cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of DA-001 As a Treatment for Telogen Effluvium

The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium

DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding.

This study aims to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosed with telogen effluvium
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in DA-001
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits
Study on Early Stage Bulky Cervical Cancers

The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.

Early stage bulky cancers of the cervix, (defined as FIGO Stages IB2, IIA2 and IIB) form a distinctive subset of "curable" cervical cancers with good 5 year survival rates with adequate treatment. Concurrent chemo radiation with or without salvage surgery is at present the standard of care for this group of cervical cancers. However, when pelvic recurrences occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is often higher than the morbidity of salvage radiotherapy following radical surgery. The advantages of downsizing the disease without the use of brachytherapy are tempting and open a completely new philosophy in radical treatment for "curable" early stage bulky cancers of the cervix. This approach is appealing especially in developing countries where the load of cervical cancers is high and radiotherapy (brachytherapy) resources are scarce.

The results of two Phase II trials conducted at Govt. Royapettah Hospital, Chennai (Neoadjuvant Chemotherapy followed by Radical Hysterectomy: Cisplatin + 5FU vs. Cisplatin +Paclitaxel) and at Govt. General Hospital,Chennai (Neoadjuvant Chemoradiation with weekly cisplatin and 50 EBRT followed by radical Hysterectomy) and one retrospective study ( Preoperative 50 GY EBRT followed by Radical Hysterectomy) have shown similar response rates and acceptable toxicity profiles when compared to concurrent chemoradiation (EBRT + Brachytherapy+ Chemotherapy). Similar studies have been published elsewhere with similar results.

With this in mind we are planning to conduct a Phase III Randomised control trial comparing Neoadjuvant Chemotherapy + Radical Hysterectomy and Neoadjuvant Chemoradiation + Radical Hysterectomy with concurrent chemoradiation in this subset of cervical cancers

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).
2. Age 18-60 years
3. Karnofsky performance status of ≥70%; ECOG PS ≤ 2

Exclusion Criteria:

1. Nonsquamous Histologies
2. Other systemic diseases, comorbidities precluding full participation in the study
3. Concomitant treatment with any experimental drug
4. Pregnant or nursing women
5. Previous or concomitant malignant diseases other than non-melanoma skin cancer
6. Previous radiation to the pelvis
Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. While anecdotal evidence exists supporting a decrease in claudication symptoms, there are no previously published data on studies employing this compression device in the treatment of arterial disease. The investigators' primary hypothesis is that patients randomized to the intervention arm of the trial will experience an increase in mean walking ability as compared to the group receiving medical standard of care.

Peripheral arterial disease (PAD) is a common disorder, affecting 12% of adults older than 50 years of age. Approximately one third of these patients experience intermittent claudication, defined as pain in the thigh or calf muscles during walking and that resolves with rest. Lower extremity pain is often severe enough to significantly limit ambulation, forcing many patients to seek medical care. Current treatments include two FDA-approved medications, supervised walking programs, arterial angioplasty and/or stent placement, and open arterial bypass surgery. The problem is that noninvasive treatments are oftentimes ineffective, while invasive treatments are effective but expensive.

A non-invasive lower extremity treatment that has shown success in treating lymphedema and venous insufficiency will be studied during this protocol to assess its effects on claudication symptoms. Half of the participants in this prospective, single-center randomized controlled trial will be treated with a pneumatic compression device in a home treatment program, while half will receive standard medical therapy. If effective, potential benefits are high, providing relief of personal disability and avoidance of costly surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* Consistent claudication symptoms for at least 6 months
* ABIs at rest as follows: 0.5\>ABI\<0.8 minimally on one leg

Exclusion Criteria:

* Refuses to consent
* Unlikely to be compliant with protocol
* Unable to perform treadmill test
* Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
* Lower extremity surgery or endovascular procedure within the last 3 months
* Currently has a non-healing wound on either leg
* DVT in the past 3 months
* Unstable hypertension, angina, uncontrolled glucose levels
* Participating in a supervised exercise regimen
* Claudication medications regime changed within the last 3 months
* Diagnosis of Raynaud's Disease
* Requires a custom fabricated boot appliance
* Single limb amputees meeting inclusion criteria may participate in this study
Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study

This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries.


Eligibility Criteria:
Inclusion Criteria:

-

Inclusion Criteria:

1. Patients presenting with clinical manifestations of caries as their chief complaint;
2. Age ≥18 and ≤70 years, irrespective of gender;
3. Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant;
4. On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant;
5. Oral panoramic radiographs that are clear, easy to interpret, and free from significant artifacts;
6. Participants who voluntarily agree to partake, can comprehend the purpose of the study, and are capable of signing an informed consent form.

Exclusion Criteria:

1. Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present;
2. Insufficient number of teeth available for study;
3. Severe tooth wear or erosion leading to significant alteration in tooth morphology;
4. Presence of supernumerary teeth, microdontia, or missing teeth;
5. Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors;
6. Limited mouth opening that precludes clinical examination;
7. Neurological disorders, psychiatric illnesses, or psychological impairments;
8. Participation in another clinical trial within the last three months;
9. Any other condition deemed by the researchers as unsuitable for inclusion in the study.
Key Longitudinal Associations With Risk and Glioblastoma Outcomes

The goal of this observational study is to find out what factors affect the health and risks in adults with glioblastoma (GBM), a grade 4 brain cancer.

The main questions it aims to answer are:

* How do genetic and immune system factors impact survival and quality of life in GBM patients?
* What occupational and medical history factors are linked to the risk of getting GBM?

Participants will:

* Fill out an online survey about their medical history and lifestyle.

Participants will have the chance to give a blood sample (from the outer arm) for genetic and immune system testing. Blood samples will be given using a home collection kit provided by the study team.

This observational study aims to investigate the various factors influencing outcomes and risks in adults diagnosed with glioblastoma (GBM). Glioblastoma is a highly aggressive and malignant brain tumor, and understanding the factors that affect patient outcomes is crucial for improving management strategies and patient care.

The study employs a case-only design where participants will be followed over time to observe how different factors affect their health outcomes. Participants will be selected based on their diagnosis of glioblastoma and will be included in the study regardless of current treatment status or disease stage.

Findings from this study are expected to provide valuable insights into the factors affecting glioblastoma outcomes and may contribute to the development of personalized treatment strategies and risk assessment tools for better management of the disease.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Pathologically-confirmed diagnosis of glioblastoma multiforme (GBM) or grade 4 brain tumor
* Participant is accessible for follow-up (has a working email address)
* Participant is willing and able to comply with the study requirements

Exclusion Criteria:

* Those who cannot read either English or Spanish
* Those who cannot view an online survey
Study of Cognitive Inhibition Disorders in Depressed Older Suicide Attempters

The purpose of this study is to compare the cognitive inhibition deficit among depressed older suicide attempters compared to depressed older suicide non-attempters.

The main objective consists in examining the association between cognitive inhibition and suicide attempt in depressed older adults (\> 65 year old).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years old
* Score of Mini-Mental State Examination (MMSE) \> 23
* Score of Hamilton Depression Scale \>27
* For Group 1 (depressed older suicide non-attempters): No history of suicide attempt
* For Group 2 (depressed older suicide attempters) : History of suicide attempt

Exclusion Criteria:

* Neurological history or medical-surgical affection in the past 3 months.
* Dependence or alcohol abuse.
* Use of neuroleptics
Cognitive Behavioral Therapy Following Myocardial Infarction

Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.

The study will include 20 patients. The MI-specific CBT lasts for 8 weeks and is delivered face-to-face via a secure digital video solution (to minimize cancelled sessions because of the COVID-19 pandemic) or at the Karolinska Universitetssjukhuset cardiac research unit, by licensed psychologists with expertise in CBT for cardiac disease. During treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety.

Eligibility Criteria:
Inclusion Criteria:

( - )MI ≥ 6 months before assessment (type 1 STEMI/NSTEMI) ( - )Age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )Able to read and write in Swedish.

Exclusion Criteria:

( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.
Protocol Based-furosemide Stress Test Versus Standard Care to Evaluate Renal Recovery During Continuous Renal Replacement Therapy

Currently, continuous renal replacement therapy (CRRT) is the main modality for renal support in critically ill patients with hemodynamic instability. Most studies have investigated the timing of RRT initiation. However, prolonged CRRT demonstrated the association of many unexpected events, such as catheter-related complications, catheter-related blood stream infection, hypotension, hypothermia, tachycardia, and atrial fibrillation. Up to now, there is a lack of evidence regarding the timing of withholding CRRT. The furosemide stress test (FST) is a tool that is easy to use and has more availability. The investigators aimed to apply FST to evaluate renal recovery compared with standard treatment in critically ill patients undergoing CRRT.


Eligibility Criteria:
Inclusion Criteria:

* Adult 20 year of age or older
* Acute kidney injury (AKI) stage 3 according to Kidney Disease Improving Global Outcomes (KDIGO) classification with oliguria (urine \<400 ml/day)
* Initiate CRRT in ICU (medical ICU, surgical ICU, cardiac care unit) for at least 48 hours (time for initiation and modality of CRRT can adjust by clinician)

Exclusion Criteria:

* Use any inotropic drug (norepinephrine, epinephrine, dopamine, dobutamine)
* Blood urea nitrogen (BUN) \>80 mg/dL
* Serum K \<3.5 or \>5 mmol/L
* Arterial potential of Hydrogen (pH) \<7.3
* Serum bicarbonate (HCO3) \<15 mmol/L
* Urine volume \<400 or \>2,100 mL/day
* Urine creatinine clearance (CrCl) at 6 hours \>20 mL/min
* Previous chronic kidney disease (CKD) stage 5 or estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2
* Previous RRT within 14 days
* Kidney transplantation
* Obstructive etiology for AKI
* Toxin/drug that necessitates RRT
* Allergy to furosemide
* Moribund with expected death within 24 hours
* Pregnancy
Propensity to Hospitalize Patients from the ED in European Centers.

The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Arrived at emergency department between 1 January 2021 and 31 December 2023

Exclusion Criteria:

* None
Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Eligibility Criteria:
Inclusion Criteria:

* Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation.

Exclusion Criteria:

* Patients with a history of hypersensitivity to Eslax or bromide.
* Patients with myasthenia gravis or myasthenic syndrome.
Effect of Action Observation Therapy in Comparison to Motor Relearning Program on Balance and Mobility Among Subacute Stroke Patients

This study is a randomized controlled trial. The purpose of this study is to determine the effect of Action Observation Therapy in Comparison to a Motor Relearning Program on Balance and Mobility among subacute stroke patients.

Action observation therapy has proven its positive effects in improving functional performance in stroke patients compared to other neurological and musculoskeletal conditions motor relearning program is also very effective in improving functional performance in stroke patients but previous studies have shown individual effects of AOT and MRP but there is no comparison of AOT with MRP on balance and mobility.

as a result, this study aims to contribute new data to the sparse literature on subacute stroke patients.

The research finidings could provide valuable insights into potential benefits, encouraging evidence-based practices.

Eligibility Criteria:
Inclusion Criteria:

* Both genders, male and female
* Ischemic stroke patients
* Age 45 years and above
* MMSE\>24
* Able to stand independently for 1 minute
* Patient can maintain starting sitting static position for 10 seconds without arm rest

Exclusion Criteria:

* Any other neurological disorder
* Orthopedic conditions(fracture) affecting balance and mobility
* Visual or auditory impairments
Infected Elders in the Emergency Department: Outcomes and Processes of Care

The purpose of this study is to determine factors which predict a complicated hospital course and then to develop from these findings an Emergency Department guideline to assist in knowing who is at highest risk of elderly patients with infection presenting for care.

The study is looking at how closely physicians adhere to treatment guidelines in caring for elderly patients, and then to determine if there are differences in elderly patient disease symptoms that result in a failure to use guidelines. If this is known, physicians can then be aware of these differences and provide appropriate care.

Eligibility Criteria:
Inclusion Criteria:

* age 65 or older
* blood cultures ordered in the Emergency Department
* admitted to the hospital from the Emergency Department

Exclusion Criteria:

* age less than 65
* prisoners
* Patient unable to provide consent and no legally authorized representative available
* non-English speaking
* ED visit or admission in the last 7 days for the same condition
* primary evaluation by the trauma team
Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema

Although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions.

Therefore the investigators evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available. This will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of either gender
2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography.

If both eyes are eligible for the study, both eyes can be included in the study.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (\> 5mIU/mL)
2. Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication
3. Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab
4. History of hypersensitivity for bevacizumab.
Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD

The purpose of this study is to identify patient and provider-chosen factors that put patients at risk for the development of hypoxemia (oxygen saturation \< 90% for 5 seconds) during endoscopy and to use this knowledge to develop a treatment protocol for specific causes of hypoxemia in adult esophagogastroduodenoscopy outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years
* English speaking
* Mentally competent to sign their own consent for treatment

Exclusion Criteria:

* Poor incisor teeth stability
* Anticipated procedure of greater than 30 minutes
* History of facial or oral surgery and a baseline oxygen saturation of less than 95% on room air