cyrilzakka/clinical-trials huggingface dataset:
Inhaled Nitric Oxide for the Adjunctive Therapy of Severe Malaria: a Randomized Controlled Trial

Despite the use of highly effective anti-malarial medications, 10-30% of African children with severe malaria will die, underscoring the need for adjunctive therapies that can be applied in endemic areas. A clinical trial of adjunctive inhaled nitric oxide (iNO) in severe malaria is warranted on the basis of firm proof of concept from animal studies and a human study using the NO donor L-arginine, together with evidence of safety from clinical experience and trials of iNO for other conditions. Our objective is to determine whether supplemental iNO (80 ppm) in addition to Ugandan Standard of Care treatment reduces levels of Angiopoietin-2 (Ang-2), a quantitative biomarker of malaria severity, in children with severe malaria compared to Standard of Care treatment alone. We will conduct a randomized placebo-controlled trial among children 1-10 years of age admitted to Jinja Hospital (Uganda) with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.

Severe malaria remains a major cause of global morbidity and mortality. While the use of artemisinin-based antimalarial therapy has improved outcomes in severe malaria, the mortality rate remains high. Adjunctive therapies that target the underlying pathophysiology of severe malaria may further reduce morbidity and mortality. Endothelial activation plays a central role in the pathogenesis of severe malaria, of which the angiogenic factors angiopoietin-1 (Ang-1) and angiopoietin-2 (Ang-2) have recently been shown to function as key regulators. Nitric oxide (NO) is a major inhibitor of Ang-2 release from endothelium and has been shown to decrease endothelial inflammation and reduce the adhesion of parasitized erythrocytes. Low-flow inhaled nitric oxide gas (iNO) is a US FDA-approved treatment for hypoxic respiratory failure in neonates. Based on compelling data on the efficacy of iNO in experimental cerebral malaria in animal models, coupled with the documented safety of iNO in clinical practice and trials for other diseases, we propose a randomized clinical trial of iNO for the adjunctive treatment of severe malaria in Ugandan children.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-10 years
* Positive malaria rapid diagnostic test in the presence of any of the features of severe malaria
* Willing and able to complete follow up schedules for the study - 14 day and 6 months after hospital discharge

Exclusion Criteria:

* Baseline methemoglobinemia
* Known renal, cardiac, or hepatic disease or other chronic illnesses like diabetes, epilepsy, cerebral palsy, clinical AIDS
* Severe malnutrition
* Severe malarial anemia without other signs of severe malaria
Treatment Outcome in Elderly Patients

A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL regimen as induction and were randomized to receive, after achieving CR or PR, a maintenance therapy including or not androgens. Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years

* Induction Therapy:

  * Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1
  * if CR or PR: randomisation = maintenance therapy including or not androgens
* Maintenance therapy :

  * 6 courses of reinduction with idarubicin (8mg/m2 d1) and cytarabine (100mg/m2d1-5, subcutaneously) every 3 months, and, between these courses, a continuous regimen of methotrexate and 6-mercaptopurine.
  * Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years or more
* "de novo" AML according to FAB criteria
* AML with 20% or more myeloid marrow blasts
* signed and dated informed consent
* OMS score \< 3
* Life expectancy \> 1 month

Exclusion Criteria:

* Patients aged \< 60 years
* or AML M3
* or not classificated according to FAB criteria
* or extramedular localisation of AML
* OMS score ≥ 3
* clinical Abnormal Cardiac fonction or with left ejection fraction \< 40 %
* abnormal renal function with creatinine clearance \< 50/ml/mn/m²
* abnormal hepatic function
* previous cerebral stroke
* previous malignancy : prostate, breast cancer (males)
* PSA dosage \> 4
* Any coexisting medical or psychological condition that would pleclude participation in the required study procedures
The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer

The human intestine is colonized with a complex microbial community and forms a super organism with the human body. Intestinal microorganisms include more than 1,000 kinds of bacterias, and their flora is very complex and functions are very diverse. The intestinal flora affects the body's nutrition, immunity and metabolism through interaction with the human body and the external environment, and is closely related to multiple systems. When the flora structure and function are changed, it will lead to the occurrence of various diseases or increase the risk of disease. In recent years, the role of intestinal microbes in tumorigenesis and development, as well as the role of diagnosis and treatment have been paid more and more attention. Abnormal intestinal flora can not only promote tumorigenesis, but also affect radiochemotherapy and immunotherapy effects. It is worth noting that the huge impact of the intestinal flora on immunotherapy suggests that immune checkpoint inhibitors can maximize the efficacy by protecting the balance and diversity of the intestinal microecology. Therefore, in this study, quantitative analysis of the diversity and abundance of intestinal, urinary tract flora, and urine components before and after adjuvant chemotherapy in patients with gastric and bowel cancer was performed. The link between treatment efficacy and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, male or female
2. Surgery specimens were clearly diagnosed as gastric cancer and colon cancer by histopathology
3. The operation method is not limited (both laparoscopic surgery and open surgery)
4. After the perioperative period, stop using antibiotics for not less than 2 weeks
5. It is planned to receive a chemotherapy regimen with a combination of platinum and fluorouracil for a period of 21 days (gastric cancer is the SOX or XELOX regimen, and colon cancer is the XELOX or FOLFOX regimen)
6. Blood routine, biochemical and other related laboratory tests showed no obvious abnormalities
7. There are no contraindications for related adjuvant chemotherapy indications.

Exclusion Criteria:

1. Neoadjuvant treatment before gastric and bowel cancer surgery
2. Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases
3. Before the perioperative period, because of anastomotic fistula and gastrointestinal perforation, reoperation
4. The following drugs were used within 2 weeks before enrollment:

   1. Various antibiotics, including antifungals (oral and intravenous)
   2. Probiotic preparations, various prebiotic preparations, etc c Glucocorticoids; d Take drugs known to have a significant effect on the intestinal and urethral flora within half a year (such as proton pump inhibitors, purgatives, bismuth, adsorbents, non-steroidal anti-inflammatory drugs, etc.)
5. Other situations that the researcher considers unsuitable to participate in the experiment;
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer

The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are:

* prognostic value of baseline MRD;
* the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;
* conversion therapy was planned;
* both sexes, age ≥18 years old;
* ECOG performance status score ≤2;
* the expected survival time was ≥3 months.

Exclusion Criteria:

* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
* treated with any systemic antitumor treatment before first-line chemotherapy onset;
* died or lost to follow-up within one month after the initiation of first-line chemotherpay;
* combined with other primary malignances.
The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery

The purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery reduces injury to the heart and vascular system during and after surgery. Furthermore, this study also aims to identify some of the post CABG clinical effects of HBO treatment prior to CABG.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective first time CABG
* Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG

Exclusion Criteria:

* Age ≤ 20 years or ≥ 85 years
* Ejection fraction \< 30%
* Unstable angina
* Recent myocardial infarction (\< 1 month)
* Any additional cardiac disease (e.g. arrythmia, aneurysm, valvular/septal disease, dissection or elevated pulmonary artery pressure)
* Any end stage organ failure (e.g. renal and respiratory failure)
* History of chronic obstructive pulmonary disease (COPD)
* Pneumothorax
* Pulmonary bullae
* Convulsions
* Current history of malignancy
* Severe myopia or intraocular lens
* Patients on K+(ATP) Channel Openers e.g. Nicorandil, Oral Hypoglycemics, Opioid Analgesics, Catecholamines.
Excimer Light Versus Blue Light in Acne

The aim is to assess the efficacy and safety of Excimer Light versus blue light in the treatment of inflammatory acne.

The use of new light energy in inflammatory acne

Eligibility Criteria:
Inclusion Criteria:

* Age group: 14- 25 years • Patients of both genders. • Patients with mild to moderate inflammatory acne lesions • Willingness and ability to comply with the requirements of the protocol

Exclusion Criteria:

* Pregnancy during the first trimester • Female patients with medical history of PCO • Topical and systemic treatment within the last month and systemic retinoids for 6 months • Patients on systemic steroids treatment or hormonal therapy • Severe systemic illness or malignancy • Photosensitivity • Scarring acne vulgaris
Patient Expectations and Dry Needling

Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions. DN has shown to be effective on pain and function in patients with mechanical neck pain. Potential effects of DN can be related to several mechanisms, including physical, cognitive and emotional factors. This study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. Expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies (PSOE) questionnaire which was adapted to the cervical spine.


Eligibility Criteria:
Inclusion Criteria:

* Non-specific mechanical neck pain of at least 3 months of duration
* At least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms

Exclusion Criteria:

* whiplash injury;
* previous cervical or thoracic surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone physical therapy in the previous 6 months;
* fear to needles
A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors

This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Life expectancy of at least 12 weeks
* Adequate hematologic and end organ function
* Histologic documentation of locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy is ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is recognized standard of care
* Tumor specimen availability
* Measurable disease according to RECIST v1.1

Exclusion Criteria:

* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
* Malignancies other than disease under study within 5 years prior to D1 of C1
* Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
* History of leptomeningeal disease
* History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
* History of autoimmune disease
* Positive human immunodeficiency virus test result
* Active hepatitis B, hepatitis C, or tuberculosis
* Severe infection within 4 weeks prior to D1 of C1
* Prior allogeneic bone marrow or solid organ transplantation
* Significant cardiovascular disease
* Known clinically significant liver disease
Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects

The world population has been growing and aging dramatically, with a rising prevalence of dementia. Worldwide, around 50 million people have dementia, with 10 million new cases added every year. Despite the epidemic scale of dementia, until now no cure or disease-modifying therapy has been identified. Therefore, the World Health Organization (WHO) has recognized dementia as a public health priority. Several large studies have demonstrated that hearing impairment is associated with a greater risk of cognitive impairment. Hearing rehabilitation could potentially provide a disease-modifying therapy to delay cognitive decline. Although auditory behavioral research has not yet revealed a reliable indicator of early cognitive impairment, cortical-evoked auditory potentials (CAEP) have shown promising evidence as a non-invasive way to identify early-stage cognitive impairment.

The peripheral vestibular apparatus is located in the inner ear and codes rotation and translation of the head to preserve a stable view. Increasing evidence suggests that bilateral vestibular function loss, also known as bilateral vestibulopathy (BVP), leads to hippocampal atrophy and reduced spatial cognitive skills, as well as structural and functional alterations in parieto-insular and parieto-temporal regions. Many studies have demonstrated that vestibular function declines with age. Vestibular dysfunction can be linked to reduced topographical orientation and memory and has been suggested as a risk factor to AD, due to increased risk of falling and deficits in activities of daily life (ADL).

Our first aim is to study the effect of SNHL and vestibular decline on CAEP, spatial and non-spatial cognitive functioning and trajectories in cognitively healthy older subjects, as well as patients with mild cognitive impairment (MCI) and AD. Our second aim is to study if MRI brain volume changes can be observed in the hippocampus, entorhinal cortex, and auditory and vestibular key regions in these populations and correlate with CAEP and cognitive functioning.

The expected outcome is important to society because it will provide data from a cognitive assessment protocol adapted for a potentially hearing-impaired population, objective outcome measures (incl. CAEP and MRI brain volume changes) to identify older subjects with SNHL and BVP at risk for cognitive decline, and will support screening and interventional studies to assess the impact of rehabilitation on slowing down cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Examination \> 12
* Dutch-speaking

Exclusion Criteria:

* Uncorrectable visual impairment
* Hearing implants
* Hearing aids
Pesticides--Health Fertility and Reproductive Risk

This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.


Eligibility Criteria:
Pesticide applicators and their spouses
Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With Early Breast Cancer Who Are Using Adjuvant Letrozole

The investigators will involve about 25 Patients of postmenopausal women who have ER/PR positive early breast cancer in each arm.

The study is a two-arm comparative, prospective, interventional, and randomized study. All patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients will receive ZOL immediately after randomization; delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment. All patients will receive daily supplements containing calcium (500 mg) and vitamin D (400-800 IU). Baseline bone mineral density and every 3 months will be done for the enrolled patients.

The investigators will involve about 25 Patients of postmenopausal women who have ER/PR positive early breast cancer in each arm.

The study is a two-arm comparative, prospective, interventional, and randomized study. All patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients will receive ZOL immediately after randomization; delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment. All patients will receive daily supplements containing calcium (500 mg) and vitamin D (400-800 IU). Baseline bone mineral density and every 3 months will be done for the enrolled patients.

-Research outcome measures:

1. Primary (main): The primary endpoint will be the percentage change in lumber spine (L2-L4) BMD at 12 months for immediate- versus delayed-ZOL patients.
2. Secondary (subsidiary): Secondary end points will include percentage change in total hip BMD at each assessment, fracture incidence, time to disease recurrence (local relapse or distant metastasis), DFS, and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic evidence of ER/PR positive breast adenocarcinoma
2. Postmenopausal women.
3. Baseline LS and total hip BMD T-score \> -2.0.
4. No prior treatment with denosumab or IV bisphosphonates is allowed.
5. No prior treatment with radiopharmaceuticals.
6. Not pregnant and not nursing.
7. Good dental health.
8. ECOG performance status 0-2.
9. Calculated creatinine clearance \>= 30 mL/min.
10. Corrected serum calcium \>= 8.0 mg/dL (2.00 mmol/L) and \< 11.6 mg/dL (2.90 mmol/L)

Exclusion Criteria:

1. Patients with dental problems.
2. Patients with impaired renal functions
3. Patients with osteopenia, or T- score is below -2.0
4. Patients with history of serious drug hypersensitivity or drug allergy.
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF

The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.

Patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Patients will be treated for 9 weeks, followed by a 3 week follow-up period. Efficacy will be assessed after 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥22 years at the time of signing the informed consent
2. Self-reported Pulmonary Fibrosis diagnosis
3. A GAD-7 score of ≥5 at pre-screening and baseline
4. If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to baseline
5. CT scan report within 5 years prior to baseline with signs of PF (interstitial changes)
6. Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device

Exclusion Criteria:

1. Self-reported manic disorders, psychotic disorders, schizophrenia, or alcohol/drug abuse during the past 6 months prior to baseline (Visit 1), as judged by the investigator or designee.
2. Self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee
3. Self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee
4. Verbal and/or written communication problems limiting ability to engage with dCBT-IPF
5. Inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee
6. Currently receiving cognitive behavioral therapy