cyrilzakka/clinical-trials huggingface dataset:
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU

Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous ACBMNC infusion in very preterm monozygotic twins

This was a randomized, placebo-controlled, double-blinded trial involving eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair. Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with ACB-MNCs infusion, along with paired controls. Feasibility, safety and clinical outcomes improvement of the ACB-MNCs infusion in both short and long term were also assessed.

Eligibility Criteria:
Inclusion criteria

1. born at study hospitals;
2. monozygotic twins (confirmed by ultrasonographic diagnosis before birth and confirm again with obstetricians during and after delivery, as monochorionic diamniotic twins and monochorionic monoamniotic Twins twins were both monozygotic twins, therefore they will be both eligible);
3. gestational age (GA) \<32 weeks (GA was calculated based on the date of the last menstrual period of the mother and an ultrasonographic screening performed during the first trimester of pregnancy);
4. enrolled within the first 24 postnatal hours;
5. free of severe perinatal asphyxia (defined as an Apgar score of 0-3 for more than 5 minutes, a cord blood gas pH \<7.00, or both);
6. free of severe congenital anomalies or genetic syndromes;
7. free of maternal sepsis24,25;
8. Written informed consent is obtained from the parents or guardians of the infants;
9. Either of the twins has available umbilical cord blood (UCB) , and the cell number was no more than 10×107 cells per kilogram, but should not be less than 2×107 cells per kilogram.

Exclusion criteria

(1) they exhibit severe congenital abnormalities (detected via prenatal ultrasound); (2) expected to die within the first 24 hours; (3) diagnosed with severe twin-to-twin transfusion syndrome confirmed by prenatal ultrasonography24.
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
* Able to dose orally
* ECOG Performance status of 0-1
* No other significant underlying ocular disease
* Adequate organ function
* Not pregnant/nursing or planning to become pregnant. Willing to use birth control

Exclusion Criteria:

* Previous treatment with a Protein Kinase C (PKC) inhibitor
* Concurrent malignant disease
* Active HIV infection or Hep B/C
* Malabsorption disorder
* Unable to discontinue prohibited medication
* Impaired cardiac function or clinically significant cardiac disease
* Any other condition which may interfere with study interpretation or results
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects

This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.

The single ascending dose study will comprise 4 dose cohorts of 8 healthy participants each. In each cohort, participants will be randomized to receive 9MW3811 or placebo by 6:2.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants between 18 and 55 years of age, inclusive.
2. Male body weight ≥50.0 kg, or female body weight ≥45.0 kg, and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
3. In good health determined by the investigator based on a medical evaluation, including a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, laboratory evaluations.

Exclusion Criteria:

1. Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
2. Having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment.
3. Use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (Excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the PI or designee)
4. Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
5. Participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening
6. Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody
7. History of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (Morphine, Methamphetamine, Tetrahydrocannabinol acid, Cocaine)
8. Participants with a positive SARS-CoV-2 test prior to admission (polymerase chain reaction (PCR) and/or rapid antigen testing (RAT), per site policy and PI discretion)
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)

This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted reproductive technology (ART) program.


Eligibility Criteria:
Inclusion Criteria:

- Women with an indication for COS prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who meet the criteria as mentioned in the current Korean ELONVA local label

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus
* Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
* Primary ovarian failure
* Ovarian cysts or enlarged ovaries
* A history of OHSS
* A previous COS cycle that resulted in more than 30 follicles ≥ 11 mm measured by ultrasound examination
* Basal antral follicle count \> 20
* Fibroid tumors of the uterus incompatible with pregnancy
* Malformations of the reproductive organs incompatible with pregnancy
* Pregnancy
* Polycystic ovarian syndrome
A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)

The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease enzyme. It will be used with interleukin-2 in patients infected with HIV.


Eligibility Criteria:
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension

The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12-85 years; of either gender.
* Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH).
* 6-minute walk distance (6-MWD) between 100-450 meters at screening.
* On a stable dose of sildenafil, with or without bosentan.

Exclusion Criteria:

* Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1 antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil within the past 12 weeks.
* Pulmonary hypertension due to conditions other than those stated in inclusion criteria.
* Additional PAH medications added within the past 12 weeks.
Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction

This study compares flare type self-expandable metal stent with conventional D-type self-expandable metal stent for malignant colorectal obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Malignant colorectal obstruction confirmed by radiologic study

Exclusion Criteria:

* Bowel perforation
* Multiple obstruction
* Benign obstruction
* Pregnancy
Evaluation Using ClearView in Determining Association to the Cardiac Risk Factors

The objective of this study is to explore the relationship between the ClearView scan results and a variety of cardiovascular risk indicators such as the Coronary Calcium Score, Framingham Risk Factors, Reynolds Risk Score, and biomarkers of inflammation. The ClearView device is a bio-electrographic tool that may assist medical professionals in rapid assessment of the systemic origin of the patient's presenting symptom(s). The ClearView is a potentially valuable resource that may benefit a physician's office by offering expedited differentiation capabilities. The subsequent results have the potential to include more data that would allow rapid patient diagnosis, triage, and treatment; optimized precious resource expenditure (nursing, physician, etc.); lower costs to facility, patient and insurance company; and decreased office wait time.


Eligibility Criteria:
Inclusion Criteria:

* Sex: Male or Female
* Age range: 18 to 85
* Patients who are recommended for and who have had a cardiac CT study that produces a Coronary Calcium Score within 30 days prior to the ClearView Scan or plan to have the CT within 14 days after the ClearView Scan.
* Patients who have had a blood test resulting in hs-CRP, fasting lipid panel and MPO results within 6 months prior to the ClearView Scan or plan to have the tests done within 14 days after the ClearView Scan.
* The patient or legal representative is able to understand and provide signed consent for the procedure.

Exclusion Criteria:

* Patients with pacemakers or another implanted electrical device, such as an automatic internal cardiac defibrillator.

  * Patients connected to an electrical device that cannot be removed or temporarily powered off (i.e. monitor) during subject testing with the ClearView Device
  * Vulnerable populations
  * Patients actively being treated for cancer or with a previous diagnosis of cancer that required chemotherapy, radiation therapy or hormonal therapy.
  * Patients missing all or any part of a fingertip (excluding fingernail).
  * Patients with involuntary hand tremors /shaking of the hands that may prevent clear imaging.
Meditation, Mindfulness, and Yoga to Reduce Perceived Stress in Resident Doctors - A Randomized Controlled Trial With Crossover Design

General practitioners perceive their work as meaningful. However, according to a report from the Swedish Medical Association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. Several studies on mindfulness, yoga and meditation have shown effect on stress and burn out symptoms. The aim of the study is to investigate whether a specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work, can reduce perceived stress levels compared to a control group.

The study is designed as a randomized controlled trial with a crossover design. The outcome measure is the level of stress assessed using the Perceived Stress Scale (PPS), Swedish version (PSS 14). Inclusion criteria are resident general practitioners in Skåne, within the preliminary catchment area of Malmö Trelleborg, who have experienced any form of stress symptoms they believe are related to their work. Participants will be recruited through an oral presentation during an educational seminar in spring 2024. Those who are interested will get a link to a webb-based questionnaire where they can fill in their informed consent and contact information. Participants will be randomised to intervention (I) or waiting list (C). The interventions lasts for 6 weeks and consists of a 6 different mindfulness/ meditation/yoga-sessions (lasting for 20 minutes each). The sessions will be sent to the participant on USB-stick or via webb-link. Each of the 6 sessions are tailored to address a specific challenge that resident doctors may face in their daily work. The preliminary themes that will be addressed are 'Handling Mistakes,' 'Letting Go of Work,' 'Setting Boundaries,' 'Taking Breaks,' 'Being Good Enough,' and 'Managing Work Stress. The participants are encouraged to perform the program at least 3 times/week. Both groups will fill in the PSS-questionnaire at study start and after 6 weeks.

The control group will start the intervention after the second questionnaire (week 7-12) and will fill out the PSS-questionnaire a third time after intervention completion. The results will be analysed according to intention to treat. The Mann-Whitney U-test will be used to compare whether there is a significant difference in the change of median values on PSS 14 between the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Resident doctor in primary care having felt work related stress at any time

Exclusion Criteria:

* none
The Effect of Nasal Hair on Nasal Obstruction

Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many studies have been performed quantifying and describing the impact of a number of factors on symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory causes. Despite this scrutiny, no attention has been paid to the nasal vibrissae as a potential anatomical contributor to nasal obstruction. The proposed study intends to elucidate that contribution, if any exists.


Eligibility Criteria:
Inclusion Criteria:

* Presence of nasal vibrissae
* Able to tolerate rhinomanometry

Exclusion Criteria:

* Anatomical or other obvious cause of obstruction
* Claustrophobia with rhinomanometry mask
Optimal Length of Pre-inserted ETT for Nasal Fiber Optic Intubation

This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic intubation and the equation to predict it.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* aged 20-65 yr (adults)

Exclusion Criteria:

* rhinitis
* bleeding diatheses
* requirement of awake intubation
* a previous major oral and maxillofacial surgery history
* anatomical deformity of the face, neck and upper airway
Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)

This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.

("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis

Exclusion Criteria:

* Not applicable
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. This study also aims to determine whether the intrauterine administration of 5 million peripheral blood monocluear cells increases implantation and pregnancy rates in patients with RIF and decreases the risk of miscarriages in patients with RM, compared to what has already been published in the scientific literature


Eligibility Criteria:
Inclusion Criteria:

* All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, without a RIF status, agreeing to participate in the study and having signed the consent form to participate in the study.
* All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, with a RIF or RM status, agreeing to participate in the study and having signed the consent form to participate in the study.

Exclusion Criteria:

* Women who need a gametes donor (eggs and / or sperm).
* Women undergoing an IVF cycle with frozen sperm.
* Women with autoimmune disease.
* Women with diabetes.
* Women with a history of chemotherapy treatment.
Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia

The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects aged 20 to 80 years
* Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN).
* Subjects must have pain present for \> 3 months after healing of the acute herpes zoster skin rash.

Exclusion Criteria:

* Other severe pain that may potentially confound pain assessment.
* Subjects with symptoms of neuropathic pain applied Medical Equipment
* Within 2 years: Subjects were diagnosed with cancer
Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial

This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.

This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses (a standard dose and a high dose) of a combination of live microbials (probiotics), currently marketed in food (including products labeled as dietary supplements), given daily for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with prior confirmed SARS-CoV-2 infection. Data collected will include demographics, comorbidities, medications, information about prior SARS-CoV-2 infection, and self-reported symptoms and adverse events (AEs). Biospecimens (saliva, nasal wash, blood, and stool) will be collected at baseline and days 21 and 42 for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (any gender, ages 18 to 60 years old) in good general health, based on medical history
* SARS-CoV-2 infection \>4 months prior confirmed by a positive polymerase chain reaction (PCR) or antigen test
* Body mass index (BMI) of 18.5-39.9 kg/m2
* Agreement to comply with the protocol and study restrictions
* Access to internet in addition to willingness and ability to use web-based questionnaires
* Available for all study visits
* English-speaking

Exclusion Criteria:

* Recent infection with coronavirus disease-2019 (COVID-19) (newly positive PCR or antigen test within prior 4 months)
* Prior receipt of antibody therapies (convalescent or monoclonal) towards COVID-19
* Prior receipt of vaccines against COVID-19
* Prior or current participation in a clinical trial of vaccines against COVID-19
* Scheduled to receive a vaccine against COVID-19 in the following month
* Regular use of any live microbial (probiotic) supplements
* Any acute or chronic respiratory tract disease besides mild to moderate asthma
* Any diagnosed immunodeficiency
* Current use of immunosuppressive drugs
* Any diagnosis of chronic gut disease, such as inflammatory bowel disease or irritable bowel syndrome
* Pregnancy or breastfeeding
* Recent use of antibiotics
* Current addiction to alcohol, drugs, or medications
Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy

The purpose of this study is to verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy.

According to the National Cancer Institute (INCA), the estimate for Brazil, 2016-2017 biennium, points to the occurrence of about 600,000 new cases of cancer, and breast cancer (58000) in women will be the most frequent. One study revealed that only 12% of women undergoing chemotherapy in CM who participated in a physical exercise program had to readjusted the dose of the medications, while 34% of those who received the conventional treatment needed to readjust the Treatment doses, with neuropathy being one of the most present adverse effects that influenced this adjustment. In this sense, the conduct to keep the patient at rest during the treatment seems to potentiate her side effects, and sedentarism is another factor detrimental to the patient's health. Objective: To verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy. Methodology: A sample will consist of 136 (136) Women, over 18 years of age, sedentary, diagnosed with non-metastatic breast cancer and initiating the first cycle of chemotherapy. They will be divided into two groups, randomly and stratified: control group: (CG n = 68) and exercise group: (eg n = 68) that will undergo a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times Weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and both groups (GC and EG) will attend lectures on health education, which are held monthly.

Eligibility Criteria:
Inclusion Criteria:

* women over 18 years of age;
* with the first diagnosis of non-metastatic breast cancer;
* Sedentary for 6 months;
* who are in the initial cycle of chemotherapy;
* with the release of the responsible physician;
* availability to participate in the exercise program;
* signing of the free and clarified consent term.

Exclusion Criteria:

* women with clinical risk for physical exercise (e.g. severe anemia, ICC, CRI);
* Pregnant women;
* Osteoarticular problems that preclude the practice of physical exercise.