cyrilzakka/clinical-trials huggingface dataset:
Taking Care of Her Program in Patients With Stage III or IV Ovarian Cancer and Spouse Caregivers

This pilot clinical trial studies the Taking Care of Her program in patients with stage III or IV ovarian cancer and spouse caregivers. This counseling program may equip the spouse caregiver with skills to support and nurture the patient through initial diagnosis and treatment. It may also help patients and spouse caregivers improve communication and coping skills.

PRIMARY OBJECTIVES:

I. Test the feasibility of the study protocol, including recruitment and retention.

II. Assess the short-term impact of the intervention on standardized measures of behavioral-emotional adjustment of spouse caregivers and diagnosed women on depressed mood, anxiety, quality of marital communication, perceived spousal support, and spouse caregivers' skills and self-confidence to manage the emotional toll of the illness on themselves and the ill partner.

OUTLINE:

Patients and spouse caregivers complete the Taking Care of Her Program comprising 5 telephone-delivered intervention sessions over 45-60 minutes every 2 weeks. The intervention sessions are designed to provide training for spouse caregivers and patients to better manage the impact and emotional toll of recently diagnosed ovarian cancer, including its impact on their interpersonal communication and support about the cancer.

Eligibility Criteria:
Inclusion Criteria:

* Spouses of women with diagnosed within the past 8 months with stage III or IV ovarian cancer will be eligible to participate, as will the diagnosed wife/partner
* Spouses and patients must be married or cohabiting and in intimate relationship for at least 6 months
* Have English as one of their languages of choice (they can be multilingual)
* Have access to a telephone
* Have not been diagnosed with a prior cancer within the recent 5 years, except basal or squamous cell skin carcinoma
* Both heterosexual and same sex couples will be eligible

Exclusion Criteria:

* Women diagnosed with stage IV ovarian cancer and who are hospice eligible
* Spouses/partners could not participate if the patient refused participation
How Are Cognitive Functions Affected by Different Sedation Methods in Geriatric Patients?

The investigators wanted to observe the change in the level of consciousness of patients undergoing ERCP after anesthesia. For this, the investigators evaluated the patients with the mini mental state examination test and the frail scale.

Background and Aim: For patients, endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure and requires deeper sedation and less body movement than routine gastrointestinal endoscopy. Different sedation methods can be used during the ERCP procedure, which is increasingly used in elderly patients, but their effects on cognitive functions are not clearly known. The main aim of our study was to observe the effect of different sedation methods routinely used in geriatric ERCP patients on cognitive functions.

Methods: Our observational prospective study included 184 inpatients aged 65 years and older who received propofol or propofol + dexmedetomidine for sedation during ERCP. To evaluate cognitive function, Mini Mental State Examination (MMSE) was administered 3 times before the procedure and 2 hours and 24 hours after the procedure. Frailty level of the patient was determined using the frail frailty questionnaire. Each patient received 0.5µg/kg fentanyl (iv). In the propofol group, propofol loading dose: 0.2-0.5mg/kg, maintenance infusion dose: 0.5-4mg/kg/h was continued. In the dexmedetomidine group, in addition to propofol infusion at the same doses, dexmedetomidine 0.5 μg/kg-1 loading dose was administered within 10 minutes and then continued as infusion at a dose of 0.2-0.7 μg/kg/h. Ramsey score was kept at 3-4. ERCP procedure time, total amount of propofol and dexmedetomidine used, atropine and ephedrine administered additionally were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years older and who underwent ERCP and were hospitalized were included in the study.

Exclusion Criteria:

* Patients with 2nd and 3rd degree Atrioventricular Block,
* Recent history of stroke
* Severe hypotensive
* Cardiorespiratory instability
* Substance abuse
* Psychotic illness
* Severe dementia
A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis

Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved for the treatment of lumbar spondylolisthesis (LSP). The present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures.

Lumbar spondylolisthesis (LSP) is the most common degenerative lumbar disease in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new direction for spinal surgeons to treat LSP. Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved. The results of pilot studies showed that it had the advantages of less traumas, fewer complications, quicker recover，and the clinical and imaging outcome was remarkable. Therefore, the present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish two-year follow-up to further quantify the clinical and imaging outcome of UBE. Therefore, the present study will further verify and quantify the safety and effectiveness of the UBE in the treatment of LSP on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of LSP.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar spondylolisthesis,
* 40 yrs\<age\< 75yrs
* fusion levels \<2

Exclusion Criteria:

* greater than Lenke-slivia classification III
* severe osteoporosis (t value \<2.5)
* ASA 》IV
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.


Eligibility Criteria:
Inclusion Criteria:

Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria

* Adult at least 18 years old
* Native speakers of American English
* Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

CHILDREN Inclusion Criteria

* Children at least 6 months old
* Native speakers of American English
* Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

  * For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.

Exclusion Criteria:

Exclusion for all Cochlear Implant Subjects:

* Inability to provide informed consent
* Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device
* Unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects:

* Inability to provide informed consent
* Hearing loss, or significant history of hearing related issues
* Unable to carry out the study protocol or tasks required in the study
Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.

Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a complete ACL tear and received a hamstring autograft ACL repair surgery (within 8 months of injury) and plan to complete physical therapy and follow up treatment with WFBH at D1 outpatient rehabilitation
* Subjects must have a smartphone capable of running the nutrition tracking app (My Fitness Pal)

Exclusion Criteria:

* Subjects must not have other ligamentous involvement, or complications during the surgical procedure.
* They must not have had a concurrent meniscal repair (debridement is acceptable).
* They must not have post-operative limitations that interfere with rehabilitation.
* Patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded.
* Females who are pregnant will not be permitted in the study.
Health Status Evaluation for Cancer Survivors by Non-intrusive Sensing System

To improve quality of life of elderly cancer survivors

1. Using physical activity and environmental sensing technology
2. Monitoring physiological indicators of cancer recurrence

   * Analyzing the patient's circadian rhythm, frailty and his/her vital sign.
   * Vital sign includes blood pressure, weight and hrv.
3. Collecting the patient information in real time

   * Giving alarm information to the patient, if any special cases our system found.
   * Giving circadian rhythm report to the patient.
   * Giving healthy report to the patient, collected from his/her vital sign.


Eligibility Criteria:
Inclusion Criteria:

* The clinical pathology and diagnostic imaging to determine the cancer who completed acute treatment, and patients with more than a month recuperating.
* Over 65 years old.
* Proficient in Chinese or Taiwanese.
* Normal cognitive function

Exclusion Criteria:

* No history of cancer
* Over 65 years old.
* Proficient in Chinese or Taiwanese.
* Normal cognitive function
Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures

Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgical fixation of hip fracture
* Patients with isolated inter-trochantric fracture
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* Patients who are able to give their own consent

Exclusion Criteria:

* Patients unable to give consent or inability to communicate/ cooperate
* Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
* Patients with allergy to local anaesthetics or any drugs included in the study
* Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection
Retrospective Analysis in Quality of Care Measures in Pediatric Adenotonsillectomy Patients

The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric health information (PHIS) databases in addition to our own perioperative Nationwide Children's data base to look at outcomes, resource utilization, and cost trends for adenotonsillectomy in the nationally versus locally. The investigators also want compare Nationwide Children's to other regional and national tertiary pediatric institutions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergone an adenotonsillectomy, tonsillectomy or adenoidectomy during the past 2 years (2013-2015) who have ICD-9 codes (International Classification of Diseases) in the databases

Exclusion Criteria:

* Non-adenotonsillectomy patients
Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients

Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality. This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.

The vascular endothelial growth factor (VEGF) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ARDS. As opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability. Studies in animal models have shown that treating ARDS with anti-VEGF therapy is effective.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or over 18 and under 90 years old.
* Confirmed COVID-19 positive diagnostic through PCR.
* Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate.
* Patient has received anti-viral and anti-inflammatory therapy.
* Present any of the following clinical-functional criteria:

  1. Respiratory distress: Tachypnea\> 30 breaths / minute
  2. Partial arterial oxygen pressure (PaO2) / Fraction of inspiration (FiO2) ≤ 300 mmHg
* Signed informed consent, directly or delegated.

Exclusion Criteria:

* Severe liver dysfunction (Child Pugh ≥ 3 or AST\> 5 times normal)
* Severe renal dysfunction with glomerular filtration \<30 mL / minute or under treatment with hemodialysis or peritoneal dialysis.
* Poorly controlled hypertension (BPs\> 160 mmHg or TAd \<100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy.
* History of poorly controlled heart disease with a NYHA\> 2.
* History of thrombosis in the previous 6 months.
* Signs of active bleeding.
* Open wounds, gastrointestinal perforation.
* Diagnosis of thrombophilic diseases or hemorrhagic diathesis.
* Active viral hepatitis or HIV not properly treated.
* Intolerance or allergy to bevacizumab or its components.
* Pregnancy.
Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization

this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.

Nano-propolis and Propolis will be used as final endodontic irrigants and will be compared to saline in Revascularization of necrotic mature teeth.

Eligibility Criteria:
Inclusion Criteria:

* mature teeth.
* teeth with periapical periodontitis.
* Maxillary anterior teeth
* Patients should be free from any systemic disease
* Patients who will agree to the consent and will commit to follow-up period.

Exclusion Criteria:

* Patients with immature roots.
* Patients with any systemic disease that may affect normal healing.
* Patients with swelling. .Pregnant females. .Patients who could/would not participate in a 1-year follow-up. .Patients with fistula. .Patients with old age. .Teeth with periodontal involvement. .Teeth with vertical root fractures. .Non-restorable teeth.
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
* Female of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.

Exclusion Criteria:

* Previous pulmonary endarterectomy.
* Recurrent thromboembolism despite sufficient oral anticoagulants.
* Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.
* Known moderate-to-severe restrictive lung disease (i.e., TLC \< 60% of predicted value) or obstructive lung disease (i.e., FEV1 \< 70% of predicted, with FEV1/FVC \< 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
* Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.
Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer

This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.

This is a prospective, randomized, controlled, open-label clinical trial, which aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute esophagitis after thoracic radiotherapy in lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent.
2. Age ≥ 18 years.
3. Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer.
4. Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV.
5. Prescription dose for the PTV: 60-70 Gy once daily (2 Gy/Fx), 45 Gy twice daily (1.5 Gy/Fx, with intervals exceeding 6 hours), or 45 Gy once daily (3 Gy/Fx).
6. Ability to orally intake food normally.
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
8. The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume.
9. Expected survival of more than 3 months.
10. Laboratory test results during the screening period:

    Complete blood count: ANC ≥ 1.5 × 10\^9/L; PLT ≥ 80 × 10\^9/L; Hb ≥ 90 g/L. Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
11. Female subjects of childbearing potential, male subjects, and partners of male subjects agree to use reliable contraceptive methods during the study period (such as abstinence, sterilization, oral contraceptives, or other contraceptive measures).

Exclusion Criteria:

1. Previous history of thoracic radiotherapy.
2. Suspected or confirmed tumor invasion of the esophagus.
3. Patients with other primary tumors.
4. History of esophageal cancer, gastric cancer, or prior esophageal surgery.
5. Concurrent active reflux esophagitis.
6. Current regular use of immunonutrition (e.g., Oral Impact®).
7. Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases.
8. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
9. Concurrent active autoimmune diseases requiring treatment.
10. Known history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS).
11. Any medical (e.g., pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric, or social condition that, in the investigator's judgment, may interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate and participate in the study, or interfere with the evaluation of the study drug, interpretation of patient safety, or study results.