cyrilzakka/clinical-trials huggingface dataset:
Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study

This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg
* Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 \< AHI \< 30 with O2 desaturation not exceeding 80% during the night.

Exclusion Criteria:

* Calculated GFR \< 30
* Carotid body located outside the defined carotid septum
* Obstructive carotid atherosclerotic disease
* Oxygen desaturation at rest below 92%
* Known structural lung disease (medical interview)
* Requirement for oxygen therapy to maintain oxygen saturation
* Patients wish to participate in mountain climbing, skin diving or free diving
* Pregnancy or anticipation of pregnancy
* Palliative care/chemotherapy
* Acute coronary syndrome or unstable angina \< 6 months prior to procedure
* Use of exogenous insulin AND history of hypoglycemic unawareness
* Stroke or transient ischaemic attack (TIA), or myocardial infarction \< 6 months prior to procedure
* Expected life expectancy less that 24months due to other disease
* Intravenous drug use
* Excessive use of alcohol or sedatives (Alcohol intake \>28 units/week)
* Obesity (BMI \> 40)
* Upper airway or facial abnormalities
* Large neck circumference (\>43.2 cm men; \>40.6 cm women)
* Febrile illness within two weeks of participation
* Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.
Selenium in Mild Thyroid Eye Disease in North America

The purpose of this study is to determine whether sodium selenite is helpful in the treatment of mild thyroid eye disease in North America.

Thyroid eye disease (TED) is a disease in which the soft tissues surrounding the eye can become inflamed, scarred, and at times permanently damaged in an autoimmune reaction highly associated with abnormal thyroid hormone levels. Some patients have much more severe TED than others, but overall, most patients reach a point with relatively stable TED after 1 to 2 years. A recent European study showed that oral selenium, a trace mineral involved in anti-oxidation and immune regulation, could actually alter the course of mild TED, lessening its signs and symptoms and even improving the quality of life of those who took it. The investigators would like to perform a sister study throughout North America. In this randomized, double-blinded, multi-center trial, some subjects with mild TED would be given 100 micrograms of sodium selenite twice a day; others would receive a placebo. Signs, symptoms, and quality of life would be measured at regular intervals throughout the 6 month period of drug administration, and for 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to provide informed consent
* Able to swallow pills
* Mild thyroid eye disease requiring no past treatment other than ophthalmic drops or ointment
* Euthyroid: at least 2 months if on medication irregardless of thyroidectomy status; at least 6 months after radioiodine therapy; if euthyroid for the year prior to enrollment, needs normal thyroid-stimulating hormone (TSH) within last 3 months; if uncontrolled for the year prior to enrollment, needs normal TSH and free T4 within last 3 months; if TSH low, needs normal T3 and free T4
* If you are currently taking any selenium supplementation, you will be asked to discontinue its usage, "wash out", for 1 month before you are enrolled.

Exclusion Criteria:

* Moderate or severe thyroid eye disease (based upon International Thyroid Eye Disease Society VISA form), including: grade 2 chemosis or lid edema; corneal exposure with threat of or resulting in perforation; optic neuropathy; grade 3 restriction of any extraocular muscle
* Double vision (diplopia) in primary or reading positions
* Duration of thyroid eye disease greater than 12 months (as per patient history)
* Drug or alcohol abuse
* Severe systemic illness (defined by treating physician)
* Pregnant or breastfeeding
Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle

This is a multi-site, prospective, open-label, randomized, 2 period cross over study comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus pen needle. The study will consist of two 15 day periods ( in which the subject will use each pen needle \[BD Nucleus pen needle or subject's current pen needle, order randomized\] for injection. At the end of the last study period, each subject will be asked to evaluate his or her perceptions using a 150mm relative VAS scale.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 - 75 inclusive)
2. Diagnosed Type 1 or Type 2 diabetes
3. Every effort will be made to recruit approximately 25% Type 1 patients (of the total population, not of each subgroup) (minimum: 10%, maximum: 50%)
4. Every effort will be made to recruit a minimum of 30 subjects with Asian ethnicity (of the total population, not of each subgroup). Ideally, 60 Asian subjects are needed for the study
5. Minimum within the last 4 months experience self-injecting insulin with a pen injector
6. Minimum within the last 2 months experience self-injecting consistently with one of the following available pen needles OR a subject may be enrolled that is using a 31G/32G pen needle that is not longer than 6mm in length who is willing to transfer to one of the following 32G pen needle with a 14 day wash-in period:

   * BD Nano™ 32Gx4mm
   * NovoFine® 32Gx6mm
   * NovoTwist® 32Gx5mm or
   * NovoFine® Plus 32Gx4mm
   * Owen Mumford PenTips 32Gx4mm or
   * Perrigo / Ypsomed ClickFine 32Gx4mm or
   * Other 32G such as UltiMed, MHC, or other private label.
7. Able and willing to provide informed consent/participant form
8. Able and willing to complete all study procedures

Exclusion Criteria:

1. Self-injecting insulin with a pen injector for less than 3 months
2. Planned changes in insulin regimen (increasing or decreasing number of injections per day).
3. Positive pregnancy test (urine)
4. Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted).
5. History of a bleeding disorder or easy bruising
6. Blood borne infection(s)
7. History of recurrent dermatological conditions or skin disorder (e.g., psoriasis, eczema)
8. Gross skin anomalies and abnormalities (e.g., scars, stretch marks, discolorations, tattoos, superficial masses, acne, inflammation) located at or very close to the injection sites
9. Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections.
10. Use of any prescription analgesic medications within 24 hours of first study injection, and during the study.
11. A current or previous medical or physical condition that, in the opinion of the investigator, would place the patient at risk or make them unable to perform study procedures or has the potential to confound interpretation of the study results.
12. Currently participating in another study
13. Employed by, or currently serving as a contractor or consultant to BD or any insulin, insulin pen, or insulin pen needle manufacturer
Effect of Non Surgical Treatment of Periodontitis on Diabetes Control

The aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. The treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three months following enrolment.

The aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. The treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three months following enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least one year
* periodontitis
* HbA1c \> 7%

Exclusion Criteria:

* Periodontal treatment in the last 6 months
* antibiotics in the last 3 months
* tobacco smoking
* pregnancy
Myofascial Release Technique in Women With Primary Dysmenorrhea

It has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. The myofascial release technique is a widely used manual therapy method characterized by the application of low-load, long-duration mechanical forces to manipulate the myofascial complex. This technique aims to restore optimal length, alleviate pain, and improve function. This study aims to examine the effect of the myofascial release technique on central sensitization, myofascial trigger points, and menstrual symptoms in women with primary dysmenorrhea.

During the evaluation period, the participants' musculoskeletal pain threshold and tolerance will be measured using an algometer, about trigger points on the identified muscles (rectus abdominis, quadratus lumborum, erector spinae, and tibialis anterior). A total of 40 women, aged 18-40, diagnosed with primary dysmenorrhea by a gynecologist, will be included in the study. The initial assessment of the participants will be conducted on their most painful days. Participants will be randomized into two groups: the myofascial release technique group (study group) and the placebo myofascial release technique group (control group). The interventions will be conducted over 10 sessions during one menstrual cycle, and all evaluations will be repeated after the treatment period. The study will be conducted as a double-blind trial, ensuring that both the evaluators and the patients are blind to the group assignments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide,
* Having regular menstruation in the last 6 months (28±7 days)
* Those who had menstrual pain between 40 mm and 100 mm according to the Visual Analogue Scale (VAS) in the last 6 months

Exclusion Criteria:

* Diagnosed with Secondary Dysmenorrhea,
* Having given birth,
* Those with serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes,
* Undergoing urogynecological surgery,
* Those who are pregnant or suspected of pregnancy,
* Those who use analgesics or non-pharmacological agents other than NSAIDs for menstrual pain,
* Those using intrauterine or oral contraceptives,
* Those taking extra supplements such as magnesium, which may affect treatment
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal function.

For subjects in the additional cohort:

* Subjects with advanced, histologically or cytologically confirmed gastric cancer.
* At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed

Exclusion Criteria:

* History of severe allergic reactions to monoclonal antibody therapy
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management
* Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
Improving Wellness for Young Men

This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.


Eligibility Criteria:
Inclusion Criteria:

* 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
* Parent/guardian consents
* Student assents

Exclusion Criteria (as assessed by school staff):

* significant psychopathology
* significant developmental delay
* significant substance abuse with behavioral consequences
* significant behavioral problems
* foster care due to consent restrictions)
Effects of LY450139 Dihydrate on Subjects With Mild to Moderate Alzheimer's Disease

The purposes of this study are to determine:

* The safety of LY450139 dihydrate and any side effects that might be associated with it.
* How much LY450139 dihydrate should be given and how long it may be detected in blood.
* To determine if LY450139 dihydrate may have an effect on a protein found in blood, called A beta. This protein is studied in subjects with Alzheimer's disease.
* To collect and store samples from blood and spinal fluid for research related to Alzheimer's disease and similar (neurodegenerative) diseases or inflammation (irritation) that may provide information on how subjects respond to LY450139 or other medications.

Length of study: Approximately 29 weeks.

Number of office visits: 11 for most subjects: initial visit, every other week during 14 weeks of study drug treatment, and 2 follow-up visits.

At no cost, approximately 45 eligible participants will receive:

* Study medication
* Study-related diagnostic and laboratory evaluations


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age and diagnosed with mild to moderate probable Alzheimer's disease
* Fluent in reading and speaking English and have a reliable study partner (caregiver) (someone who is in frequent contact and can make sure study medication is being taken correctly).
* If currently treated with certain drugs for Alzheimer's disease, doses must be the same for at least the last 2 months prior to starting study drug.

Exclusion Criteria:

* Cannot be currently using or require MAOI antidepressants (such as selegiline or Eldepryl(R)), antipsychotics, benzodiazepines, calcium channel blockers for heart disease, and propanolol.
* Cannot have a clinically significant and/or uncontrolled condition or other significant disease, including a condition requiring treatment with warfarin or heparin; or have had or currently have a peptic ulcer, reflux disease, or gastrointestinal (GI) bleeding.
Treatment of Acute HIV Infection to Preserve Immune Function

While most people with HIV experience significant destruction of their immune systems, some people appear to have preserved immune function and can control the virus without drugs. Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to control the virus once the drugs are stopped. This study will evaluate the immune system response of HIV infected people who are treated with anti-HIV drugs soon after being infected.

Studies have identified a potent CD4 T helper (Th) cell response in some infected people, and have shown a correlation between virus-specific Th cells and low levels of viremia. Early institution of potent antiviral therapy in the earliest stages of acute HIV infection have led to strong Th cell responses, analogous to those seen in people who are able to control viremia in the absence of antiviral therapy. This may be because potent antiviral therapy is able to protect virus-specific Th cells as they become activated, and thus these cells are not lost in the earliest stages of infection. This study will characterize the immune response of patients with acute HIV infection who receive antiretroviral therapy and will determine the effects of interruption of therapy in those people who have immune responses to HIV that are similar to patients with long-term non-progressing infection.

Participants in this study will be followed through June 2004. Study visits vary from only once to every month and are scheduled at the discretion of the study officials. Study visits include an interview and blood tests.

Eligibility Criteria:
Inclusion Criteria

* Acute HIV infection
Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula

The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.

Severe cases of cow's milk protein allergy are treated with the amino acid formula. The amino acid formula is composed of essential and non-essential amino acids, vegetable oils with or without MCT oil, and glucose polymer from various carbohydrate sources. Such formula is also fortified by minerals, trace elements,and vitamins.

Eligibility Criteria:
Inclusion Criteria:

* Singleton
* Clinical diagnosis of cow's milk protein allergy

Exclusion Criteria:

* Other diseases
Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial

Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial

This is a single center, randomized (1:1, active : standard of care), controlled, open-label, investigator-initiated pilot phase IIa trial in patients with septic shock investigating the efficacy and safety of administrating OctaplasLG® as compared to crystalloids, such as Ringer-Acetate (standard of care) in a total of 40 patients.

40 patients will be enrolled:

* Patients in the active treatment group (n = 20 patients) will receive OctaplasLG® as volume support according to trial algorithm.
* Patients in the standard of care group (n = 20 patients) will receive crystalloids, such as Ringer-Acetate, as volume support according to trial algorithm.

All patients will be treated according to the standard ICU care.

Eligibility Criteria:
Inclusion Criteria:

1. Adult intensive care patients (age ≥ 18 years) AND
2. Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND
3. Quick SOFA (qSOFA) with two or more of

   1. Respiratory rate ≥ 22/min
   2. Altered mentation (Glasgow Coma Scale score \< 15)
   3. Systolic blood pressure ≤ 100mmHg AND
4. Septic shock, defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L despite adequate volume resuscitation AND
5. Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND
6. Respiratory failure requiring intubation and mechanical ventilation

Exclusion Criteria:

1. Documented refusal of blood transfusion OR
2. Treatment with GPIIb/IIIa inhibitors \< 24h from screening OR
3. Withdrawal from active therapy OR
4. Previously within 30 days included in an interventional trial OR
5. Known IgA deficiency with documented antibodies against IgA OR
6. Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100)) OR
7. Known severe deficiencies of protein S OR
8. Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR
9. Severe cirrhotic hepatic failure with expected need for treatment with terlipressin
AI-Driven Cancer Diagnosis and Prediction With EHR

This is a multi-center, clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for identifying and diagnosing cancer, leveraging multimodal health data.

Cancer diagnosis and early detection are crucial for improving patient outcomes and survival rates. Early identification of cancers and appropriate intervention can significantly impact treatment success and prognosis. In clinical practice, oncologists often need to integrate a variety of patient data, including medical history, laboratory test results, imaging data such as CT scans and MRIs, and genetic markers, to make an accurate diagnosis and develop a personalized treatment plan. As precision medicine becomes increasingly important, the challenge remains to identify cancer at early stages, especially when symptoms are subtle or absent. Recent advancements in artificial intelligence and data analysis techniques have shown great promise in enhancing the diagnostic accuracy and speed of cancer detection. This study aims to develop an AI-assisted decision-making system by integrating multimodal data from electronic health records, imaging, laboratory results, and genetic data. The objective is to improve diagnostic accuracy, optimize clinical workflows, and provide more personalized treatment options for cancer patients. Ultimately, this system seeks to improve early detection, guide effective treatment strategies, and enhance patient survival rates.

Eligibility Criteria:
Inclusion Criteria:

1、Patients with comprehensive electronic health records (EHRs), including medical history, laboratory test results, imaging data, and genetic data (if available).

2. Individuals without severe cognitive impairments or conditions that would prevent them from providing informed consent or participating in the study.

3. Parents or guardians must provide informed consent for minors, while adult participants must provide informed consent for themselves.

Exclusion Criteria:

1. Patients with incomplete or missing key electronic health record data or insufficient follow-up data.
2. Individuals with severe cognitive disorders or other terminal illnesses that would prevent meaningful participation.
3. Pregnant women (although pediatric cancers are being considered, pregnant women would be excluded for safety reasons).
Brillant Blue Versus Indocyanine Green for Macular Hole Surgery

Macular Hole Surgery with two different Dyes


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic stage 3 and 4 macular holes
* Stage 2 macular holes, followed up for at least 6 months
* Pseudophakic and phakic eyes
* Age over 60 years

Exclusion Criteria:

* Traumatic macular holes
* Secondary macular holes
* Severe ocular diseases