cyrilzakka/clinical-trials huggingface dataset:
Thrust Manipulation Versus Non-Thrust Manipulation

The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.

Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.
* For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.

Exclusion Criteria:

* The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
* Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°
* Muscle weakness involving a major muscle group of the lower extremity,
* Diminished lower extremity muscle stretch reflex
* Diminished or absent sensation to pinprick in any lower extremity dermatome)
* Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy
Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Model 4196 LV lead complication-free survivability will be summarized.

Eligibility Criteria:
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive an Attain Ability Model 4196 LV lead
* Patient within 30 day post implant enrollment window

Exclusion Criteria

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin


Eligibility Criteria:
Inclusion Criteria:

* Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
* Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
* HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard)

Exclusion Criteria:

* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy

The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and preoperative bevacizumab injection. Bevacizumab(Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative intravitreal bevacizumab (IVB) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.

To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative IVB injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment)

Exclusion Criteria:

* Follow-up period of less than 6 months
* Intraoperative use of long-acting gas or silicone oil
* Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage
* Not first vitrectomy
* Uncontrolled hypertension
* Medical history of abnormal blood coagulation
* Time interval between IVB injection and PPV longer than 2 weeks and recent history (within 3 months) of IVB treatment
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed BV according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

Adult, post-menarchal, pre-menopausal women aged 18 years or older

* Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:

  1. Thin, white, yellow, homogenous discharge
  2. Clue cells on microscopy (more than 20 percent of epithelial cells)
  3. pH of vaginal fluid above 4.5
  4. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
* Having decisional capacity and providing written informed consent
* Negative urine pregnancy test at screening
* Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
* Refrain from sexual intercourse or use a condom until Day 7
* Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening

* Anticipated menstruation during the treatment period (Day 0 till Day 7)
* Patients who are pregnant or breastfeeding
* Patients who were treated for BV within the past 14 days
* Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
* Patients who have used pH-modifying vaginal products within the last 14 days
* Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
* Known/previous allergy or hypersensitivity to any product constituent
* Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion
Virtual Coach for Mindfulness Meditation Training

Evaluate the effectiveness of using a virtual computer coach to provide mindfulness meditation training, and the coaching support required to initiate a regular practice.


Eligibility Criteria:
Inclusion Criteria:

* over 18, no previous mindfulness experience, computer literacy

Exclusion Criteria:

* substance abuse, anxiety/depression, psychosis
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects, 18 years or older
* Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
* Subjects who have been implanted between January 2016 and December 2021.
* Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.
* Subjects who are fluent in French (language used in the questionnaire and speech tests)
* Subjects who are not opposed to participating in the study
* Subjects for who the medical record data is available throughout the defined data search period.

Exclusion Criteria:

* Subjects with single-sided deafness (SSD).
* Subjects who are not affiliated to the French Social Security.
* Subjects who are under legal protection.
Improving Depression Management Through Peer Support

We conducted a randomized controlled trial (RCT) that compared the effectiveness of a telephone delivered, recovery focused, peer-support intervention to enhanced usual care for VA patients with depression.

Peer-support interventions have been recommended by prestigious national task forces and incorporated into the VA Comprehensive Mental Health Strategic Plan. Patients who cope with longer term depressive symptoms may benefit from these interventions.This study examines the effectiveness of a feasible, scalable mutual peer-support intervention for VA patients in depression treatment and will inform leaders who are considering implementing peer-support initiatives.

In this study, each study participant (a veteran in treatment for depression) was matched with another participating veteran and the pairs were randomized to enhanced usual care or to the telephone based peer-support intervention (DIAL-UP). All study participants received usual care plus written materials outlining depression self-management strategies, behavioral activation, and recovery.

DIAL-UP participants also received: a) a peer-support manual that outlined peer support principles and provided peer discussion topics and b) access to a specialized telephone platform that permited free calls to their partners, ready access to mental health staff for back-up and advice, and recorded tips on depression management. Patients were encouraged to call their partners at least once per week during the 6-month intervention period. Patient outcomes were assessed at 3, 6, and 12 months following enrollment.

Eligibility Criteria:
Inclusion Criteria:

* currently in treatment at Ann Arbor, Detroit, Battle Creek, or Saginaw VA or their associated community based outpatient clinics
* not receiving formal mental health services or regularly attending mutual self-help programs outside of the VA
* diagnosis of a depressive disorder in the last 24 months that is confirmed by the relevant clinician
* being seen less than bi-weekly by clinicians for psychiatric or substance use disorders
* past trial of psychotherapy and/or antidepressant trial
* have a current PHQ-9 scores \> 10 or WSAS scores \> 10
* have stable access to and ability to communicate by telephone

Exclusion Criteria:

* diagnosis of schizophrenia, schizoaffective disorder, MDD with psychotic features, or Bipolar I in the past 24 months. Diagnosis of active substance dependence in the past 12 months or substance abuse in the last 6 months
* an immediate risk of suicide, requiring hospitalization or urgent evaluation
* clinician assessment that participation in the study could have an adverse impact on the patient or his/her partner.
Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus

The aim of this study was to assess the value of an unusual relative position of the superior mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of volvulus.

First, feasibility study was done to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.

A systematic screening of the mesenteric vessels position was performed at each pregnancy required ultrasound.

When the fœtus had an unusual position of the mesenteric vessels, an MRI was suggested between 30 and 35 GA and the couple met the pediatric surgery team.

Few days after birth, an abdominal ultrasound was achieved as well as a barium enema and upper gastrointestinal. If there were a hight probability of malrotation with a higher risk of volvulus, a prophylactic surgery was proposed. The children were flollowed up during 1 year.


Eligibility Criteria:
Inclusion criteria:

* pregnant women
* second or third trimester ultrasound.

Exclusion criteria:

* fœtal ultrasound anomaly
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols

The substantial range of individual responsiveness to plant sterols has important ramifications. Marked differences across individuals in particular aspects of the cholesterol metabolic pathway must alter the impact of plant sterol consumption. As such, a pronounced need exists to understand the genetic and metabolic factors that explain the substantial degree of heterogeneity in response of lipid concentrations to plant sterols across individuals. The primary focus of this trial is to delineate the impact of differing cholesterol synthesis levels on response of LDL-C and other plasma lipids to plant sterol consumption. Participants pre-identified as high or low endogenous cholesterol synthesizers, according to their screening level of lathosterol to cholesterol ratios, will be given PS or a placebo containing margarine to consume under supervision for 4 weeks in a crossover design. The trial will characterize the responsiveness of the participants' total, LDL, and HDL cholesterol, as well as triacylglycerol (TG) concentrations, to plant sterol consumption. This research will determine if cholesterol synthesis phenotype predicts the responsiveness of lipids to plant sterol consumption. Variations in candidate genes involved in cholesterol metabolism will also be investigated in order to find associations with both cholesterol metabolism phenotypes and responsiveness of lipids to plant sterols. The output of this research will be to advance the knowledge of which genetic factors influence the degree of cardiovascular benefit derived from plant sterols through lipid lowering.


Eligibility Criteria:
Inclusion Criteria:

* fasting serum LDL cholesterol \>3.0 mmol/L
* high or low lathosterol to cholesterol ratio

Exclusion Criteria:

* smoking
* use of lipid lowering therapy
* documented cardiovascular/atherosclerotic disease
* inflammatory disease
* diabetes
* uncontrolled hypertension
* kidney disease
* liver disease
* other systemic diseases
* cancer
* chronic alcohol consumption (\> 2 servings/day)
Preoperative Anxiety During COVID-19

The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al, will be used after permission from the authors, to investigate the preoperative anxiety of patients undergoing surgery during the 4th wave of the pandemic

Studies have been conducted on the stress and anxiety induced by the COVID-19 pandemic in both the general population as well as specific groups, such as health care workers, pregnant women and adolescents. Given that anxiety has a strong bearing on the physical, mental and emotional well-being of the patients and their subsequent recovery from surgery and other procedures, we were interested in assessing anxiety among the patients presenting for elective procedures in the post-lockdown phase of the pandemic. The primary objective of the present study was to assess the anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic, and the secondary objective was to assess the factors accentuating the same. The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al will be used after permission from the authors.

Eligibility Criteria:
Inclusion Criteria:

* Adult consecutive patients, \>18 years old
* Undergoing surgery in the UHL

Exclusion Criteria:

* Patients aged\<18 years
* Patients that will refuse to participate
* Patients unable/not fit to consent
Impact of Psychological Therapies on Emergency Medical Patients

Prevalence of anxiety and depression in the general population is known, but is under researched in the acute hospital setting and there is little evidence on the prevalence of anxiety and depression within the emergency medical admission population. A potential intervention for treating such mental health prevalence would be in the form of IAPT methodology which has been utilised in other parts of the NHS demonstrating good outcomes. Therefore, this feasibility study will explore the utility of IAPT in the acute setting.

This study will explore the prevalence of anxiety and depression in the emergency medical population within medical inpatient wards , utilising the assessment tools adopted by the IAPT services and explained in detail below.

The study will explore a) feasibility of introducing psychological intervention to an emergency medical ward and b) provide preliminary data on the outcome of this intervention on hospital length of stay and readmission rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Ipswich Hospital into a ward that cares for patients who are medical emergencies.
* Patients who score 3 or higher on one or both of the GAD 2 and PHQ 2.
* Patients that have capacity to consent.
* Over 18 years old.
* Ability to speak and read in English as the study will not have the resources to employ interpreters or to get documentation translated.
* Participants that are not deemed suicidal via screening and medical and nurse assessment.

Exclusion Criteria:

* Patients not receiving care on a ward caring for medical emergencies.
* Patients under the age of 18 years old.
* Patients scoring \< 3 on both GAD 2 and PHQ 2.
* Patients who do not have capacity to consent.
* Participants that are suicidal as via screening and medical and nurse assessment.
Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke

The purpose of this study is to investigate effects of tDCS stimulation in the left primary motor area followed by naming therapy to improve language functions in patients with aphasia in the sub-acute stage.

Transcranial Direct Current Stimulation (tDCS) is a simple and non-intrusive method that has demonstrated promising results in language rehabilitation of patients with aphasia. Various studies have used different stimulation set-ups, some based on prior structural and functional brain mapping in order to choose the optimal stimulation region. An additional approach that was found beneficial is stimulation of the left primary motor area (M1). A major advantage of this approach is its relative simplicity that may increase the application of this intervention in clinical settings. This intervention approach has been studied in patients with chronic aphasia and targeted on naming ability. In the current study the investigators aim to study the influence of a stimulation set-up at M1 in stroke patients suffering from aphasia that are in the sub-acute stage. In addition the investigators aim to study additional language functions including pragmatics and grammar. The study will include 30 patients suffering from aphasia which are in the sub-acute stage. The patients will undergo complete language assessments at 3 time points: baseline, post intervention (third week from recruitment) and one month follow-up. The study group will include 15 patients that will undergo TDCS at the left M1 region followed by naming therapy. The intervention will be given daily for duration of two weeks (5 days/week). The control group will include 15 patients that will undergo the same protocol apart from sham TDCS. The effect of the intervention will be examined taking into account the extent and location of the brain damage on language functions.

Eligibility Criteria:
Inclusion Criteria:

* patients post stroke with right hemiplegia and aphasia with cognitive capacity to understand instructions and at the aphasia cut-of level defined by "SHEMESH" assessment

Exclusion Criteria:

* unstable clinical state, craniotomy, epilepsy, heart pacer or lack of cooperation