cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.

Eligibility Criteria:
Main eligibility criteria:

* Participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (BMI) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m\^2), and weight ≥ 50 and ≤ 95 kilograms (kg)
* Participant has hemoglobin of ≤ 16 grams per deciliter (g/dL) at the time of study entry
* Participant has normal iron stores
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.

36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose; Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each treatment period. The screening period will be up to 13 days in duration. After fulfilling screening requirements, subjects will check into the clinic on Day -1 for baseline assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. They will be domiciled in the clinical testing facility for at least 14 days for Treatment Period 2 and will return intermittently for study procedures for 7 outpatient visits.


Eligibility Criteria:
Inclusion:

* Healthy adult men and women (age 18 to 55 years)
* Body mass index greater than or equal to 18kg/m2 and less than or equal to 32kg/m2 at the time of Screening and at each Baseline
* Platelet count between 120x109/L and 300x109/L at Baseline
* Women of childbearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the treatment phase of the study

Exclusion:

* Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of the study
* Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
* Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy
* History of arterial or venous thrombosis, including partial or complete thromboses (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
* Hemoglobin less than the lower limit of normal levels (women, 7.1 mmol/L; men, 8.1 mmol/L) In addition, other standard criteria for healthy volunteers will be used.
Clinical Characteristics and Genetic Profiles of Severe Combined Immunodeficiency in China

Severe combined immunodeficiency (SCID), a rare primary immunodeficiency dieases (PID), is poorly characterized in mainland China. We meant to explore the patients with SCID refered to our hospital and summarize their clinical manifestations and genetic features.

Diagnostic criteria were based on recommendations by the Pan-American Group for Immunodeficiency and the European Society for Immunodeficiencies, which included failure to thrive, persistent diarrhea, respiratory symptoms, and oral candidiasis, or Pneumocystis pneumonia, severe bacterial infections, and disseminated Bacillus Calmette-Guérin (BCG) infection during the first 2 to 7 months of life. In addition, patients included in the study were \<2 years of age, with either transplacentally acquired maternal T cells or \<20 % CD3+ T cells, the absolute lymphocyte count (ALC) \<3000/mm3. Exclusion criteria include HIV infection, congenital rubella, DiGeorge syndrome, Zap70 deficiency, Cartilage hair hypoplasia, PNP deficiency and MHC class II deficiency.

Eligibility Criteria:
Inclusion Criteria:

Diagnostic criteria were based on recommendations by the Pan-American Group for Immunodeficiency and the European Society for Immunodeficiencies, which included failure to thrive, persistent diarrhea, respiratory symptoms, and oral candidiasis, or Pneumocystis pneumonia, severe bacterial infections, and disseminated Bacillus Calmette-Guérin (BCG) infection during the first 2 to 7 months of life.

Exclusion Criteria: HIV infection, congenital rubella, DiGeorge syndrome, Zap70 deficiency, Cartilage hair hypoplasia, PNP deficiency and MHC class II deficiency.
COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit

Patient admitted in intensive care unit (ICU) for acute infection whether it be viral or bacterial had major impairment of the immune response. One hallmark of the immune impairment is presence of immature granulocyte (IG) in blood. Depend of initial trigger (virus or bacteria) concentration, phenotype and function of IG seems to be different. In this prospective trial, immature granulocytes will be analyzed in depth in immunocompetent patients hospitalized in the intensive care unit for an acute viral or bacterial infection.

Granulocytes are a key actor of immune response during acute viral or bacterial infection. During their maturation in bone marrow they went from immature form to mature form. In physiological condition only mature form are present in blood. However, in case of acute viral or bacterial infection, immature granulocytes (CD10low/CD16low) could be released in blood. But concentration, phenotype and function of these IG seems to be different between bacterial and viral infection. Indeed, in bacterial infection, concentration of IG is high (\> 20%) and they expressed CD64 and CD123. In case of viral infection, blood concentration of IG is lower and they expressed CD62-L. These phenotype differences are probably associated with functional modification. A more precise characterization of the phenotype and functions of IG according to the stimulus (bacterial or viral) could provide a better understanding of the innate immune response in patients hospitalized in ICU for acute infection. The investigators will analysis by flow cytometry IG subsets (PDL1 CD62L LOX-1 CD45 CD64 CD15 CD123 CD16 CD10 CRTH2) of adult immunocompetent patient hospitalized in ICU for less than 24 hours for acute infection. Transcriptomic and cytokine analysis will be also performed. Infectious status will be validated by a blind adjudication committee which will classify patient in certain bacterial infection, certain viral infection, co-infection and no confirmed infection.

Eligibility Criteria:
Inclusion Criteria:

* Bacterial infection:

  * Adult patient hospitalized for less than 24 hours in ICU for community documented sepsis
  * Vasopressor support
  * SOFA score \> 4
* Viral infection:

  * Adult patient hospitalized for less than 24 hours in ICU for confirmed viral acute infection.
  * High flow oxygen, non-invasive or invasive ventilation since less than 24 hours
  * Moderate to severe ARDS with PaO2/FiO2 \< 200mmHg and a FiO2 ≥ 0.6.

Exclusion Criteria:

* Bacterial infection:

  * Antibiotics or hospitalized in ICU in the previous 3 months
  * Immunocompromized patient
  * Ongoing acute or chronic viral infection
* Viral infection:

  * Antibiotics or hospitalized in ICU in the previous 3 months
  * Immunocompromized patient
  * Current antibiotics
  * Ongoing chronic viral infection.
The Vitamin D Dose-Response Relationship

The purpose of the study is to determine the importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.

The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships.

Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Healthy

Exclusion Criteria:

* Sun bed use
* Holiday or business travel south of 45 degrees latitude during trial
* Illness
* Drug addiction
* Pregnancy
* Lactating
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects

This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial.

This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.

Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe stable chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis
* Affected body surface area (BSA) greater than or equal to 15%
* Physician's Global Assessment (PGA) score of 3 or more
* Female subjects of non-childbearing potential or postmenopausal for at least 1 year. Male subjects must agree to use effective method of birth control
* Body Mass Index (BMI) less than or equal to 38.0 kg/m2

Exclusion Criteria:

* Concomitant anti-psoriatic treatment
* Infectious disease requiring systemic anti-infectious treatment within the 2 weeks prior to administration of trial drug
* Known history of Human Immunodeficiency Virus (HIV)
* Hepatitis B and/or C (determined by test)
* Live virus or bacteria vaccines within the last month before drug administration
* Known active herpes/herpes zoster/cold sores
* Kidney insufficiency
* Liver insufficiency
* Lymphoproliferative disease
* History or signs of malignancy within the last 5 years
Mercuri Analysis Contribution on Handicap Evaluation in ArthrogypOsis, a Congenital Neuromuscular Disease

The aim is to evaluate the correlation of quantified fibro-adipous infiltration of muscles, using the MRI-based Mercuri score, with deficiencies, activity limitations and social participation in patients with arthrogryposis multiplex congenita.

Arthrogryposis multiplex congenita (AMC) refers to a rare disease spectrum characterized by the presence of joint contractures at birth in at least two different body areas. Causes are multiple. Amyoplasia and distal arthrogryposes are the most frequent causes. Phenotypes consist of muscle weakness and atrophy of variant severity and joint deformities. The impact on mobility, activities or daily living and participation is variable (Dai et al, 2018).

Mercuri et al. (Mercuri et al, 2002) have developed a semi-quantitative score to mesure fibro-adipous muscle infiltration on muscle MRI.

Correlations between fibro-adipous infiltration and muscular deficits have already been studied in other neuromusclar diseases such as Pompe disease (Figueroa-Bonaparte et al, 2016) or Duchenne muscular dystrophy (Brogan et al, 2018). These studies revealed good correlation between disease onset, muscle strength and the degree of muscle fibro-adipous infiltration, calculated using the Mercuri score. The authors concluded that muscular MRI can be used to follow the neuromuscular disease progression as it is correlated with muscle function.

Contrary to these progressive diseases, AMC is a congenital non progressive condition. It is therefore tempting to hypothesize that the muscular fibro-adipous infiltration in these patients could be of prognostic value for future capacities.

Our aim is to evaluate the fibro-adipous muscle infiltration in a thoroughly phenotyped cohort of adult patients with Amyoplasia and Distal Arthrogryposes using the Mercuri score, based on muscular MRI, in order to evaluate the correlation with deficiencies, activity limitations and social participation.

Eligibility Criteria:
Inclusion Criteria:

* adults
* with a diagnostic of Amyoplasia or distal arthrogryposis
* evaluated by a all body MRI
* functionnal evaluation during day hospitalisation in neurorehabilitation department
* between 2010 and october 2020

Exclusion Criteria:

* other aetiology of Arthrogryposis multiplex congenita (AMC)
* incomplete MRI or medical files
* interaction with other disease
Application and Evaluation of Transference Focused Psychotherapy Modified for Adolescents

Normal adolescence requires a successful resolution of identity crisis, which results in the development of satisfying relationships, success in school/work pursuits, and achievement of personal goals. Adolescents, who do not resolve this crisis, are at high risk for problems in those areas of functioning. Transference Focused Psychotherapy for Adolescents (TFP-A) is a treatment that specifically addresses these issues, permitting adolescents to develop satisfying friendships, more appropriate interactions with authority, and achieve realistic life goals.

This study will evaluate the application of TFP-A, (a empirically validated treatment for adults with identity disturbance), to adolescents exhibiting the same behavioral and identity pathology. Subjects will be females; ages 14-21, with behaviors associated with identity problems, interpersonal difficulties with teachers, parents and/or peers, and live with their families. These adolescents will be randomly assigned to one of two treatment cells, TFP-A or Treatment as Usual (TAU). Subjects in TFP-A will receive weekly individual therapy for six months. The TAU group will receive standard individual therapy in the Outpatient Department. Both will receive medication as necessary. All subjects will participate in initial, weekly, and bi-monthly assessments during the six-month treatment period, and participate in a naturalistic follow-up study for an additional six months.

Hypothesis:

Adolescents with identity problems as seen in interpersonal, school, and/or family difficulties in the Transference Focused Psychotherapy for Adolescents (TFP-A) group will reduce these problem behaviors and improve management of their feelings and moods compared to adolescents with identity problems in the treatment as usual control group (TAU).


Eligibility Criteria:
Inclusion Criteria:

1. Female Adolescents, ages 14-21
2. A score of five out of nine critical items on the Borderline Personality Disorder Dimension Interview Scale.
3. Have interpersonal difficulties in school, family, and/or peer functioning.
4. Live at home with family.
5. Willingness to attend evaluation sessions and weekly, individual therapy.

Exclusion Criteria:

1. The presence of psychosis, substance dependence, non-verbal learning disability, antisocial behavior, and/or primary diagnoses of eating disorder, bipolar disorder, and obsessive-compulsive disorder.
2. The need for hospitalization for symptom management.
3. Significant cognitive impairment (Full Scale IQ \<85).
4. The presence of a life-threatening medical illness.
Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea

This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing (Day -1).

From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or Cilostan CR Tab. 200mg once a day).

Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72 hours after 5th study drug dosing.

After 9 days of washout period (Day 15), Subjects will be dosed study drug and pharmacokinetic samplings will be done by crossover manner.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* BMI (body mass index) between 18.0 and 27.0
* Agreement with written informed consent

Exclusion Criteria:

* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
* Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin \> 1.5 x UNL)
* Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab
* Taking OTC (Over the counter) medicine including oriental medicine within 7 days
* Clinically significant allergic disease
* Subject with known for hypersensitivity reaction to Cilostazol
* Previous whole blood donation within 60 days or component blood donation within 30 days
* Previous participation of other trial within 90 days
* Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment

The study explores the safety of breast conserving treatment (BCT)(defined as complete removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.

The standard breast surgical procedure of locally advanced breast cancer in Norway is mastectomy. There is increasing interest in performing breast conserving treatment (BCT) in locally advanced cases after chemotherapy or hormonal treatment - if there is a partial or complete clinical remission. To increase the evidence for the safety (no residual tumor) of such a procedure directly compared to mastectomy without compromising the safety of the treatment, a breast preserving procedure followed by an immediate mastectomy can be performed within a study. It would then be possible to study the margins after the breast preserving procedure as well as the tumor status in the rest of the breast.

Patients included in the study will receive neoadjuvant treatment followed by evaluation of the tumor reduction by magnetic resonance imaging (MRI) and selection of BCT candidates. Candidates will be prepared for BCT, and during the surgical procedure, BCT will be performed (as one surgical specimen) followed by immediate removal of the rest of the breast tissue (mastectomy). The BCT specimen and mastectomy specimen will be analysed for residual tumor cells. The tumor removal completeness of the BCT procedure can be evaluated, with comparison to the clinical and primary tumor characteristics, including analysis of the tumor biopsies and imaging before and during the neoadjuvant treatment, for selection of candidates for BCT in the future.

Eligibility Criteria:
Inclusion criteria:

* Patients with locally advanced breast cancer (cT3-4c, N0-3) with tumors \> 5 cm, as determined by MRI, where the present guidelines include them for neoadjuvant systemic therapy
* Written informed consent (informed consent document to be approved by the Independent Ethics Committee) prior to study-related procedures and examinations.
* Female age \> 18 years
* Able to comply with the protocol
* Histologically confirmed adenocarcinoma of the breast
* American Society of Anesthesiologist's physical status category 1 or 2 before surgery. Category 1 and 2 includes healthy patients and patients with only mild systemic disease, whereas category 3 includes patients with more serious systemic diseases (but still operable).

Exclusion criteria:

* Inflammatory breast cancer or diffuse locoregional involvement of the skin
* Stage IV - metastatic disease
* Locoregional relapse of earlier breast cancer
* Inability (irrespective of reason) to receive the recommended neoadjuvant treatment, - as decided by the treating physician.
* American Society of Anesthesiologist's physical status category 4-5
Epidemiology of Sleep Apnea Syndrome

To define the prevalence of Sleep Apnea Syndrome (SAS) in a community-based sample of Hispanic adults.

BACKGROUND:

The Sleep Apnea Syndrome consists of sleep-induced disturbances of breathing and breathing-induced disturbances of sleep. Symptoms of pathologic sleepiness and, less commonly, frequent awakenings and light sleep reflect the fragmentation of sleep by repeated respiration-related arousals. Snoring, intermittent choking, and nocturnal dyspnea reflect varying degrees of upper airway obstruction associated with Sleep Apnea Syndrome. Observations of breathing during sleep show varying combinations and degrees of periodic breathing, apneas, and hypoxemia. In more severe cases, cardiovascular complications, including systemic and pulmonary hypertension and cardiac arrhythmias, occur. The clinical spectrum thus varies from the asymptomatic patient, to one with chronic cardiac and respiratory failure who is at risk of sudden death. Most patients are disabled by varying degrees of pathologic sleepiness.

The rapid increase of clinical activity with the Sleep Apnea Syndrome created an urgent need for a more complete description of this condition. Clinical descriptions were derived from case series of severely afflicted patients. Limited epidemiologic data, however, indicated that symptoms and objective manifestations of Sleep Apnea Syndrome occurred commonly in the population. It was unknown whether subjects with these findings were unrecognized patients, premorbid individuals at risk, or normal subjects with no special impairments. There was a need to define the frequency of signs and symptoms of Sleep Apnea Syndrome in the general population, and to determine the health effects related to these findings.

DESIGN NARRATIVE:

Subjects were recruited from a previous survey, the Belen Health Study, conducted from July 1984 through November 1985. Based on the data of the earlier survey, 421 subjects were identified for recruitment and 275 actually participated. The Belen Health Study questionnaire included items directed at Sleep Apnea Syndrome. Subjects for the sleep study were selected based on responses to the initial questionnaire. For the sleep study, an additional questionnaire was used, as well as new techniques of home monitoring of breathing during sleep, and polysomnography to define the prevalence of symptoms and manifestations of Sleep Apnea Syndrome. An assessment of the health effect of Sleep Apnea Syndrome was made by reference to the demographic, socio-economic, and health data from the Belen Health Study. Diagnostic criteria and the utility of home monitors for clinical diagnosis were also determined.

Eligibility Criteria:
No eligibility criteria