cyrilzakka/clinical-trials huggingface dataset:
A Study of Lasmiditan in Healthy Participants

The purpose of this study is to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it by comparing the results of healthy elderly participants to those of healthy young participants. The tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected.

This study will last up to approximately 19 days, not including screening. This study requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four days/three nights. Participants will return for a follow-up seven days after last dose of study drug. Screening is required within 28 days prior to Day 1.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination.
* Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening.

Exclusion Criteria:

* Have known allergies to lasmiditan, related compounds or any components of the formulation.
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
* Show evidence of active renal disease or estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute (mL/min) per 1.73 m².
* Show evidence of or positive serology for human immunodeficiency virus (HIV) infection, hepatitis B or C.
* Are women with a positive pregnancy test or women who are lactating.
* Have a clinically significant abnormality in the neurological examination.
* Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.
* Have orthostatic hypotension with or without dizziness and/or syncope at screening or Day -1 upon repeat testing, or a history of it.
Chest Pain Pilot Study

The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.


Eligibility Criteria:
Inclusion Criteria:

* Pain or discomfort in the chest without any identifiable cause and severe enough for the patient to seek primary medical or similar care.
* History of pain or discomfort in the chest for at least the last two weeks prior to enrollment.

Exclusion Criteria:

* Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease.
* Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.
The Effect of Contrast Media on Erythrocytes in Healthy Volunteers

The purpose of the study is to test the effect that contrast media (dye) has on cellular integrity (structure)

The influence of several radiological contrast media on erythrocyte morphology and function has been investigated in the past (1). However, published data is sparse and does not include the assessment of iso-osmolar agents as compared to low-osmolar agents.

In addition, the effect of the injection of contrast media at higher temperatures (i.e. \> room or body temperature), which may be beneficial for the rapid injection of more viscous contrast media at multi detector-row CT angiography, has never been evaluated.

We intend to assess the hypothesis, that iso-osmolar contrast media (i.e. Visipaque) exerts less effect on erythrocyte morphology and function as compared to low-osmolar agents.

In addition, we intend to identify the upper temperature limit, at which contrast media can be injected, without affecting erythrocyte integrity.

Subjects will have up tp 400 mLs (approximately 26 tablespoons) of blood drawn. The blood will be kept at body temperature in a petri dish or similar container and exposed to contrast media (dye).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years old
* Subjects must be at least 110lbs and

Exclusion Criteria:

* Subjects may not be pregnant
* Subjects must not possess any medical conditions that would preclude them from participating
The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa

The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids?

The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients

There are several specific objectives for this study:

1. To subjectively and objectively compare the efficacy of intranasal phototherapy and intranasal corticosteroids in treating allergic rhinitis via assessment of rhinomanometry, peak nasal inspiratory flow (PNIF) and visual analogue scale(VAS) score.
2. To determine mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.
3. To determine mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids.

Patients who meet the criteria to join the study will be randomized in a single-blinded manner(investigator). Patients will be given information about the study and consent form, patients will be randomized to 2 treatment group (rhinophototherapy and Nasonex nasal spray). Patients will be evaluated before and after treatment in two weeks time.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years and above
* Newly diagnosed allergic rhinitis
* Allergic rhinitis is confirmed via positive skin prick test or serum Immunoglobulin E

Exclusion Criteria:

* Anaphylaxis /poorly controlled bronchial asthma
* Refused nasal biopsy
* Usage of intranasal corticosteroids and/or antihistamine sprays for the past 1 month
* Consumption of oral leukotriene receptor antagonist or oral steroids for the past 1 month
* Concomitant nasal pathology (malignancy, chronic rhinosinusitis with nasal polyposis, severe deviated nasal septum)
* Bleeding disorder or on anticoagulant/antiplatelet therapy
* Recent URTI/Covid-19 within past 14 days
* Pregnancy
Clinical and Pathologic Studies in Neuroendocrine Tumors

This research involves the study of neuroendocrine tumors in order to better understand how the disease grows and spreads. This study requires will use tissue collected from from biopsies performed during your regular medical care (i.e. tissue leftover after your diagnosis has been made) and/or blood and urine samples. This study may lead to the development of special materials that could be used, in the future, to treat neuroendocrine tumors or to follow the response of neuroendocrine tumors to treatment


Eligibility Criteria:
Inclusion Criteria:- Patients are eligible if they have a histologically proven neuroendocrine tumor and are 18 years of age or older

- Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:None
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months

The aim of the present study is formulation and production of sachets containing macronutrients and micronutrients to enrich food at home and evaluate its effectiveness on pregnant mothers and children aged 6 to 60 months living in Sistan and Baluchestan province

This study is conducted in three steps. At first, fortification sachets are formulated and produced in accordance with international recommendations for micronutrients (vitamins A, D, zinc, and iron) and macronutrients for use in normal home conditions. In the second step, efficacy of fortified sachets are evaluate in three subgroups including pregnant mothers, 6-24 months and 2-5 years old children. Nutritional, anthropometrical and biochemical indices are evaluated at the beginning and after 6-9 months intervention. At the third step, costs and cost-effectiveness of the intervention in each of the studied groups in comparison with the usual program for that age group in the health care system of the country is determined.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women

   * being in the first trimester of pregnancy
   * free of chronic diseases before pregnancy
   * no intention to change residence until delivery
2. Children 6 to 23 months

   * age 6 to 7 months
   * no intention to change residence or migrate in the next 12 months
   * free of acute or chronic illness
3. Children 2 to 5 years (60-24 months)

   * age 24 to 48 months
   * no intention to change residence or migrate in the next 6-12 months
   * free of acute or chronic diseases

Exclusion Criteria:

1. Pregnant women

   * premature termination of pregnancy
   * change of residence before delivery
2. Children 6 to 23 months

   -change of residence before delivery
3. Children 2 to 5 years (60-24 months) -change of residence before delivery
Intradermal Lidocaine Via MicronJet600 Microneedle Device

The purpose of this study is to determine efficiency and safety of injecting a micro-amount of 2% lidocaine with the commercially available microneedle device MinronJet600 (NanoPass Technologies Ltd, Israel) (registration number RZN2017/5544 by Federal Service for Surveillance in Healthcare of Russian Federation) to achieve rapid local anesthesia for peripheral venous cannulation.

The trial is prospective, randomised, open-label, placebo-controlled. The start date of patient enrolment was January 29 of 2019. Simple randomization was performed to allocate subjects into two groups using the Microsoft Excel random number generator. As a result of randomisation, subjects were allocated into two groups - Group1 and Group2.

In this study, each subject from Group1 received injection of local anaesthetic into the left arm and sterile saline as a placebo into the right arm, the injections were performed with MicronJet600 and followed by the intravenous cannulation; each subject from Group2 will receive injection of local anaesthetic into the left arm, which was performed with MicronJet600 and followed by the intravenous cannulation, with no pre-treatment prior to the intravenous cannulation in case of the right arm. Pain caused by the cannulations was rated by the subjects in accordance with 100-point visual analogue scale. Safety parameters was assessed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Any gender
* Age at 18-65 years

Exclusion Criteria:

* Pregnant or lactating women
* Evidence of allergy to lidocaine
* Presence of pain of any localization and character not associated with the study or treatment with any analgesics
* Any perceptual disorders
* Neuropathies or stroke in anamnesis
* Any psychiatric disorders
* Any disorder of tissues at the site of intervention - the antecubital fossa
Comparison of Two Pericardial Bioprostheses in AVR

The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.

This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier Edwards Perimount Magna Ease according to the randomization result. The primary end point is postoperative 1-year transvalvular mean pressure gradient. The secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events.

Eligibility Criteria:
Inclusion Criteria:

* patients who are going to undergo aortic valve replacement with bioprosthesis

Exclusion Criteria:

* heart failure with severe LV dysfunction (LV EF \<30%)
* active infective endocarditis
* with other critical cardiovascular disease (e.g. acute aortic dissection)
* with other critical comorbities by which the expected life span is less than 1 year
* inadequate participant by the researcher's discretion
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis

It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4 (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects

20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals (control;C) were included in this study. Clinical periodontal parameters were measured. Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent assay.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* clinical diagnosis of periodontitis
* clinical diagnosis of periodontal health

Exclusion Criteria:

* history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
* nonsurgical periodontal treatment (previous 6 months)
* surgical periodontal treatment (previous 12 months)
* presence of\<10 teeth
* current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
* diabetes
* diagnosis of rheumatoid arthritis
* pregnancy
* lactating
* smoking
* excessive alcohol consumption.
Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention

Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.

Skin fibrosis is a significant global health problem that has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis.

In vitro data show that LED-RL can modulate key cellular and molecular processes involved in skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent for all study procedures
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Suitable candidate for elective mini-facelift surgery
* Pass a screening photosensitivity test

Exclusion Criteria:

* Current use of any photosensitizing medications
* Light-sensitive conditions
* Diabetes mellitus
* Systemic lupus erythematosus
* Current tobacco use
* History of bleeding or coagulation disorder
* Lax skin associated with genetic disorders
* Open wounds on the face or neck
* Fibrotic skin disease, pre-existing scar(s), or other skin conditions affecting the periauricular skin
* History of surgery or procedure involving or affecting the periauricular skin within the past 6 months (e.g., prior facelift, fillers, laser therapy)
* Tattoos that cover the proposed treatment sites on the periauricular skin
* Any other medical condition(s) that could be compromised by exposure to the proposed treatment
Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury

The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is "stem cell" therapy, which has been well studied and published in prestigious journals.

In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.


Eligibility Criteria:
Inclusion Criteria:

1. Must be able to give voluntary (patients may not be able to write) consent.
2. Must be able to understand study information provided to him.
3. Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), \< 2 weeks in acute category and 2-8 weeks in subacute patients.
4. The level of spinal cord injury must be between C4 and T12(neurological level)
5. Spinal cord injury categorized in terms of ASIA Impairment scale.
6. Age should be between 20-55 years

Exclusion Criteria:

* Mechanical ventilation due to neurological impairment
* Multiple level trauma
* Undetermined size and location of Spinal Cord injury
* Gunshot or other penetrating trauma to the spinal cord
* Longitudinal dimension of injury by MRI is greater than 3spinal segments
* Associated severe head injury
* More than 9cms long bone fracture
* Women who are pregnant or lactating
* Serious pre-existing medical conditions
* Disease or impairment that precludes adequate neurological examination.
* Should not have co-morbidities like Diabetes, Systemic Hypertension etc.
* Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb \< 8mg/dl
Association of Lifestyle With Complications in the Diabetic Population

This study is a prospective study of patients with diabetes. The main objective of this study is to investigate the relationship between lifestyle and long-term complications in diabetic patients, which will help to screen out the high-risk group at an early stage and provide scientific advice for the prevention of complications in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a normative diagnosis of type 2 diabetes
2. Age ≥20 years old, regardless of gender
3. From January 2022 to December 2025, he was treated in Nanfang Hospital

Exclusion Criteria:

1. In the acute infection phase
2. The researchers judged that it was not suitable to participate in this study
Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Life-threatening physical illness may powerfully re-activate existential conflict. There is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.

Severely physically ill patients may experience existential distress symptoms including helplessness, hopelessness, death anxiety, perceived burdensomeness and a sense of pointlessness. The latter can significantly interfere with end-of-life care processes and outcomes (receipt of treatment according to preferences, expression of desire for hastened death). So far, empirically tested psychotherapeutic programs in advanced life-threatening illness have predominantly been ultra-short and applied supportive and resource-oriented techniques. Psychodynamic treatment allows to address clinically significant existential distress through its conceptualization from early relational life experiences.

The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.The inverstigators will

1. analyse the feasibility of the treatment, and
2. investigate changes in process- and patient-relevant outcomes over the course of the treatment

The inverstigators will conduct a single-group pre-post study with five assessment points in which 50 adult patients diagnosed with advanced cancer will receive a manualized psychodynamic short-term therapy. Target parameters are assessed by diagnostic interviews, focus interviews, self-assessment questionnaires as well as electronic patient records. For research objective b) the investigators will compare the intervention group with a matched comparison group of a longitudinal cohort sample (NCT04600206). Matching will be based on stress level, demographic, and medical parameters across the 5 assessment points.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* UICC stage IV solid tumor
* Informed consent
* Current physical condition that allows for at least 12 therapy sessions
* Indication: Presence of a mental disorder with existential stress and limitations in coping capacity

Exclusion Criteria:

* Acute suicidality
* Psychotic disorder (ICD-10: F2 diagnosis)
* Substance dependence or abuse (ICD-10: F1 diagnosis)
* Structural deficits that interfere with attending to regular appointments
* Other psychotherapeutic treatment
* Severe cognitive impairment
* Severe physical impairment
* Insufficient German to give informed consent and complete self-report questionnaires