cyrilzakka/clinical-trials huggingface dataset:
Study in Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury

The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI (acute lung injury) patients with the purpose to assess the treatment associated changes of extravascular lung water (EVLW) within 7 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control
* meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS):
* Onset of ALI within 48 hours
* Bilateral infiltrates seen on frontal chest radiograph
* PCWP ≤ 18 mm Hg or no clinical evidence of left atrial hypertension
* paO2/ FiO2 ratio ≤ 300 mm Hg
* EVLW in PiCCO® at screening ≥ 8 ml/PBW
* Meeting criteria for extensive hemodynamic monitoring according to investigators discretion
* ICU Patients being mechanically ventilated and are stable in this condition for at least 8 hours
* Negative pregnancy test and adequate contraception in female patients of childbearing potential
* Informed consent:
* For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.

Exclusion Criteria:

* History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
* Brainstem death at screening
* Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure \< 90 mm Hg or mean arterial pressure (MAP) \< 70 mm Hg for not less than one hour which cannot be reversed with fluid resuscitation)
* Neutrophil count \<0.3 x 109 L
* Patients under immunosuppression: high dose steroids (\> 80 mg Prednisolone /d; \> 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
* BMI \< 18.5 or \> 35
* Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
* Pregnancy / lactation or intention to fall pregnant during the time course of the study
* Women of childbearing potential as well as men of procreative capacity who are not using adequate contraception
* Participation in other interventional drug trials
Newborn Sequencing Screening in China

The project will carry out the genetic testing of 10000 neonates. The aim of the project is to assess the application of targeted sequencing technology in the screening of neonatal diseases.

Neonatal screening (NBS) is the last step of birth defects prevention. Currently, biochemical and mass spectrometry are commonly used for NBS, but there are limited diseases and certain false positive/negative. High-throughput sequencing (NGS) has been widely used in prenatal diagnosis, tumor-targeted biomarkers detection and pathogen detection. Although the application of NGS in new screening has a broad prospect and many countries around the world have begun to explore it, there are still challenges in the selection of screening diseases, gene clinical phenotypes, genetic counseling and clinical pathway.

Since 2019, our team began to explore the appllication of NGS technologies in the clinical application of tertiary prevention, combined with Clinva, HGMD, OMIM database, on the basis of screening specific disease-causing genes and mutation sites as the target, A NGS panel for Newborns in China (NeoExome) was designed, covering 542 single-gene diseases with 601 genes. The rationality and validity of the NGS panel was preliminarily verified in 3423 neonatal blood samples collected from 5 new screening centers in China.

In order to further optimize the gene screening spectrum of neonatal diseases in the Chinese population, evaluate the efficacy of targeted sequencing technology in the screening and diagnosis of neonatal diseases, standardize the clinical pathway, and lay a foundation for the formulation of China's new screening NGS guidelines, the investigators further optimized the targeted sequencing package (NeoexOME-V2) on the basis of the first phase. 491 genes covering 485 single-gene genetic diseases were designed to launch the "Budding Action". The project plans to collect 10000 samples nationwide and carry out the multi-center clinical research on the application of targeted sequencing technology in the screening of neonatal diseases.

Eligibility Criteria:
Inclusion Criteria:

* -- Subjects: all newborns (from birth to 28 days);
* -- After fully understanding the program, the guardian signs the informed consent and agrees to participate in the program.

Exclusion Criteria:

* Other similar clinical research projects are under way for the examined neonates;
* Neonates have received transfusion of allogeneic blood products;
* Newborns whose guardians explicitly refuse to participate in the program after receiving the mission.

Elimination criteria

* Samples that are not properly collected or stored for testing;
* Samples with non-standard data records;
* Samples without clinical follow-up results;
* The project recalls newborns who are required to withdraw by their guardians during the follow-up.
Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing

A pilot Study

To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.

Pilot RCT for upto 60 subjects across 2 arms

Intervention A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants.

Each online session will be circa 40-50 minutes in length. This will include an Introduction and warm up; Breathing practice including yogic breathing and a final cool down and relaxation.

Sessions will run at set times to ensure efficient use of resources but will try to accommodate different time points periods of the day when patients might be functioning best.

Comparator A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.

Primary co-outcomes

Change in

* Breathlessness: Chronic Respiratory Disease Questionnaire-Dyspnoea domain (CRQ-D)
* Functional measure: 5 repetition chair to stand (5RCTS)

Secondary measures include other measures of breathlessness, function, adherence and completion (see full text for detail).

Eligibility Criteria:
Inclusion Criteria:

* Either hospitalised or non-hospitalised with confirmed COVID-19 acute infection.
* Received a comprehensive clinical respiratory assessment
* Persisting (\>12 weeks) self-reported breathlessness (on CRQ-D) following COVID-19 and confirmed dysregulated breathing (Nijmegen Questionnaire score NQ \>23)
* Age 18 - 80 years of age
* Ability to give informed consent
* Able to understand and speak English language

Exclusion Criteria:

* Severe mood disturbance that limits engagement with the intervention and study outcomes
* No access to online delivery and/or IT illiterate
* Significant diagnosed Myalgic Encephalitis/Fibromyalgia/Chronic Fatigue Syndrome prior to developing COVID-19
* Severe asthma or other chronic lung disease prior to COVID-19
Early Detection of Advanced Fatty Liver Disease

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects.

The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.

The investigators will run an algorithm for the non-invasive diagnosis of advanced fibrosis in non-alcoholic fatty liver disease on a participants without known liver disease.

Nafld Score and Elastography are now being used to predict the severity of liver fibrosis and deciding whether the patient is going to a biopsy, clinical follow-up or further investigation of liver cirrhosis and complications.

The detection of participants with Nafld Score more than 0.675 (advanced fibrosis) will enroll them to an elastography test. Participants with advanced fibrosis according to elastography will be introduced to follow-up and treatment that should delay or prevent progression of the disease to more advanced conditions like: cirrhosis, portal hypertension, esophageal varicose veins and hepatocellular carcinoma.

If the investigators find that the results of the study are consistent with their hypothesis, this will lead to applying the flowchart to a larger sample of population in order to use it as a future survey.

Moreover, the investigators will check whether there is a correlation between Nafld Score and elastography in participants without know liver disease with Nafld Score more than 0.675.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily.
2. Subjects without known liver disease.
3. Subjects agree to sign a consent form. -

Exclusion Criteria:

1. History of right-sided heart failure
2. History of liver disease including positive infectious serology for hepatitis B or C
3. Pregnant women
4. People incapable of judgment -
Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection.

Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed.

Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.

Eligibility Criteria:
Inclusion Criteria for Step 1:

* HIV infected
* HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry
* Willing to use acceptable means of contraception
* d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm
* Coenrolled in ACTG A5152s

Exclusion Criteria for Step 1:

* On ARV therapy for 7 days or more any time prior to study entry
* NNRTIs or 3TC at any time prior to study entry
* Current peripheral neuropathy of Grade 2 or higher
* Pregnancy or breastfeeding
* Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.
* Human growth hormone within 30 days prior to study entry
* Initiation of testosterone or anabolic steroids within 30 days prior to study entry
* Certain other medications within 30 days of study entry
* Hypersensitivity to components of the study drug formulations
* Drug or alcohol use or dependence that would interfere with adherence to study requirements
* Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry
* Recent infection with drug-resistant HIV
The Effects of Acupressure Applied to the Primiparous During Episiotomy

This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.

The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.

Introduction: This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.

Methods: The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 or older,
* having a single healthy newborn,
* Giving spontaneous birth through a medio-lateral episiotomy incision,
* No signs of infection such as vaginal redness or swelling,
* Women with full and healthy tissue integrity in the area where acupressure will be applied.

Exclusion Criteria:

* The need to use unusual lidocaine during episiotomy repair (lidocaine 2% higher than 5 ml),
* having any postpartum complications (such as bleeding, hypertension).
Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3

RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing, or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow to cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer from forming.

PURPOSE: This randomized is studying how well zoledronate works in treating patients with cervical intraepithelial neoplasia 2/3 or 3.

OBJECTIVES:

* Assess clinical response, in terms of lesion size and histological grade, of oledronate in patients with cervical intraepithelial neoplasia 2/3 or 3.

OUTLINE: This is a randomized, placebo-controlled, double-blind, pilot study. Patients are stratified according to degree of cervical intraepithelial neoplasia (CIN) (CIN2/3 vs CIN3). Patients are randomized to 1 of 2 treatment arms.

* Zoledronate: 100 cc of saline with 4 mg of Zoledronate intravenous (IV), over 20 minutes, for 3 doses one week apart
* Placebo: 100 cc of saline (IV), over 20 minutes, for 3 doses one week apart

In both arms, treatment repeats every 21 days for up to 3 courses. In week 8, patients undergo surgical resection comprising loop excision or cone biopsy.

After completion of study treatment, patients are followed at week 10 by telephone.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3

  * Planning loop excision or cone biopsy
  * Diagnosis within 2 months prior to study entry
  * Standard histological grading according to Richart
* Visible lesion by colposcopy

  * No unsatisfactory colposcopy or lesions extending into the endocervical canal that cannot be visualized entirely by colposcopy
* No suspicion of invasive cervical cancer by cytology, histology or colposcopy
* No cytologic evidence of glandular atypia or dysplasia

PATIENT CHARACTERISTICS:

* Creatinine normal
* Screening laboratory values within normal range (e.g., complete blood count, liver function tests, renal panel, and electrolytes)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to read and speak English or Spanish
* No known hypersensitivity to bisphosphonates
* Not immunocompromised
* No known HIV positivity
* No aspirin-sensitive asthma due to association of bisphosphonates with bronchoconstriction
* No unexplained abnormal vaginal bleeding

PRIOR CONCURRENT THERAPY:

* No concurrent loop diuretics, aminoglycosides, other nephrotoxic drugs, immunosuppressive drugs, or other investigational agents
Clinical Study of Generic and Brand Bupropion in Depression

Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.

The protocol is a prospective, randomized, double-blinded, crossover study with Major Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).

Subjects will be studied in 4 phases for a total of approximately 28 weeks:

Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).

Eligibility Criteria:
Inclusion Criteria

Each subject must meet all of the following criteria:

1. Adult outpatients age 18-75 years
2. Currently on once daily bupropion HCl 300mg XL (brand or any generic), for a minimum of 4 months
3. Major depressive disorder (MDD), in partial or full remission for at least 4 months, as confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). Spontaneous relapse of depression unrelated to medication changes is less likely - about 5% chance per year - after remission has been maintained for at least 4 months.2
4. Ability to understand and willingness to comply with study procedures, and to provide written informed consent

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

1. Remission from depression not clearly attributed to bupropion treatment
2. Current severe side effects attributable to bupropion
3. Poor adherence to bupropion treatment per patient self- report and history of refill persistence
4. History of active seizure disorder, or seizure treatment within past year
5. History of significant hepatic or renal disease, based on physician assessment
6. Currently taking drugs or natural products known to influence cytochrome P450B6 (CYP2B6) activity
7. Currently taking drugs for hepatitis C or multiple sclerosis, due to their ability to cause depression
8. Dementia or other significant cognitive impairment, per diagnosis or investigative team's assessment
9. Lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order, delusional disorder, or current psychotic symptoms diagnosed by SCID
10. Abuse of or dependence on alcohol or other substances within the past 6 months as determined by SCID, and confirmed by study physician interview
11. Current suicidal ideation
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China

The purpose of this study is to learn about the safety and what the body does to the medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple myeloma.

Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies).

This study is seeking participants who:

* have non-Hodgkin lymphoma or multiple myeloma.
* have worsened with (or lack of improvement to) a standard treatment taken before.
* have relatively normal functioning organs.

All participants in this study will receive Maplirpacept as an intravenous (IV) infusion (given directly into a vein) at the study clinic every week.

Participants will continue to receive Maplirpacept until:

* the cancer worsens.
* some serious side effects show up.
* the participants do not wish to take the study medicine any more.

The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine Maplirpacept, is safe and can be given to Chinese people.

The study is composed of 2 parts. In Part A, approximately 3-6 participants are expected to be enrolled to confirm the tolerability in Chinese participants. If deemed safe, the enrollment of Part B will proceed to include a total of approximately 9 participants in the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy of single agent PF-07901801 (Maplirpacept).

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed relapsed/refractory non-Hodgkin lymphoma without other effective therapeutic option. Or relapsed/refractory multiple myeloma exposed to therapies including PI, IMiD and anti-CD38 antibody.
* With measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Adequate organ functions (including hematologic status, coagulation, hepatic, and renal)

Key Exclusion Criteria:

* Active plasma cell leukemia, or POEMS syndrome.
* Known, current central nervous system disease involvement.
* Significant cardiovascular disease.
* Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.
* Radiation therapy within 14 days of study treatment administration.
* Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or participants with active GVHD disease.
* Use of any anticancer drug within 14 days before planned start of study treatment.
* Prior anti-CD47 or anti-SIRP alpha therapy.
* Participation in other studies involving investigational drug(s) or vaccines within 4 weeks from the last dose
* Known active, uncontrolled bacterial, fungal, or viral infection.