cyrilzakka/clinical-trials huggingface dataset:
Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix

The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy.
* No evidence of para-aortic or distant metastases. Must have evaluable disease.
* Zubrod Performance Status 0-2 or Karnofsky Performance Status \> 60
* Laboratory values must be as follows:

White blood cell count: \> 3,000/mm3,Absolute granulocyte count: \> 1,500/mm3, Hemoglobin \> 8.0 g/dl, Platelets: \> 100,000/mm3, Serum creatinine: \< 2.5 mg/dl, Serum calcium: \< 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin \< ULN for the institution,

* Signed study-specific informed consent p
* Age \> 18 years.
* Peripheral neuropathy must be \< grade 1.

Exclusion Criteria:

* Prior or simultaneous malignancies (other than skin cancer) unless disease-free
* Medical illness preventing the use of taxane-based chemotherapy.
* Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic.
* Previous or current medical or psychiatric illness that would prevent informed consent
* Patients known to be infected with HIV or a history of AIDS are excluded.
* Prior surgery for carcinoma of the cervix other than a biopsy.
* Patients with para-aortic disease.
* Previous pelvic radiation therapy or systemic chemotherapy is not permitted.
* Women who are pregnant or breast-feeding are excluded from this study.
* Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.
Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain?

Background Back pain is among the most common cause for sick leave in the working population and is the main cause of years lived with disability globally. In Norway, about 30% report to live with chronic pain and women are affected more than men. Pharmacological strategies for pain management e.g., opioid medications, is a common treatment method. This is despite clinical guidelines suggesting limiting pharmacological treatment in management of chronic back pain. Long-term use of opioids is linked to opioid-induced hyperalgesia, paradoxically. However, it is suggested that RNA sequencing (seq.) profiling may identify individuals that are at risk of opioid-induced hyperalgesia. To help reduce medication intake brief intervention (BI), a method for discontinuing long-term medication use, has shown to be successful. In this pilot RCT the investigators aim to investigate the feasibility of a full scale RCT and observational study using BI on opioid-using patients with back pain and concurrently study if the response can be predicted by RNA seq.

Method Ten outpatients aged 18-67 years with back pain will be recruited from the orthopaedic department at Akershus University Hospital. Inclusion criteria includes daily use of opioids for more than two weeks consecutively, and sufficient language (Norwegian) skills. Exclusion criteria includes severe medical or surgical condition such as cauda equina syndrome, rheumatic disease, psychiatric disease, or recent surgery. The patients will be randomised into two groups (5+5) where one group receives the BI and the other gets treatment as usual. Data collection will be conducted at three-time points; baseline, four weeks follow-up and three months follow-up (end of trial). The primary outcome for this pilot RCT is to test feasibility and estimate effect size for a later full-scale study. Secondary outcomes include subjective and objective findings from the data collection.

Results Primary results concerning feasibility are mainly qualitative and will be presented as such. Secondary results including demographic information as well as tentative effect size, patient reported outcomes such as pain intensity, anxiety, depression, quality of life, psychosocial stressors in the workplace and the RNA seq will be presented descriptively.

Conclusion The results from this pilot study will assist in constructing the optimal design for a full-scale RCT.


Eligibility Criteria:
Inclusion Criteria:

* age 18-67 years, admitted from their GP to Ahus due to back pain,
* daily use of opioids such as ≥ 30 mg codeine or ≥ 45 mg tramadol or ≥ 3 mg oxycodone or other opioids corresponding to a morphine equivalent dose ≥ 10-20 mg

Exclusion Criteria:

* cauda equina syndrome
* recent surgery (within 1 month)
* pregnancy
* psychiatric disease
* rheumatic disease
* diabetic polyneuropathy
* cancer
* insufficient proficiency in the Norwegian language
* no remaining work potential and/or permanent sick pension.
Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department

This study aims to address both the management and evaluation of pain. The primary aim of this study is to determine the efficacy of low dose ketamine in adults with moderate to severe pain in the emergency department as compared with parenteral opioids alone. Another aim is to examine the safety of low dose ketamine compared to opioids alone.

The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.

Management and assessment of pain in the Emergency Department (ED) can be challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, inadequate analgesia is often a problem when opioids alone are relied on for pain control. In the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain. Ketamine may play a role in maximizing analgesia in the ED.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Adults age 18-65
* Able to understand and give informed consent
* Comfortable with the experimental protocol as outlined to them by the research team
* Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
* Acute pain, pain duration \< 7days
* Deemed by treating ED attending physician to require IV opioid analgesia
* ASA (American Society of Anesthesiologists) class I or II

Exclusion Criteria:

* Previously enrolled in the study
* Neurologic, respiratory, or hemodynamic compromise
* GCS (Glasgow Coma Scale) \<15
* Pox \<94%, RR \<10, or RR \>22
* SBP \<90, SBP\>180, or DBP \>110
* Discretion of treating physician
* Pregnancy or breastfeeding
* Known or suspected allergy to ketamine or morphine
* Ketamine within 24 hours of presentation (prescription or illicit drugs)
* Conscious sedation in ED (per treating physician), includes ketamine (for non-study purposes)
* Known Renal (Cr\>2.0) or Liver Failure
* Unstable psychiatric disease (as per treating physician)
* History of stroke
* History of cardiac disease
* Prior myocardial infarction; Angina (Stable or Unstable)
* Cardiac stents or bypass surgery
Whole-body MRI for the Detection of Metastasis

Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate diagnostic accuracy through application of optimized protocols for screening of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

- Cancer patient

Exclusion Criteria:

* Poor general condition
* Pacemaker or other MRI contraindications
Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

The pilot study investigates the potential benefits of the Transcendental Meditation program in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned to either the TM program or a wait list control group for a period of four months.

This randomized controlled pilot study will evaluate the effects of Transcendental Meditation ® (TM) on female offenders with trauma. Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, Oregon, with at least four months left of incarceration, will be enrolled in the study. Subjects will be randomly assigned to either a TM (n=11) or a wait-list control group (n=11). Subjects will be measured at baseline and four-month posttest, using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C) Twenty of the subjects (10 in each group) will take part in their treatment assignment and complete post-testing.

Eligibility Criteria:
Inclusion Criteria:

* female inmates, at least 4 months left of incarceration, signed written informed consent prior to baseline testing

Exclusion Criteria:

* none
Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System

This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.


Eligibility Criteria:
Inclusion Criteria:

* Primary/ Solitary Liver Transplant
* Lab MELD\<35
* Donor age \<65

Exclusion Criteria:

* Donor Liver \> 30% Macrosteatosis
* DCD donor liver
* Multi-organ Recipient
* Recipient in ICU
* Retransplant
Comparison of Techniques in Determining Femoral Veins Location

This study aimed to determine the accuracy of the V technique in predicting the location of the femoral vein compared to the technique of palpating the femoral artery with the use of USGss as a standard in determining the exact location of the femoral vein.

One hundred and fifteen subjects were allocated into two large groups, V tecnique group and palpation tecnique group. Researchers will perform the V technique on the patient's inguinal area. This technique was performed using the researcher's contralateral hand. After the V technique is performed, the next researcher will perform the technique of palpating the femoral artery pulse at the exact location as the V technique. This technique is done by palpating the femoral artery pulsation using the examiner's index and middle fingers along the inguinal ligament; the location of the femoral vein is at 1 cm. medial to the femoral artery 2 cm inferior to the inguinal ligament. This location is marked "y" with a UV marker. researchers will compare the accuracy of both techniques in determining the exact location of femoral veins.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-65 years
* body mass index (BMI) of 18-25 kg/m2

Exclusion Criteria:

* could not lie supine
* had congenital or acquired abnormalities in the pelvic and inguinal region
* had a history of previous femoral vein puncture
* allergic to USG gel
The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis

The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.

* Design: Prospective study
* Setting: hospital rehabilitation department
* Intervention: Participants are randomly assigned 4 different exercise group: flexibility exercise, bracing exercise + stabilization exercise group, bracing exercise+ walking exercise group and bracing+ walking + stabilization exercise group
* Main outcome measures: Numeric rating scale(NRS), Oswestry disability index Peak torque of lumbar extensor by surface electromyography Time duration of capability of maintenance the posture

Eligibility Criteria:
* Inclusion Criteria:

  * Age\>20
  * Who suffered low back pain more than 3 months.
* Exclusion Criteria:

  * Pregnancy
  * Under 20-year-old
  * Who have significant neurologic deficit
  * Who experienced spine operation
  * Who cannot walking
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male Volunteers

First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of BI 11634 on coagulation parameters


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

* Age ≥18 and ≤50 years
* Haemoglobin within the normal ranges
* Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation

Exclusion Criteria:

* Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Relevant surgery of gastrointestinal tract
* History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
* History of gastric ulcera and cholecystectomy
* Occult blood in feces
* Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Relevant chronic or acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Alcohol abuse (more than 40 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Vulnerable subjects (e.g. persons kept in detention)
* The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
* Subjects with a history within the past 2 weeks of closed head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
Validation of a Simultaneous Ocular/Cervical VEMP With Mastoid Vibration by B250

A Validation study in which the standard separate cVEMP and oVEMP will be compared with a new protocol in which the cVEMP and oVEMP can be recorded simultaneously in response to a mastoid vibration by bone transducer B250


Eligibility Criteria:
Inclusion Criteria:

-) dizzy patients attending the balance laboratory -

Exclusion Criteria:

-) age \< 18 years old
Timely Reperfusion in Acute ST-segment Myocardial Infarction

The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.

In the regional health trust of North Norway, time to reperfusion in acute ST-elevation myocardial infarction is below the national average and below recommendations. The aim of this study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. The study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. Before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI)

Exclusion Criteria:

* Reperfusion therapy not indicated or contraindicated
Sonography-guided Resection of Brain Mass Lesions

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

Intraoperative sonography is usially used in neurooncology to detect brain tumors and exclude their remnants. A few studies describe it's usage while removing hematomas or vascular malformations. Ultrasound is the only method allowing to observe brain tissue in real time. It is chip and doesn't violate surgical workflow. Main disadvantages of sonography are lengthy learning curve and poorer image quality compared to magnetic resonance imaging. Novel acoustic coupling fluid, contrast-enhanced ultrasound and elastography expanded it's effectiveness. Meanwhile problems of locating of isoechogenic lesions with poor margins and elimination of artefacts are steel actual.

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

A surgeon will intraoperatively locate mass lesion and assess extent of it's resection with sonography. Ultrasound scanning will be performed through the same surgical approach or at a distance through enlarged craniotomy, periodically or permanently. To facilitate approach to subcortical and deep small mass lesions ultrasound-guided needle or ultrasound wire-guided port will be used.

Eligibility Criteria:
Inclusion Criteria:

* all intracranial tumors
* cavernomas
* arteriovenous malformations
* spontaneous (non-traumatic) intracerebral hemorrhages
* traumatic intracerebral hemorrhages
* supratentorial localization
* newly diagnosed
* age 18-100 years
* stable hemodynamics

Exclusion Criteria:

* rapid cerebral dislocation
* previously performed brain radiotherapy
Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy

Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* Sepsis
* Admission to ICU

Exclusion Criteria:

* CNS infection
* History of cerebrovascular disease
Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis.

This is a single-center, open-label clinical study to evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis. The main outcome indicators are the record of adverse reactions and the rate of change of amyotrophic lateral sclerosisFunctional Rating Scale score. The secondary outcome indicators include survival time-time to the end event (death, tracheotomy, continuous ventilator dependence), forced vital capacity (FVC), recognition Knowledge function evaluation (ECAS score).

Eligibility Criteria:
Inclusion Criteria:

* Meet the following diagnosis standard: confirmed, proposed and laboratory supported diagnosis;
* Age 50-70 years old ;
* 3-18 months course of disease;
* Forced vital capacity (FVC) ≥70% predicted value;
* Total amyotrophic lateral sclerosis Functional Rating Scale score ≥36, scores of respiratory related items ≥10;
* Take Riluzole regularly before participate in this trial (25\~50mg twice a day for at least 30 days continuously) without obvious side effects and can continue to take for 22 months;
* Participants of childbearing age take reasonable and effective contraceptive measures from the time of enrollment to the end of follow-up;
* Signed informed consent.

Exclusion Criteria:

* Familial amyotrophic lateral sclerosis;
* Female during pregnancy and lactation;
* Positive hepatitis B, hepatitis C or HIV in screening
* History of cytomegalovirus and malaria infection;
* After tracheotomy and ventilator-dependent state (daily use of non-invasive ventilator ≥ 22 hours for 7 consecutive days);
* After percutaneous gastrostomy (PEG) operation;
* Has had allergic reactions and other adverse reactions during blood transfusion;
* Have diseases of the blood system (including Immunoglobulin A deficiency);
* alanine transaminase, Aspartate transaminase≥ 3 times the upper limit of normal;
* Abnormal renal function (Cr, BUN);
* History of malignant tumors;
* Combining severe cardiopulmonary diseases, autoimmune diseases, mental diseases, substance abuse history, etc;
* Currently participating in other clinical studies or using other drugs in researching.
Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

In the present study, we evaluated whether RIPC with RIPostC reduce the major neurocomplication in patients undergoing STA-MCA anastomosis.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists
2. Adults 18 to 65 years of age
3. In patients with planned MCA-STA anastomosis under general anesthesia
4. Patients who pre-agreed to the study

Exclusion Criteria:

1. If there is a history of peripheral vascular arterial or venous disease
2. If there is a previous history of peripheral nerve disease
3. Other brain or cerebrovascular disease
4. In case of serious cardiovascular disease, pulmonary disease, kidney disease
5. Patients who do not agree with the test
Neural Changes in the Aging Auditory System

The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.

Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT.

Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons.

.

Eligibility Criteria:
Inclusion Criteria:

* Healthy middle ears

Exclusion Criteria:

* ototoxic medications
* serious medical health problems
* neurological conditions
* Meniere's disease or labyrinthitis
* those who failed cognitive screening tests (Mini-Mental Test)
* current/heavy smokers
* conductive hearing loss
* history of noise damage and/or audiograms signifying noise damage
* poor speech discrimination scores (80% or less)