cyrilzakka/clinical-trials huggingface dataset:
REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, And/or Outbursts Associated with Dementia Due to Alzheimer's Disease)

The purpose of this study is to evaluate safety of REXULTI in patients under daily clinical settings. In addition, information on efficacy will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Alzheimer's disease

Exclusion Criteria:

-
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Fragile X Syndrome, who are at least moderately ill based on a Clinical Global Impression Severity score of at least 4 and have qualifying scores on the ABC-C and IQ test at Visit 1

Exclusion Criteria:

* Advanced, severe or unstable disease that may interfere with the study outcome evaluations
* Cancer within the past 5 years, other than localized skin cancer
* Current treatment with more than two psychoactive medications, excluding anti-epileptics
* History of severe self-injurious behavior

Other protocol-defined inclusion/exclusion criteria may apply
The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies

The purpose of the study is to determine whether castor oil is effective in inducing labor.

Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an initiator of labor was previously tested only in one clinical trial. Unfortunately this study (by Garry et al.) was not sufficiently controlled.

We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery that had past their due date. Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at 40-42 weeks gestation
* Good obstetrical dating
* Singleton
* Intact membranes
* Preinterventional Bishop score less than or equals 4
* No evidence of effective uterine contractions by external tocography
* Living close to hospital

Exclusion Criteria:

* Multiple gestation
* Oligohydramnios or Polyhydramnios
* Abnormal FHR tracing
* Obstetric complication (hypertension, bleeding)
* Ruptured membranes
* Suspected intrauterine growth restriction
* Biophysical score \< 8
* Previous cesarean section / myomectomy / Other uterine operation
* Fever, malaise at recruitment
* Chronic illness (renal, hepatic, endocrine)
Developing Better Computerised Vision Tests (CVTV)

Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available.

There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum.

The aims of this two year linked program are to:

Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these.

Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration.

All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive.
* Patients able to understand the information sheet, and willing and able to give informed consent to participate.
* Patients with visual function ranging from normal to severely impaired.
* Willing and able to comply with the visual function testing protocol.
* Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration).

For Part B of the project which aims to develop and pilot a home monitoring application, only adult (18-99 years) subjects complying with the above who also own a suitable browser device will be recruited.

Exclusion Criteria:

* Unwilling or unable to comply with the visual function testing protocol.
* Unwilling or unable to give informed consent.
* Unwilling to participate.
* In other research trials.
Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized Patients

The occurrence of VTE in hospital is an important cause of unexpected death of inpatients, and has become a serious problem faced by hospital managers and clinical medical staff.Under the target of "Improving the Standard Prevention Rate of Venous Thromboembolism" proposed in the "National Medical Quality and Safety Improvement Goal in 2022", it is urgent to establish a highly sensitive VTE risk assessment and monitoring system.At present, VTE risk assessment scale is used for risk screening and monitoring in combination with D-dimer in clinical practice, but D-dimer has low specificity and poor sensitivity, which makes it impossible to accurately assess the risk of venous thrombosis.Therefore, it is very important to explore highly specific molecular markers of thrombosis for VTE risk assessment.This project will analyze the value of single or combined detection of different thrombus molecular markers in VTE risk assessment, establish the best VTE risk assessment scheme, improve the standardized prevention of VTE, realize the early intervention of VTE, truly achieve early detection, early prevention and early treatment, and effectively reduce the occurrence of VTE.

This project is intended to explore the specificity and reliability of single or combined detection of different thrombus molecular markers in venous thrombosis risk assessment by detecting and analyzing the levels of various thrombus molecular markers in VTE high-risk patients, so as to establish the best evaluation strategy for early identification of VTE high-risk patients, build the hospital VTE early warning management system, guide the clinical to formulate targeted graded intervention measures, and effectively reduce the occurrence of VTE. At the same time, it will provide support for the realization of "improving the standard prevention rate of venous thromboembolism" proposed in the national medical quality and safety improvement goal in 2022 and reducing medical risks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Surgical inpatients
* Patients who were assessed as high-risk by venous thrombosis risk assessment after admission (caprini score ≥5)
* Did not receive anticoagulation or thrombolysis before admission
* Patients without chronic cardiovascular disease, autoimmune disease, malignant tumor and other diseases
* Patients without previous history of venous thrombosis of lower limbs
* The molecular markers of thrombus were detected routinely at admission
* The family members of the patients signed informed consent

Exclusion Criteria:

* Abnormal coagulation function due to blood disease or severe liver and kidney dysfunction
* Patients with major trauma or vegetative survival within 3 months
* Patients with long-term use of anticoagulant drugs, glucocorticoids and hemostatic drugs
Osteopenia and Renal Osteodystrophy: Evaluation and Management

The purpose of this study is to demonstrate whether pamidronate will preserve or increase bone mass in patients with adynamic bone disease, caused by low bone turnover.

Detailed Summary: Bone disease has been a well-recognized complication of renal disease for over 100 years. Until the advent of dialysis, however, it was only another of the many dreadful complications of a fatal disease. Almost since the onset of dialysis, however, bone disease and calcium metabolism presented major difficulties to patients and physicians. Recently we reported that dialysis patients had an 8-fold increase in hip fracture rate, compared to the normal population. In younger dialysis patients (age 30-50 years) this risk was increased to nearly 100 fold. We have also noted a similar or even higher incidence of fracture in the transplant population. Low bone mass has been found in dialysis patients by ourselves and other investigators, a finding in the general population which predisposes to fracture. In the dialysis population, bone histologic studies done by us and others have reported the adynamic (low turnover) lesion in more than half of the dialysis population. This lesion is similar to what is seen in osteoporosis. Thus, dialysis patients, like osteoporotics, have low bone mass, low bone turnover, and a high fracture rate. In the osteoporotic patients, various bisphosphonates have been shown to inhibit bone resorption, increase bone mass and decrease fracture rate. The only bisphosphonate approved for use in patients with renal failure is pamidronate. This agent has not been used extensively in the general population because it must be given intravenously. This, together with the fact that pamidronate has a bone half-life of over 300 days, actually makes this drug a strong candidate for the treatment of patients with renal failure. In this investigation we propose using pamidronate in patients with renal failure to prevent bone loss and fracture. We will monitor bone mass by DEXA in patients to assess treatment response, assess bone histology in selected subjects, and collect data on fractures in the population.

Comparison: Subjects with normal or low parathyroid hormone (PTH) who receive dosing with pamidronate will be compared to similar subjects who receive placebo. Comparison groups will be randomly assigned and assignment will be blind.

Eligibility Criteria:
Inclusion Criteria:

* Dialysis dependent for a minimum of 3 months
* Age greater than 18 years
* Low or normal bone turnover as defined by a mean intact PTH ≤400 pg/ml from a minimum of two values 6 months apart
* Informed consent

Exclusion Criteria:

* Mean serum aluminum levels \> 20 mcg/L during 1 year prior to consent
* Documented dementia
* Comorbidity such that survival for \>3 years is unlikely
* Use of steroids within 3 months of consent
* Use of bisphosphonates in previous 2 years
* Use of sex hormones (testosterone or estrogen) within 3 months of consent
* Mean calcium \< 9.0 mg/dL during the two months prior to consent
* Peritoneal dialysis patients
* Body weight \< 45 kg
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
* Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

* Previous chemotherapy for locally advanced or metastatic gastric cancer
* Previous platinum or anti-angiogenic therapy
* Radiotherapy within 28 days of randomization
* Evidence of Central Nervous System (CNS) metastasis at baseline
Lubiprostone Effects on Visceral Pain Sensitivity

The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.

Subjects will be enrolled in an 8-week study requiring a total of 7 visits to the UNC Center for Clinical and Translational Research. The protocol is divided into 4 two-week periods: (1) Two-week baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) Two-week treatment with either Lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. In addition, patients will be tested for whole gut transit time by the radio-opaque marker (Sitzmark) technique in the second week. (3) Two-week washout period, during which patients will continue the symptom diary. (4) Two-week crossover to Lubiprostone or placebo, identical to the second two-week period.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of IBS-C
* meeting Rome III diagnostic criteria for IBS-C
* age 18 or older

Exclusion Criteria:

* use of laxatives or prokinetics within two weeks prior to the study or during the study
* use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
* use of analgesics for 48 hours prior to the study
* hypothyroid condition
* history of bowel resection except appendectomy or cholecystectomy
* psychotic disorder, major depression, substance abuse (other than tobacco), or other psychiatric condition likely to interfere with the conduct of the study. Subjects treated for depression more than 2 years ago or for situational circumstances may be eligible for the study at the investigator's discretion
* renal disease
* inflammatory or ischemic disease of the rectum
* known to be an unreliable subject
* Because this study involves exposure to radiation, subjects who are pregnant or planning to become pregnant, employees currently working with radiation, and subjects who have participated in research involving radiation within the past year will also be excluded.
Peer-Delivered Episodic Future Thinking for Returning Citizens

The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD).

The main questions it aims to answer are:

1. Determine preliminary implementation potential of the EFT intervention, including acceptability and feasibility of conducting the intervention.
2. Examine the preliminary effectiveness of this approach, with a specific focus on patient outcomes, including changes in delay discounting, treatment retention, treatment motivation, and substance use.

Participants will be asked to participant in pre and post assessment questionnaires, participate in a single-episode brief intervention followed by tailored phone call follow-ups.

Returning citizens with substance use disorders (SUD) are at the greatest risk for overdose in the first two weeks following the transition from incarceration. Thus, the reentry period is of specific importance for ensuring individuals are engaged and retained in specialized intervention services. Individuals also face numerous, and highly impactful, decisions during this period. They are required to navigate complex tasks (finding employment, securing housing), often with limited financial and social supports. Of particular concern, recent research suggests that the reentry period, often characterized by instability and limited resources, may reinforce a decision-making approach that favors meeting immediate needs relative to engaging in long-term planning. This focus on attaining smaller but immediately available rewards relative to larger, delayed, rewards (known as delay discounting), in turn, has been associated with a number of negative health outcomes, including substance use and poor treatment outcomes (higher dropout and lower motivation). In other words, the reentry context may create an environment which reinforces individuals' tendencies to engage in short-term, reward-seeking behaviors (e.g. substance use, skipping treatment appointments) at a time when their decisions have highly significant consequences (relapse, recidivism). This study will examine the efficacy of implementing a low-cost, brief intervention (Episodic Future Thinking) targeting the reduction of delay discounting with the reentry population to inform broader public health efforts aimed at reducing substance misuse and improvements in treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Experience in an incarceration setting within 12 months
3. Identify as an individual in substance use recovery
4. Willing to participate in the study
5. Able to participate in written assessments and an intervention conducted in English
6. Willing to receive brief bi-weekly check-in calls for one month, email, and other phone messages related to study participation including SMS/text messages as needed

Exclusion Criteria:

1. Individuals' ineligible or unwilling to participate in study activities and assessments
2. Self-reporting of active and untreated psychosis
Simulation Training as a Tool for Teamwork Improvement in Multidisciplinary Intensive Care Team

The purpose of the study is to check whether training mixed teams of physicians and nurses from intensive care units on patient simulators improves teamwork within the teams.

Patient safety and the prevention of medical error are primary goals of healthcare organizations. One of the means of reducing such errors is teamwork improvement. Simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses. We intend to compare simulation training of a mixed team of physicians and nurses, using specifically designed scenarios based on real life experience, to frontal teaching sessions designed to enhance teamwork, by assessing teamwork, using accepted behavioral scales, during routine work, before and after both interventions.

Eligibility Criteria:
Inclusion Criteria:

* intensive care physicians and nurses working in respiratory ICU willing to participate in the study

Exclusion Criteria:

* unwilling to participate
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.

The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.


Eligibility Criteria:
Inclusion criteria :

* Patients aged of 75 years old or more,
* Chronic kidney disease stage 5 defined by :
* either an estimated GFR (MDRD) ≤ 15ml/mn/1,73 m² in a non-dialysis patient with a nephrology follow-up \> 3 months ("Pre-dialysis cohort"),
* or a dialysis treatment started for more than 3 months and less than one year, after a pre-dialysis follow-up \> 3 months ("post-dialysis cohort"),
* Signed and dated informed consent.

Exclusion criteria :

* Moderately severe to severe dementia (MMS ≤ 15),
* Major depression and/or GDS-15 \> 10/15,
* Severe dependency (ADL \< 3/6).,
* Psychosis, mutism or aphasia,
* Malignancy or any pathology with life expectancy \< one year.
* Ongoing specialized geriatric care
Studying Corneal Epithelial Stability Following Limbal Stem Cell Transplantation in Cases of Limbal Stem Cell Deficiency

Integrity of the corneal epithelium is the function of intact limbal stem cells. The reduction in the population of LSCs and their dysfunction result in abnormal corneal epithelialization and invasion of the corneal surface by the conjunctival epithelium with or without corneal neovascularization that is, limbal stem cell deficiency (LSCD). Different techniques have been developed to treat cases of limbal stem cell deficiency due to traumatic or congenital cases. Recent innovations developed to predict the early stages of stem cell deficiency. One of these methods is measurement of the central epithelial thickness as it was found that limbal stem cell deficiency causes reduction of the central epithelial thickness.

The aim of this study is to study changes in the corneal epithelial thickness at different quadrants of the cornea to observe the exact time of epithelial stability following stem cell transplantation.

Patients with unilateral chemical ocular injury will be included in the study(12 eyes). All selected patients will receive a thorough explanation of the study design and aims and informed consent will be obtained in all patients. Eyes of all participants will be subjected to: Best corrected visual acuity, Slit lamp examination and ocular ultrasound if no fundus view.

Staging of degree of limbal stem cell deficiency is done by Roper Hall classification and then the patient will have conjunctival limbal autologous transplant (CLAU).

The patient will be followed up at a week, a month, 3 months, 6months and 9 months postoperative.

Corneal epithelial mapping will be done at the previous schedule in both the donated and the recipient eyes using anterior segment OCT (Optical Coherence Tomography)

Exclusion criteria:

Bilateral cases and patients with severe conjunctival scaring and symblepharon.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 15 to 70 years
* Unilateral limbal stem cell deficiency
* Grade 4 stem cell deficiency

Exclusion Criteria:

* Cases with extensive symblepharon
* Cases with very poor visual acuity ( no light perception)
* Cases with posterior segment problem evident in ocular ultrasonography