteria:

* Self-reported numbness in hands
* Inability to pass a brief screening for decisional capacity
Short-Term Effects of PT on Physical Activity

The primary purpose is to examine the impact that physical therapy (PT) interventions, including manipulations, have on physical activity levels outside of the clinical environment in persons with low back pain (LBP) as measured both objectively with an accelerometer and subjectively with questionnaires.

The secondary purpose is to determine if a relationship exists between objective physical activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk distance, lower extremity muscle endurance.

The tertiary purpose is to assess the predictive value that a standing manual lumbar unloading technique has for relief of pain following manipulation

At session 1: Participants are screened for eligibility. Baseline outcome measures are conducted (self-report questionnaires and physical performance tests). Accelerometer which is an instrument to measure physical activity is issued.

At session 2 (To occur at least one-week later): Accelerometer data is retrieved and downloaded to a computer. Participant numerically rates low back pain level at rest and in most painful position. Participant receives a manual distraction procedure. Participant rates pain level again. Participant starts the physical therapy intervention (manipulation of the spine, muscular strengthening and cardiovascular exercise, education). Accelerometer is reissued again.

At session 3 (At least one-week later): Accelerometer is collected and data is retrieved. Participant continues with the intervention (manipulation, exercise, education).

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient referred to outpatient PT with a LBP related diagnosis

  2. LBP without radiating pain distally to the knee \> 3 months in duration

  3. Ability to read and write in English or Spanish

  4. Age between 18 and 70 years

  5. Able to ambulate independently without assistive devices

  6. Access to a computer or cell phone with an email address and/or the ability to receive short text messages

Exclusion Criteria:

* 1. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine

  2. No clinical indication of nerve root pathology such as: straight leg raise less than 45 degrees, asymmetric lower extremity deep tendon reflexes, lower extremity muscle strength deficits or radiating pain, numbness or tingling below the knee

  3. No surgical or biological fusion to the spine

  4. No previous spinal surgery

  5. No known diagnosis of osteoporosis or rheumatoid arthritis

  6. No use of oral steroids within the past 6 months

  7. No epidural injection over the previous 4-weeks to the lumbar spine region

  8. No current litigation, workman's compensation or disability claim for a low back injury

  9. No known pregnancy
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)

This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.


Eligibility Criteria:
Inclusion criteria:

* Body mass index (BMI) of 18 to ≤37 kg/m\^2
* Diagnosis of chronic HCV infection
* Must be infected with HCV GT1a, GT1b, or GT3

Exclusion criteria:

* Co-infection with GT1 and GT3 HCV
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease
* Positive Hepatitis B surface antigen
* History of human immunodeficiency virus (HIV) infection or positive HIV serology
* Major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior
* History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
* Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, autoimmune hepatitis
* Previous treatments(s) with nonstructural 5A (NS5A) protein inhibitors
* Treatment with protease inhibitor(s) \<30 days prior to study enrollment
* Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of MK-8325 in the study
* Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* ≥ 37-week pregnancy
* singleton pregnancy
* elective cesarean section with a low transverse incision
* ASA I or II

Exclusion Criteria:

* Personal history of uterine atony or postpartum hemorrhage
* Abnormal placental implantation (known or suspected)
* \> 3 cesarean sections in the past
* Personal history of a classic uterine incision
* Estimated fetal weight \> 4500g
* Hemoglobin \< 100 g/L
* Regular use of tocolytic drugs
* Cesarean section under general anesthesia
* Known allergy to carbetocin
* Refusal
* Inability to obtain informed consent
Home Spirometry in Primary Care: an Implementation Study

Rationale: Spirometry is essential in the diagnosis of airway disease and can be useful in monitoring patients. Despite the essential role, spirometry remains largely underused in primary care. Due to Coronavirus disease (COVID-19), the use of office spirometry is contraindicated in many countries. Furthermore, spirometric devices are costly and personnel requires special training. Referral for spirometry increases the cost for patients and lowers the feasibility. Part of the reason for underdiagnosis of airway disease are the specific situations (such as exercise-induced asthma) in which spirometry in office setting might not reveal abnormalities. In recent years, handheld spirometry linked to phones/apps has been developed for study purposes and remote monitoring.

Objective: To study the feasibility, quality and added value of at-home spirometry for the diagnosis and monitoring of asthma and Chronic Obstructive Pulmonary Disease (COPD) in primary care.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years
* Spirometry indication
* Able and willing to use at-home spirometry

Exclusion Criteria:

* On the discretion of the recruiting clinician if he or she deems a patient not eligible.
* Inability to understand and sign the informed consent form
* Known previous inability to perform spirometry
* Contraindications to perform spirometry as listed in the standardization of Spirometry 2019 update (Graham et al., 2019)
StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students

This study was a randomized controlled trial of an original online mental health promotion program. This study aimed to: 1) establish program effectiveness by examining symptom change between conditions and 2) examine predictors of symptom change. The program was previously tested in open trial feasibility study by the same Principal Investigator and has since been rebuilt as informed by feasibility findings and participant qualitative feedback.

Participants were randomly assigned to either a waitlist condition or eight weeks of the intervention condition. Baseline, posttest, and follow-up electronic surveys collected self-reported symptoms of stress, anxiety, and depression. Motivational variables were also assessed at baseline and then tested as moderators of intervention effects.


Eligibility Criteria:
Inclusion Criteria:

* enrolled as a student at UCLA (Fall 2017 - Winter 2018)

Exclusion Criteria:

* concurrent enrollment in a similar online anxiety and depression treatment study on campus
* invalid data reporting (e.g., straight-lined responses to surveys) -- post hoc exclusion
Intensive Activities-based Locomotor Training Program in Children With Cerebral Palsy

The goal of the proposed work is to investigate the impact of an intensive 3-week activities-based locomotor training (AB-LT) program on activity capacity, activity performance, and participation in children with cerebral palsy (CP). Caregiver perspectives will provide a holistic assessment of the program.


Eligibility Criteria:
Inclusion Criteria:

* Intervention: Participants will be included if they have a diagnosis of CP and are between the ages of 2 to 12 years. They must also be enrolled in the 3-week AB-LT program at Fortis Therapy Center.

Parent Interview: Participants will be included if they are the parent or guardian (any age) of a child who participated in the 3-week AB-LT program and attended at least 3 sessions with their child.

Exclusion Criteria:

* Intervention study: Participants will be excluded if they have had surgery or botulinum toxin injections in the previous 6 months or have uncontrolled epilepsy or cardiovascular disease.

Parent Interview: Participants will be excluded if they have not attended at least 3 AB-LT sessions with their child.