cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours

Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
* Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol
* Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event
* Hypertension (high blood pressure) or significant cardiovascular disease
* Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies
Effect Of Schroth Method On Balance In Upper Crossed Syndrome

The study will be conducted to investigate the effect of Schroth method on balance in patients with the upper cross syndrome

Upper crossed syndrome (UCS) is the most common postural dysfunction in the musculature of the shoulder girdle /cervicothoracic region, which creates joint dysfunction, particularly at the atlanto-occipital joint, cervicothoracic joint C4-C5 segment, glenohumeral joint and T4-T5 segment.

The Schroth method helps patients to halt curve progression, reverse abnormal curves, reduce pain, increase vital capacity and improve posture and appearance The Schroth method consists of sensorimotor, postural, and breathing exercises aimed at recalibration of normal postural alignment, static and dynamic postural control and spinal stability.

There are no studies on Schroth method on the upper cross syndrome, so this study will be conducted to know the effective method of treatment for upper cross syndrome.. forty patients with the upper cross syndrome will be allocated randomly to two equal groups; one experimental group will receive Schroth method twice a week for four weeks and control group will receive postural correction exercise twice a week for four weeks.

Eligibility Criteria:
Inclusion Criteria:

* The patient's age ranged from 17 to 22 years
* Body mass index between 20-25 kg/m2
* The participants are diagnosed with upper cross syndrome
* Patients with normal cognitive aspects willing and able to participate in a program safely

Exclusion Criteria:

* The participants have experienced any recent trauma (within 3 months of the initial consultation)
* The participant's primary complaint is that of headaches or facial pain.
* Participants have any sort of structural abnormality in upper and middle back e.g., Scoliosis, or had a positive Adams test.
* Participants who are taking anti-inflammatory or muscle relaxant medication had to have a three-day "wash out" period before participating in the study
Endothelial Bleb Response With Toric Lenses

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.

Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
2. At least 18 years of age and mentally competent to sign an informed consent form.
3. Healthy eyes and no use of ocular medication.
4. Similarity of optical parameters between eyes.
5. Physical appearance typical of Asian eyes

Exclusion Criteria:

1. A medical or ocular condition that may influence the outcome of this trial.
2. Current use of ocular/systemic medication that may influence the outcome of this trial.
3. Failure to wear soft lenses for 2 weeks prior to the start of the study.
4. Current enrolment or participation in another clinical study.
5. Current state of pregnancy or breastfeeding
6. Anisometropia greater than 1.00D (equivalent sphere).
7. Unequal acuities between eyes (greater than 1 line)
8. Unequal corneal curvatures (\>1.00D)
Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration

The purpose of this study is to compare the reaction time (as measured by braking reaction time in seconds during simulated driving) under glare and no-glare conditions in subjects implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs. This study will enroll subjects previously implanted with IOLs in both eyes for at least 3 months.

Subjects completed 2 visits to the investigational site.

Eligibility Criteria:
Inclusion Criteria:

* Pseudophakes with ACRYSOF® IQ monofocal IOLs or clear (no blue light filter) IOLs in both eyes for at least 3 months.
* Willing and able to understand and sign an informed consent form.
* Corrected visual acuity (CVA) of 20/40 or better.
* Have a valid driver's license.
* Depth perception of at least 100 arc seconds.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular pathology, degeneration, or media opacity.
* Color vision defect.
* Use of ocular or systemic medications that impact macular pigment density or reaction time, including but not limited to, lutein, zeaxanthin, barbiturates, tranquilizers or amphetamines.
* System conditions affecting connective tissue or sensory-motor coordination.
* Other protocol-specified exclusion criteria may apply.
Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

This is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all.

This is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Eligibility Criteria:
Inclusion Criteria:

* all Adult Patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias.

Exclusion Criteria:

* operations which were converted from TAPP to other procedures (such as open repair or TEP).
* Patients who were unfit for general anesthesia
* patients who refused to participate in the study
* patients with chronic pain disorders requiring long term pain management before the procedure.
* cases with complicated hernias that required emergency repair.
Japanese Pradaxa PMS, Long Term

The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab

The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan

Exclusion Criteria:

* None
Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes

This is a prospective analysis of patient registry data of intensive care patients. The aim is to investigate if frailty is a predictor of decline of functional status of critically ill patients during their hospital stay.

Elderly critical-ill patients with a high frailty level are becoming increasingly important in the ICU and the health system. Especially, questions about the course of the individual proceeding, withhold of therapy and level of care are controversial among caretakers, as outcome and functional independence remain still unclear in these patients.

This applies particularly in view of the fact that large studies such as VIP1 showed an inverse association of high frailty classes with short-term survival.

Our main objective in this study was to focus on functional outcome and independency measured by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity and prognosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* intensive care stay \> 48 hours

Exclusion Criteria:

* none
A Study to Evaluate ALN-AGT01 RVR in Adult Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.


Eligibility Criteria:
Inclusion Criteria

* Is an adult healthy volunteer
* Has a body mass index ≥18 kg/m\^2 and ≤28 kg/m\^2

Exclusion Criteria

* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN)
* Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
* Has an estimated glomerular filtration rate (eGFR) of \<90 mL/min/1.73m\^2 at screening

Note: other protocol defined inclusion / exclusion criteria apply
PREPARE - PREoPerative Anxiety REduction

The study aims to verify if a short individual psychological intervention might increase perceived self-efficacy in managing preoperative anxiety in patients who will undergo pancreatic surgery. It is a randomized clinical trial where half of participants will attend a psychological intervention based on "the four elements protocol" by Elan Shapiro the day before surgery, while the other half will follow usual care.

Patients who have to undergo surgery experience multiple sources of stress. A recent narrative review carried out on 115 studies by Powell et al. (2016) reported different and inconsistent findings on the relation between psychological interventions and surgery outcomes, due to the heterogeneity of these interventions, mainly based on information giving and patient education, and the very different samples of patients considered. Some evidences showed that pre-operative psychological interventions may contribute to reduce post-operative pain, duration of hospital stay (mean difference of 0.52 days) and negative affect. No studies were conducted with patients who had to undergo pancreatic surgery nor specific psychological interventions were devoted to increase self-efficacy in managing anxiety.

The aim of the present study is to verify if a short individual psychological intervention devoted to improve patient's ability to manage anxiety could increase his/her confidence to cope with pancreatic surgery, either in terms of perceived self-efficacy (main outcome) or less state anxiety reported on STAI-Y1 scale. Post-surgery outcomes are also collected: pain reported during the days following surgical intervention, length of hospital stay and number and type of clinical complications.

The study will involve 400 patients randomly divided in two arms and it is organized in four phases: T0,T1,T2,T3.

T0: Once obtained the informed consent, demographic information will be collected using a structured questionnaire. Clinical variables will be collected by self-administered tools, for which patients can ask support, if needed.

T1: The day before surgery, all patients will indicate their perceived self-efficacy in managing anxiety and will fulfil specific anxiety scales.

T2: after randomization, patients in the experimental group will participate to the psychological intervention, whereas the control group will follow usual care.

T3: After surgery pain, length of hospital stay and the number of post-operative complications within 30 days will be evaluated as secondary outcomes on all patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years old
* cognitively able to give personal consent to participate to the study
* to be scheduled to have general anaesthesia for pancreatic surgery

Exclusion Criteria:

* age under 18 years and over 80 years
* cognitively unable to give personal consent to participate to the study
* postponement of surgical operation
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries

In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures. 33 of these patients couldn't followed for various reasons. Screw or suture buttone method was applied on 110 patients. And patients were examined with lots of data to compare their results. A retrospective study was conducted.


Eligibility Criteria:
Inclusion Criteria:

* Ankle fractures associated with syndesmotic injury
* Age group 19-91 years
* Dislocation or non-dislocation ankle fractures
* Fractures due to acute injury (less than 3 weeks)
* Patient compliance with follow-up

Exclusion Criteria:

* Patients younger than 18 years of age
* Conservative treatment
* Pathological and neglected fractures
* Patient's non-compliance with follow-up
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers

The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.

During Dosing Period 1, blood samples for pharmacokinetic (PK) analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 12 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, and 12 hours) for Cohort 4; through 36 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, and 36 hours) for Cohort 3; through 60 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, and 60 hours) for Cohort 2; and through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours) for Cohorts 1 and 5.

During Dosing Period 2 (Cohorts 2, 3, and 4 only), blood samples for PK analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours).

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥18 years of age.
* American Society of Anesthesiologists (ASA) physical status 1 or 2.
* Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before the first study drug administration.
* Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* History of abnormal bleeding tendencies/clotting disorders.
* Regular use of anticoagulants (except for low dose aspirin for cardioprotection).
* Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during his/her participation in this study.
* Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
* Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
* Received bupivacaine or other local anesthetic within 7 days of first study drug administration.
Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms

The investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Assigned female at birth
* 18-70 years of age
* Body mass index (BMI) \<30 kg/m2

Exclusion Criteria:

* Assigned male at birth
* Pregnancy, breastfeeding
* Body mass index ≥30 kg/m2
* Oral hormonal contraception in last 6 months, history of hormone replacement therapy, oophorectomy
* Current smoking/nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications
The Physiotherapy Approaches in Patients With Subacromial Impingement Syndrome

The aim of this study is to investigate the effectiveness of Electromyographic Biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality in patients with subacromial impingement syndrome.

This study is planned as a prospective, randomized clinical study. Patients with subacromial impingement syndrome who volunteered to participate in the study, met the inclusion criteria, and signed the consent form were randomly assigned to the proprioception exercise group and the proprioception exercise with electromyographic biofeedback group. Demographic and clinical data of the patients were recorded. Shoulder function with Disabilities of the Arm, Shoulder and Hand scale, pain with VAS, painless active shoulder flexion, abduction, and external-internal rotation with goniometer, muscle strength with Manual Muscle Tester, proprioception (55°-90°- 125° angles of flexion and abduction, and angular deviations) with the Laser-pointer assisted angle reproduction test were evaluated, and patient satisfaction was evaluated with The Global Rating of Change Scale. After the initial evaluations were completed, only proprioception exercises and proprioception exercises with EMG-BF were applied 2 days a week for 8 weeks. Additionally, both groups were given Want exercises.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with subacromial impingement syndrome,
* Being between the ages of 18 and 65,
* Not having received medical treatment,
* Not having received a shoulder-related physiotherapy program in the last year,
* Not having had any shoulder-related surgery,

Exclusion Criteria:

* Neurological deficits of the upper extremity and the presence of another orthopedic disorder, rheumatic or congenital disease other than subacromial impingement syndrome,
* Presence of mental problem,
* Having received corticosteroid treatment in the last year,
* Upper extremity fracture,
* Acute cervical pathology,
* Having cardiovascular and systemic diseases that prevent working,
* Pregnancy,
* Those with communication problems.
A New Intelligent Stocking for Quantification of Edema in the Lower Limbs

The purpose of the study is to evaluate a prototype of an intelligent stocking (Edema Stocking Device \[ESD\]), consisting of two stretch sensitive sensors, as a new method for continuously lower leg volume monitoring. The study is a scientific evaluation of the ESD compared with water displacement volumetry and tape measure.

Background:

Balance of body fluids is strictly regulated within a narrow range and is controlled by water movement between the interstitial compartment and the capillaries. An unnatural balance between the two compartments can be seen in several diseases, leading to a net filtration out of the vascular space, resulting in the formation of edema. Monitoring of edema formation represents a unique way of evaluating the degree of the underlying disease and effect of treatment. Numerous different methods can be used to quantify leg volume. However, no current method provides continuous quantitative assessment. The feasibility of continuous lower leg measuring using an intelligent stocking was hypothesized.

The aim of the study was to evaluate the Edema Stocking device (ESD) as a tool for continuous quantification of edema compared with water displacement volumetry (WDV) and tape measure.

Materials and methods:

Study design: Non-randomized equivalence study. Experimental comparison study of new method compared to golden standard.

Eligibility Criteria:
Inclusion Criteria:

* Edema of the lower legs.
* Between 20-18 years.
* Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.

Exclusion Criteria:

* Length of lower leg of more than 34,0 cm (measured from floor to knee).