cyrilzakka/clinical-trials huggingface dataset:
Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)

The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).


Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18,
2. Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
3. Patients that have capacity to provide medical consent

Exclusion Criteria:

1. All patients under the age of 18
2. Prisoners, diabetics, increased risk of bleeding, and pregnant women.
3. Patients with prior surgery or history of infection on the joint of interest.
4. Patients with an estimated glomerular filtration rate (eGFR) \<50 ml/min
5. Patients on dialysis or renal transplant.
6. Patients on steroid preoperatively.
7. Allergy to sulfas
8. Inability to provide medical consent.
9. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
* Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
* Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
* Performance status of no more than 2.

Exclusion Criteria:

* Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
* Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .
A Pilot Efficacy and Safety Study of ST101 in Essential Tremor

This study will look at the ability of ST101 to treat symptoms in subjects with Essential Tremor. This study will also examine the safety and tolerability of the drug. This study is evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that all patients will receive both ST101 and placebo, but they will receive it in a random (by chance) order.

Essential tremor (ET) is a slowly progressive, chronic neurological disorder characterized by a 4- to 12-Hertz tremor, which can involve the arms, head, voice and lower extremities. Although the hallmark of the disorder is thought to be the kinetic tremor, ET patients usually also manifest a postural tremor as well. Kinetic tremor (tremor with voluntary movements) may interfere with fine motor skills (e.g., writing, eating, drinking from a cup, pouring liquids); and depending upon its severity, may result in significant disability and diminished quality of daily living. Essential tremor represents an area of unmet medical need and this study is designed as a safety, tolerability and proof-of-concept investigation of the ability of ST101 to improve tremor. In this 2-stage study, subjects will be randomly assigned to either ST101 or placebo in Stage 1, and will receive the alternate treatment in Stage 2.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite or probable essential tremor (ET) as defined by the Tremor Investigational Group with involvement of the hands and arms of at least 2 years duration
* Tremor severity score of \>/= 2 in at least one upper extremity on the Fahn-Tolosa-Marin Tremor Rating Scale
* Subject who is accessible by telephone
* Subject who can comply with study visits, study drug compliance, and study procedures.

Exclusion Criteria:

* Subject whose tremor is adequately controlled on a current treatment
* Subject who is pregnant, plans to become pregnant during the study or within 2 months of completing the study or who is presently lactating or breast-feeding
* Subject with other medical conditions that may cause or explain subject's tremor
* Subject with a recent history of hematologic/oncologic disorders
* Subject taking medication(s) that might produce tremor or interfere with the evaluation of tremor
* Subject who has had surgical intervention for their tremor in the past (e.g., ablative thalamotomy or gamma knife thalamotomy), or has had a botulinum toxin injection in the 6 months prior to screening
De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients

Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied.

This project plans to a cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients with HER2 positive breast cancer diagnosed by biopsy in Peking University People's Hospital;
* 2) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
* 3) Received treatment in our hospital and had hospitalization records;
* 4) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

* 1) Lack of clinical and pathological data (such as imaging data and pathological data);
* 2) Patients with metastatic breast cancer or bilateral breast cancer;
* 3) At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
* 4) Receiving other regimens besides the established neoadjuvant regimens
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score \> 11


Eligibility Criteria:
Inclusion Criteria:

1. Head and neck squamous cell carcinomas, stage I to IVb
2. First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy
3. HADS- T \>11
4. Aged 18 to 75 yo, written consent required
5. OMS\>2

Exclusion Criteria:

1. Palliative care
2. Previous head and neck cancer
3. Bipolar disorder or schizophrenia
4. Severe major depressive disorder (DSM-IV TR)
5. Expressed suicidal ideation
6. Severe untreated organic disorder, especially acute infectious disorder
7. ASAT/ALAT \> 3N
8. Clearance of creatinin \< 30 ml/mn
9. Hyponatremia
10. Antecedent of delirium tremens or acute alcohol withdrawal disorder
11. Antecedent of upper gastro-intestinal bleeding
12. Antecedent of toxicity or inefficacy of a previous treatment with escitalopram
13. Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline
14. Pregnancy or lactation
Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

122 ASA I-II patients were enrolled into the study. IV propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. Sugammadex was given for neuromuscular blockade reversal. A multi-modal analgesic regimen was utilized. Primary outcome measures were PACU bypass rates and hospital discharge times. Secondary outcome measure was to compare discharge scoring systems for PACU bypass assessment: modified Aldrete Scoring System (mASS), White's Fast-Tracking Scoring System (WFTSS), and SPEEDS criteria

After obtaining hospital's ethics committee approval (University of Medical Sciences, Gülhane Training and Research Hospital- Date: 06/05/2018; No: 18/148) and written informed consents obtained from patients, 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study . After anesthesia application applied to all groups with the same procedure, patients were extubated after surgery. After extubation, patients were evaluated using mASS, WFTSS and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;). Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU). All patients were followed in the ward until hospital discharge. IV tramadol PCA (Patient -Controlled Analgesia; infusion rate: 4 mgh-1, bolus dose: 4mg, lock-out time: 30 min., 4 hours-limit: 30 mg), paracetamol (10 mgkg-1 IV with 6 hrs. intervals) and oral diclofenac sodium (75 mg with 8 hrs. intervals) were given in a multimodal analgesic regimen. Pain was evaluated using Visual Analogue Scale (VAS) with 2 hours intervals and IV pethidine 0.5 mgkg-1 was given as rescue analgesic throughout the study period when VAS was \>3. PONV was treated using IV 4 mg ondansetron. Discharge from hospital was evaluated using Post Anesthetic Discharge Scoring System (PADSS), . Patients with a PADSS score ≥ 9 were discharged from the hospital by the escort of their relatives.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status I-II patients
* elective primary lumbar discectomy performed for one or two vertebra levels under general anesthesia
* minimal risks for perioperative bleeding and airway safety

Exclusion Criteria:

* patient's refusal
* urgent surgery,
* regional anesthesia,
* history of previous lumbar surgery
* difficult ventilation and intubation,
* treatment for chronic pain
* obstructive sleep apnea,
* morbid obesity (BMI≥40 kg/m2)
* allergy to drugs
Shared Decision Making: Prostate Cancer Screening

Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve the interaction of physicians and their patients about prostate cancer screening. Educational material is provided in primary care practices using either standard paper information or a novel web-based interactive curriculum that explores the risks and benefits of screening measures for prostate cancer for older men. The impact of the intervention on shared decision-making with both actual and standardized patients will be assessed.

Prostate cancer is an important cause of death and disability in US men, but the value of screening for the disease with the prostate specific antigen (PSA) test remains highly controversial. Many primary care physicians use PSA testing routinely, with little patient counseling. Interventions to Improve Shared Decision-Making: Prostate Cancer Screening is a prospective study of educational interventions to improve shared decision-making of physicians and their patients about prostate cancer screening. Physicians will be randomized by practice site to receive standard informational brochures (control group) or a novel web-based interactive curriculum that provides education about prostate cancer screening, including potential benefits and harms, fundamentals of effective patient counsel, and shared decision-making. In addition, patients at intervention sites will be randomized to receive either the brochure or a patient-oriented interactive curriculum covering content similar to that contained in the physician tool. The intervention will be evaluated among 140 physicians within a variety of primary care settings (i.e., University-based clinics, staff-model managed care clinics, and military affiliated outpatient clinics). Approximately 10-15 actual patients of each participating physician will complete a post-visit questionnaire describing their discussion with their doctor about prostate cancer, PSA, and their decision about whether to be screened. Physicians in all groups will also see one unannounced standardized patient (SP) trained to portray a patient interested in discussing PSA. Study groups will be compared on the extent of shared decision-making they engage in with both actual and standardized patients. Pre- and post-study changes in physician knowledge and attitudes about PSA as well as the physicians' pre- and post-study PSA test ordering rates will be ascertained.

Eligibility Criteria:
Inclusion Criteria:

* Physicians in primary care practice settings with male patients age 50-75

Exclusion Criteria:

* None
Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction

It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia after rapid ascent to high altitude (4559 m).


Eligibility Criteria:
Inclusion Criteria:

* abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia
* ability to climb Margherita Hut

Exclusion Criteria:

* Birth at or above 1500 m altitude
* any cardiovascular or pulmonary disease
* Infection disease
* Intake of drugs, in particular Acetazolamide, Nifedipine, corticosteroids or PDE-5-inhibitors.
* Pregnancy
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department

There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED). Investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.

In this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in reduction of depressive and suicidal symptoms as well as length of stay. Select patients will be given 0.2mg/kg of ketamine IV and observed in the ED for two hours. Vital signs and symptoms will be monitored. Patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. Surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ED providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ED administration for this purpose.

Specific aims are as follows:

1. To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients.
2. To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient.
3. To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS.
4. To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.

Eligibility Criteria:
Inclusion Criteria:

* Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)
* Require inpatient stabilization for SI or actions based on clinical observation and interview
* Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus
* Have a Glasgow Coma Score (GCS) of 15
* Age 18-65

Exclusion Criteria:

* Current or past history of psychosis
* Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater
* History of ketamine use disorder
* History of liver transplant
* Pregnancy or breastfeeding
* Imprisonment or inability to consent
* Positive urine drug screen or serum alcohol level
* Hypertension (SBP \> 160 or DBP \> 100 before administration of ketamine)
* Hypotension (SBP \< 90)
* Presence of acute medical condition requiring admission to medical service
* Allergy, intolerance, or previous adverse reaction to ketamine
* Patient has 8+ lifetime ketamine exposures
* The treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contradindicate ketamine treatment)
Rate Control in Patients With Atrial Fibrillation

To search for the best marker for the patients in atrial fibrillation with rate control

In an aging society, the prevalence of atrial fibrillation is increasing. The main treatment strategy is to reduce the complications of embolic stroke and heart failure. Among these patients, a group of them will choose to have "rate control" based on the heart conditions and the preference of the patients. The strategy is to control the ventricular rate by drugs to prevent the heart from failure. However, when the physicians attempt to do so, they encounter two questions: how much is the optimal drug dose? And what is the best marker we are looking to? To answer these questions, the investigators design a prospective, cross-over study to explore this issue. The participants will do cardiopulmonary exercise test (CPET) before and after treatment. They will receive another CPET if drug dose is titrated up. With the study, the investigators will understand whether a resting heart rate can be a good marker for optimal drug dosage, and what is the optimal range of heart rate the physicians should target.

Eligibility Criteria:
Inclusion Criteria:

1. 20\~90 years old
2. Rate control is preferred after shared decision making

Exclusion Criteria:

1. cannot cooperate with or complete CPET
2. has contraindication for CPET, such as uncontrolled heart failure, hypertension, angina, valvular heart disease, lung function impariment that SaO2\<90% at room air.
3. Ventricular rate below 80/min before any medication
4. Permanent pacemaker implanted
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients

The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin Lymphoma, intermediate or advanced stage
* Age \>60 and \<75 years
* ECOG 2 or better
* No major organ dysfunction
* Ability to take aspirin or LMW Heparin

Exclusion Criteria:

* HL as composite lymphoma
* Prior use of lenalidomide
* Prior use of chemo- or radiotherapy
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression

Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Women seeking prenatal care at KPNC
* Identify as Black or Latina
* Current prenatal PHQ-9 score 10-19
* Gestational age \<30 weeks
* Owns a smartphone or computer with internet access
* English- or Spanish-speaking

Exclusion Criteria:

* Regular (3 times per week or more) stress reduction practice
* Cognitively impaired
* Deaf
Effect of Ghrelin on Sympathetic Nervous System

Ghrelin is a newly discovered peptide that is secreted by the stomach. Its main role is to stimulate food intake but recent studies indicate that it also acts on the cardiovascular system to confer beneficial effects. The mechanism of action is unclear but experimental studies suggest that ghrelin decreases the sympathetic nervous system. Beside there is new evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin injection seems to protect against symptoms of stress. Given that circulating levels of ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between lean and obese subjects. Ghrelin could represent an attractive therapeutic strategy for the treatment of cardiovascular diseases. The aim of the study if to gain more knowledge of the effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and obese subjects.

This study will investigate the effect of intravenous administration of ghrelin on blood pressure, heart rate, muscle sympathetic nervous activity and baroreflex control in lean and obese individuals and will investigate whether ghrelin administration can influence the response to stress. Both lean and obese individuals will be recruited and will receive an intravenous administration of ghrelin at increasing doses for 1 hour. Their blood pressure, heart rate and sympathetic activity (small recording electrode in the peroneal nerve) will be recorded and subjects will be submitted to a mental arithmetic stress towards the end of the infusion. Blood samples will be taken at regular intervals for various metabolic tests. These responses will be compared to those when submitted to saline infusion.

Eligibility Criteria:
Inclusion Criteria:

* healthy lean subjects with a BMI \< 25 kg/m2 and subjects with central obesity (according to IDF definition)

Exclusion Criteria:

* any current medication
* a history of diabetes
* hypertension
* cardiovascular, cerebrovascular, liver, thyroid disease
* mental illness