cyrilzakka/clinical-trials huggingface dataset:
Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial

This study determines the effects of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact of physical activity to manage/controlling diabetes. Some studies were conducted on animals to study the impact of physical activity on diabetic neuropathy and neurogenesis. There is no study on the impact of physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans. This study finds the impact of moderate physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type-II Diabetes
* Diagnosed cases of Peripheral Diabetic Neuropathy
* Peripheral Diabetic Neuropathy Stage 1 \& 2
* Numbness or reduced ability to feel pain or temperature changes.
* Tingling or burning sensation.
* Sharp pains or cramps.
* Increased sensitivity to touch
* Males and females
* Age: 35-65
* HbA1c above 6.5
* Mild activity level on IPAQ-7 (\< 150min/per week)
* Berg Balance Scale score (\< 45)

Exclusion Criteria:

* Cardiac Issues
* Any neurological issue
* Lower limb deformity
* Acute injury
* Hip and Knee OA
* Patients with walking difficulty
* Diabetic foot
Near-Infrared Spectroscopy and Cranial Doppler in Premature Newborns With Anemia

It is aimed in this study to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

Anemia in newborn babies is defined as the mean of hemoglobin values according to postnatal age is below 2 standard deviations. Disruption in tissue perfusion and oxygenation, hyperdynamic cardiac failure, increase in need of oxygen, increase in respiratory effort, inability to be separated from mechanical ventilation, failure to thrive, paleness, increase in frequency of morbidities of prematurity (necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage, etc.) may be seen as a result of progressive anemia. When critical hemoglobin values are reached in premature newborn babies with concomitant disruption of tissue oxygenation, transfusion is performed with erythrocyte suspensions. The main goal here is to correct impaired tissue oxygenation, provide perfusion in sufficient quantity, and prevent anemia-related morbidities. Although frequently applied, there is no consensus in our country and in the world regarding threshold hemoglobin values and supporting parameters for transfusions. As a result, there are no guidelines prepared for newborns based on evidence with clearly defined borders and accepted by everyone. Many countries and centers implement different transfusion protocols based on their experience. Given the risk of oxygen radical damage and associated diseases as a result of erythrocyte transfusions (infections, bone marrow suppression, necrotizing enterocolitis, retinopathy of prematurity, etc.), there is a need to develop new methods for taking and supporting transfusion decision, and to prepare more objective and more accepted guidelines. The origin of our study is the subsequent protective compensation mechanisms after deterioration in brain oxygenation due to symptomatic anemia in premature newborn babies. For these reasons, it is aimed to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

Premature babies less than 32 gestational weeks or less than 1500 grams of birth weight and Documented anemia in postnatal 28 days according to Turkish Neonatal Society guidelines

Exclusion Criteria:

Babies older than postnatal 28 days Major congenital anomalies Chromosomal anomalies Inborn errors of metabolism Hypoxic ischemic encephalopathy Disseminated intravascular coagulation Unstable hemodynamic status Severe neonatal sepsis Patients who are not volunteered to participate
Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females between Age 18 and 80 years.
* Type 2 diabetes mellitus (as guideline WHO, 1999);
* Body mass index (BMI)≤35㎏/㎡;
* Fast blood glucose (FBG)≥7.0 mmol/L, and Hemoglobin A1c (HgbA1c)≥7％;
* Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. If patients have tested positive, they will be consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mmHg or \>180mmHg
* Resting heart rate \> 100 bpm;
* Active clinical infection within one week of enrollment.
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
The Effect of Mirror Therapy in Patients With Frozen Shoulder

The aim of this study compares mirror therapy and visual feedback treatment with the control group in frozen shoulder patients.

Thirty-six individuals divided three groups as mirror therapy, visual feedback, and control groups were included in the study for 15 sessions of treatment. All individuals received basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack, stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises. The mirror group bilateral exercised with an affected arm behind the mirror; visual feedback group bilateral exercised by seeing both arms in the mirror; control group bilateral exercised without a mirror for 10 minutes after every session. Pain severity was evaluated with the "Visual Analogue Scale (VAS)", ROM and proprioception were measured with a universal goniometer, and functional status was evaluated with "shoulder pain and disability index (SPADI)" and "Modified Constant Score". Evaluations were made before, day after the treatment and 4 weeks after the treatment by the same researcher. Data analysis was performed with SPSS.23.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were diagnosed with "Unilateral Frozen Shoulder" by the specialist;
* Normal radiological imaging;
* Aged between 18-75 years old;
* Symptoms persist for 2-12 months.

Exclusion Criteria:

* If patients had following comorbidities: rotator cuff injury, cervical radiculopathy, romatological diseases, neurological diseases, fracture, tumour, congenital deformities, dislocation or sublocation, surgery in the shoulder, uncontrolled hypertension or diabetes mellitus;
* Pregnancy;
* Patients who had previously received physical therapy;
* Patients having problems in the perception of tests and exercises were excluded from this study
COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY)

PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.

The investigators will recruit women age 13 or older under investigation for COVID-19 or with confirmed COVID-19 at any clinical state across the United States. Eligible participants will be identified through voluntary physician referrals.

When an eligible patient is referred to the PRIORITY Coordinating Center at UCSF, a UCSF study coordinator will follow-up by phone with the patient and consent verbally. The participant will be asked to complete an approval to release medical information. The investigators will use patient questionnaires to assess symptoms, maternal clinical course, pregnancy outcomes, and neonatal outcomes from initial investigation of COVID-19 to 12 months. The investigators will also obtain all medical records for the participant to data abstract key clinical and pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women or women who have been pregnant within the last 6 weeks
2. Able to give informed consent
3. Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under investigation") since January 1, 2020

Exclusion Criteria:

1. \<13 years of age.
Evaluating Interventions for Intimate Partner Violence Use in Washington State

Intimate partner violence (IPV), specifically physical and psychological aggression toward an intimate partner, represents a public health crisis that affects millions of Americans each year. There currently exists very little evidence from randomized controlled trials for the effectiveness of abuser intervention programs designed to prevent and end perpetration of IPV in the general population. This is troubling considering that approximately half a million men and women are court-mandated to these programs each year.

The investigators will conduct a randomized control trial (RCT) investigating the efficacy of the Strength at Home (SAH) intervention in reducing intimate partner violence (IPV). The overarching aim of this study is to test the efficacy of SAH with court-involved-partner-violent men through an RCT comparing those who receive SAH with those who receive other standard IPV interventions offered in the state of Washington (treatment as usual- TAU).

The specific aims are:

1.1: Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). It is expected that greater reductions in IPV frequencies will be evidenced in SAH than TAU over the course of the year.

1.2: Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants. It is expected that greater reductions in these symptoms will be evidenced in SAH than TAU over the course of the year.

1.3: Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5). It is expected that treatment satisfaction will be higher in SAH than TAU.


Eligibility Criteria:
Inclusion Criteria:

Men:

1. Identify as a man
2. Provide consent for the research team to contact his intimate partner(s) for data collection purposes;
3. Court-referred for IPV intervention in Washington state

Women:

1. Identify as a woman
2. Were or currently are an intimate partner involved in an incident of IPV with a court-referred participant

Exclusion Criteria:

1. demonstrates active psychosis that may interfere with their ability to participate in group
2. expresses prominent suicidal or homicidal ideation that requires hospitalization
3. does not possess proficiency in spoken English
4. periods of incarceration after study enrollment
Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage

The primary aim of the current research project is to answer the question, whether plasma trimethylamine N-oxide (TMAO) level may be used as a marker of ischemic changes in the brain. TMAO is associated with endothelial dysfunction, inflammation and oxidative stress.

The hypothesis is that circulating TMAO level may predict leukoaraiosis (LA) and/or stroke.

Secondary, the investigators would like to examine whether plasma TMAO concentration is related to cognitive impairment and determine whether choline consumption is associated with an incidence of LA severity and dementia.

In the study, subjects will be recruited in the hospital among the patients with brain MRI performed within past 4 weeks. All MRI scans will be reviewed by the neurologist to evaluate ischemic changes. Upon detection of LA, patients (n=150) will be informed about the study aims. In the same time, aged- and sex-matched control group (n=150) with no detected ischemic changes will be recruited.

In each group, the blood samples will be collected, to determine the concentration of plasma TMAO, oxidative stress markers, as well as serum endothelial dysfunction markers and biochemical parameters. To determine the cognitive performance psychological test will be carried out. The diet of all recruited participants, with special consideration on the choline-rich products and supplements, will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* the ischemic changes in the brain (diagnosed by neurologist by MRI scans)

Exclusion Criteria:

* no ischemic changes in the brain (diagnosed by neurologist by MRI scans)
Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with AML through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Besides, patients should meet the following conditions:

   Patients aged 60-80 who newly diagnosed AML with WHO criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte).

   Patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation;
2. Gender and race are not limited;
3. Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
4. Expected survival time ≥ 3 months;
5. The examination results meet the following requirements:

   ALT and AST ≤ 3 × Upper limit of normal value (ULN); Total bilirubin ≤ 3 × ULN; Creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 40mL/min; The left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scanning is within the normal range (\>50%);
6. The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
7. Patients who voluntarily participate in this clinical study and have signed an informed consent.

Exclusion Criteria:

1. Patients who have suffered from malignant tumors;
2. Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
3. Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
4. Suffering from life-threatening diseases other than AML;
5. Allergic to the drugs in the research;
6. Patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease;
7. Patients with test positive for HIV, HCV or HBV;
8. Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
9. Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
10. Patients with mental illnesses or cognitive impairments;
11. Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;
12. There are other conditions that the investigators consider inappropriate for inclusion.
Evaluation of the Effect of an Emergency Department Information Video on the Risk of Post-Traumatic Stress Disorder 30 Days After an Emergency Visit.

Post-traumatic stress disorder (PTSD) is a psychological disorder characterized by the re-experiencing of distressing symptoms, avoidance of traumatic memories and physiological hyperarousal in people who have been exposed to a traumatic event. The consequences of PTSD are manifold: financial, quality of life, absenteeism, morbidity, and mortality.

An emergency department visit can be a traumatic event and associated with anxiety.

Studies have explored the prevalence and factors associated with the occurrence of PTSD among a selected population of patients admitted to the emergency department for either cardiological or traumatological reasons. The prevalence of PTSD at 1 month varied among these populations, from 12% to 25%.

Several factors have been described that could be independently associated with an increased risk of developing PTSD: factors linked to the patient himself (basal state and severity of acute pathology) or to the patient pathway (care structure, care modalities, waiting time). Given the serious medical, psycho-social and economic consequences of PTSD, it is important to identify the risk factors that can be controlled during a patient's stay in the emergency department.

In 2025, a general information procedure for patients and next of kin will be deployed in three emergency departments.

The aim of this procedure is to improve the quality of the information provided to emergency patients, thereby enhancing the experience of patients and those accompanying them. It will consist of video support delivering standardized information to patients from the moment they arrive in the emergency department until they are discharged. These videos will describe the patient's journey through the emergency department.

The aim of this study is to evaluate the effect of this information procedure on the risk of developing PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Triage level 1, 2, 3 by the triage nurse (according to CIMU, FRENCH or other scale used locally)
* Non-opposition to participation in the study after information and delivery of the information note
* Possibility of 30-day follow-up (self-questionnaire to be completed by e-mail)
* Patient with cognitive or sensory capacity to view and understand information videos

Exclusion Criteria :

* Inability to consent (neurological disorder, coma, acute intoxication, cognitive impairment)
* Patient does not have a good understanding of the French language.
* Estimated life expectancy less than 6 months
* Participation in other clinical intervention research
Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome

Our study purpose is to evaluate the predictive power of various clinical, neurophysiological, and neuroimaging biomarkers-acquired and analyzed using advanced and integrated techniques-on motor functional recovery and disability post-stroke. The goal is to construct an integrated individual biomarker algorithm with a high predictive value for outcomes.

Ability to predict post-stroke individual recovery still represents an important challenge to develop personalized and effective neurorehabilitation strategies. The aim of this study is to verify the predictive power of different clinical, neurophysiological and neuroimaging biomarkers in combination, acquired and analysed using advanced, integrated techniques, on functional motor recovery and post-stroke disability.

Patients with ischemic or hemorrhagic stroke and hemiparesis are subsequently enrolled and undergo multimodal assessment that includes measures spanning 4 assessment categories: demographic/medical history, clinical biomarkers, neurophysiological biomarkers (Motor Evoked Potentials, High-density EEG), neuroimaging biomarkers (infarct volume, corticospinal tract injury) at T0 (from 14 to 30 days post-stroke), T1 (after 2 months of intensive rehabilitation treatment) and T2 (4-6 months after discharge). Primary endpoint is change in arm Fugl-Meyer score. Secondary endpoints are changes in lower limb Fugl Meyer motor, Nine hole peg test, National Institute of Health Stroke Scale, mRS Rankin Scale, modified Barthel Index scores.

Multivariate analyses will indicate which biomarkers at baseline have the greatest value to predict significant changes in primary and secondary endpoints at T1 and T2.

A model incorporating measures of clinical, neurophysiological and neuroimaging biomarkers could best predict individual treatment-induced behavioral gains and therefore allow to plan a "tailor-made" rehabilitation project, select rehabilitation therapy, appropriate allocation of time and human resources and stratify clinical trial enrollees.

Eligibility Criteria:
Inclusion Criteria:

* First stroke in the middle cerebral artery territory.
* Ischemic or hemorrhagic stroke (7-30 days post-acute event).
* Upper limb plegia or paresis.
* Both genders, aged \>18 years.
* Ability to provide informed consent by the patient or caregiver/responsible relative.

Exclusion Criteria:

* Previous stroke.
* Stroke in territories other than the middle cerebral artery.
* Inability to provide informed consent.
* Contraindications to TMS or MRI.
* History of cancer in the past two years.
* Presence of other neurological conditions interfering with biomarkers