cyrilzakka/clinical-trials huggingface dataset:
Investigating Therapies for Freezing of Gait

Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG. Participants in this study will undergo all three types of treatments in a randomized counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.

Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD), and negatively impacts quality of life (Walton et al., 2015). Furthermore, advanced FOG does not respond well to treatments commonly used in Parkinson's disease (Nutt et al., 2011), therefore warranting the use of adjunct treatment options. The development of potential treatment strategies for FOG should focus on the underlying mechanism. The cross-talk model of FOG proposes that FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to FOG (Lewis \& Barker, 2009). Hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in FOG episodes. Previous studies have demonstrated the efficacy of therapies targeting these domains in PD and healthy individuals, however, these have yet to be explored in FOG. Therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with FOG.

This study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. Sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. Participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. The cognitive training will utilize the "Smartbrain Pro" computer software, which has previously demonstrated efficacy in individuals with Parkinson's disease (Paris et al., 2011). The sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. This training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). The limbic training group will undergo cognitive behavioural therapy (CBT) focusing solely on anxiety symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Either gender
* Diagnosed with idiopathic PD by a Neurologist
* Self-reported FOG with the use of UPDRS-II (Question 14)
* Confirmation of present FOG by a movement disorder specialist
* Able to walk 10 meters, unassisted
* Able to understand English instructions

Exclusion Criteria:

* A neurological disease other than PD
* Peripheral neuropathy
* Clinically diagnosed with dementia
Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Have unipolar depressive episode based on the MINI with or without psychotic symptoms
* Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of a consultant brain stimulation psychiatrist
* Are over the age of 18
* Pass the TMS adult safety screening (TASS) questionnaire
* Are voluntary and competent to consent to treatment

Exclusion Criteria:

* Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month
* Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder
* Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes
* have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
* currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
* Lack of response to accelerated course of iTBS or rTMS in the past
A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to Humalog®Mix 75/25 in patients with type 2 diabetes.

BIOD-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.

Eligibility Criteria:
Inclusion Criteria:

* Established clinical diagnosis of type 2 diabetes, consistent with ADA classification criteria for 6 months or longer.
* Body Mass Index 27 - 45 kg/square meter, inclusive.
* Screening HbA1c between 7.5 and 11.0%, inclusive.
* Up to two injections per day of U-100 basal (NPH, glargine, or detemir), pre-mixed, or self-mixed basal/prandial insulins or insulin analogs at stable total daily doses between 40 -200 units/day, inclusive, for ≥ 3 months prior to screening.

Exclusion Criteria:

* Regular use of Humulin®R U-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening.
* History of bariatric surgery.
* Subject has had one or more severe hypoglycemic episodes associated with seizure, coma, or unconsciousness within the past 6 months.
* History of known hypersensitivity to any of the components in the study medication.
* New York Heart Association (NYHA) Class III or IV functional capacity, unstable angina pectoris, myocardial infarction, severe peripheral vascular disease, ischemic strokes or transient ischemic attacks within 6 months of screening.
* Systolic blood pressure ≥ 180 mmHg or sitting diastolic blood pressure ≥ 100 mmHg confirmed on repeat during screening visit.
Effectiveness of Childbirth Preparation Education

The act of birth, which is considered a natural event, is an act that the mother will remember with positive experiences in her life if it progresses normally. However, sometimes birth can be perceived as stressful and traumatic for women. Stress during pregnancy is a problem that should be emphasized and managed due to its negative effects on the health of the mother and the baby. As the pregnancy progresses, the levels of stress hormones may increase. In addition, the thought of spontaneous birth exposes women to physical discomfort, stress and uncertainty during pregnancy. The perception of traumatic birth is an important concept that emerges as a result of the woman's mental birth scenario, the information she has acquired about birth, and every situation she experiences during the birth, and also affects the postpartum period. In studies conducted in Turkey using the Traumatic Birth Perception Scale, it was determined that 23.6% and 26.9% of women experienced a high level of traumatic birth perception. Nulliparity, negative feelings about birth, inadequate antenatal care, inadequate psychosocial support, risky pregnancies, and lack of information about birth are among the factors that may cause traumatic birth perception. Physical and mental preparation for birth and information about pain management are considered to be the basic elements of prenatal education classes. There are study results indicating that birth preparation classes benefit women in many aspects such as self-sufficiency, reduced fear of birth, and positive pregnancy experience. No study results have been found in the literature examining the effect of birth preparation education on the perception of traumatic birth during pregnancy. Based on this, this study was needed to examine the effect of pregnant women's participation in childbirth preparation training on their perceived stress level and perception of traumatic birth.


Eligibility Criteria:
28-34th weeks of pregnancy Agree to participate in the study Be literate Be able to speak and understand Turkish
Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

the main aim of this study is to clinically assess the effectiveness of topical chamomile oral gel in the prevention of chemotherapy-induced oral mucositis.

The study was designed as a randomized, controlled, clinical trial. patients who were undergoing to receive chemotherapy were divided into three groups: Group I: was given conventional treatment. Group II: was given topical oral gel of chamomile. Group III: was given topical oral gel of chamomile in combination with the conventional treatment.

All patients have clinically evaluated at the start of the chemotherapy and three weeks later for pain and oral mucositis severity.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive 5-Fluoroucil (5-FU) based chemotherapy regime.

Males and females with an age of not less than 20 years and not exceeding 70 years.

Exclusion Criteria:

* 1. Patients suffering from any uncontrolled systemic diseases that affect integrity of the epithelium (such as diabetes, cardiovascular, liver disorder and renal dysfunction) 2. Pregnant and lactating women 3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure
Engaging Pacific Islanders in Mental Health Treatment

This study will create and pilot test a culturally grounded intervention (Talking Story) to increase mental health treatment seeking among Pacific Islanders with mental disorders (e.g., major depressive disorder, generalized anxiety disorder).

For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilottest of the culturally grounded Talking Story mental health treatment-seeking intervention with 48 Pacific Islander participants (24 intervention arm, 24 wait-list control) in preparation for larger R01 randomized wait-list controlled testing.

Eligibility Criteria:
Inclusion Criteria:

1. Of Pacific Islander or part Pacific Islander heritage,
2. Must be over 18 years of age,
3. Live in Los Angeles County or surrounding areas,
4. Fluent (oral and reading) in English,
5. Not have dual comorbidities in major depressive disorder, generalized anxiety disorder, and/or alcohol use disorder (they may have one of these disorders and still participate but not two or three).

Exclusion Criteria:

1. Do not meet inclusion criteria,
2. Are unwilling to participate,
3. Fail to provide or retracts consent,
4. Reside outside the target communities.
Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Exsmokers
* Low PImax compared to reference values \[lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old \].
* Stable patients without history of exacerbation or hospitalization four weeks before starting the study.

Exclusion Criteria:

* Lack of motivation and compliance.
* Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value
* Unstable cardiac disease \[severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)\].
* Uncontrolled hypertension
* Recent pneumothorax (within 6 weeks)
* Recent abdominal or thoracic surgery (within 6 weeks)
* Known progressive neuromuscular disorders
* Recent gastrointestinal bleeding (within 4 weeks)
* Current smokers
* Active cancer
* Patients with advanced liver diseases, or renal impairment.
* Known connective tissue diseases
* Significant endocrinal abnormalities
mNGS Versus Blood Culture in FN

Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.


Eligibility Criteria:
Inclusion Criteria:

* hematologic disease
* febrile neutropenia

Exclusion Criteria:

* refuse to consent
* age\<=14
* not caused by infection
Effect of Coaching on Surgeon Well-Being, Job Satisfaction, & Fulfillment

Researchers are trying to determine if individualized professional coaching improves physicians' sense of well-being and job satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Surgeons at Mayo Clinic

Exclusion Criteria:

* Retired surgeons at Mayo Clinic; physicians in other disciplines or organizations
Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention

The aims of this study are to:

* Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
* Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder).
* Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

The MuST is based on the association between the RL technique in that it uses the entire length of the available vessel through progressive rotation, and the buttonhole (BH) cannulation technique since there are three specific cannulation sites for each cannulation day during the week, meaning that each site is only cannulated once a week (allowing the puncture site to heal in between cannulations).

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agree to participate in the study and sign an informed consent;
* Are on a regular haemodialysis (HD) program with three weekly sessions;
* AVF has been in use for at least 4 weeks without incident;
* AVF with blood flow (Qa) ≥500 mL/min evaluated by thermodilution;
* AVF paths allow cannulations along the entire length of the vein with at least 6 cm of distance between bevels, or two distinct areas of 3 cm in length;
* Adult patients

Exclusion Criteria:

* Those who decline to take part;
* Those who have undergone angiography or surgical intervention in the last 4 months in the AVF in use;
* Those who have undergone three or more interventions in the AVF in use;
* Those with use of anesthetic creams at cannulation sites.
A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions

The primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting. By regularly measuring outcomes longitudinally in patients treated in a real-world setting, this study will provide valuable and necessary information as to the impact of both the disease and its treatments on patients over time and will inform the optimal clinical management of patients with living with dermatological disease.

The study is a multi-center, longitudinal, observational study to describe longitudinal trajectories of Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) in patients with select dermatological conditions. This study will collect data using validated clinical instruments and patient-reported data on the disease course of alopecia areata (AA), atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis (PsO), and vitiligo (VL), including symptom assessments and quality of life (QoL) measures from a patient perspective, to supplement routine clinical data collected from their healthcare providers. ClinRO data will be collected at baseline and routine follow-up visits for up to two years. PRO data will be collected directly from patients at baseline and at pre-specified follow-up time points (as defined in Tables 1 - 2e) for up to two years.

The objectives of this study are:

* To describe longitudinal changes in disease activity, symptom control and both physical and mental HrQoL based on both ClinROs and PROs
* To identify patient, disease and treatment factors associated with changes in PROs over time
* To describe the association between PROs, ClinROs and clinical outcomes

Eligibility Criteria:
Inclusion Criteria:

* Adult (defined as the age of majority in their state of residence or older) at enrollment
* Able to read and communicate in English
* Have a smart phone or other internet enabled device capable of PRO data collection
* Diagnosed with a qualifying, clinically confirmed, diagnosis of a study condition in the judgement of the treating physician at presentation
* Willing and able to provide informed consent
* Willing to participate in the collection of patient-reported outcomes for up to two years

Exclusion Criteria:

* Current (or planned) participation in an interventional clinical trial where treatment and/or management of any of the study conditions is being dictated by a protocol.
* Patient is not expected to be actively followed (i.e., seen at least annually as part of routine care) at the site for the duration of the follow-up period.
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma

This pilot clinical study is to evaluate the efficacy \& safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).

An open-label, pilot study to evaluate the efficacy \& safety profiles of SR-T100 gel in treating patients with VINs or EGWs. Male \& female older than 20 years old have at least one VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The primary endpoint is evaluated based on patients who has received 16-week treatment and presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be evaluated based on all patients with measurable values for VINs or EGWs, recruited patients in this study has never had experiencs associated with prior SR-T100 treatment of any sorts during their life time before becoming a participant in this study. The study plans to recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total of 40 patients involved.

Eligibility Criteria:
(EGW group)Inclusion Criteria:

* Male \& female patients older than 20 years old presents at least one pathologically confirmed with histopathology EGW with lesion size greater than 5mm in diameter.

(EGW group)Exclusion Criteria:

* Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy \& lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.

(VIN group)Inclusion Criteria:

* Female patients older than 20 years old presents at least one histopathologically confirmed VIN with lesion size greater than 5mm in diameter.

(VIN group)Exclusion Criteria:

* Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy \& lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.
Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program

This study will advance the knowledge in the field by determining the effectiveness of discharge education regarding prevention of a new infection which is the highest cause of readmission for sepsis patient. In evaluating the impact care teams will develop a clearer link between specific home-based education interventions and infection prevention. This study is an exploratory study designed to identify whether patient education through an innovative teaching method can have an impact on readmissions. This study may the first of several based on findings from this initial, exploratory study.


Eligibility Criteria:
Inclusion Criteria:

* Oncology patients discharged to home following a diagnosis of sepsis, severe sepsis or septic shock
* Patient must have a mobile phone/device
* English speakers
* Age range 18 - 85 years

Exclusion Criteria:

* Less than 18 years of age and older than 85 years of age
* No mobile phone/device
* Non-English speaking
* No diagnosis of sepsis, severe sepsis, or septic shock
* Non-Oncology patient
Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.

The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion.

HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP)
* Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.

Exclusion Criteria:

* Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation