cyrilzakka/clinical-trials huggingface dataset:
Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

A randomised controlled trial to assess the impact of femoral artery block on the incidence of tourniquet hypertension in patients receiving cruciate ligament surgery with \> 30 minutes of tourniquet under combined anaesthesia (balanced general anaesthesia and femoral nerve blocks).


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I to III
* Receiving cruciate ligament surgery with \> 30 minutes of tourniquet
* Combined anesthesia (balanced general anesthesia and femoral nerve block)

Exclusion Criteria:

* Nerve block contraindications (block site infection, allergic to local anesthetic)
* Tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft)
* Tourniquet inflation time \< 30 min
* Patient refusal
* Pregnant patients
* Patients with a active psychiatric disease.
Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)

A comparison of reported estimated blood loss with quantified blood loss in all patients whose medical records indicate Triton was used during their vaginal delivery.

This study is a retrospective blinded cohort trial comprised of two data collection phases. In the first phase data will be collected on all women who had vaginal deliveries between 2010 and 2015 who had a procedure code indicative of transfusion (99.0x) or received a diagnosis suggestive of peripartum hemorrhage (e.g. diagnosis x code 666.xx, 641.x, 645.x, 646.x 674.x). Phase 2 will consist of all women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician. This will be accomplished by reviewing the records of women who delivered and were discharged within the data collection period.

Eligibility Criteria:
Inclusion Criteria:

* All women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician.
* All women who had vaginal deliveries between 2010 and 2015 at HackensackUMC who had a procedure code indicative of transfusion (99.0x) or received a diagnosis suggestive of peripartum hemorrhage (e.g. diagnosis x code 666.xx, 641.x, 645.x, 646.x 674.x).

Exclusion Criteria:

* Women who received transfusions unrelated directly to pregnancy (e.g. renal disease, anemia of pregnancy, genetic or viral conditions causing anemia).
Impact of Online Patient Feedback (OQ) to Therapist

Dropout represents one of the largest problems in substance abuse treatment. International and Nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. At the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. In spite of the serious and continuous challenge dropout represents the phenomena is not well understood and there is a need to explore more of the factors that influence dropout and how it can be counteracted. As also stated: "...effective methods for reducing the problem of dropouts from treatment is one more area in need of further research" (NOU 2003:4, s 77).

For the general field of mental health one of the most important innovations involves providing therapists with patient feedback about their progress. The most well-established and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has been shown to improve treatment outcomes, including reduced treatment dropout and length of treatment, but the system is yet to be utilized with a substance abusing patient group. The aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing patients.

Hypotheses and research questions

1. The OQ-45.2 feedback will be effective in identifying patients at risk of dropout of substance abuse treatment.

1a. The condition were feedback is withheld from the therapist, will correctly identify patients who will dropout.

Research Question: Is there variation in the accuracy of dropout prediction as a function of age, gender differences or type of substance abuse?

2. The OQ-45.2 feedback will be effective in reducing dropout in outpatient substance abuse treatment.

2a. The feedback condition will result in less dropout than the no-feedback condition.

Research Question: Is there a variation in the OQ-45.2 preventive dropout effect due to age, gender or type of substance abuse?

3. The OQ-45.2 feedback will shorten length of inpatient substance abuse treatment.

3a. The feedback condition will identify patients who are ready to terminate therapy.

Research Question: Is there variation in identification of patients ready to terminate as a function of age, gender differences or type of substance abuse?

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of addiction, F10-19, using the International Classification of Diseases, admitted in 2011-2014 for treatment at the department of addiction treatment - youth, Oslo University Hospital

Exclusion Criteria:

* Ongoing psychoses, severe language difficulties
Physiological Data in the Menstrual Cycle

Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
* Regular cycling (28 days +/- 2)
* Non-hormonal contraception methods used
* German-speaking
* Written informed consent to participate in the study

Exclusion Criteria:

* Any health-related issues that may affect menstrual cycle
* Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
* Frequent travel between time zones
* Sleeping disorders
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.

The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)
* Planned for catheter-based ablation of VT
* All patients will have an existing ICD
* Accessibility of renal vasculature (determined by renal angiography)
* Ability to understand the requirements of the study
* Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria:

* MI or CVA within 30 days
* Coronary Artery Bypass Graft (CABG) within 30 days of this procedure
* Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)
* GFR \<30 ml/min (unless receiving dialysis)
* Life expectancy \<1 year for any medical condition
* Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding)
* Inability to give informed consent
* Known pregnancy or positive -HCG within 7 days of procedure.
A Study of CDX-585 in Patients With Advanced Malignancies

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

This study will determine the maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 in patients with cancer.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-585. The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study.

Approximately 130 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study.

Eligibility Criteria:
Key Inclusion Criteria:

1. Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma).
2. Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting.
3. Measurable (target) disease by iRECIST.
4. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment.
5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

Key Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies.
2. Previous treatment with any anti-ILT4 antibody.
3. Patients who have received more than 1 anti-PD-1 or anti-PD-L1 targeted therapy, including in the adjuvant setting.
4. Prior anti-PD-L1 based therapy within 12 weeks and prior anti-PD-1 based therapy within four weeks to the planned start of study treatment.
5. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least one year to be allowed to enroll.
6. Thrombotic events within the last six months prior to study treatment
7. Active, untreated central nervous system metastases.
8. Active autoimmune disease or documented history of autoimmune disease.
9. History of (non-infectious) pneumonitis or has current pneumonitis.

There are additional criteria your study doctor will review with you to confirm eligibility.
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

* ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
* Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.

• SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects
* Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

Exclusion Criteria:

* Known history or presence of any clinically significant medicalcondition.
* Known or suspected carcinoma.
* Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year.
* Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
* Use of tobacco or nicotine-containing products within 6 months priorto drug administration.
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants

The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.

Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.


Eligibility Criteria:
Inclusion Criteria:

- Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)

Exclusion Criteria:

* Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
* Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
* Have acute unstable neuropsychiatric disease
* Have active or uncontrolled neurologic disease, or clinically significant head injury
Improvement of Quality of Life by Cannabinoids in Oncologic Patients

The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.

170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general.

The following gain of knowledge is expected:

* substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.).
* substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.).
* compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy.
* importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance.
* possible reduction of costs and improved economics through CAM

Eligibility Criteria:
Inclusion Criteria:

* ≥25 years old and legally competent
* Palliative oncological therapy
* ECOG status 1, 2 or 3, incapacitated for work
* ESAS TSDS \> or equals 16
* Nutritional Risk Screening \> or equals 3
* Pain numerical rating scale \> or equals 4
* informed consent
* for WOCBP:

  * Negative pregnancy test
  * Reliable contraception (Pearl Index \< 1%)

Exclusion Criteria:

* nausea \> or equals grade 3 (CTCAE) or vomiting \> or equals grade 2 (CTCAE) in the preceding week
* Inability to understand and complete the questionnaires
* Cannabis use in the last 6 weeks
* Alcohol addiction
* Pregnancy/lactation
* Contraindications or intolerance to the study medication (esp. psychosis)
* Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)
* Any other condition as judged by the investigator, e.g. non-compliance
Clinical Pharmacokinetics Study on Pikamilone

Study on the phamacokinetics of Pikamilone in healthy Chinese subject and provide informations for further phase II study.


Eligibility Criteria:
Inclusion Criteria:

* nonsmokers and in good health
* weight: BMI: 19-24
* written informed consent was finished.

Exclusion Criteria:

* disease
* taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study.
Timing of Initiation of LMWH Administration in Pregnant Women With APS

Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)

Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
* Early pregnancy body weight is 50-90 Kg

Exclusion Criteria:

* Women with systemic lupus erythematosus (SLE)
* Women with active thromboembolic disorders
* Women with history of previous thromboembolic disorders
Blood Flow Rextriction Training in Upper Extremity of Elderly

Our study aims to decrease independence by increasing upper extremity strength and performance by applying blood flow restrictive training, which has entered the literature as a new method, to the upper extremity in the elderly. The application will only be applied to the upper extremity and will last for 6 weeks.

People are living longer now than in the past. The experience of old age in modern societies has gained importance with the prolongation of life expectancy. Over the years, the elderly lead to a decrease in physiological capacity and an increase in the risk of various diseases, resulting in a decrease in the functional capacity of the individual. Many physiological changes occur in the organism with advancing age. Muscle strength is an important determinant of healthy aging. It is known that the decrease in muscle mass and strength impairs body function and can have significant consequences for the individual, as well as increase economic costs. Impairment in function initially results in difficulties performing common daily activities such as carrying household items; however, when body strength falls below a clinically relevant threshold, mobility restriction increases and may affect independence in activities of basic daily living. Loss of independence requires support from caregivers; often leads to social withdrawal and adverse effects on well-being and quality of life. Muscle strength, function and mobility are the biggest determinants of independence. Handgrip strength is used in clinical practice, rehabilitation, and public health research to determine musculoskeletal function and assess frailty and disability.

The aim of our study is to determine the effect of BFRT applied to the upper extremity for 6 weeks on general function, hand grip strength, upper extremity functional status, activities of daily living and functionality for elderly individuals between the ages of 65-75. Our hypothesis is that BFR will increase upper extremity function and related activities of daily living and mobility by increasing hand grip strength in elderly individuals.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 65 and over who are classified as advanced age according to the World Health Organization
* Volunteer basis

Exclusion Criteria:

* History of acute trauma to the hand or wrist
* Scrapped upper extremity
* Patients with symptoms of shoulder or elbow pain and rheumatoid arthritis,
* Those who have participated in upper extremity weight training training in the last 6 months,
* Those taking sedatives
* Upper extremity venous thrombosis,
* Being at high risk for cardiovascular conditions that interfere with exercise, unexplained chest pain or heart disease, fainting or dizziness during physical activity/exercise
Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer

This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.

Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection.

Exclusion Criteria:

* 1. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment