cyrilzakka/clinical-trials huggingface dataset:
Trial of Sinphar Lipucan Capsule to Regulate Immune Function

Trial of Sinphar Lipucan Capsule to regulate immune function

The immune system is the line of defense for the health of human life entities. If the function decrease, it will reduce the body's defense to outside pathogen and easily lead to the occurrence of diseases. Immune response includes two kinds of reactions: (1) The innate immune system refers to inherited, germ-line defense mechanisms that are directed against molecular components found only in micro-organisms.. (2) The humoral immune response denotes immunologic responses that are mediated by antibodies. Health hazards have always been a trend based on health awareness. Therefore, how to use a healthy diet to promote the immune system is currently the most concerned research direction.

Because of the immunomodulatory effect of " Sinphar Lipucan Capsule " in previous animal experiments (1) Promote the secretion of Th1 type cytokine by T cells and inhibit the secretion of Th2 type cytokine; 2) Promote the secretion of IFN-γ by macrophages. 3) Promote the production of OVA antigen-specific antibodies in BALB/c female mice; 4) It can inhibit the secretion of IL-10 cytokine by antigen-specific (OVA) immune cells (that is, inhibit the secretion of Th2 cytokine), we think " Sinphar Lipucan Capsule " may be beneficial in reducing the severity and incidence of Acute Upper Respiratory Tract Infection. Therefore, human clinical trials were started to confirm its clinical effects and immunomodulatory effects.

Eligibility Criteria:
Inclusion Criteria:

- Healthy Volunteers

Exclusion Criteria:

1. Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
2. Positive pregnancy test or currently breastfeeding
3. History of autoimmune disease
4. History of allergic rhinitis
5. History of physician diagnosed eczema
6. Known allergic reaction to Poria cocos or related species,
7. Pregnancy or currently breastfeeding.
8. History of autoimmune disease or immune disorders.
9. History of asthma.
10. History of allergic rhinitis.
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)

To investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication Study hypothesis:Cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Opioid dependency
* Participant in the Janus heroin programme of the UPK Basel
* Able to control parallel consumption of other drugs
* Stable i.v. substitution for at least 3 months

Exclusion Criteria:

* co-morbid psychiatric disturbances
* Current medical conditions excluding participation
* Recent history of systemic or topic glucocorticoid therapy
* known hypersensitivity to the IMP under investigation (cor-tisol)
* pregnancy, breast-feeding
* inability to read and understand the participant's information
Intravenous Immunoglobulin (IVIG) in Lung Transplantation

The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.

An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.

Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipients \> 3 months after transplant surgery
* Immunoglobulin G (IgG) \< 500 mg/dL
* Stable medical regimen

Exclusion Criteria:

* Acute rejection
* Active infection
* Contraindication to IVIG
* Pregnancy
* Recent thrombotic event
Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have stage IV colorectal cancer
* Patients whose disease has worsened despite prior anti-cancer therapy
* Patients who have satisfactory bonemarrow, kidney and liver function

Exclusion Criteria:

* Patients who are being simultaneously treated with another anti-cancer therapy.
* Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
* Patients that are pregnant or breast-feeding
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
* At least three months after activation of the cochlear implant.
* Eighteen years or older at the time of consent.
* User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
* Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.
* Fluent speaker in English.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* One or more electrodes turned off in the MAP used regularly.
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages

Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. The investigators randomized them to four groups receiving common analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after first intake. The investigators compared the aggregation via aggregometry of platelet rich plasma.


Eligibility Criteria:
Inclusion Criteria:

* Planned traumatologic, orthopedic, visceral or plastic surgical procedures

Exclusion Criteria:

* Prior intake of drugs with effect on the platelet aggregation
* Patients with diseases of the gastrointestinal systems
* Patients with cardiac or circulatory diseases
* Patients receiving corticoids
* Patients with cold or asthma
* ASA-classification \> 3
Emotional Reaction and Self Injury in Patients With Borderline Personality Disorder and Healthy Controls

The current study investigates the emotional response of patients with borderline personality disorder and healthy controls on stimuli associated with self-injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are able to use skills and have some therapy experiences.

Exclusion Criteria:

* Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
MUcociliary Clearance IN Stroke

Stroke patients frequently suffer from stroke associated pneumonia. Pathophysiologically speaking, dysphagia and central nervous system (CNS)-injury induced immunosuppression largely contribute to the risk for pneumonia. In mouse models for stroke, the self-cleaning mechanisms of the lung are also affected by stroke, possibly further contributing to this risk.

The investigators designed a pilot-study to examine the structural and functional integrity of the self-cleaning mechanisms of the lung in stroke patients.

Survival and functional outcome of stroke is strongly depending on the occurence of pneumonia (stroke-associated pneumonia, SAP). Early diagnose and treatment of SAP is paramount in the treatment of stroke patients. While dysphagia strongly contributes to its pathogenesis, recent years have also shown a strong risk-modulation by CNS injury induced immunosuppression, making stroke patients more susceptible to SAP. Additionally, murine models of stroke showed changes in mucociliary clearance as possible contributors to SAP. It remains unclear, whether structural integrity and mucociliary clearance of the respiratory epithel change in stroke patients, and whether these changes might contribute to the occurence of SAP.

Therefore, the investigators designed this exploratory observational pilot-study to examine the structural and functional integrity of respiratory epithel in severely affected stroke patients and correlate these findings to immune phenotyping and occurence of SAP. The investigators will conduct bronchoscopy in severely affected stroke patients to collect histological samples in order to evaluate multiple tissue predictors, as well as perform optical coherence tomography to examine ciliary kinetics in-vivo. The investigators will furthermore perform serum and plasma immune phenotyping, record occuring pneumonias and correlate these data in order to identify possible predictors of pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed consent signed by patient or legal representatives
* Acute ischemic stroke within the past 2 weeks (except the control group)
* Indication for diagnostic or therapeutic bronchoscopy

Exclusion Criteria:

* Confirmed lung malignancies or specific inflammations of the lungs
* Pneumonia (only control group)
* Autoimmune diseases of respiratory system (only control group)
* Chronic inflammatory diseases of respiratory system (only control group)
* chronic obstructive pulmonary disease (COPD) and spastic diseases of respiratory system (only control group)
* Patients being committed to psychiatric institutions or prisons
Transcranial Direct Current Stimulation for Depression

Several studies have shown that tDCS is valuable and safe options to improve depressive symptoms in adult patients . However, regarding the tDCS to treat depression in elderly population, only few studies have been reported, and there is no consensus among them. To our knowledge, prefrontal cortex tDCS could be reasonably safe and efficient options for the treatment of several psychiatric illnesses in a population presenting resistance to and/or intolerance of pharmacotherapy . Moreover, the safety tolerability profile of tDCS is a strong argument in favour of exploring their use in the depressed population. Therefore, current study will investigate the efficacy and safety of prefrontal tDCS used as additive treatment in patients with LLD.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who meet the criteria of major depression defined by DSM-5 criteria
2. Participants will be non-responders and taking an antidepressant of adequate dose and for ≥4 weeks in the current episode which has not led to sufficient clinical improvement (defined as a minimum level of 2 on the ATHF); or can't tolerate the adverse effects of antidepressant in the current episode
3. Ambulatory participants with or without any aiding device

Exclusion Criteria:

1. An urgent risk of suicide or severe depression
2. A history of ineffectiveness with tDCS
3. People who are clinically contraindicated to receive tDCS intervention or MRI assessment, such as having any brain lesion, intracranial implants (clips, cochlear implants), a tattoo or metal embedded in their scalp or brain
4. Any instable medical condition
5. A history of epilepsy,
6. A history of substance use (within one year)
7. People with dementia or psychotic disorder.
8. Any condition which would make the subject unsuitable for the study under the physician's assessment.
A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers

This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

Healthy Male Volunteers

Exclusion Criteria:

Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen
Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video

The purpose of the research is to study a new safety monitoring system developed by SafelyYou to help care for a loved one with dementia. The goal is to provide better support for unwitnessed falls.

The SafelyYou system is based on AI-enabled cameras which detect fall related events and upload video only when these events are detected. The addition of a Human in the Loop (HIL) will alert the facility staff when an event is detected by the system.

This process enables staff to know about falls without requiring residents wear a device and to see how falls occur for residents that cannot advocate for themselves while still protecting resident privacy by only uploading video when safety critical events are detected. Seeing how the resident went to the ground (1) prevents the need for emergency room visits when residents intentionally moved to the ground without risk and (2) allows the care team to determine what caused an event like a fall and what changes can be made to reduce risk.

PRELIMINARY EVIDENCE. The proposed study follows a series of pilots. In pilot 1, we showed the technical feasibility of detecting falls from video with 200 falls acted out by healthy subjects. In pilot 2, in a 40-resident facility, we demonstrated the acceptance of privacy-safety tradeoffs and showed a reduction of total facility falls by 80% by providing the system for 10 repeat fallers. In pilot 3, we addressed repeatability of fall reduction in a cohort of 87 residents with ADRD in 11 facilities of three partner networks. In pilot 4 (NIH SBIR Phase I), we demonstrated that falls can be detected reliably in real-time within the partner facilities. We detected 93% of the falls; reduced the time on the ground by 42%; showed that when video was available, the likelihood of EMS visit was reduced by 50%; and reduced total facility falls by 38%.

Eligibility Criteria:
The study population includes residents of care facilities that are a high fall risk with a particular focus on care facilities with high populations of individuals with Alzheimer's disease and related dementias. There are no gender, race, ethnicity, language or literacy requirements for participation and all residents are eligible.

Inclusion criteria - Living at a participating skilled nursing facility or equivalent, CCRC,

Exclusion criteria

- 18 years old or younger
InBody Validation Study

With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.

This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age
* Have a Body Mass Index ≥ 18.5 kg/m2

Exclusion Criteria:

* Are not English speaking
* Are younger than 18 years of age
* Weigh more than 450 lbs
* Taller than 6'6" due to size constraints of the iDXA
* Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
* People having radioactive iodine thyroid treatment.
* People who have had a nuclear medicine study or a barium X-ray within the last 5 days.
* People with large amounts of metal in their bodies.
* People with arthritis of the spine recorded in the medical record.
* Are pregnant
European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus

By this study, the investigators want to test if the value of adjuvant pulse glucocorticoid therapy for pemphigus can be determined by comparing an experimental arm (dexamethasone pulse therapy, prednisolone, and azathioprine) with a control arm (placebo pulse therapy, prednisolone, and azathioprine). The investigators will determine the rate of complete remission with dexamethasone pulse therapy; the time needed for complete remission; and the duration of remission, and compare these data with those of the placebo arm.

Pemphigus is a severe chronic dermatological disease which appears to be incurable. Oral glucocorticoid now forms the cornerstone of treatment. From previous uncontrolled studies it has been suggested, that the use of high dose intravenous glucocorticoid pulse therapy may lead to complete remission without further therapy. Prospective placebo-controlled studies of adjuvant pulse therapy for pemphigus are lacking. This prospective, multi-centre, randomised, double-blind, placebo-controlled trial assesses the efficacy and steroid-sparing effect of oral high-dose glucocorticoid pulse therapy as adjuvant added to the standard combination therapy of prednisone and azathioprine in the treatment of pemphigus vulgaris, in terms of complete remission rate (primary endpoint), initial control, disease control, and adverse events. In the experimental arm glucocorticoid pulse therapy is given, comprising monthly pulses with 300mg oral dexamethasone on three consecutive days. In addition the patients receive daily prednisone and azathioprine treatment, the latter dose adjusted to the thiopurine-methyltransferase level. In the control arm the glucocorticoid pulse therapy is replaced double blindly by monthly oral placebo capsules on three consecutive days. in addition the patients receive the same daily combination schedule with prednisone and azathioprine as in the experimental arm. This study design requires 30 patients in each arm, with one year follow-up. Only new patients with pemphigus vulgaris and/or pemphigus oris are included.

Eligibility Criteria:
Inclusion Criteria:

* New patients with diagnosis of pemphigus vulgaris

Exclusion Criteria:

* Diagnosis of pemphigus different from vulgaris type
* Current use of adjuvant treatment other than azathioprine. A wash out period of at least 2 weeks is required before inclusion is acceptable.
* Presence of contra-indications for the use of high dose steroids
* No availability for follow-up.
* Concomitant diseases treated with oral steroids.
* Glucocorticoids administered for pemphigus vulgaris longer than two months.
* Presence of contra-indications for the use of azathioprine.
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily agree to participate by giving written informed consent.
2. Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
3. The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease.
4. Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression.
5. Has measurable lesion on imaging based on RECIST version 1.1.
6. Have a life expectancy of at least 3 months.
7. ECOG performance status 0-1.
8. If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment.

Exclusion Criteria:

1. Has any malignancy \<5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer \>3 years.
2. Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody.
3. Known to have autoimmune disease.
4. Recived other anticancer therapy 4 weeks before randomization.
5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
6. Untreated and/or uncontrolled brain metastases.
7. With high risk of vaginal bleeding or gastrointestinal perforation.