cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants

The purpose of this study is to learn about:

* how Zavegepant is changed and removed from the body after taken.
* safety of Zavegepant.
* the extent to which side effects can be tolerated after taking Zavegepant for the possible short-term treatment of migraine.

This study is seeking participants who:

* are healthy Chinese adults and includes participants who are between 18 to 55 years old.
* have body mass index (BMI) of 18 to 30 kg/m\^2.
* have a total body weight of:
* equal to or more than 50 kilograms (110 pounds) for males.
* equal to or more than 45 kilograms (99 pounds) for females.
* are non-smoker (no use of tobacco or nicotine products).

All participants in this study will receive Zavegepant by nose, once at the study clinic.

The experiences of the participants receiving the study medicine will be looked at. This will help see if the study medicine is safe.

Participants will take part in this study for around 9 weeks. During this time, participants will have 2 study visits at the study clinic and 1 contact over the phone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese adults and includes participants who are between 18 to 55 years old
* BMI of 18 to 30 kg/m\^2; and a total body weight ≥50 kg (110 lb) for males and ≥45 kg (99 lb) for females
* Non-smoker (no use of tobacco or nicotine products).

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Use of medication other than topical products without significant systemic absorption.
* Previous participantion in a clinical research study or investigational study prior to the first dosing.
* Any clinically significant abnormal laboratory test results or positive test.
* Evidence of organ dysfunction or any clinically significant deviation from normal.
* Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).
* Standard 12-lead ECG that demonstrates clinically relevant abnormalities.
* Abnormalities in clinical laboratory tests: AST or ALT level \> ULN; Total bilirubin level \> ULN; ANC or ALC level \> ULN.
* Positive urine drug screen, alcohol breath test, or urine cotinine test.
* Positive pregnancy test.
* Positive result for COVID-19.
* History of significant alcohol abuse or drug abuse.
* History of anaphylaxix reaction or a clinically important reaction to any drug.
* Donation of plasma within 30 days prior to dosing. Donation or loss of blood of approximately 400 mL or more within 60 days prior to dosing.
* Inability to be venipunctured and/or tolerate catheter venous access.
* Habitual use of snuff tobacco.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Mortality Following Surgery for Proximal Femoral Fractures

Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).

We evaluate relationship between the monitored parameters and 30 day survival.

Observed parameters:

* age of the patient
* sex of the patient
* 90 days mortality rate
* American Society of Anesthesiologists (ASA) score
* time since injury and surgery (hours)
* whether surgery was initiated during the day (7:00 - 20:00) or at night (20:00-07:00)
* type of administered anesthesia (GA, epidural anaesthesia, Subarachnoid (spinal) block)
* hemoglobin level prior to surgery
* haemotransfusion administration during surgery
* perioperative administration of vasopressors
* anesthetist erudition (with / without accomplished residency)
* surgeon erudition (with / without accomplished residency)

Eligibility Criteria:
Inclusion Criteria:

* isolated fracture of proximal femur indicated for surgery

Exclusion Criteria:

* children under 18 years
* none isolated trauma
* isolated fracture of proximal femur without surgery
Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma

Esophageal squamous cell carcinoma is one of the most common malignant tumor of upper digestive tract. However, the detection rate and diagnosis accuracy of early esophageal squamous cell cancer is low. The aim of this study is to develop a computer-assisted diagnosis tool combining with optical magnifying endoscopy for early detection and accurate diagnosis of it.


Eligibility Criteria:
Inclusion Criteria:

* high risk patients for esophageal cancer aged 18 years or older;
* Histologically verified early esophageal squamous cell cancer.

Exclusion Criteria:

* patients whose images of esophagus not suitable for the training, validation and testing the computer-assist diagnosis tool.
Developmental Sequelae of Severe Chronic Lung Disorders

To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress.

BACKGROUND:

Bronchopulmonary dysplasia in infancy has been shown to be related to less optimal physical and psychological functioning later in life. Although infants with the disorder increased from 1978 to 1988, little was known about potential developmental problems early in life which might lead to the documented negative sequelae shown in previous research.

DESIGN NARRATIVE:

In this longitudinal study, infants were followed from birth and given standardized assessments of developmental and physical functioning. Demographic, birth, and medical data were collected at baseline through chart review. Standardized questionnaires measuring parental stress and family support were administered to the parents. Infants were followed at eight months, and one, two, and three years at which time parental measures were repeated and standardized assessments made of the children's physical growth, medical status, cognitive, language and behavioral development. Feeding behaviors were assessed through standardized observation and interview at each visit. Data were evaluated descriptively as well as through a series of multivariate analyses of variance with repeated measures.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Dissemination of SARS-COV-2 (COVID-19) in the Environment of Infected Patients Admitted to Intensive Care Unit

The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

Respiratory viruses are frequently responsible for acute respiratory failure which justifies hospitalization in intensive care unit. Actually, recent epidemics of emerging viruses (including COVID-19) have highlighted the possibility of air-type transmission in this specific population. Despite the fact that the risk of environmental contamination has never been objectified, It is probable that in intensive care patients, this contamination is greater than in other patients because of the gravity of the patients (greater inoculum) and the use of ventilation techniques responsible for probably increased exhaled viral expression. Defining the mode of transmission of respiratory viruses has major consequences in terms means of prevention. The "air" mode of transmission absolutely requires hospitalization in a single room and sometimes additional air treatment. The droplet transmission mode due to its short range requires simpler measures (wearing a surgical mask, no specific air treatment) and has also led to the discussion of the value of the individual room. Indeed, the use of high flow ventilation system such as "optiflow" or non-invasive ventilation, can transform a droplet risk into "air" risk. For this reason, measuring the extent of environmental contamination around infected patients in intensive care is a major issue.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Patient admitted to intensive care unit for a low respiratory infection during which the SARS-Cov-2 virus is documented, with a positive RT-PCR in the 48 hours before taking samples.
* Information and not opposition from the patient / or family

Exclusion Criteria:

* No documentation of SARS-Cov-2 viral respiratory infection.
* Patient under guardianship / curatorship
Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients

1. Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular and humoral immune responses in refractory rheumatoid arthritis (RA) patients.
2. Design: This study has been performed as a phase 1 clinical trial.
3. Setting and conduct: Autologous bone marrow derived mesenchymal stem cells were obtained by bone marrow aspiration and cultured in Minimum Essential Medium-Alpha (MEM-alpha) for 4 weeks in standard clean room and then transfused to RA patients intravenously.
4. Participant's major eligibility criteria is as follows: Ten refractory rheumatoid arthritis patients who show resistance to non biological Disease-modifying antirheumatic drugs (DMARDs) after 6 to 12 months have been enrolled in this study.
5. Intervention: A single dose of intravenous autologous bone marrow derived mesenchymal stem cells have been administered into patients with resistance to non-biological DMARDs.
6. Main outcome measures (variables): Finding of mesenchymal stem cell therapy effects on the cellular and humoral immune responses and evaluation of the effect of chemokines in homing of immune cells following the intervention.

Refractory rheumatoid arthritis patients who met the inclusion/exclusion criteria have been selected. After signing informed consent form, autologous stem cells were obtained by bone marrow aspiration. Isolation and culture (3 to 4 weeks in MEM-alpha medium) of mesenchymal stem cells (MSCs) were performed in accredited good manufacturing practices (GMP) clean room. A panel of cluster of differentiation (CD) markers including CD105, CD166, CD44, CD45, CD90, and CD34 were checked for making sure about differentiation of cells into MSCs after 3-4 weeks of cell culture. Viability of MSCs was checked by Trypan blue testing and all of the cultivations were negative for bacterial contamination. A single dose of 1000000 to 2000000 mesenchymal stem cells/kg infused into patients intravenously. To prevent anaphylactic reactions, a single intravenous dose of hydrocortison (100 ml) and oral dimenhydrinate (10 ml) were administered before MSCs infusion into patients. The effects of mesenchymal stem cells on the cellular and humoral immune responses and also the role of chemokines in homing of immune cells were studied at time points 1, 6 and 12 months after intravenous administration of MSCs in refractory rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Resistant RA patients to non-biological DMARDs;
* Treated RA patients by non-biological drugs;
* Treated RA patients by Prednisolone, Hydroxychloroquine, Sulfasalazine and Methotrexate;
* Patients age between 35-60 years;
* Refractory RA patients with no other rheumatologic disorders and inflammatory diseases.

Exclusion Criteria:

* Non-resistant RA patients to non-biological DMARDs.
Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab

An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.

The scalp sample of all subjects was taken to be analyzed for its microbial diversity. The samples were processed with Next-Generation Sequencer and analyzed with bioinformatics analysis.

The primary outcome was the characteristics of scalp microbiome

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Aged 18 years old or older who had not undergone menopause
* Consenting to the study

Exclusion Criteria:

* Scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy)
* Systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases)
* Use of topical and oral antifungal agents
* Use of cytostatic agents
* Use of topical and oral antibiotics
* Use of topical and oral vitamin D
* Use of chemical products on hair (e.g. bleaching, permanent blow, hair coloring, hair straightener)
* Pregnancy
* Lactating
* Hypersensitivity towards basic ingredients of shampoo (e.g. synthetic detergent, conditioner, thickening agent).
Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)

This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;
2. Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM
3. Age from 18 to 75 years old, regardless of gender;
4. The score of each dimension of the sputum assement scale is ≥1;
5. Those who have not participated in other drug clinical research in the past one month;
6. Sign the informed consent letter.

Exclusion Criteria:

1. Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.
2. Loose stools due to Spleen deficiency and stomachache caused by cold.
3. Diabetes or severe cardiovascular, liver (ALT\>1.5×ULN), kidney (Cr\>1.5×ULN) and other primary diseases.
4. Pregnant and lactating women.
5. Patients with acute and chronic respiratory failure.
6. Those who cannot give full informed consent due to mental disorders.
7. People with disabilities recognized by law.
8. People with allergies, or allergic to the ingredients of the drug used in this test.
9. Those who have used drugs with expectorant effects within the day.
10. Patients who are participating in clinical trials of other drugs. -
Kangroo Mother Care

infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs and comparing the pain intensity with preterm infants who receive conventional care.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants whose corrected gestational age from (32 - \<37) weeks of pregnancy
* Preterm infants who do not experience any painful procedure for last 24 hours
* Preterm infants do not receive any sedation for last 24 hours

Exclusion Criteria:

* full-term infants whose corrected gestational age is \>37 weeks
* extremely preterm (\< 28 weeks)
* very preterm (28-\<32 weeks)
* proven or suspected sepsis
* major congenital malformations
* all heart defect except neonatal Patent ductus arteriosus (PDA)
* necrotizing enterocolitis
* neurodevelopmental disability
* who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure, or high-flow support
* indicated for surgery
* contraindication to oral sucrose
* Twins
* infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 or older) being treated or managed for PBC

Exclusion Criteria:

* Inability to provide written informed consent
* Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC
Cancer, Vulnerability, and Financial Quality of Life: A Mixed Methods Study

The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life.

The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life. For people who are experiencing financial hardship, a cancer diagnosis can be devastating. For others, cancer may cause or even worsen financial stress, for example, with their work, their ability to maintain benefits such as health insurance, their ability to pay bills, and their ability to get the cancer treatment they need. The impact of cancer on financial quality of life is an important area of study within cancer care. Considering the financial burden of cancer also lends greater appreciation for the problems that people face if they cannot handle cancer's costs, or if needed resources are either not present or are too stretched to help with the care they need. For this study, up to 180 cancer patients will be interviewed with a written questionnaire. Of this group, 15 people will also be asked if they would like to participate in a follow-up personal interview with the researcher. The major hypothesis of this study is: The greater the vulnerabilities in predisposing factors and enabling factors, the greater the need factors with respect to cancer diagnosis and treatment, and the lower the perceived ability to adhere to treatment, the poorer will be the financial quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent

Exclusion Criteria:

* Pediatric patients; non-English-speaking patients
Examination of Efficacy and Safety of Baricitinib in RA Patients

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

1. Baricitinib treatment for 12 months
2. Biologics treatment for 12 months
3. Tofacitinib treatment for 12 months


Eligibility Criteria:
Inclusion Criteria:

* RA patients

Exclusion Criteria:

* Not RA patients
* RA patients who are allergic to the drugs, refused to do this research, or who are pregnant
GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds

A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.


Eligibility Criteria:
Inclusion Criteria:

1. Between 18 years and 85 years of age inclusive, as of the date of screening
2. Confirmed diagnosis of Type I or Type II Diabetes
3. Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
4. Wound is located on the foot below the malleoli
5. Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
6. Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule
7. Patient has adequate circulation to the foot as documented by either:

   * Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or
   * In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 \> 30 mmHg, or
   * Skin perfusion pressure \> 30 mmHg

Exclusion Criteria:

1. Index Wound is of non-diabetic pathophysiology
2. Gangrene is present on any part of the affected foot
3. Index Wound is over a Charcot deformity
4. The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
5. Patient has a glycated hemoglobin A1 (HbA1c) level of \>14%
6. Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment
7. Patient has a wound within 15cm of the Index Ulcer identified for study consideration
8. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
9. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
10. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
11. Patient has active malignancy other than non-melanoma skin cancer
12. Patient's random blood sugar is \>450 mg/dl at screening
13. Patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the Investigator
14. Pregnant women
15. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
16. Patient has allergy to primary or secondary dressing materials used in this trial
17. Patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
18. In the opinion of the Investigator, the patient is unsuitable for participation in the study