cyrilzakka/clinical-trials huggingface dataset:
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma

The primary objective of this study is to evaluate the tolerability and safety of a combination of lenvatinib plus nivolumab in participants with hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have confirmed diagnosis of hepatocellular carcinoma (HCC) with any of the following criteria:

  * Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
  * Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection
* Part 1: HCC for which no other appropriate therapy is available; Part 2: No prior systemic therapy for advanced/unresectable HCC
* Participants categorized to stage B (not applicable for transarterial chemoembolization), or stage C based on Barcelona Clinic Liver Cancer staging system
* Child-Pugh score A
* Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 to 1
* Age greater than or equal to (\>=) 20 years at the time of informed consent

Exclusion Criteria:

* Active co-infection with hepatitis B and hepatitis C
* Participants with any active, known, or suspected autoimmune disease
* Participants being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study
* Females who are breastfeeding or pregnant
CT-scan Airways Mensuration - Correlation to External Measurements

Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective intubation into the right or left mainstem bronchus, which can lead to contralateral lung atelectasis and hypoxemia.

The purpose of this study is to determine whether there is a correlation between the measurement of the airway of an adult population and criteria that would be easily accessible in daily clinical practice: the height of the patient and the size of their feet.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for a CT-scan including the airways and the upper part of the chest at least until the carina
* patient size between between 150 cm and 195 cm

Exclusion Criteria:

* significant deformity of the cervical spine to accurately measure the size of patients (kyphoscoliosis...)
* impossibility of reliably know the size of the patient
* history of pharyngo-laryngeal surgery resulting in a significant deformity or a loss of anatomical landmarks incompatible with reliable measurements between dental arches and glottic plan (total laryngectomy...)
* history of lung surgery not allowing reliable location of the carina (pneumonectomy, double-lung transplant)
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Induction and support of lactation in women with preterm delivery and inadequate milk production.


Eligibility Criteria:
Inclusion Criteria:

* Delivered at the hospital system associated with the trial center
* Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
* Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
* Produced \< 200 mL milk in 24 hours prior to randomization
* Delivered 96 to 192 (+4) hours prior to randomization

Exclusion Criteria:

* Pre-pregnancy body mass index (BMI) \> 50 kg/m\^2
* Mastitis
* History of breast trauma, breast surgery, nipple piercing
* Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
* Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
* Unstable thyroid disease
* Moderate or severe renal or hepatic impairment
* Mental illness
* Significant nasal congestion or mucous production
* Use of anti-psychotic drugs within past 12 months
The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain

For the past few years, the military has been looking for an innovative way to decrease the use of opioids for chronic pain. This has prompted military treatment facilities to begin integrating complementary and/or alternative medicine modalities into their conventional plans of care. Reiki, a bio-field energy therapy, is one such modality. The purpose of this prospective repeated measure study is to: 1) introduce the concept Reiki therapy to military healthcare beneficiaries experiencing chronic pain, 2) assess pain outcome after receiving six treatments of Reiki therapy, and 3) assess participant's impression of Reiki therapy as a possible complementary and/or alternative option for the management of chronic pain.

Thirty military healthcare beneficiaries with the complaint of chronic pain will receive a brief introduction to Reiki therapy followed by six 30-minute Reiki sessions provided by trained Reiki Level 1 Practitioner. Participant's knowledge of Reiki will be assessed using pre and post questionnaires; pain will be assessed using the Brief Pain Inventory, Defense Veterans Pain Rating Scale, DoD (Department of Defense) VA (Veteran's Administration) Pain Supplementary Questionnaire, McGill Pain Questionnaire and pain medication diaries; and participant's impression will be assessed using the Patient Global Impression of Improvement Scale and along with a post study questionnaire. If it is found that Reiki therapy helped in decreasing chronic pain outcomes, this treatment modality may be added to Landstuhl Regional Medical (LRMC) Pain Clinic's pool of complementary and alternative medicine options.


Eligibility Criteria:
Inclusion Criteria:

1. Has chronic pain (defined as pain that lasts 3 months or more since first onset).
2. Is receiving a stable pain medication regimen (defined as a regimen that has not increased 10% to 20% in the past week prior to enrollment), if on pain medication.
3. Is affiliated with at least one of the 13 installations within the Kaiserslautern Military Community area
4. Is eligible to receive healthcare at Landstuhl Regional Medical Center
5. Is 18 years and older
6. Can read and speak English
7. Is able to commit to 6 treatments (approximately 2-3 weeks)

Exclusion Criteria:

1. Have had surgery or a painful procedure in the last 30 days or are being scheduled for any surgeries or painful procedures during the duration of the study
2. Already have a working knowledge (e.g., credentialed Reiki Level I, II or III Practitioner or Reiki Master) of Reiki or have had Reiki therapy in the past
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)

The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.


Eligibility Criteria:
Inclusion criteria;

1. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will
2. Japanese healthy male adult volunteers
3. Participants who are between 20 and 54 years of age at the time of obtaining written consent
4. Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening

Exclusion criteria;

1. Participants with a present illness or history of allergy to drug or food, or seasonal allergy
2. Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
3. Participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions
4. Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
5. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or those who are human immunodeficiency virus (HIV)-positive, or those who are positive for syphilis screen
6. Participants who underwent blood transfusion within 12 weeks prior to, those whose 400 mL or more of whole blood was collected within 12 weeks prior to, or those whose 200 mL or more of whole blood was collected within 4 week prior to study drug administration
RLIP76 in Human Serum in Adults With Rheumatologic Diseases

It is the investigators aim to determine the feasibility of directly detecting anti-RLIP76 auto-antibodies in human serum using prepared RLIP76 antigen peptides in persons with rheumatologic disease and persons without rheumatologic diesease ("healthy subjects").

This is an exploratory study conducted to see the feasibility of measuring the anti-RLIP76 antibody and to standardize the methods for its measurement. We will perform these studies on blood samples obtained from human subjects after informed concent for blood draw for research purposes is obtained by the Clinical Research Co-ordinator (CRC).

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study.

Exclusion Criteria:

* Children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.
Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.


Eligibility Criteria:
Please contact site for information.
ECCO2R in the Treatment of Acute Exacerbation of COPD With Severe Hypercapnia

Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.


Eligibility Criteria:
Inclusion Criteria:

* AECOPD patients.
* The patients with hypercapnia respiratory failure were admitted to ICU and needed noninvasive ventilation.
* The results of blood gas analysis showed pH \<7.30, PaCO2\> 50 mmHg.
* There were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the pH value was ≤ 7.30, while PaCO2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate ≥ 30 times / min, assisted respiratory muscle breathing; contradictory breathing.
* Informed consents were sighed.

Exclusion Criteria:

* The mean arterial pressure was less than 60 mmHg after volume and vasoactive drug treatment.
* There were anticoagulant contraindications.
* Weight over 120kg.
* Patients with malignant tumor or other complications, the expected survival time was less than 30 days.
* It could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use appropriate birth control throughout the study
* Must have a diagnosis of CSU for at least 6 months
* Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines
* Must agree to take an anti-histamine every day during the trial
* Must be willing to enter information about symptoms in an electronic diary twice a day

Exclusion Criteria:

* Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling beneath the skin)
* Must not have a current or recent active infection requiring antibiotics
* Must not have a history of anaphylaxis (severe, life threatening allergic reaction)
* Must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.)
* Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU
The Efficacy of Lymphatic Massage on Lower Extremity Edema and Performance After Treadmill Exercise in Sprinter Compare to Static Stretching and Cold Water Immersion

Background: Lower extremity edema is often seen after exercise in healthy individuals, especially sprinters, in sports physical therapy practice. Edema is defined as the excessive fluid accumulation in the interstitial space. Recent studies showed that there could be an increase in fluid up to 31.2 ml after a 15-minute running bout in healthy individuals. Fluid accumulation may be resulted from (1) high intensity training, (2) compression of blood and lymph vessels due to increased soft tissue tension and (3) the effect of gravity. Lower extremity edema not only causes great impact on athlete's recovery and performance, it could also lead to fibrosis, dysfunction and contracture. The pilot study showed that lower extremity edema not only existed post-exercise, and decreased ankle circumference was found after a 5-minute massage session, not only when compared to the status after exercise, but also when compared to the baseline (resting). The result also showed lower extremity edema may exist both during resting and after exercise. However, no studies to date investigated the solutions to decrease lower extremity edema during resting and after exercise in sprinters. Massage has been proven beneficial to athletes by increasing range of motion, promote recovery and increase skin blood flow, however, no study investigated the effect of massage on lower extremity edema and compared that to different common recovery modalities such as cold water immersion and static-stretching.

Purposes: To explore the effects of massage on sprinter's gastrocnemius after running on edema and strength with immediate and short-term follow ups.

Methods: This study will recruit both male and female sprinters age between 20-30 years old who participate in the event of 100, 200 and 400 meter sprints. After individuals' enrollments and baseline data collections, all subjects will receive all three different treatments (massage, cold water immersion and static stretching) in randomized orders a week apart, respectively. Outcome measures are: visual analogue scale (VAS) score, lower leg volume, pressure pain threshold and horizontal jump distance. All measurements will be recorded at baseline, immediately after exercise, immediately after treatment, and 10 minutes after treatment as the follow up. Descriptive statistics will be used for participants' characteristics. Three-way ANOVA (3 treatments x 4 times x 2 legs) with repeated measures design will be used to detect differences, and post-hoc analysis will be used when interactions are identified. p value of \< .05 will be used in this study.


Eligibility Criteria:
Inclusion criteria:

1. 20-30 years-old of age.
2. Sprinters participate in 100-meter, 200-meter or 400-meter sprint events.
3. Trainings at least 5 days per week and at least 2 hours per day.

Exclusion criteria:

1. Lymphedema
2. Peripheral arterial disease
3. Chronic venous disease
4. Musculoskeletal injuries of the testing leg in recent 3 months (that would influence practice schedule)
Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection . Patients with no lip numbness and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers with including criteria and with no spontaneous pain, reporting no or mild (Visual analog scale≤54) pain in response to cold testing and electric pulp tester, are participating. The patients will be divided into 3 groups on a random basis and will be randomly given one of the oral medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection with one carpule of 4% Articaine with 1:100000 Epinephrine. Patients with no anesthetic sign (lip numbness) and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age ranged 18-65
* without systemic diseases
* without any medicine consumption
* non smoking
* non pregnant
* non breast feeding
* with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment
* without any medicine consumption or analgesic and sedation
* understand and sign the VAS and consent forms

Exclusion Criteria:

-
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability

The main objective of this study is to establish whether there are differences in self-recognition and self/other distinction in subjects with psychological vulnerability compared to healthy volunteer controls.

This study is based on the properties of the double mirror "Alter Ego" which is a device that appears as a double-sided mirror surrounded by light diodes whose intensity can be varied. Thanks to this variation of luminosity, this special paradigm creates morphs between two real subjects seated on both sides, resulting in different faces, each morphed to a varying extent.

In this task, participants watch a double mirror in which a picture of their own face gradually transforms into the face of an unfamiliar other (self-to-other direction) or vice versa (other-to-self direction), and indicate at which point they judge the morph to look more like the target face than the starting face.

The comparison of the thresholds obtained by different individuals makes it possible to establish whether there could be differences between subjects with psychological vulnerability and healthy controls and to explore hypothetical links between self/other distinction abilities and symptoms of psychological vulnerability .

Eligibility Criteria:
Inclusion criteria for patients:

* Aged from 15 to 25 years
* Subject meeting the Ultra High Risk criteria at CAARMS and / or SPI-A
* Signature of the consent (participants and parents for minors)
* Subject affiliated to the social security scheme or benefiting from such a scheme

Inclusion criteria for healthy volunteers:

* Aged from 15 to 25 years
* Subject not familiar to the patient to whom it is matched
* Signature of the consent (participants and parents for minors)
* Subject affiliated to the social security scheme or benefiting from such a scheme

Exclusion Criteria for both patients and healthy volunteers:

* History of epilepsy and / or migraine (due to the epileptogenic potential of light stimuli)
* Refusal of participation of the minor even if the legal representatives want the subject to participate in the study
* Claustrophobia
* Wearing glasses
* Abnormal right and left visual acuity without contact lenses
* Distinctive signs on the face which cannot be temporarily removed
* Subject under legal protection (curators / guardianship) or deprived of liberty