cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer

The aim of this study is to evaluate the real-life efficacy of durvalumab treatment in consolidation after radio-chemotherapy.

Immune checkpoint inhibitors (ICIs) such as anti-PD-1/PD-L1 have revolutionized the field of immuno-oncology, inducing significant and durable responses in patients with all types of tumor, and in particular advanced stage (II-IV) non-small cell lung cancer (NSCLC). The use of durvalumab in consolidation, after radiochemotherapy, in locally advanced NSCLC has significantly improved progression-free survival and overall survival (see PACIFIC trial). Durvalumab now has marketing authorization for this indication, in cases of PD-L1≥1% overexpression on tumor cells.

However, 50% of patients experience tumor progression at 1 year, and there is currently no biomarker (clinical, biological or radiological) predictive of tumor response to durvalumab in consolidation.

Elucidating the determinants of response and resistance to treatment, as well as predicting severe immune-mediated adverse events, are essential to improving patient outcomes and developing new therapeutic strategies

Translated with DeepL.com (free version)

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable locally advanced non-small-cell lung cancer (stages II, IIIA, IIIB and IIIC) responding to or stable after concomitant or sequential platinum-based radiochemotherapy and having received durvalumab consolidation therapy
* Minimum radiotherapy dose of 54 Gy to 66 Gy
* Age greater than or equal to 18 years
* WHO 0-1
* Non-opposition of living patients formulated

Exclusion Criteria:

* Age \< 18 years.
* Refusal to participate
* Patients under legal protection (curatorship, guardianship, etc.)
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* A positive poly chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and clinical symptoms suggestive for this disease on Day -2.
* Further exclusion criteria apply
Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery

After cardiopulmonary bypass heart surgery, with the rewarming of body temperature, the metabolic capacity of the body is enhanced, the microcirculation is opened, and tissue perfusion is increased. At the same time, the body pays off the oxygen debt formed by the low temperature and reduced blood flow in cardiopulmonary bypass, so that the tissue oxygen demand increases and oxygen consumption increases.Analgesia and sedation are important treatment measures for patients after cardiopulmonary bypass. S-isomer of ketamine and eselamine enhanced the sedation and enhanced the analgesic effect, but whether it can improve the imbalance of oxygen supply and oxygen consumption after cardiopulmonary bypass is unknown.

After cardiopulmonary bypass, the body usually appears in a state of hypermetabolism. In addition to anesthesia resuscitation and recovery of spontaneous respiration, chills, pain and anxiety can increase oxygen demand, increased oxygen consumption is also related to a series of neuroendocrine reactions.At the same time, the body needs to repay the oxygen debt formed by low temperature and reduced blood flow in extracorporeal circulation, so that the tissue oxygen demand increases, and the systemic oxygen consumption is significantly higher than the normal physiological state.

Sedation and analgesia treatment is one of the important early treatment measures for patients after heart surgery. Patients with heart disease are prone to anxiety and restlessness due to reduced cardiac function reserve, severe surgical trauma and extracorporeal circulation, which can lead to hemodilution, tissue edema, ischemia and reperfusion injury, etc. In addition, patients with high preoperative mental stress are prone to anxiety and restlessness.Appropriate sedation and analgesia treatment is very important to reduce stress response, reduce oxygen consumption and maintain the stability of hemodynamics.

The application of ketamine in sedation and analgesia has the characteristics of high controllability, and it does not inhibit respiration and mildly excites circulation, but whether it can improve the imbalance of oxygen supply and demand in patients after cardiopulmonary bypass is unknown.Therefore, it is of great significance to investigate the effect of ketamine on oxygen supply and oxygen consumption of patients after cardiopulmonary bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult (\>18years)patients after heart surgery

Exclusion Criteria:

* Chronic kidney disease (CKD); ECMO or IABP assistance is required; Malignant tumor; Acquired immunodeficiency syndrome; receive psychiatric medication.
Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)

PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of ondansetron when they request morphine.


Eligibility Criteria:
Inclusion Criteria:

* Age between 15-60 years old

Exclusion Criteria:

* History of motion sickness, smoking
CPAP In-home Assessment NZ

Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.

Phase 1:Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
* Be fluent in spoken and written English

Exclusion Criteria:

* Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) therapy
* Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
* Persons with obesity hypoventilation syndrome or congestive heart failure
* Persons that require supplemental oxygen with their Positive Airway Pressure (CPAP or AutoCPAP) device.
* Persons with implanted electronic medical devices (e.g cardiac pacemakers)
* Persons who are pregnant or think they may be pregnant.
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes without effective pharmacological treatment. Inflammation following ICH contributes to barrier disruption and peri-hematoma edema, leading to deterioration of neurological function. Preclinical evidence suggests that bone marrow hematopoietic stem and progenitor cells (HSPCs) are swiftly activated after ICH. Thereafter, these HSPCs produce an increased output of anti-inflammatory monocytes as an endogenous protective mechanism. Stimulation of β3 adrenergic receptor using selective agonists promotes the production of anti-inflammatory monocytes in bone marrow, and thereby reduces neuroinflammation, brain edema and neurological deficits. This study is to assess the safety and efficacy of a β3 adrenergic receptor agonist Mirabegron as a potential treatment option in ICH patients.

This study is to evaluate the efficacy and safety of mirabegron in patients with intracerebral hemorrhage based on standard therapy

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged above 18 years old.
2. The volume of the hematoma is 5-30 ml (including the cerebral cortex; Putamen, thalamus, caudate nucleus and related deep tracts; Cerebellar hemorrhage), which determined by CT scan.
3. The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.
4. Patients with Glasgow Coma Scale (GCS) score ≥6 and \< 12.
5. Before the onset of the disease, function was independent and mRS score\<1.
6. Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Exclusion criteria:

1. Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
2. Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.
3. Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.
4. Patients who interfere with drug use due to nausea or vomiting.
5. Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary tract infection, severe urinary tract obstruction, medically uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg), pregnant and lactating women, and a history of malignant tumors within 5 years.
The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating uremic pruritus and investigate the association between improvement of pruritus and change of serum parameters, including routine biochemical data, immune profile and dialysis adequacy.

We would conduct a randomized study to evaluate the effect of NB UVB therapy on uremic pruritus. The intensity of pruritus will be evaluated using visual analog scale (VAS) score (0 \[no pruritus\]-10 most severe pruritus\]) and a detailed questionnaire assessing various characteristics of pruritus at baseline . The patients with the intensity of pruritus VAS score more than 5 will be randomized to narrow band UVB and control group. Phototherapy was administered to the whole body surface 2-3 sessions per week for total 18 sessions in a UV irradiation cubicle. The dose increased from 210mJ/cm2 .Doses were increased by 10 % at every session. The control group received time-matched exposures to long-wave ultraviolet light. The investigator will determine the pruritic intensity at baseline every 3 sessions by VAS score and by detailed questionnaire at baseline and after 18 sessions. The blood sample will also be collected at baseline and after treatment to determine factors associated with improvement.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease with moderate to severe uremic pruritus for longer than 2 months

Exclusion Criteria:

* pregnancy history of photosensitivity photo-aggravated disease
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain

The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.

The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC.

Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment.

The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component.

Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (21or over)
* unilateral amputation at or above wrist or ankle
* phantom limb pain occurring at least weekly
* living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
* able to read and speak English

Exclusion Criteria:

* Current alcohol or drug dependence
* active psychosis
* medical problems that preclude participation
* current enrollment in behavioral pain management
Sandostatin for Patients With Androgen Independent Prostate Cancer

This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study will require 27 evaluable patients.

Primary Objective:

To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.

Secondary Objective:

To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1.

To evaluate the safety of Sandostatin LAR in this patient population. To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum.

Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy. Additionally, given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth, it is felt that testing in the "early" androgen independent state is warranted. This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate.
* Biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in PSA with PSA determinations at least 4 weeks apart and each PSA value \> 0.2 ng/ml.
* Four weeks since prior therapy with Flutamide.
* Six weeks since prior therapy with Bicalutamide or Nilutamide.
* Current PSA \> 5 ng/ml.
* Testosterone \<50 ng/dL.
* SGPT (ALT) \< 1.5 times upper limit of normal.
* Fasting blood glucose \> 60 mg/dL.
* ECOG performance status 0, 1 or 2.
* No visceral or bony metastatic disease (Lymph node only metastases are allowed).
* No prior chemotherapy for prostate cancer.
* No current treatment with insulin or an oral hypoglycemic.
* No history of treatment with octreotide analogs for prostate cancer.
* No NYHA Class 3 or 4 cardiac status.

Exclusion Criteria:

* Diabetes Mellitus requiring medical therapy and/or that which is not controlled by dietary means (HbA1C\<6.0).
* A history of gallstones that has been clinically significant. Patients who have undergone cholecystectomy are eligible.
* Other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements.
* Prior treatment with chemotherapy for prostate cancer.
* No current treatment with Saw Palmetto, or Proscar. Patients must be off these medicines for more than 4 weeks.
Trial for Epilepsy Patients Non-responsive to AEDs Using Medical App

Trial for epilepsy patients non-responsive to AEDs, using medical app reminding patients to take their physician-prescribed medications


Eligibility Criteria:
Inclusion Criteria:

1. Patients in whom seizures are not controlled by their anti-seizure medication
2. Must have at least 2 seizures per month
3. History of any of the following seizure types: tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized, complex partial seizures and drop attacks (tonic/atonic)
4. At least four clinically countable seizures within 4 weeks of study entry \[tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)\]
5. The subject to a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
6. History of treatment with at least two AEDs, including one trial of a combination of at least two concomitant drugs, without successful seizure control
7. Subjects with vagal nerve stimulation system must be in stable settings for a minimum of 6 months prior to enrollment
8. RNS deep brain stimulation or the ketogenic diet can be considered equivalent to a drug trial and must be on a stable ratio for a minimum of 3 months prior to enrollment
9. Completed seizure diary for four weeks (±3 days) prior to initiation of the dose titration period (visit 2). The subject will be considered a screen failure if seizure diary was not appropriately completed
10. Anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.

Exclusion Criteria:

1. Neurodegenerative or deteriorated neurological disease
2. Psychosis or past psychotic event and/or anxiety disorder
3. Current or history of drug abuse/addiction
4. Abnormal creatinine
5. Any chronic ophthalmology disease
6. The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
7. Renal, hepatic \[ALT/AST \>2x upper limit of normal (ULN), bilirubin \>2x ULN\], pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
8. The subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
9. The subject is currently enrolled in or has not yet completed a period of at least 60 days since ending another investigational device or drug trial(s)
10. Unable to comply with study visits/requirements
11. Diagnosis of Dravet Syndrome, Lennox-Gastaut syndrome, or any other congenital or childhood syndrome will be excluded completely from this trial
12. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a serum pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while on trial. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study
New Era of DIEP With Minimally Invasive Mastectomy

The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.

Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022.
* Patients who have a minimum follow-up duration of six months post-reconstruction.

Exclusion Criteria:

* Patients who did not meet the six-month follow-up duration was excluded from the study.