cyrilzakka/clinical-trials huggingface dataset:
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A

Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability.

The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.

In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A.

120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary.

Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.

Subjects in prophylactic treatment arms will undergo clinical evaluation at 10 weeks. Those with adequate control of bleeding will undergo randomization to every 5 or 7 day infusion. Those with continued bleeding will remain in treatment arm and have an increase in dose.

Part B-major surgery - optional sub study included to collect information on efficacy of BAY94-9027 in major surgical setting. Due to rarity of surgery in this population, enrollment to this sub-study may be independent of participation in main study.

Eligibility Criteria:
Inclusion Criteria:

* Male; 12-65 years of age
* Subjects with severe hemophilia A
* Previously treated with factor VIII for a minimum of 150 exposure days

Exclusion Criteria:

* Inhibitors to FVIII (current evidence or history)
* Any other inherited or acquired bleeding disorder in addition to Hemophilia A
* Platelet count \< 100,000/mm3
* Creatinine \> 2x upper limit of normal or AST/ALT (aspartate aminotransferase/alanine aminotransferase) \> 5x upper limit of normal
Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia

The aim of this study is to test the efficacy and efficiency of varying the phobic stimuli during the augmented reality (AR) exposure therapy using multiple stimuli versus one single stimulus through projection-based AR (P-ARET) for the treatment of participants diagnosed with cockroach phobia.

Specific phobia (SP) refers to an extreme and persistent fear of a specific object or situation that is out of proportion to the actual danger or threat. SP is the most prevalent anxiety disorder with substantial impairment and comorbidity. Animal fear is one of the most prevalent subtypes of SP. In vivo exposure is the treatment of choice for this problem, but this technique is associated to limitations in its implementation related to the access and acceptability (i.e., low acceptance on the part of patients and therapists, high dropout rates, limited access to the treatment and, difficulties in its application in the clinical context). Augmented Reality (AR) offers some advantages in delivering the exposure technique: 1) Exposure to multiple virtual stimuli; 2) Going beyond reality; 3) Allowing complete control over the situation; 4) It allows privacy and confidentiality. Particularly, the most significant aspect of AR is that the virtual elements add relevant and helpful information to the physical information available in the real world.

The study will follow the guidelines of a multiple-baseline single case design with alternating treatments. Participants (N = 4) who received a diagnosis of SP for cockroaches (DSM-5), will be randomly assigned to different baselines (ranging between 8 and 14 days) and all of them will receive the two experimental conditions: 1) AR exposure therapy with multiple stimuli and; 2) AR exposure therapy with a single stimulus. Five evaluation moments will be included: pre-intervention (baseline), post- intervention, and follow-up at the first month, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Meeting DSM-5 diagnostic criteria for SP (animal subtype) to cockroaches
* Having a minimum of six-month duration of the phobia
* Sign an informed consent
* Presenting a score of at least 4 on the fear and avoidance scales of the diagnostic interview applied

Exclusion Criteria:

* Presence of another severe mental disorder that requires immediate attention
* Having current alcohol or drug dependence or abuse, psychosis or severe organic illness
* Currently being treated in a similar treatment program
* Being capable of inserting their hands in a plastic container with a cockroach (during the behavioral test)
* Receiving other psychological treatment during the study for cockroach phobia
* Start receiving pharmacological treatment during the study (or in case of being already taking them, change the drug or dose)
Endoscopy-related Phone Consultation During the COVID-19 Outbreak

The aim of this study is to evaluate patient and consultant experiences with phone consultations for endoscopy-related outpatient appointments during the COVID-19 outbreak.

Telephone consultations as a method for telehealth do not provide visual cues and limit interpretation of visual signs such as visualization of skin lesions. However, the need of such feedback is almost non-existent for endoscopy-related consultations as their purpose is focused. The main foci of endoscopy-related outpatient clinics are two: 1 - inform and consent the patient for an endoscopic procedure that is to be done in the near future; 2 - explain the results of a recent procedure already performed and which has a copy provided to the patient. Therefore, phone consultations might be a good fit for endoscopy-related outpatient clinics. The practicalities and indications for the use of phone consults has been described by van Galen \& Car (2018) and fit the above description.

Patients will be invited to participate only after the consultation have been finalised and all questions regarding the endoscopic procedure to be done/that was done have been clarified. Patients and consultants will fill questionnaires to evaluate the phone consultation.

The primary outcome will the the comparison of "failed to attend" (FTA) occurrences compared to a similar period of the past year. Secondary outcomes will be patients' and consultants' satisfaction with the phone consultation.

Eligibility Criteria:
Inclusion Criteria:

* Patients booked for an outpatient consultation in the Post-Endoscopy clinic or Advanced Endoscopy clinic
* Consultation determined to be held over the phone as per preventive measures due to the COVID-19 outbreak
* Age \> 18 years
* Ability to give informed consent

Exclusion Criteria:

* Phone consultation done with a relative as per patient's preference or inability to talk over the phone
* Patient that is deemed as confused/not able to understand
* Unwilling/unable to participate in the post-consultation survey
Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is Japanese.
* Subject is at a minimum 23 years of age.
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked for at least the last 3 years
* Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
Propofol Versus Midazolam+Alfentanil for Sedation During Bronchoscopy: Comparison by Cutaneous Carbon Dioxide Tension

Although propofol is a popular agent for sedation during flexible bronchoscopy, some clinicians have raised concerns that it may cause greater respiratory drive reduction than more common drugs. However, this factor is difficult to accurately examine with pulse oximetry. The introduction of a novel device that noninvasively measures carbon dioxide (CO2) levels can help to resolve this controversy. The aim of this study is to evaluate the safety of conscious sedation with midazolam+alfentanil compared to propofol.

Methods: The study group included 115 patients undergoing flexible fiberoptic bronchoscopy(FFB). Patients were randomly assigned by a computer before the procedure to receive sedation with midazolam+alfentanil or propofol. Local anesthesia was induced by application of 2% lidocaine to the oropharynx. Sedation was started with intravenous injection of a bolus of 2-4 mg midazolam and 0.5 mg alfentanil or 20-50 mg propofol. It was maintained with intermittent boluses of 1-3 mg intravenous midazolam or 0.5 mg intravenous alfentanil, according to clinical judgment, or with boluses of 10-20 mg intravenous propofol, administered at short intervals (\~2 minutes) or according to clinical judgment.

In all cases, monitoring included continuous electrocardiography, pulse oximetry, and automated noninvasive blood pressure recordings every 5 minutes. In addition, percutaneous carbon dioxide tension (PcCO2) was measured with a cutaneous digital sensor (Sentec AG, Therwil, Switzerland) that was placed on the earlobe prior to the procedure. It was removed when the patient left the bronchoscopy suite.

During the procedure, all patients received supplemental nasal oxygen at 2-5 L min-1. Significant hypoxemia, defined as functional oxygen saturation (SpO2) of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1. The duration of bronchoscopy was calculated from the administration of sedation until the flexible bronchoscope was removed from the tracheobronchial tree.

Percutaneous carbon dioxide tension, blood oxygenation, heart rate, and blood pressure were compared between the groups.

A questionnaire evaluating pain and discomfort by Visual Analog Scale was completed by the patient when awake after the procedure.(\~30 minutes after the end of the procedure

Eligibility Criteria:
Inclusion Criteria:

* The study group consisted of patients scheduled for flexible bronchoscopy under local anesthesia with sedation at a tertiary medical center.

Exclusion Criteria:

* Inability or refusal to provide informed consent, age less than 18 years, bronchoscopy through an artificial airway, and allergy to soya or to one of the sedative drugs.
The Meaning of Suicidality for Older Persons With Suicidal Tendencies and Their Families

The purpose of the proposed study is to examine the phenomenon of suicidality in old age and its unique characteristics. This will be performed through observing the multigenerational aging family from the life-course perspective, which enables the researchers to address life transitions, including crises leading to suicidal tendencies.


Eligibility Criteria:
Inclusion Criteria:

* Hebrew speaking
* Suicidal
* Families of elderly suicides
* Cognitive ability

Exclusion Criteria:

* All others
Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring

This prospective interventional study investigates transpharyngeal sonography (TPS) as an additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular surgery. In the first part of the study the investigators will investigate the feasibility of TPS for visualization of aortic arch branches including the innominate and the carotid arteries in patients undergoing cardiac surgery with cardiopulmonary bypass. In the second part the investigators plan to adopt the investigators previous experiences on TPS to a selected population of patients undergoing ascending aortic and/or arch repair in hypothermic circulatory arrest (HCA).


Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular Surgery
* Age \> 18 yrs
* Informed Consent

Exclusion Criteria:

* Contraindication for TPS
* Carotid artery stenosis
CT-2106 for the Second Line Treatment of Ovarian Cancer

The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
* Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
* At least one measurable lesion according to RECIST
* ECOG performance status 0 or 1
* at least 18 years old
* Adequate haematological function
* Adequate renal and hepatic functions
* Normal coagulation parameters

Exclusion Criteria:

* Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of \> 12 months
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis;
* Current active infection per investigator assessment;
* Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
* Current history of chronic diarrhea \>= grade 1 (CTCAE version 3);
* Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
* Other uncontrolled, serious illness or medical condition, as determined by the investigator;
* Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
* Concurrent treatment with any other anti-cancer therapy;
* Known HIV positivity or AIDS-related illness;
* Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
Turkish Version of the Brief-BESTest Scale

The aim of this study is to investigate the validity and reliability of the Turkish version of the brief-BESTest (short BESTest) scale in stroke patients.

Brief Balance Evaluation Systems Test (Brief-BESTest) is a short version of the Balance evaluation systems test (BESTest). Balance assessment systems test (BESTest) The balance assessment systems test developed by Horak consists of 6 sub-sections that evaluate the systems related to balance; 1) biomechanical limitations, 2) stability limit, 3) postural responses, 4) intuitive postural adjustments, 5) sensory orientation and 6) walking. It consists of 36 tests in total. Each question is rated between 0-3. The highest score that can be obtained is 108. Low test scores show that the balance is disturbed. BESTest has been found to be reliable among raters evaluating a cohort of individuals with and without various neurological diagnoses. In studies conducted, it was stated that BESTest is reliable when compared to other scales evaluating balance.

The necessary permissions have been obtained from the authors for Short BESTest, whose validity and reliability features will be tested, and the translation process to Turkish has been completed and the survey has been finalized. The basis for the use of special tools such as the scale is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation stage from the original language to the other language.

At the stage of translation into Turkish, two experts who knew a good level of English translated the questionnaire from English into Turkish. These translations have been translated back into Turkish by two native speakers of English and distant medical subjects. In addition, these translations were re-examined by the researchers and turned into a single form. This form was sent to five specialists in the field, checking the content and compliance with Turkish was evaluated. With the opinion of experts, the scale was finalized.

The study will include individuals over 40 years of age who have been diagnosed with an ischemic or hemorhagic stroke, who applied to the Kırıkkale University Faculty of Medicine Physical Therapy and Rehabilitation Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Being 40 years old or older,
* Diagnosis of stroke,
* No cooperation and communication problems
* To be able to walk 10 m independently with or without an auxiliary device

Exclusion Criteria:

* Another neurological or orthopedic problem other than stroke that will affect functionality and balance
* Individuals with advanced contraindications for cardiovascular disease and mobilization will not be included in the study.
Cepheid Rectal Sample Validation Study

The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.

A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen.

The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.

Because of its high sensitivity and specificity, NAAT testing has largely replaced bacterial culture for the diagnosis of genital CT and GC in both males and females. NAAT assays have the greatest potential for detecting CT and GC in the rectum; however, no NAAT is currently cleared for use with extragenital specimens by the US Food and Drug Administration.

In order to comply with CLIA regulations, laboratories must perform in-house validations to use NAATs with rectal and pharyngeal specimens. There are multiple studies in the literature evaluating NAAT assays in diagnosing CT and GC in rectal and pharyngeal specimens using expanded reference standards, which includes positive culture result and secondary confirmatory NAAT assays. The proposed validation study is intended to provide data to support the use of NAAT for rectal and pharyngeal specimens.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants aged 18 and older
2. Women or men who have a history of engaging in receptive anal intercourse
3. Willing to provide written informed consent for participation in this study

Exclusion Criteria:

1. Use of oral antibiotics in the past 7 days
2. Use of rectal douche or other rectal product in the past 24 hours
3. If female, use of a vaginal douche or vaginal product in the past 24 hours
Research on the Characteristics of Chronic Airway Diseases (asthma, COPD)

This study will to investigate the correlation between the characteristics of the population with chronic airway diseases (asthma, chronic obstructive pulmonary disease) and syndromes, in order to reveal the disease and syndrome features of the population; Secondly, screening and identifying biomarkers for asthma and chronic obstructive pulmonary disease to provide a basis for precise prevention and treatment of the disease.

Chronic airway diseases are a group of non-specific chronic airway inflammatory diseases, with a heavy disease burden and serious harm to public health. Bronchial asthma and chronic obstructive pulmonary disease are the most common and representative chronic airway diseases, with significant clinical heterogeneity and unclear disease syndrome relationships. Clarifying the characteristics of asthma and chronic obstructive pulmonary disease populations, disease features, syndrome features, and their interrelationships is an important prerequisite for achieving personalized treatment and improving efficacy. Therefore, this study adopted a stratified random sampling clinical epidemiological survey method, selecting more than 10000 asthma and chronic obstructive pulmonary disease patients nationwide, and applying an optimized respiratory disease intelligent clinical research platform to collect patient population data (age, respiratory disease history, etc.), disease information (staging, grading, typing), and syndrome information (empirical, deficiency, and mixed syndrome). Using intelligent algorithms such as high-dimensional Bayesian optimization MCC-BO, T-distribution random nearest neighbor embedding, multidimensional correlation analysis, etc. to analyze the correlation between population characteristics and diseases and syndromes; Elucidate the correlation points between different stages, grades, types, and syndromes of asthma and chronic obstructive pulmonary disease. Using phenomics and adaptive multi omics global similarity fusion method to identify their biomarkers, further revealing the disease characteristics of asthma and chronic obstructive pulmonary disease populations, and guiding the precise treatment of traditional Chinese and Western medicine.

Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnostic criteria for asthma or COPD.
* Age of athma range from 12 years to 80 years.Age of COPD range from 18 years to 80 years.
* The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Exclusion Criteria:

* Patients with respiratory diseases such as interstitial lung disease, lung malignant tumor, lung infectious diseases, pneumothorax, pleural effusion, etc., which affect the syndrome differentiation.
* Patients with combining severe cardiovascular and cerebrovascular diseases, severe liver and kidney diseases, severe hematological malignancies, etc., affecting syndrome differentiation.
* Patients with delirium, dementia, various mental illnesses.