cyrilzakka/clinical-trials huggingface dataset:
Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.

At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.

The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA.

Eligibility Criteria:
Inclusion Criteria:

1. Age group 18-64 years old
2. ASA I-II
3. BMI 20-29.9
4. Patients accepting the study and consenting
5. Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.

Exclusion Criteria:

1. ketamine allergy
2. Morphine allergy
3. History of cardiac, neurological, or psychiatric disease, glaucoma,
4. Patients with a body mass index of less than 20 or more than 30 kg/m2
Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study

Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

Subjects enrolled in the PNET/GI-NET study OX4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. Subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol OX4219s). Subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s

Exclusion Criteria:

* Subject has not received fosbretabulin treatment in the study OX4218s
Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

The primary objective of the protocol is to define percentage of patients with acromegaly in relation to the total number of screened patients with confirmed clinically significant set of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I, Growth Hormone, Oral Glucose-Tolerance Test \[IGF-1, GH, OGTT\]) and instrumental examination methods (Magnetic Resonance Imaging \[MRI\]).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years and above with associated somatic disorders observed at the Moscow Endocrinology dispensary or Endocrinology Hospital at First Moscow State Medical University
* Patients who signed the Informed Consent Form for participation in the survey before collection of any information.

Exclusion Criteria:

* Patient already diagnosed with acromegaly
* Patient's refusal to participate in the survey.
Physiotherapeutic Approach to Tinnitus

Intervention experiments in the physiotherapeutic field targeted diagnostics and therapy of tinnitus. The goal is to find various groups of tinnitus patients and an ideal therapeutic approach between physical therapy means, manual techniques and physical education approach.

Clients will be divided into individual (8) therapy groups. The proband groups formed will be treated by individual researchers according to a similar methodology, each with a different therapeutic intervention for tinnitus. The main dominant variables to be monitored will be tinnitus intensity assessed on a visual numerical scale from 0-10, and quality of life observed using different questionnaires (which questionnaires will be used will be addressed in the course of the research, as this is not standardly used for tinnitus in the Czech region). The questionnaires will measure the quality of life and intensity of tinnitus of probands at the beginning and the end of the experiment, regardless of their racial, political, social, religious, and philosophical views and classification. Sexual orientation and criminal offences will not be questioned or addressed. As part of the questionnaires, clients will be subjected to musculoskeletal diagnosis by kinesiological analysis and tinnitus diagnosis by examination and will be further assigned to appropriate therapy sections (8). The questionnaires will be given to probands in hard copy at the initial assessment, during which the proband will complete and submit the questionnaire. The exit questionnaire will be administered similarly at the exit examination, i.e. the proband's last visit to the research team.

The selected therapeutic interventions in each section will be a low-power laser, high-power laser, radiofrequency therapy, manual therapy of the temporomandibular joint, manual treatment of the cervical and adjacent thoracic spine, myofascial chain work in the context of closed and open kinematic patterns, psychological guidance mediated by a psychosomatic physician, and addressing healthy lifestyle issues. The therapy will take place 2-3 times a week; the therapeutic unit will be 45 min and will be oriented to one therapeutic approach from the above list. The total number of therapy sessions will be limited to 3 months (i.e. three months, 2-3 times a week). The therapy will take place at the clinical workplace of private practice (anonymise) and the practice rooms of the Department of Physiotherapy Faculty of Physiotherapy of Charles University. At the end of the 3-month therapy, a follow-up examination will be performed again by kinesiological analysis, questions about the intensity of tinnitus according to a numerical scale and quality of life by a selected questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* neurologically diagnosed tinnitus
* age 20-80 years
* tinnitus of any nature persisting for more than 3 months

Exclusion Criteria:

* acute or chronic medical conditions requiring medication
* history of head and cervical spine trauma
* oncologic therapy
* psychological or psychiatric treatment
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Lung adenocarcinoma
* Wld-type EGFR
* Stage IIIB/IV
* Failure to prior chemotherapy
* Life expectancy of more than 3 months
* Tissue sample desired for genomic study
* Age ≥ 18 years
* Performance status (WHO) \< 3
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
* Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
* Informed consent

Exclusion Criteria:

* Have previously received pemetrexed or TKIs
* Other concurrent uncontrolled illness
Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Functional tricuspid regurgitation (FTR) remains a common finding in patients with left-sided valvular heart diseases especially mitral valve regurgitation or stenosis. It is mainly caused by dilatation and flattening of the tricuspid valve (TV) annulus as a result of right ventricular (RV) enlargement and is inevitably affected by the RV function. Multiple studies support the better outcome of using rigid ring annuloplasty over suture repair for treating FTR in concern with the durability and freedom from residual regurgitation. These studies refer the superiority of rigid ring annloplasty to the three-dimensional configuration achieved by such rings which matches the normal tricuspid annulus and, at the same time, to the rigid support of the annulus. On the other hand, other studies support the use of flexible prosthetic bands like Dacron or polytetrafluroethilin (PTFE), especially over suture techniques, due to their easy applicability and availability with good postoperative results. Therefore, suture annyloplasty became nowadays less convenient for FTR repair since both flexible bands and rigid rings appeared to offer good midterm outcomes in recent meta-analysis studies. However, the ideal annuloplasty method for repairing FTR is still debatable between the three-dimensional (3D) rigid rings versus flexible prosthetic bands. In this retrospective comparative study, we share our experience with flexible fashioned bands in FTR.


Eligibility Criteria:
Inclusion Criteria:

* All patients presented at Assiut University Hospital with tricuspid valve regurgitation

Exclusion Criteria:

* Age less than 18 years old.
* Tricuspid valve stenosis.
* Organic tricuspid valve disease.
* Infective endocarditis on tricuspid valve.
A Research Study for Patients With Metastatic Renal Cell Carcinoma

The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study participation:

* Age ≥ 18 years;
* Histologically confirmed Renal Cell Carcinoma (RCC);
* Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
* Failure of prior cytokine therapy;
* Documented progressive disease;

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

* Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
* History of serious ventricular arrhythmia
* Corrected QT interval (QTc) ≥ 500 msec
* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
* Previous extensive radiotherapy involving ≥ 30% of bone marrow
* Coexistent second malignancy or history of prior malignancy within previous 5 years
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)

A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the skin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AA
* Duration and extent of current episode of AA
* Evidence of active hair loss

Exclusion Criteria:

* Evidence of diffuse, spontaneous terminal hair regrowth
* Receipt of treatment known to potentially affect the course of AA within last month
Zenith(R) Connection Endovascular Covered Stent Clinical Study

The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation in the treatment of aorto-iliac and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* An aortoiliac or iliac aneurysm of appropriate size
* Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty

Background:

Total knee arthroplasty (TKA) is one of the most common operations in orthopedics. After surgery, the decline of bone mineral density and muscle mass was proved, oral bisphosphonate is commonly used to prevent BMD loss in clinic treatment, however, the loss of muscle mass can only be maintained with exercise intervention. The goals of TKA rehabilitation should be based on control pain, improve ambulation, maximize the range of motion, develop muscle strength, and provide emotional support. We planned to find out a potential adjuvant effective option in muscle mass for the management of post-TKA. Literature suggested that exercise training has been found to have the considerable effect on TKA. However, no suitable exercise prescription was established on the scientific basis. The current study aimed to find out a potential treatment mode.

Study Rationale:

This project will be performed for consecutive three years, the patients with post-TKA patients are managed with the treadmill exercise training in the first year. In the second year, resistance exercise is prescribed. In the third year, eccentric exercise plus resistance training will be arranged in the exercise group. We will analyze the data of the three years and cross-comparative analysis. A prescription of exercise training, a period of 24 weeks each year, 3 times a week, for each 10 minutes warm-up, 40 minutes exercise training, and 10-minute cool down for exercise prescription

Study Objectives:

To investigate the effect of long-term exercise training, eccentric and resistance exercise on muscle mass in patients with total knee arthroplasty. To monitor the performance index included: physiological indices, muscle mass, ambulation and the quality of life index.

Study Design Duration of Treatment: Total of 6-month exercise intervention in each year. The number of Planned Patients: 35 subjects in each control and exercise group in one year, the total of 210 subjects in three years.

Investigational Product: Automated biochemistry analyzer, Biospace Inbody 7.20 Analysis of body composition instrumentation; Dual Energy X-ray Absorptiometer (DEXA), isokinetic muscle strength measurement, VICON to analysis ambulation, functional fitness, the questionnaire including SF-36, KOOS and VAS pain score.

Endpoints: Data collection in pre-surgery, 3 months, 6 months, 9 months and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.

Exclusion Criteria:

* The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients

Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.

Aim of the study

1. To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.
2. To detect time to improvement in oxygenation among both groups.
3. To detect duration of hospitalization and mortality rate in both groups.
4. To detect incidence and duration of mechanical ventilation in both treatment arms.
5. To monitor of adverse events of both drugs.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patients with pneumonia evidenced by chest CT scan.
* Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
* And at least one of the following:

  1. Respiratory frequency ≥30/min.
  2. Blood oxygen saturation ≤93% on room air (RA).
  3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
  4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.

Exclusion Criteria:

* Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 5-fold the upper limit of the normal range.
* Pregnancy.
* Known hypersensitivity to drugs or any component of the formulation.
* Serious co-morbidity, including: Hepatic patients child Pugh class C.
Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour

The purpose of this study is to assess pain in women randomised to digital or speculum placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also to be evaluated as well as maternal satisfaction with induction of labour.

The most common method described for placing the Foley catheter is under direct visualisation of the cervix during a sterile speculum examination. Another method is to place the catheter during a digital cervical examination.

Maternal discomfort/pain during speculum placement of the catheter has been evaluated in a few studies whereas studies that compare the digital method with the speculum method of placement are lacking.

The visual analogue scale is used to subjectively assess pain. With a skin conductance algesimeter an objective assessment of pain is possible.

Eligibility Criteria:
Inclusion Criteria:

* singleton fetus in cephalic presentation with a Bishop score of 3-5 and
* indication for induction of labour

Exclusion Criteria:

* low-lying placenta,
* undiagnosed vaginal bleeding,
* more than one previous caesarean section,
* previous use of an induction or pre-induction agent during the same pregnancy,
* signs of infection (maternal fever)
* non- proficiency in the Swedish language.
Evaluating CVD Medication Adherence Program in Low SES

The investigators propose to evaluate the implementation of an efficacious medication adherence program in a group at high risk for CVD. The program involves patients receiving/responding to e-reminders to take CVD medications via patient-selected technology \[mobile/web-based applications, short message service (SMS; text messaging), interactive voice response (IVR), or e-mail\] supported by a tailored, monthly, self-management program administered by either research staff or a case manager staff member from the Duke Outpatient Clinic via the telephone. This is a hybrid type II implementation science study.

The investigators propose to evaluate the implementation of a medication adherence program among patients who attend Duke Outpatient Clinic (DOC). It is anticipated that, among the providers' patient panels, at least 100 and up to 300 with CVD risk and poor CVD medication adherence (\<0.08 medication possession ratio) will consent to the program.

Using procedures from the investigators previous studies, the investigators will identify potential patients from the EHR, and will identify a pool of potential patients using electronic health records, with the goal of administering the program to at least 100 patients. Patients will be mailed letters, signed by their own provider or medical director of DOC, requesting their participation in the programs. The RA will contact patients via telephone to explain the study, screen for eligibility, and determine what mode of administration individuals prefer to receive the program (SMS, IVR, or email).

The primary outcome will be that the effectiveness/impact of the proposed adherence program will be a 10% improvement in MPR and CVD outcomes (anticipate reducing SBP by 5 mmHg, Hgb a1c by 0.5%, LDL-C by 20 mg/dl).

Eligibility Criteria:
Inclusion Criteria:

1. Medicaid recipient (preferred); however the investigators will include those patients with other types of insurance or those who are uninsured
2. Enrolled in Duke Outpatient Clinic for at least one year
3. Outpatient diagnostic code for hypertension and/or hypercholesterolemia and/or diabetes
4. Poorly controlled BP levels (\>140/90) and/or LDL-C (\>130mg/dl) and/or HbA1c of \>8 within last 6 months

Exclusion Criteria:

1. No access to cell phone
2. Not proficient in English
3. Nursing home/long-term care facility resident or receiving home health care
4. Impaired hearing/ speech/ vision
5. Participating in another trial (pharmaceutical or behavioral)
6. Planning to leave the area in the next 12 months
7. Pregnancy (or planning)
8. Diagnosis of life-threatening disease with death probable within 1 year
9. Active Diagnosis of psychosis or dementia (has been hospitalized in the last 30 days)
10. Diagnosis of ESRD
Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer

The objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤55 years old at the time of diagnosis of pancreatic cancer
* Age ≥ 18 years
* Written informed consent obtained.

Exclusion Criteria:

* Any pancreatic neoplasm other than pancreatic cancer (e.g. cholangiocarcinoma, ampullary cancer,duodenal cancer, non-invasive mucinous cystic neoplasm, pancreatic intra-epithelial neoplasia 1 and 2, non-invasive intraductal papillary mucinous neoplasm, serous cystic neoplasm, pseudo papillary solid tumor, neuroendocrine tumor)
* Absence of informed consent.
* Age \< 18 years or \> 55 years old at the time of diagnosis of pancreatic cancer