cyrilzakka/clinical-trials huggingface dataset:
The Effect of Aerobic Exercise on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in Burn Patients: A Randomized Controlled Study

In the study, it was planned to investigate the Effect on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in burn patients by creating 2 different exercise groups. The aim of this study is to investigate the effect of aerobic exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratios in burn patients.

Burn injuries are a trauma that is seen due to causes such as flame, hot liquid, radiation, chemical, cold or electricity and causes destruction in the skin and/or organic tissues due to energy transfer.

Burn injuries cause profound hypermetabolic and catabolic responses that can last for months or even years. Especially in burn patients with involvement of more than 20% of the total body surface area (TVSA), lipolysis, proteolysis, glycolysis, and hyperdynamic and high fever, Many severe hypermetabolic responses are seen. These hypermetabolic responses seen in patients lead to decrease in lean muscle mass, inflammation, deterioration of cardiovascular, endocrine and glucose systems, coagulopathy, deterioration of fibrinolytic activity, decrease in functional capacity, delay in wound healing, weakening of the immune system and serious mortality.

In severely burned patients, the resting metabolic rate may exceed 140% of normal.

Various parameters are used to monitor all these systemic responses of the burn. Various scores have been developed in the clinic, especially using inflammatory cells such as neutrophils, monocytes, lymphocytes and platelets. In the literature, major diseases such as cancer, heart diseases and burns It has been stated that a systemic inflammation occurs due to trauma and calculations of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratios are prognostic indicators.

Exercise in burn patients; It is a highly effective method with high evidence value in minimizing the effects of the hypermetabolic response caused by the burn, preventing muscle atrophy, increasing the pulmonary function and functional capacity, reducing the inflammatory response and healing the burn.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

Conscious patients Enterally fed \>18 years old

Exclusion Criteria:

With inhalation burn In addition to existing burn trauma, those with other trauma (fracture, loss of limb, etc.) Organ dysfunctions or multiple organ failure History of chronic diseases such as diabetes, cholesterol and blood pressure

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Adding Exercise to Antidepressant Medication Treatment for Depression

This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

Partial response to antidepressant treatment is common in people with MDD and is associated with significant morbidity and reduced quality of life. Pharmacological therapies have been used to augment the effect of antidepressants; however, such therapies are associated with a range of adverse effects. Studies indicate that exercise may be safe and effective in augmenting depression treatment. This study will determine whether exercise can complement selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have residual symptoms of depression despite drug treatment.

Participants will be randomly assigned to either high frequency exercise or low frequency exercise for 12 weeks. Depression symptoms will be measured weekly. Quality of life and satisfaction with the study will also be measured. Depression scales and self-reports will be used to assess participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder
* Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
* 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
* Sedentary lifestyle
* Physically capable of exercise
* Body mass index (BMI) less than 40 kg/m2
* Willing and able to comply with study requirements

Exclusion Criteria:

* Significant cardiovascular disease or other medical conditions
* Uncontrolled hypertension
* Abnormal exercise stress test
* Hematologic disorders
* Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
* Alcohol and/or substance abuse in the past 6 months
* Hospitalization for mental illness within the past year
* High suicide risk
* Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
* Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
* Significantly elevated blood lipids
* Pregnancy
Xiangtong TM Full Degradation Sinus Drug Stent System Prospective, Open, Single-center, Randomized Controlled Clinical Trial

Xiangtong® Fully Degradable Sinus Drug Stent System is a high-tech medical device independently developed by Puyi Bio, specially designed for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS).The product is implanted into the target site during and after surgery, which not only supports the separation of the wound and fixes the repaired mucosal flap, but also controls edema, prevents adhesions, maintains smooth drainage, and sustains the target site to fight against inflammation and promotes healing by means of slow-release hormones.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are 18-65 years of age, male or non-pregnant female. The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs an informed consent form.

Subjects must meet the diagnostic guidelines for chronic rhinosinusitis, have a confirmed diagnosis of bilateral chronic rhinosinusitis, and have a CT scan confirming bilateral Lund-Mackay scores \>6 (CT scan within 3 months prior to surgery is valid).

* Female subjects who are not breastfeeding at the time of the screening visit and who do not plan to breastfeed or become pregnant for up to one year after the starting point.
* Subject has not participated in another clinical trial in the previous 3 months and agrees not to participate in another clinical trial until the endpoints of this trial have been met.

Exclusion Criteria:

* Subject has a known allergic reaction or contraindication to the device material and its degradation products (mometasone acid, levulinic acid, racemic polylactic acid, propyl lactate, lactic acid).
* The subject is on long-term oral hormonal medications.
* The subject is receiving immunosuppressive therapy or has a known immunosuppressive or autoimmune disease: the subject has diabetes mellitus.
* The subject has or has had glaucoma or high intraocular pressure.
* The subject has cataracts.
* The subject has an artificial eye.
* Acute bacterial sinusitis and acute fungal sinusitis.
* Subject has a life expectancy of less than 12 months.
* Subject has participated in a clinical trial of another drug or device that did not meet the primary study endpoint: Subject is unable or unwilling to participate in this trial.
Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor.

Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor's requirements. A basic fee will be requested to recover the cost of making the product. After an agreement is made, a contract will be signed between the 2 parties. A week before the treatment, requestors will contact the study team for possible FMT product delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using FedEx services. Each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

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Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD

Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.

Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 years old
* Underwent selective CABG surgery

Exclusion Criteria:

* History of central nervous system or psychiatric disorders
* History of taking sedative, antidepressants, or alcoholism
* MMSE score less than 23
* Visual or auditory disorders
* Educated less than 7 years
* Claustrophobia
* Can not be supine
* Can not tolerate iodinated contrast agents
Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)

In vitro sperm selection for ICSI is important as it has a direct influence on the paternal contribution of preimplantation embryogenesis. Various laboratory tests were developed to assess the functions of the spermatozoa. Among them, only the tests for sperm DNA fragmentation, hyperactivation of the spermatozoa and the hyaluronan-binding ability are simple and fast.

In vitro sperm selection for ICSI is important as it has a direct influence on the paternal contribution of preimplantation embryogenesis. Men with oligozoospermia who require ICSI often demonstrate compromised DNA integrity and increased chromosomal aberrations of the sperms in their semen. Studies have shown that embryos resulting from ICSI in those men have higher risk of sex chromosome disomies, chromosomal aneuploidies, de novo numerical chromosomal aberrations and cytogenetically detectable structural chromosomal aberrations. Although the main candidates for ICSI are oligozoospermic men, there is an increase in the use of ICSI, therefore, more couples are potentially exposed to those potential risks.

Various laboratory tests were developed to assess the functions of the spermatozoa. Among them, only the tests for sperm DNA fragmentation (Halosperm), hyperactivation of the spermatozoa and the hyaluronan-binding ability (HBA) are simple and fast enough to allow the same semen sample tested to be used for oocytes' insemination. Spermatozoa that are fail to bind to hyaluronan have many aspects of immaturity. They retain histones in the sperm nucleus, cytoplasm on the sperm neck, and have higher aberrant sperm head morphology, in addition to, lower genomic integrity. It has also been shown that sperm DNA fragmentation is associated with male factor of infertility, correlating with the morphology and motility of spermatozoa.

The aim of the present study is to carry out a comparative analysis between two groups: Hyaluronan binding system for sperm selection for ICSI procedures and another group of conventional morphology sperm selection (ICSI-PVP), both in cycles with only male infertility factor. The evaluated parameters were semen quality, fertilization and cleavage rates, chemical and clinical pregnancy, and miscarriage rates.

Eligibility Criteria:
Inclusion Criteria:

* Female 20-40 years
* Male factor infertility

Exclusion Criteria:

* Other factor of infertility (tubal, uterine, ... etc)
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital

The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.


Eligibility Criteria:
Inclusion Criteria:

* ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
* Age between 18 to 40 years
* Singleton pregnancies

Exclusion Criteria:

* • Allergy to oxytocin

  * Ruptured uterus
  * Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
  * Known risk factors for postpartum haemorrhage or uterine atony
  * Inherited or acquired coagulation disorder
  * History of post partum haemorrhage
Long-term PAS in Rehabilitation After SCI

The investigators have recently shown in two pilot incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1). In this study, the investigators will administer long-term paired associative stimulation to incomplete SCI patients in a long-term manner, keeping each patient in the study for as long as continuous improvement is observed.


Eligibility Criteria:
Inclusion Criteria:

* incomplete SCI

Exclusion Criteria:

* epilepsy
* metal inclusion in the head area
* pacemaker
* hearing device
* high intracranial pressure
Study of Placental Inflammation in Gestational Diabetes

The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6

The aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6, compared to women with uncomplicated pregnancy

Eligibility Criteria:
Inclusion Criteria:

* Women with gestational diabetes mellitus
* Women with uncomplicated pregnancy
* Age \>18 years
* Singleton pregnancy

Exclusion Criteria:

* Age \< 18 years
* Infections (HIV,HCV)
* Multiple pregnancy
* Cancer
Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.

The aim of the present investigation will be to evaluate diaphragmatic excursion velocity during non-invasive ventilation and spontaneous breathing at both inspiration and expiration.

this analysis will be performed through diaphragmatic tissue Doppler assessment.

Early weaning from invasive ventilation, in patients admitted to intensive care, is associated with a marked reduction in ventilator-associated pneumonia, length of stay in intensive care unit and hospital, total duration of mechanical ventilation and decrease in overall mortality. Moreover, in case of need of protected extubation, non-invasive ventilation has allowed to prevent re-intubation and decrease hospital mortality compared to the simple administration of oxygen through a facial mask, in particular when applied immediately after extubation.

The diaphragmatic tissue doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of the heart's motility. It can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive.

The aim of the study is the evaluation of the diaphragmatic excursion velocity variations using diaphragmatic tissue doppler, measured in venturi mask and non-invasive ventilation in the post-extubation period, in order to compare the diaphragm stress variations during the two different modes.

Method Patients after extubation will be randomly submitted to a spontaneous breathing test in venturi mask and in facemask or helmet NIV.

Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragm examination will be performed to assess the speed speed of muscle displacement, acceleration and deceleration.

Inclusion criteria: invasive mechanical ventilation \> 24h with consequent extubation.

Exclusion criteria: refusal to grant consent, pregnancy, age \< 18 years, haemodynamic instability, difficult management of secretions, required inotropic and / or vasoactive drugs at high doses.

During the study, vital parameters will be given.

Eligibility Criteria:
Inclusion Criteria:

* invasive mechanical ventilation \> 24h with consequent extubation

Exclusion Criteria:

* refusal to grant consent
* pregnancy
* age \>18 years
* haemodynamic instability
* difficult management of secretions
* required inotropic and / or vasoactive drugs at high doses
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )

Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients

Approximately forty-eight (48) participants will be randomized 1:1 to receive

(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)Intramuscular (IM) placebo (normal saline) at the same frequency. The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.

This cohort excludes oncology patients on treatment

Eligibility Criteria:
Inclusion Criteria:

1. A written, signed informed consent, or emergency oral consent, by the patient or the patient's legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing Study participation
2. Men and women aged ≥ 25 - 80 (included) years of age
3. Hospitalized patients with two absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:
4. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at \>4L per minute nasal cannula or greater to keep saturations \>90%, non-invasive positive pressure ventilation (e.g., BIPAP), or patients intubated / ventilated for respiratory failure
5. Confirmed infection with COVID-19 by any acceptable test available / utilized at each site
6. Willingness and ability to practice contraception regardless of the gender of the patient during 5 month after last drug exposure
7. Private insurance or government / institution financial support (through CMS or other)

Exclusion Criteria:

1. Pregnancy or breast feeding
2. ALT and/or AST \> 5 x ULN
3. Known, active auto-immune disease;
4. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing
5. Patients with past history of Solid Organ transplant
6. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load
7. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation \>85% with maximal available therapy for \>6 hours
8. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day equivalent hydrocortisone and/or anti-IL-6R treatments like Tocilizumab or Sarilumab or anti-IL-1 treatment like Anakinra which should preferably be minimized
9. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission
10. Patients showing an increase of the NEWS2 score by more than 6 points during the screening/ baseline period (48 to 72 hrs prior to first administration)
11. Patients under guardianship
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)

Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.

The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression. In the study, 226 pregnant women, some of whom are considered high risk due to past mental illness or psycho-social risk factors, will participate. The high-risk women will be divided into two groups. One group will undergo the PACT training, which involves computer and virtual reality exercises spanning five weeks, designed to improve mood and emotional regulation. The other group will receive usual care. The study also involves a low-risk group (n=146), although these individuals are not part of the intervention trial but are merely followed up with the same assessments for background comparisons.The main aim is to observe whether the women who undergo PACT intervention are less prone to depression after childbirth compared to those who do not.

This study has potential to offer a simple, non-invasive method to bolster mental health in expectant mothers, which could also positively impact their infants.


Eligibility Criteria:
Inclusion Criteria for General Pregnant Population:

* Second or third trimester pregnancy.
* Age ≥ 18 years.
* Ability to speak and read Danish.

Inclusion Criteria for High-Risk Pregnant Group:

* Either:
* Negative cognitive bias in emotional reactivity to infant distress (cut-off \> 96 on a scale from 0-100).
* High-risk status according to the Antenatal Risk Questionnaire (ANRQ) which means:
* Personal history of severe mental illness.
* Experienced childhood emotional, physical, or sexual abuse.
* Total score on psycho-social risk factors is above the cut-off (\> 23).

Inclusion Criteria for Low-Risk Pregnant Group:

* Absence of a personal or family history of mental illness.
* Absence of negative bias.
* Three or fewer of the additional risk factors mentioned above.

General Exclusion Criteria:

* Schizophrenia.
* Current substance use disorder.
* Score of 9 or more on the Hamilton Depression Rating Scale-6 items (HDRS-6), indicating moderate depression.
* Pregnant women diagnosed with a personality disorder (note: they will still be included at baseline and follow-up after birth but will be excluded from randomization).
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers

The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
* ECOG status 0-1

Exclusion Criteria:

* WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
* Symptomatic brain metastasis
* Uncontrolled or significant cardiovascular disease
* History of thromboembolic events or bleeding diathesis in past 6 months
* Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
* Serious non-healing wounds, ulcers or bone fractures in past 3 months
* Hemorrhage or bleeding event \>= CTCAE grade 3 in past 4 weeks
* Proteinuria \>= 2+ on dipstick or \>= 1gm/24 hours
* Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product
* Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers