cyrilzakka/clinical-trials huggingface dataset:
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)

This is a multicenter, randomized, open label, phase II study.

This is a multicenter, randomized, open label, phase II study assessing the efficacy and safety of penpulimab plus chemotherapy or penpulimab plus anlotinib or penpulimab plus chemotherapy and anlotinib as neoadjuvant/adjuvant treatment in patients with resectable locally advanced non-small cell lung cancer. Eligible patients will be randomized to receive either penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) or penpulimab (200mg, iv, Q3W) plus anlotinib (12mg, po, day 1-14, Q3W) or penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) and anlotinib (12mg, po, day 1-14, Q3W) in a 1:1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Early stage IIB-IIIB (N2), operable non-small cell lung cancer, confirmed in tissue.
* Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
* Lung function capacity capable of tolerating the proposed lung surgery.
* Patients had never received surgery, chemotherapy, radiotherapy or biotherapy.

Exclusion Criteria:

* Large cell carcinoma and mixed cell lung cancer.
* Any systemic anti-cancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, experimental treatment.
* Prior treatment with local radiotherapy.
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
* Prior treatment with antilotinib and other antiangiogenic drugs.
* History of hypersensitivity to any active or inactive ingredient of Penpulimab, Anlotinib or chemotherapy.
* Patients with multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, and intestinal obstruction, etc.).
* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.
* Patients whose tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels and cause fatal massive hemorrhage during follow-up study.
* Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism.
* Pregnant or lactating women.
* History of neurological or mental disorders, including epilepsy or dementia.
Use of Electroanalgesia in Pain and Pulmonary Function.

It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.

This is an uncontrolled cross-sectional clinical trial with a sample of 66 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes. Through this research, it is expected that the patients who perform TENS present a reduction in postoperative pain and, consequently, a lower impact on lung function.

Eligibility Criteria:
Inclusion Criteria:

* This research will include patients who are in the postoperative period of bariatric surgery and who are aged 18 years or over

Exclusion Criteria:

* Patients over the age of 50;
* Individuals who present hemodynamic instability in the postoperative period;
* Use of mechanical ventilation for more than 24 hours;
* Contraindications regarding the use of TENS (presence of a cardiac pacemaker, hypersensitivity regarding the use of TENS);
* Previous history of epilepsy;
* Pregnant women during the first trimester;
* Patients with a score, on the Glasgow coma scale (Appendix I), less than 15;
* Patients who choose to withdraw during the study.
Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy

Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.

Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.

Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.

Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.

Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.

Or benefits and safety LMA in front of intubation during bronchoscopy.

Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .

Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.

Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.

Study group : LMA is inserted under sedation and used during the procedure.

Control group - performing bronchoscopy under sedation without LMA.

About 50 people are needed each group.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 y.o
* Competency to sign informed consent.
* Room air oxygen saturation above 95%
* Stable hemodynamically and respiratory during the start procedure.
* Undergoing elective bronchoscopy.

Exclusion Criteria:

* Pregnant women and special groups will not be included in the study.
The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Eligibility Criteria:
Inclusion Criteria:

* Only subjects fulfilling all of the following criteria will be eligible for the study:

  * People aged from 18 months to 65 years old.
  * The subjects or subjects' guardians are able to understand and sign the informed consent
  * The subjects or subjects' guardians allow to comply with the requirements of the protocol
  * Subjects with temperature \<=37.0°C on axillary setting
  * The subjects have signed informed consent already

Exclusion Criteria:

* Subjects will not be eligible for the study if any of the following criteria is met:

  * Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
  * Have a history of neurological symptoms or signs
  * Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
  * Suffering from serious chronic diseases
  * Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
  * Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
  * Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
  * Any prior diseases including human immunodeficiency virus infection or related
  * Bleeding constitution or prolong bleeding time situation
  * Accept hepatitis A vaccination within a month
  * Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
  * People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
  * Caught a fever with axillary temperature 38°C or higher in past 3 days
  * Take part in another clinical researchers
  * Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
  * Pregnancy test result is positive
PsA Treatment With hOKT3γ1 (Ala-Ala)

hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.

Psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. Treatment typically include drugs such as methotrexate, azathioprine, and etanercept, which suppress the immune system in a nonspecific fashion in an attempt to control the immune responses causing the disease. In some severe cases of psoriatic arthritis, these drugs cannot adequately control the disease, often requiring patients to undergo continuous treatment to prevent or combat disease activity. hOKT3gamma1 (Ala-Ala) is a genetically engineered monoclonal antibody directed against the CD3 antigen on T cells. hOKT3gamma1 (Ala-Ala) specifically targets immune cells that are actively involved in destructive immune responses, such as those that cause psoriatic arthritis. In a small pilot study of eight people with psoriatic arthritis who received a 2-week course of hOKT3gamma1 (Ala-Ala), the drug appeared safe and caused no serious side effects. This study will test the safety and efficacy of hOKT3gamma1 (Ala-Ala) in alleviating symptoms in psoriatic arthritis patients.

This study will last 2 years. Individuals with psoriatic arthritis who are receiving methotrexate or azathioprine therapy and have active disease are eligible to participate. Participants will be randomly assigned to receive hOKT3gamma1 (Ala-Ala) or placebo. Participants will receive a 5-day treatment with the drug or placebo every month for the first 4 months of the study. There will be 5 study visits over 2 years to assess the safety and effectiveness of hOKT3gamma1 (Ala-Ala) and to evaluate laboratory measures related to the underlying immune problems that cause psoriatic arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of psoriatic arthritis. Participants do not need to have concurrent psoriasis to participate in the study;
* Active inflammation in 3 or more joints;
* Currently receiving ongoing therapy with methotrexate or azathioprine; and
* Willing to use acceptable forms of contraception.

Exclusion Criteria:

* Active infection with HIV, hepatitis C virus, or hepatitis B virus;
* Uncompensated heart failure or a recent myocardial infarction (heart attack) within the 6 months prior to study entry;
* Certain other serious illnesses or cancers;
* Participation in another clinical trial within the 6 weeks prior to study entry; or
* Pregnant or breastfeeding.
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
Effects of Transcranial Pulse Stimulation in Parkinson's Disease

The investigators are studying if Transcranial Pulse Stimulation (TPS) can improve various symptoms, including movement problems, thinking abilities, mood, fatigue, freezing while walking, voice quality, and issues with smell and taste. Previous research suggests TPS might help in Alzheimer's disease and could be helpful for Parkinson's as well. Investigators will check if TPS is safe, practical, and if it makes a noticeable difference in these symptoms compared to before the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (52) or as confirmed by a co-investigator neurologist or confirmation via medical records or a letter from a patient's physician.
2. Age from 40 to 90 years old.
3. Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
4. Taking stable medications for PD for at least 30 days.

Exclusion Criteria:

1. Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes.
2. History of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions.
3. History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
5. Contraindications to transcranial brain stimulation (i.e., metal objects in the head, metal implanted brain medical devices, cortisone treatments within six weeks before the first stimulation session, CNS thrombosis, etc).
6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease).
7. Contraindications to MRI according to MGB screening in the Martinos-Center (i.e., pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, or drug infusion devices - if the models of these devices are not compatible with MRI).
8. Pregnancy.
9. Epilepsy or disorders that significantly increase the likelihood of seizures, including: (i) severe traumatic brain injury; (ii) congenital birth defects leading to seizures; (iii) brain tumor; (iv) metabolic disorders associated with seizures; (v) intracranial or subarachnoid hemorrhage; and (vi) non-lacunar strokes.
10. Bed- or wheelchair-bound patients.
Risk-adapted Donor Lymphocyte Infusion After Allo-HSCT in Children With Hematologic Malignancy

Allo-hsct is potentially curative method of treatment for children and adolescent with hematologic malignancy. However, relapses of disease after allo-hsct occur up to 50% of patients and constitute the main cause of mortality after HSCT. Donor lymphocytes infusion (DLI) is a form of immunotherapy based on developement of reaction "graft versus from leukemia". This study evaluates the safety and efficacy of risk-adapted srtategy of DLI for prophylaxis and prevention posttransplant relapses in children and adolescent with hematologic malignancy.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 months - 18 years old
* Diagnosis: acute lymphoblastic leukemia, acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, chronic myeloid leukemia
* Signed by legal representatives informed consent
* High risk disease ( for ALL - initial hyperleukocytosis\> 50x109 / L, T-cell ALL, hypodiploid karyotype, complex karyotype, MLL gene rearrangement, SIL-TAL deletion, primary resistent of the disease, early/very earle relapse, infant ALL; for AML patients - rearrangement of the MLL gene (except for t (1; 11) and t (9; 11) with M5 morphology), inv (3), t (3; 3), complex karyotype anomalies, t (8; 21 ) with trisomy 4, t (16; 21), monosomy 7, monosomy 5, M7 without t (1; 22), FLT3+, M6, t (7; 12), AML with multilineage dysplasia, p53 gene mutations, NUP98 translocations, primary resistent of the disease, early/very earle relapse infant AML, secondary AML; all juvenile myelomonocytic leukemia and myelodysplastic syndrome; allo-HSCT at 3 or more remission; persistence MRD before alloHSCT; allo-HSCT out of remission; persistence MRD after alloHSCT; cytogenetic relapse after alloHSCT )
* Donor chimerism=\>95%
* No poor graft function (haemoglobin concentration \< 100 g/L; neutrophils \< 1.0 × 10E + 9/L; and platelets \< 30 × 10E + 9/L on day ≥ 30 post transplant with complete donor chimerism and no graft-versus-host disease or relapse )
* ECOG 0-2 status
* Karnofsky/Lansky status \>30%

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
* Ejection fraction less than 50%
* Requirement for vasopressor support at the time of enrollment
* Somatic or psychiatric disorder making the patient unable to sign an informed consent
* Acute GVHD grade 3-4 in patient medical history
* Severe chronic GVHD in patient medical history
Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa

Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is severe with some morbidity such as mitten hand deformity.

The management of these patients is very difficult because no effective treatment has been known yet.

The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas of hand which is without the skin. In this study the investigators assess the safety of autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for them.

Epidermolysis Bullosa patients with mitten hand deformity were included. (based on inclusion \& exclusion criteria) These patients should be offered for surgery to release the adhesions between fingers and MCP. When the consent form was accepted and the lab test was confirmed, a small skin biopsy was removed from retro auricle and fibroblast cells were separated and cultured. These cells were seeded on AM and the microbial test was done as evidence to prove the safety.

Under general anesthesia, when the hands adhesion was removed, the autologous fibroblast cultured on AM was transplanted to the both hands (specially the area without skin coverage) and the hands were dressed afterward.

The dressing was changed and the wound was checked regularly to detect any complications.

Eligibility Criteria:
Inclusion Criteria:

* Both genders Age: 5-25y No history of other systemic disease No history of other cell therapy method No infection in donor or recipient site HCV Ab/HIV Ab/ HBS Ag tests were negative

Exclusion Criteria:

* Age less than 5y or more than 25y. History of other systemic disease History of other cell therapy method Infection in donor or recipient site Positive Lab tests for contagious viral diseases Pregnancy or lactating History of malignancy
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

Open-label pharmacokinetic drug interaction study.

Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in Cohort 1, a decision was made on whether to enroll subjects in Cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was not enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Greater than or equal to 6 months post-liver transplantation
* Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months.
* Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).
Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)

This is a randomized, open-label, controlled, parallel group, multicenter clinical trial. Patients with confirmed secondary sclerosing cholangitis (SSC-CIP) will be randomized either in the intervention group undergoing scheduled invasive evaluation of the biliary tract or in the control group treated with non-interventional standard of care to demonstrate that programmed endoscopic therapy compared to a conservative strategy reduces the occurrence of treatment failures.


Eligibility Criteria:
Inclusion Criteria:

Patients have to fulfill all of the following inclusion criteria to be eligible for participation in this study:

1. Men, women\*, inter/divers, age ≥18 and ≤ 80 years (conscious or unconscious patients may be included)
2. Signed written informed consent obtained by patient or legal representative in case of unconscious patient
3. Willingness to comply with treatment and follow-up procedures
4. Suspected SSC-CIP = episode of critical illness and intensive care unit treatment \> 3 days within last 12 months
5. SSC-CIP is confirmed by ERC, (if the first ERC is performed at baseline, the patient may be considered as screening failure if the diagnosis is not confirmed)
6. Elevation of bilirubin ≥ 2.5 upper limit of normal (ULN) at Screening
7. Elevation of alkaline phosphatase (AP) or gamma-glutamyl-transferase (GGT) \> 2.5 ULN or elevation of both at Screening
8. \*Women without childbearing potential defined as follows:

   * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
   * hysterectomy or uterine agenesis or
   * ≥ 50 years and in postmenopausal state \> 1 year or
   * \< 50 years and in postmenopausal state \> 1 year with serum Follicle Stimulating Hormone (FSH) \> 40 IU/l and serum estrogen \< 30 ng/l or a negative estrogen test, both at screening or

     \*Women of childbearing potential:
   * who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
   * who have sexual relationships with female partners only and/or with sterile male partners or
   * who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception (failure rate of \< 1% per year) from the time of screening until end of the clinical trial.

Exclusion Criteria:

1. Patient is too unstable to undergo ERC
2. Inclusion in any other intervention trial within the last 30 days
3. Pregnancy or lactation period