cyrilzakka/clinical-trials huggingface dataset:
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is:

- What is the difference is the major amputation rate between the study arms?

Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.

Objective: The primary objective is to assess the (cost-) effectiveness of HBOT in addition to standard wound care and vascular surgical treatment for patients with a DFU and leg ischaemia.

Study design: An international, multi-arm multi-stage (MAMS) design is chosen to conduct an efficient randomised clinical trial. At a planned interim analysis the best performing study arm(s) will be chosen to continue.

Study population: We need up to 544 patients with a Meggitt-Wagner stage 3 or 4 DFU and proven peripheral ischaemia.

Intervention: Patients will be randomised to receive standard care (wound treatment and surgical interventions following international guidelines) with either 0, 20, 30 or at least 40 sessions of HBOT. These sessions will compromise 90-120 minutes of HBOT at a pressure of 2.2-2.5 ATA according to international standards.

Main study parameters/endpoints: The primary endpoint is major amputation rate after 12 months. Secondary objectives are amputation-free survival, wound healing, health-related quality of life and cost-effectiveness of the interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Type I or II diabetes
2. One or more deep and clinically infected lower extremity ulcers, classified as Meggitt-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W\>1, I\>1 and fI\>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
3. Leg ischaemia, characterized by a highest ankle systolic blood pressure \< 70 mmHg, or a toe systolic pressure \< 50 mmHg or a TcpO2 \< 40 mmHg
4. Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
5. Patients have to be discussed in, and included after a multidisciplinary consultation.
6. Adults
7. Written informed consent

Exclusion Criteria:

1. Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
2. Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
3. End-stage renal disease requiring dialysis
4. Metastasized malignancy
5. Left ventricular failure with ejection fraction (EF) \<20% or external pacemaker
6. Recent thoracic surgery or middle ear surgery
7. Severe epilepsy
8. Uncontrollable high fever
9. Pregnancy
10. Insufficient proficiency of local language/English, or inability to complete the questionnaires
fMRI of Language Recovery Following Stroke in Adults

The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.

Aphasia (difficulty speaking) is one of the most dreaded consequences of stroke. It is associated with high mortality and severe motor, social, and cognitive disability. During the past decade, therapies administered by stroke teams have made great strides in limiting the damage due to a stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. Evidence suggests that the brain may have untapped potential for recovery of aphasia after stroke.

Using functional magnetic resonance imaging (fMRI), researchers now are able to examine the areas of the brain that are responsible for language recovery after stroke. Such data may explain how the brain recovers after stroke, and may lead to new therapies to help individuals who have suffered an aphasia-causing stroke.

In this study, researchers will examine the changes the brain undergoes while recovering from an aphasia-causing stroke and the mechanisms that underlie such recovery, and test the effectiveness of a new and promising method of aphasia rehabilitation called constraint-induced aphasia therapy (CIAT). The scientists will perform fMRI studies of brain activation in people who have suffered an aphasia-causing stroke in order to better understand the underlying mechanisms of recovery from aphasia. Specifically the researchers will compare language activation between adults with stroke and children with perinatal and postnatal stroke (from previous studies); map changes in language activation, characterize the patterns of language reorganization that occur following stroke; and use the fMRI measures to assess recovery using CIAT.

The study will last one year, during this time participants will have language testing to evaluate the degree of aphasia and its recovery; and five fMRI scans scheduled at 2 weeks, 6 weeks, 12 weeks, 26 weeks, and 56 weeks. Participants with remaining moderate aphasia will be offered a chance to participate in an extension treatment study that will last up to 3 months (STUDY).

A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.

Eligibility Criteria:
Inclusion Criteria:

* MCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
* Moderate aphasia (Token Test score between 40th and 90th percentile)
* Written informed consent by the patient or the next of kin

Exclusion Criteria:

* Underlying degenerative or metabolic disorder or supervening medical illness
* Severe depression or other psychiatric disorder
* Pregnancy
* Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention

The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) which is an internet-accessible cross-platform that includes additional implementation support strategies to increase the reach, effectiveness, and implementation of an evidence-based breast and cervical cancer screening and HPV vaccination program for Latinas (SEMM).

This study tests a multicomponent and multifaceted implementation strategy, SEMM-DIA and serves as a model for developing other implementation strategies designed to build the capacity of clinic leadership, intervention champions, and LHWs to plan, manage, and deliver SEMM. Investigators will examine the effect of SEMM-DIA program implementation in a randomized group trial comparing the impact of SEMM-DIA vs. SEMM- Usual Implementation Practice on the reach, effectiveness, implementation, and cost-effectiveness of SEMM in safety-net clinics.

Eligibility Criteria:
Inclusion Criteria:

Organization inclusion criteria:

* Clinic or community health center (CHC) with LHWs serving Latina populations.
* Expressed intent to participate in the implementation of SEMM.
* Serve low-income populations with low or no-cost screening and vaccination.
* Provide comprehensive primary health care services.

SEMM Participant Inclusion criteria:

* Latinas who self-identify as Hispanic/Latina.
* Latinas who have at least one unmet breast or cervical cancer prevention need, following Electronic Clinical Quality Measures.
* (1) Latinas aged 21-64 years who have not had a Pap test in the past 3 years, and (2) Latinas aged 30-64 who have not had a HPV test in the past 5 years (CMS eCQM ID: CMS124v9).
* (3) Latinas aged 51-74 years who have not had a mammogram in the past 2 years (CMS eCQM ID: CMS125v9).
* (4) Latinas aged 18-26 years who have not initiated HPV vaccination.

  * Note: Some women will have more than one unmet need (e.g., HPV vaccination and pap test), so they will be included in more than one non-adherent group.

Exclusion Criteria:

Organization exclusion criteria:

- Clinics/Community Health Centers not located in Texas.

SEMM Participant Exclusion criteria:

- Latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.
Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital

Aim of the study was to assess the quality of sleep among adult patients, to explore the perceived sleep distractors among adult patients, to determine the relationship between quality of sleep and perceived sleep distractors score among adult patients.

and to determine the association of quality of sleep and perceived sleep distractors score among adult patients with selected variables.

A total of 150 adult patients were selected from surgical, orthopedic and medical wards to participate in the study 50 patients from each ward. All the adult patients were selected using convenience sampling technique. Self-introduction and establishing rapport with the subjects was done. Purpose of the study was explained to the subjects, the confidentially of their responses was assured, and informed consent was taken prior to the study. The data was collected by Modified Pittsburgh Sleep Quality Index and Structured Perceived Sleep Distractors Performa.

Eligibility Criteria:
Inclusion Criteria:

The study includes adult patients who were:

* between age group of 18-65 years
* hospitalized minimum for 7 days.
* willing to participate in the study.
* present at the time of data collection.

Exclusion Criteria:Adult patients who were not:

* alert and oriented.
Green Light and Transcranial Direct Current Stimulation in Migraine Patients

There is a lack of evidence on the clinical outcome of green light exposure, as it is the emerging, novel proposal of treatment. There are a lot of researches present with small sample size which should be done on large population. In last conducted studies, session numbers of the applied modality are less. There is no comparison of tDCS with green light for migraine. The literature suggested the neuromodulation influenced by these interventions that may result in reduction of migraine.

Migraine treatments encompass both medicinal options, such as acute and preventive medications, as well as a variety of non-pharmacological therapies. The range of acute medications that are available can be categorized into four different treatment approaches for treating mild to moderate-severity attacks, which involve the use of acetaminophen and/or NSAIDs. For patients experiencing severe attacks or those who do not respond to the initial strategy, a triptan-based strategy is recommended. According to the American Academy of Neurology (AAN), there is strong supporting evidence for the effectiveness of several medications in preventing migraines, including metoprolol, timolol, propranolol, divalproex sodium, sodium valproate, and topiramate. There are some non-pharmacological approaches present like non-invasive and invasive neuromodulation. In non-invasive treatment, transcutaneous cranial nerve stimulation, vagus nerve stimulation, single-pulse transcranial magnetic stimulation (sTMS), transcranial direct current stimulation (tDCS), percutaneous mastoid stimulation and non-painful brachial electric stimulation are involved. In invasive neuromodulation, occipital nerve stimulation, sphenopalatine ganglion stimulation, and high cervical spine cord stimulation are involved.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria established by the International Headache Society,
* patient must have had at least 5 headache attacks that lasted 4-72 hours (untreated or unsuccessfully treated)
* headache must have had at least 2 of the following characteristic; Unilateral location \& Pulsating quality,
* An average headache pain intensity of migraine episodes of ≥5 at numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study.

Exclusion Criteria:

* Mental illness,
* Photophobic individual,
* Presence of shunt and/or implant at the cranial region,
* Brain tumors,
* Wound at skull
Encouragement-induced Movement Therapy in Daily Life

Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.

The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.

ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
* Ability to lift arm against gravity (\>30 degrees flexion or abduction)
* Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
* Ability to give informed consent as documented by signature

Exclusion Criteria:

* Major untreated depression
* Severe cognitive impairment
* Suffering from comprehensive aphasia
* Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
* Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
* Expected hospitalization during study period
* Known intolerance to device material
* Known or suspected non-compliance, drug or alcohol abuse
* The investigator, his/her family members, employees, and other dependent persons
Prevention Strategies for Adolescents at Risk of Diabetes

The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk assessment tool to identify those children with chronic disease risk factors (including Type 2 Diabetes).

Data will be collected in 5 European Commission countries (500 adolescents in total). A range of biological and lifestyle measures will be collected in order to investigate the adolescent's lifestyle and will include body weight and other anthropometric measurements, blood pressure, blood capillary sample, self-reported physical activity, sedentary behaviour and dietary habits. Their parent/guardian will complete a number of questions to gather information about variables that have been associated with chronic disease (including type 2 diabetes) and include peri-natal history (birth weight, gestational diabetes), socioeconomic status, family health and medical history.

A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future has been developed systematic review results and a Delphi procedure. This draft tool will be evaluated and refined. This draft risk tool will be evaluated by independent clinical reviewers against the data collected from the 500 adolescent data sets. The results for each adolescent will be independently reviewed by clinicians who will assign either a "lower" or "higher" risk to each case. The results will be compared to the results from the draft 'PRE-START tool', used to further refine this identification tool using appropriate statistical methods.

The outputs of this study will be a fit for purpose 'PRE-STARt tool' that can be used for recruitment to interventional studies whose primary objective is to reduce the risk of developing chronic disease (including type 2 diabetes) in the future.

Eligibility Criteria:
Inclusion Criteria:

* Young people aged between 12-14 years of age
* be willing and able to give assent
* have obtained written parent/guardian consent.

Exclusion Criteria:

* are outside the age range of interest (i.e. aged less than 12 years or greater than 14 years of age)
* do not have parental consent or do not give assent
* have an existing diagnosis of type 1 or type 2 diabetes
The LODOCO STINT Pilot Study

Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.

This study will test the effects of LODOCO in those who have previously been identified as statin intolerant, meaning they are unable to continue taking statins because of side effects. The primary objective of this study is to evaluate the safety and efficacy of low-dose colchicine (LODOCO) in subjects with statin intolerance. Safety will be assessed by monitoring the incidence of adverse events from baseline to four weeks. Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline to four weeks..

Eligibility Criteria:
Inclusion Criteria:

* History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction
* Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month
* Patients able to provide informed consent.
* Aged 18 to 80 will be enrolled in the study.

Exclusion Criteria:

* Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.
* Renal impairment (eGFR \<45 mL/min/1.73 m2)
* Transaminitis (ALT or AST \>3 times upper limit of normal)
* Cirrhosis
* Severe Heart Failure
* Active cancer or currently on chemotherapy
* Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies
* Active infection
* Autoimmune or inflammatory condition
* Pregnancy or breastfeeding.
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract

This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.

2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.

The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore，the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.

In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.

Eligibility Criteria:
Inclusion Criteria:

* Aged-related cataract patients between 65 and 90 years ;
* Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
* Scheduled for phacoemulsification combined with intraocular lens implantation.
* The number of corneal endothelial cells \> 1500cells/mm2.
* Dilated pupil diameter ≥6mm

Exclusion Criteria:

* A history of ophthalmic trauma or surgery;
* Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
* Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has diagnosis of schizophrenia for at least 2 years
* Subject has persistent predominant negative symptoms
* Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
* Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
* Subject has been clinically stable and is in the non-acute phase of illness

Exclusion Criteria:

* Subject has clinically notable positive symptoms
* Subject is considered to be treatment refractory
* Subject has current history of substance abuse/dependance
* Subject is considered a suicide risk or risk to harm others