cyrilzakka/clinical-trials huggingface dataset:
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) \[ADAS-Cog 13\], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) \[ADCS-ADL-MCI\].


Eligibility Criteria:
Key Inclusion Criteria:

* Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
* A Clinical Dementia Rating (CDR)-Global Score of 0.5.
* Objective evidence of cognitive impairment at screening
* An MMSE score between 24 and 30 (inclusive)
* Must have a positive amyloid Positron Emission Tomography (PET) scan
* Must consent to apolipoprotein E (ApoE) genotyping
* If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
* Must have a reliable informant or caregiver

Key Exclusion Criteria:

* Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
* Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
* Clinically significant unstable psychiatric illness in past 6 months
* History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
* Indication of impaired renal or liver function
* Have human immunodeficiency virus (HIV) infection
* Have a significant systematic illness or infection in past 30 days
* Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
* Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
* Alcohol or substance abuse in past 1 year
* Taking blood thinners (except for aspirin at a prophylactic dose or less)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure

Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic inflammation and alleviate liver injury in mice model. However, there are no studies evaluating PGE2 as a predictor of early mortality.This study is designed to investigate whether plasma PGE2 and its receptors are associated with development of MOF and predict short-term mortality in patients with acute-on-chronic liver failure. By the way, we will also measure several other potential predictive factors (C-reactive protein,severe hyponatremia, Second infections,Diabetes mellitus,High density lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte ratio,soluable urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute-on-chronic liver failure according to Asian-Pacific Association for the Study of the Liver (APASL) diagnostic criteria

Exclusion Criteria:

* Hepatocellular carcinoma(HCC)
* Portal vein thrombosis
* Pregnancy
* Human immunodeficiency virus (HIV)
* Patients who had received immunomodulator,or cytotoxic/immunosuppressive therapy within at least the preceding 12 months
Ewha Birth and Growth Study (Birth Cohort)

Ongoing longitudinal birth cohort established at Mok-dong Hospital, Ewha Woman's University, Seoul, South Korea, between 2001 and 2006.

Cohort composed of mothers, who visited to prenatal care between 24 and 28 weeks of gestation, between 2001 and 2006. After the child was born then, we collected information at birth outcome and conducted mail surveys at 6, 12, 18, and 24 months. Regular check-up was conducted at 3, 5, and every year after 7 years of age(last check up point: 15 years old). In check-up survey, after an 8-hour overnight fast, blood and urine samples (3 ml EDTA-blood and 5 ml serum) were obtained from subjects by venepuncture. following parameters were checked: physical growth, blood pressure. metabolic biomarker(Total cholesterol, HDl-cholesterol, TG(triglyceride), glucose, uric acid, etc.), K-CBCL(Korea-child behavior checklist), 24 hour recall method for nutrition, FFQ(Food Frequency Questionnaire), Questionnaires including Socio-economic status and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Participants' mothers, who visited to prenatal care between 24 and 28 weeks of gestation.
* An individual who can be followed up during the study period and is capable of complying with the study requirements

Exclusion Criteria:

* An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
Reducing Breast Cancer Recurrence With Weight Loss

The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
* BMI between 25 to 45 kg/m2
* Able to comply with all required study procedures and schedule

Exclusion Criteria:

* Serious medical condition or psychiatric illness
* Inability to be moderately physically active
* Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
* Currently enrolled in a weight loss program
* Current use of weight loss medication or supplements
* Previous surgical procedures for weight reduction
* Planning weight loss surgery in the next 2 years.
* 6+ months use of meds likely to cause weight gain or prevent weight loss
* Planned surgical procedure that can impact the conduct of the study
* Currently pregnant/breastfeeding
* Planning to become pregnant within the next 2 years
* Have plans to relocate from area within 2 years
* Family relative or close friend is a trial staff member or a study participant
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
This Study Aims to Measure the Effect of Acute Hospitalisation on the Physical and Cognitive Functioning of Older Orthopaedic Patients (Aged 65 or Above).

This study aims to investigate the impact of hospitalisation on physical and cognitive performance in patients aged 65 and older admitted with an orthopaedic injury. This will be achieved by asking patients to participate in a series of physical and cognitive performance questionnaires and tests. These questionnaires and tests will be performed by the patients as close to their admission as possible and then again at day 7 of hospitalisation (or discharge if earlier) and at 4-6 weeks after discharge. However, if a patient's hospital stay lasts more than 30 days, they will be asked to take part in the interim data collection timepoint.

To summarize, patients will be assessed at least 3 times, 4 if your hospital stay is longer than 30 days. The first and second assessments will be in the hospital, and the third will be 4-6 weeks after discharge at you home (or where is appropriate). Additionally, patients will be asked to wear an activity watch between the first and second assessment.

The study will also explore patients experiences of their hospital stay and opinions on deconditioning, including the views and opinions of hospital staff. This information will be gathered by having interviews with a sample of the patients who took part in the questionnaires and tests and by having interviews with hospital staff. The interview will be conducted by the main researcher, Thomas Cartledge, and will take place either over the phone, online or in-person, depending on your preference. The interviews will be audio and/or video recorded, however the recordings will be deleted immediately once transcription is completed. The duration of the interview will last approximately 30-60 mins.


Eligibility Criteria:
Patient criteria:

Inclusion:

* Older adults aged 65 years or older
* Able to provide written consent
* Admitted to Southampton General Hospital (SGH) for an acute orthopaedic condition
* Been admitted to SGH \<72 hours before recruitment

Exclusion:

* Older adults who are not able to safely complete the quantitative measurement tools, as advised by the patient's clinician
* Patients receiving end of life care
* Require a hoist to transfer from bed to chair prior to hospitalisation
* Been admitted to SGH \>72 hours before recruitment
* Unable to consent

Hospital staff criteria:

Inclusion:

* Work at SGH
* Work with older orthopaedic inpatients
* Be able to provide written consent
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites

This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85 years who have provided written informed consent.
* Patients requiring skin grafting due to burns, trauma or chronic venous ulcers, with a donor site expected to be between 20 and 200 cm2 on a non-articulated area.
* Female patients of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.

Exclusion Criteria:

* Patients with burns involving more than 15% of their total body area.
* Patients with sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery.
* Patients with inhalation injury requiring artificial respiratory assistance.
* Patients requiring skin grafts following removal of suspicious skin lesions.
* Patients who have received treatment with systemic steroids during the 30 days prior to surgery.
* Patients who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to surgery.
* Patients with a history of malignancy in the previous three years.
* Patients with uncontrolled diabetes or diabetic ulcers.
* Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
* Patients who have previously had skin grafts harvested from the area to be studied.
* Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
* Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
* Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Patients undergoing investigations or changes in management for an existing medical condition.
* Patients who are or who become pregnant up to and including Day 0 or who are lactating.
* In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
Effect of Lorcaserin on Cannabis Withdrawal and Self-administration

In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have developed a laboratory model to investigate the effects of potential treatment medications on cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non treatment-seeking cannabis smokers. In this study, the investigators are interested in testing how lorcaserin influences the effects of cannabis in a human laboratory model of cannabis use.

Eligibility Criteria:
Inclusion Criteria:

* Current cannabis use
* Able to give informed consent and perform study procedures
* Women practicing an effective form of birth control
* English speaking

Exclusion Criteria:

* Presence of any clinically significant medical diagnoses
* History of heart disease and cardiac risk factors, severe chronic obstructive pulmonary disease, uncontrolled hypertension, or diabetes
* Current parole or probation
* Certain psychiatric diagnoses
* Current pregnancy or lactation
Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement

The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.

Exclusion Criteria:

* with cervical spine disease
* expected difficult airway
* upper airway abnormalities
* body mass index (BMI) more than 35 kg/m2
* high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation)
* postoperative ventilator care
* surgeries requiring positions other than supine.
The Role of Hydration on Exercise Performance - ODIN

During exercise in the heat, there is a need to replenish fluids in order to avoid dehydration and decrease the risk for heat illness. What drives this urge to drink is the thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before there is a replenishing of fluids. However, there is little scientific evidence of where thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself influence exercise performance. Further, during rehydration studies, it is very difficult to successfully blind a subject to their drinking/hydration protocol. Previous studies that have blinded a subject to their drinking have used various methods such as intravenous fluid administration and/or nasogastric tubes. Therefore, the purpose of this research is to examine the mechanistic roles thirst inhibition plays while exercising in the heat while undergoing intravenous fluid administration. Specific attention will be directed to the cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular, thermoregulatory, and perceptual measures are shown in the diagram below.


Eligibility Criteria:
Inclusion Criteria:

* Cycling Racing History category 3 or higher USA cycling certification
* maximal oxygen uptake \>55 ml/kg/min

Exclusion Criteria:

* History of heat stroke
* Renal, cardiovascular, metabolic diseases
* Regular medication
Assessment of Dental Implants Placed in Posterior Maxillary Ridge Using Densah Burs Versus Standard Drills

comparing the drilling technique of using densah burs osseo densification drills in posterior maxilla with the normal surgical kit drilling

the densification of bone using the densah burs are thought to be improving the bone quality surrounding the implants thus increasing the primary stability and decreasing the marginal bone loss surrounding the implants comparing to the normal drilling techniques using the conventional implant drilling kit

Eligibility Criteria:
Inclusion Criteria:

* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤3.5 width implants.
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement

Exclusion Criteria:

* Sinus pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Sopran - Omeprazole Treatment Versus Surgery

The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment


Eligibility Criteria:
Inclusion Criteria:

* Previous inclusion into Astra study I-635 and willing to continue for another 10 years,

Exclusion Criteria:

* Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.
Stepped Care in the Treatment of Trichotillomania

Trichotillomania (TTM), repetitive pulling out of one's own hair to the extent that noticeable hair loss occurs, is a distressing condition interfering substantially with functioning and quality of life. The longterm objective of this research is to determine whether psychological treatment of TTM could be disseminated more effectively by using a stepped care model in which less intensive interventions are tried first, with more intensive interventions used only if initial treatment proves insufficient. This project is a pilot study of the first two steps in a stepped care model of treatment. After baseline assessment, 50 participants with TTM will be randomly assigned to (a) Immediate condition, in which they are offered 10-week self-help treatment via an interactive website (Step 1) or (b) Wait List/Delayed Start condition, a 10-week wait list prior to being offered Step 1. In each condition, at the end of Step 1, participants will be offered 8 weeks of in-person habit reversal training provided by psychology graduate students (Step 2). TTM symptoms will be measured from baseline through a follow-up 3 months after the end of Step 2, as will depression, anxiety, quality of life, functional impairment , treatment utilization, and treatment satisfaction.

The specific aims of the study are:

1. To gather preliminary data on the efficacy of web-based self-help, compared to wait list control;
2. To characterize the acceptability of stepped care to patients with TTM by assessing the proportion of enrolled participants who proceed from step 1 to step 2 treatment;
3. To evaluate the convergent validity of four decision rules for concluding that a patient with TTM has benefited sufficiently from a treatment step: (a) No longer meeting TTM diagnostic criteria; (b) Showing a 25% or greater reduction in total scores on self-report and clinician-rated TTM symptoms; (c) achieving complete abstinence from hair-pulling; and (d) clinically significant response on both self-report and clinician-rated TTM symptom measures
4. To evaluate the concurrent and predictive validity of criteria for sufficient benefit from a treatment step by relating them to treatment satisfaction, treatment utilization, and scores on a measure of functional impairment from TTM.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* regular internet access
* if taking medications for Trichotillomania, on stable dose for at least 4 weeks
* have trichotillomania (DSM IV criteria except that increasing and decreasing tension with pulling not required)

Exclusion Criteria:

* current suicidality
* current major depression
* current psychosis
* current severe anxiety
* current substance abuse
* current psychotherapy focused on trichotillomania
Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation

The aim of this study is to determine whether or not continuous combined oral contraceptive pills (COCP's) decrease the risk of recurrent endometrioma formation. The investigators' hypothesis is that patients who have endometriomas surgically removed and then are started on COCP's will have a decreased incidence of recurrent endometrioma formation. The investigators' research protocol is designed to show a statistically significant decreased incidence of endometrioma formation in the hopes that physicians will use COCP's in patients they have removed an endometrioma in who do not desire immediate fertility. Long term, the investigators hope to establish a standard of care that COCP's be used postoperatively in appropriate candidates to decrease the chance of recurrent endometrioma formation.

We plan to identify patients planning to undergo conservative surgery for endometrioma at the University of Oklahoma private practice OB/GYN clinic and at the University of Oklahoma Resident Women's clinic. After clear and appropriate consent and discussion regarding options, we plan to randomize patients to monophasic OCPs vs. placebo following surgery. We plan to enroll 35 patients in each arm and follow them for 24 months following the surgery. Surveillance with pelvic exam and transvaginal ultrasonography will occur at 2, 6 and 12 months. The patients surgery will be done prior to enrolling in our study. We will use information from their surgery only to confirm the diagnosis of endometrioma. The only procedure the subjects will undergo during the protocol are periodic transvaginal ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of ovarian endometriotic cyst that has been surgically excited.

Exclusion Criteria:

* Current desire to achieve pregnancy or other contraindication to combined oral contraceptive pills.
Chronic Pain in Children and Adolescents.

Medically unexplained chronic pain - without identifiable somatic origin - is yet an insufficiently known and explored field in children and adolescents by international clinical works. This research aims to characterize somatic, psychological, psychopathological and environmental (particularly attachment styles and family functioning) processes trough an observational study with three pain management centers.

The study concerns children and adolescents from 7 to 17 years old, suffering of medically unexplained chronic pain and their parents who are referred to a pain center. It is composed of a somatic, psychological and family functioning assessment on the one hand and psychopathological and attachment evaluation on the other hand.

Participation in the study involves an additional visit to 1 day pain center to answer questionnaires about anxiety, family environment, depression and psychological testing

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescent with chronic pain no proven medical cause, type of painful somatic complaints within the scope of one of the following diagnoses to ICD-10 (International Classification of Diseases) and DSM-IV and DSM-V (Diagnostic and Statistical Manual of Mental Disorders) to somatoform disorders, distinguishing between :

  * pain disorder
  * somatoform disorder
  * undifferentiated somatoform disorder
* Addressed to the pain centers or in pediatric chronic pain services hosting children.
* being fluently French-speaking and French-reading

Exclusion Criteria:

presence of current or past organic pathology including migraines and epilepsy, which may interfere with somatic expression of studied disorder
School Feeding to Improve Cognitive Performance in Disadvantaged Children

This trial investigated the impact of providing a regular meal with and without additional multiple micronutrients for children in Northwest Pakistan on their performance at school, in comparison to a local government school that served as a control i.e. no school meal.


Eligibility Criteria:
Inclusion Criteria:

* Prep or class 1
* Male/ female

Exclusion Criteria:

* Any contraindicating condition