cyrilzakka/clinical-trials huggingface dataset:
Dysfunctional Hemoglobin CO-ox

The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female.
* The subject is of any racial or ethnic group.
* The subject is between 18 years and 45 years of age.
* The subject does not have significant medical problems.
* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

Exclusion Criteria:

* Has a BMI greater than 31
* Has had any relevant injury at the sensor location site
* Has deformities or abnormalities that may prevent proper application of the device under test.
* Has a known respiratory condition.
* Is currently a smoker.
* Has a known heart or cardiovascular condition.
* Is currently pregnant.
* Is female and actively trying to get pregnant.
* Has a clotting disorder.
* Has Raynaud's Disease.
* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia).
* The subject has a COHb greater than 3% or MetHb greater than 2%.
* Has taken blood thinners or medication with aspirin within the last 24 hours.
* Has unacceptable collateral circulation from the ulnar artery.
* Has donated more than 300 mL of blood within one month prior to start of study.
* Is unwilling or unable to provide written informed consent to participate in the study.
* Is unwilling or unable to comply with the study procedures for the primary objectives.
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :

Serum Systemic VEGF levels. Retinal Vascularization.


Eligibility Criteria:
Inclusion Criteria:

Infants with Type 1 ROP according to ETROP study which is defined as:

* Zone I ROP with plus disease
* Zone I, stage 3 ROP without plus disease
* Zone II, stage 2 or 3 ROP with plus disease

Exclusion Criteria:

* Eyes with previous intravitreal injection
* Eyes with previous laser therapy
* Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study

Early identification of intracranial atherosclerotic disease (ICAD) may impact the management of patients undergoing mechanical thrombectomy (MT). The aim of the study is to develop and validate a scoring system for pre-thrombectomy diagnosis of ICAD in posterior circulation large vessel/distal medium vessel occlusion strokes (LVOs/DMVOs).


Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥18 years
2. Patient with posterior circulation strokes who underwent mechanical thrombectomy.

Exclusion Criteria:

1. Patients with anterior circulation stroke.
2. Patients with intracranial hemorrhage
3. Patients without baseline radiological data.
4. Extracranial large vessel atherosclerosis related strokes.
Gaze Training on Task Performance Regional Anaesthesia

Regional anaesthesia is the performance of spinal, epidural or peripheral nerve blocks to allow patients to undergo surgery awake and to provide post-operative pain relief. Anaesthetists inject local anaesthetic using specialist needles close to nerves to prevent transmission of pain. Hand-held ultrasound is often used by anaesthetists to direct these needles to the correct position i.e. close to, but not in the nerve itself. If the needle is not adequately seen using the hand-held ultrasound it may pierce the nerve causing permanent nerve damage and significant patient harm.

Within the time and resource constraints of postgraduate medical training, it would be advantageous to optimise expertise acquisition of practical skills with a cheap, self-directed educational intervention. Therefore, the aim of this study is to determine whether gaze training is associated with improved performance of an ultrasound-guided needle task. The investigators hypothesise that improved gaze control will translate to better technical performance of an ultrasound-guided regional anaesthesia task.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate Science, Technology, Engineering or Maths (STEM) students who are capable of giving informed consent

Exclusion Criteria:

* Previous experience of gaze training or eye tracking software
* Previous experience of regional anaesthesia needling tasks
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:

* What is the safe dose of KQB365 by itself or in combination with cetuximab?
* Does KQB365 alone or in combination with cetuximab decrease the size of the tumor?
* What happens to KQB365 in the body?

Participants will:

* Receive KQB365 infusion weekly alone or in combination with cetuximab
* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.


Eligibility Criteria:
Inclusion Criteria:

* PART 1 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
* PART 1 (combo therapy) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active primary central nervous system tumors
* Cardiac abnormalities
* Active interstitial lung disease
eNose-TB: Electronic Nose for Tuberculosis Screening

An electronic-nose (e-nose) is being investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.

The study population consists of 2 groups:

Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB.

Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.

Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.

Eligibility Criteria:
- Inclusion Criteria:

Validation Phase (Group 1):

* Adult and children
* Suspected of having TB
* Agree to participate in the study
* Able to produce exhaled air samples
* Able to produce samples for Xpert MTB/Rif examination

Screening Phase (Group 2):

* Adult and children
* Agree to participate in the study
* Able to produce exhaled air samples
* Currently not in TB treatment

  - Exclusion Criteria
* Invalid measurements of breath tests
* Incomplete CXR data
* Missing specimens
* Unable to breath normally for 2 minutes due to respiratory illness
Social Cognition and Interaction Training for Adults With Psychotic Disorders: An Open Pilot Study in Finland

33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the intervention. Main outcome was improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.

33 clinically stable in- and outpatients with chart diagnoses of schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis, aged 18-56 years, were given 22-24 weekly or twice weekly sessions of a manualized group treatment for improvement of social cognition, Social Cognition and Interaction Training (1,2). Main outcome was defined as improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.Emotion perception was measured with the Facial Emotion Identification Task (FEIT) (3); Theory of Mind was measured with the Hinting Task (4) and attributional bias with the Ambiguous Intentions Hostility Questionnaire-Ambiguous Items (AIHQ-A) (5). In addition, broad-based social cognitive accuracy, attributional bias and metacognitive overconfidence was measured with the Social Cognition Screening Questionnaire. All the measures were evaluated at the baseline and immediately after the intervention. Changes in total scores for the FEIT and Hinting Task, and the three subscales of AIHQ-A and SCSQ were analysed separately using paired samples t-test in IBM SPSS Statistics version 21.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of schizophrenia, schizoaffective disorder or psychosis NOS
* inpatients in longer-stay rehabilitation wards or outpatients in supported housing
* stable clinical condition
* written informed consent
* problems in social relationships according to the clinical staff
* standard medical treatment provided by the care facilities

Exclusion Criteria:

* inadequate command of Finnish language
* unstable clinical condition
Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome

Spontaneous bacterial peritonitis (SBP) is a severe complication of ascites in cirrhotic patients. Under clinical experience, this condition seems to be more uncommon in Finland. The aim of this study was to measure the incidence of SBP in consecutive patients with ascites requiring hospitalization in a Finnish University Hospital.

Spontaneous bacterial peritonitis (SBP) is a complication of liver cirrhosis with high mortality and low survival rates. The incidence of SBP is reported to range from 11-35% in patients with ascites requiring hospitalization. Under clinical experience, the incidence of SBP in Finland seems to be lower than reported elsewhere. Alcohol is the dominant etiologic factor of liver cirrhosis in Finland (90%), which might be a factor affecting the incidence of SBP. The aim of this study is to measure the incidence of SBP in Finland. We included consecutive patients who underwent diagnostic paracentesis for ascites in Tampere University Hospital during 2/1994 - 12/1998 and 1/2005 - 3/2007. Spontaneous bacterial peritonitis was diagnosed when the ascitic fluid contained over 250 polymorphonuclear cells / mm\^3 regardless of culture and with no evidence of intra-abdominal source of infection e.g. an abscess or a perforation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic paracentesis performed during the study period
Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.

In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA).

Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the postoperative phase after back surgery. The common use of PCIA with morphine is associated with a rather slow onset-time and active metabolites, with occurrence of potential harmful side effects as sedation and desaturation.

This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited. Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the first 72h postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* scheduled elective laminectomy or spinal fusion
* American Society Anesthesiology Classification system (ASA) I-III

Exclusion Criteria:

* chronic opioid use (\>3 months)
* pregnancy
* obstructive sleep apnea syndrome
* supplemental oxygen therapy at home
* postoperative use of non-steroidal anti-inflammatory or anti-neuropathic drugs
A Prospective Pilot Study (BIO|SELECT Pilot)

Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode. They are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.

Enrolled patients will undergo the baseline medical tests to assess the cardiac functions (e.g. echo, blood test, and 12-Lead ECG) prior to the implantation of Biotronik CRT-D and QP lead featured with MultiPole Pacing parameter. At implantation, LV-LV conduction delays are measured in predefined LV pacing and sensing configurations. One month after the successful implantation, the patients revisit the investigation site to be adjudicated for programming MultiPole pacing or continuing bi-ventricular pacing mode, based on their echo readings by then. Patients are subsequently followed up at four and seven month post implantation to acquire the LV-LV conduction delays and echo readings, etc. at the time.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study enrollment, candidate patients must meet all of the following criteria

* Indicated for a CRT-D implantation
* Has never received CRT
* Planned to be implanted with a quadripolar LV Lead, and CRT-D with MultiPole pacing feature, both manufactured by BIOTRONIK
* Geographically stable and willing to comply with the required follow-up schedule
* With written informed consent

Exclusion Criteria:

Candidate patients will not be eligible if either of the following criteria is applicable

* Underwent a cardiac surgery within last 3 months, or scheduled for cardiac surgery other than CRT implantation
* Life expectancy is less than a year
* Can not be programmed to MultiPole pacing "ON"
* Does not agree to the concept of HomeMonitoring System
* With known pregnancy
* At age below 20 years
* Participated in another interventional clinical study
A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme

The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* histologically-or cytologically-confirmed glioblastoma multiforme
* age 18 years or older

Exclusion Criteria:

* Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma
* co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Biological Age in Health Promotion - Novel Health Technology

The purpose of this cross-sectional study is to collect relevant molecular markers of aging and measures of physiological function. Together these biomarkers are used to develope a new Biological Age model, useful in health promotion interventions in the public health sector .

Study design: 100 participants representing the healthy danish working adult population. This study seek to include both men and women equally distributed in the range of 18-65 of age.

Data collection: After recruitment, participants need to attend once to the laboratory, overnight fasted and without having exercised for the previous 24 hours.

All analyse are done in investigators lab (Xlab) at the department of Biomedical Sciences, Copenhagen University. When analyzes are done, the results are used in algorithm developement in cooperation with Technical university Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Males and females interested in their personal health status
* Healthy males and females

Exclusion Criteria:

* Pregnancy
* Previous or current cardiovascular disease
* Use of medication that affects our measurements such as betablockers,statins or medication that affects the metabolism.
Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

This Phase 1/2a study is intended to assess the safety, tolerability, and effects on intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Documented diagnosis of POAG or OHT, in both eyes
* Willing and able to provide written informed consent

Exclusion Criteria:

* History of any form of glaucoma in either eye, other than POAG
* Subjects who are unwilling or unable to discontinue contact lens wear prior to and during study
* History of ocular trauma in either eye \<6 months prior to Screening
* History of ocular infection or ocular inflammation in either eye \<3 months prior to Screening
* History of chronic or recurrent severe inflammatory eye disease, any severe ocular pathology, or clinically relevant or progressive retinal diseases in either eye
* Clinically relevant, severe central visual field loss, or documented significant progression of a visual field defect within 6 months prior to Screening in either eye
* Use of any ocular hypertensive medications (if applicable), in either eye, during the washout period and for the duration of the study
* Use of any glucocorticoid medications \<2 weeks prior to Screening and throughout the duration of the study
* Use of any medication or substance on a chronic basis which has not been taken at a stable dose for at least 30 days prior to Screening
* Use of any nondiagnostic, topical, ophthalmic preparations, in either eye, other than artificial tears
* The presence of any concurrent condition or clinically significant laboratory findings at Screening that may interfere with any aspect of safety, study conduct, or interpretation of results
* Women who are pregnant or breast feeding
* Inability or difficulty instilling eye drops
Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial

The purposes of this study are to determine:

1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.
* Have received no prior chemotherapy for Non-Small Cell Lung Cancer.
* Have at least one measurable lesion.
* Have an adequate performance status.
* Sign an informed consent.

Exclusion Criteria:

* A female who is pregnant or breastfeeding.
* Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.
* Treatment with radiation therapy within the last 4 weeks.
* Brain metastasis that is uncontrolled.
* Active infection or other serious condition.
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

The purpose of this study is to test if specific therapeutic benefits of acupuncture are mostly attributable to contextual and psychosocial factors, such as patients' beliefs and expectations.The investigators propose using the 2 acupuncture methods, which refrains from inserting needles in the affected area, in order to evaluate the short-term and long-term efficacy of acupuncture in a clinical setting compared with placebo and compared with invasive needling that does not adhere to "correct" acupuncture rules.

The main novel features of this study:

1. First aim to assess the effect of distal needling on knee pain
2. Second aim to directly compare two acupuncture techniques, placebo, needling at "wrong" places and "correct" needling for knee pain

Advantages of the study compared to published data:

1. Distal needling - enables assessment of range of motion (ROM) and pain level during needling.
2. Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions.
3. Exploratory studies in the clinic of DP show that it is possible to distinguish between "correct" and "incorrect" needling, at least in the short term. Long term effects have not been assessed yet.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years old), suffering chronic stable pain score \>40 mm on 100 mm VAS of the knee due to patellar tendonitis.
* Patients have had X-rays or other tests confirming they are not candidates for surgery nor are scheduled for steroid injections or hyaluronic acid injections within 8 weeks from the beginning of the study.
* Adult patients (\> 18 years old), two weeks after ACL reconstruction surgery (with or without meniscal involvement), with pain score \>40 mm on 100 mm VAS of the knee (all patients at this stage have significant ROM limitation).

Exclusion Criteria:

* Patient refusal
* Soldiers
* Pregnancy
* Morbid obesity
* Diabetes
* Peripheral vascular disease
* Lower limb neurological deficit (such as multiple sclerosis, nerve palsy), other serious co-morbidity (including severe back pain or hip pain)
* A history of prolonged or current steroid use
* Received hyaluronic acid injections within the previous 3 months
* Have needle phobia or allergy to sticking plaster.