cyrilzakka/clinical-trials huggingface dataset:
TNF in Melanoma Patients Treated With Immunotherapy

This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.

The study will be conducted on a population of patients treated with ICI in the context of routine care, separated in two subgroups:

* Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
* Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)

For each included patient, blood samples will be collected during baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1).

If feasible, tumor biopsy (of primary tumor or metastasis) will be performed during baseline and on Week 12 Day 1 visit (predose). If tumor biopsy is not feasible, available archived tumor specimen (frozen or FFPE block) may be collected for the study.

All included patients will be followed-up for tumor status and/or survival status every 3 months until a maximum duration of 1 year from the first study dose.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of study entry.
2. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma.
3. Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone or nivolumab + ipilimumab) has been decided.
4. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
5. Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started).
6. ECOG Performance status 0-2.
7. Life expectancy of at least 3 months.
8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures and to comply with the study protocol.
9. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patient pregnant, or breast-feeding.
2. Uveal melanoma.
3. Any condition contraindicated with sampling procedures required by the protocol.
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Diet and Microbiome Longitudinal Monitoring With Food Intervention

The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.


Eligibility Criteria:
Inclusion Criteria:

* willing to sign consent and have samples collected,
* able to read and speak English,
* participants must be willing to use an electronic food diary and consume study provided foods,
* only individuals able to provide a US address will be included.

Exclusion Criteria:

* Subjects not able to sign consent on their own accord (ie requiring a Legally Authorized Representative \[LAR\]),
* Current parenteral nutrition,
* Received cancer treatment within past 6 months prior to signing consent,
* Taken antibiotic treatment within the past 1 month prior to signing consent,
* Received oral x-ray contrast within the past 1 month prior to signing consent,
* Received any type of gastrointestinal bowel preparation in the past 1 month prior to signing consent,
* History of organ transplant,
* Shellfish allergy,
* Insect allergy,
* Cacti allergy,
* Carmine allergy,
* Dragon fruit (pitaya) allergy,
Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation

The aim of this study is to investigate the change of physical activity in COPD-patients performing a whole body vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a standard rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
* Severe disease other than COPD, that could influence the results of the study
* Abuse of alcohol or drugs
* Simultaneously participation in another study
* Tachypnea (\>30/min)
* Severe exacerbation during rehabilitation
* Cardiac insufficiency (NYHA IV)
* Myocardial infarction during the last 6 weeks
* Mental-health problem
* Pregnancy
* Known HIV-infection
* Slipped disk
* Acute discopathy
* Acute thrombosis
* Implants in trained regions of the body (lower extremities)
* Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
* Acute tendinopathy in trained regions of the body
* Acute hernia
* Fresh fractures, wounds or scars in trained regions of the body
* Gallstones or stones in the urinary tract collection system
Safety and Efficacy Study in Acute Ischaemic Stroke

A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke

An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.

Eligibility Criteria:
Summary of Inclusion Criteria:

1. Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
2. Aged 18 and above
3. Provide consent
4. Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive.
5. NIHSS score greater than 5 or less than or equal to 20.

Summary of Exclusion Criteria:

1. Coma
2. Stroke with unknown time of onset
3. Minor stroke symptoms and sings (\<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
4. Major stroke symptoms and signs (\>20 on the NIHSS)
5. History of stroke in previous 6 weeks
6. History of brain tumours
7. CT scan results in an ASPECT score of \<5
8. Haemorrhagic risk
9. Abnormal laboratory values
10. Positive urine pregnancy test, lactation or parturition within previous 30 days.
11. Weight \>135 kg
12. Uncontrolled hypertension.
13. Raised blood glucose
14. History of or current serious illness
15. Participation in another clinical trial within 4 weeks of drug administration

    -
Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer

This is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
2. No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Participants who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
3. Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only participantswho have evaluable PD-L1 results are eligible.
4. At least one measurable lesion by the investigator per RECIST v1.1.

   .
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Key Exclusion Criteria:

1. Known mutations in:

   * EGFR gene Note: For non-squamous NSCLC, articipants with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Participants found to have EGFR-sensitizing mutations will be excluded.
   * ALK fusion oncogene.
   * BRAF V600E
   * ROS1
2. Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
3. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
5. Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Brain Natriuretic Peptide (BNP) Usefulness In Elderly Dyspneic Patients (BED)

The purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.

Measurement of BNP concentration is approved for use in the diagnosis of heart failure (HF) in elderly patients below 80 years of age. The value of plasma BNP assays as diagnostic tools has not been determined in very elderly populations because the plasma BNP increases with age. This large, multicenter, prospective, observational, study in 300 participants is aimed to prospectively test the usefulness of measuring plasma BNP for diagnosis of HF in dyspneic patients aged 80 and older.

Eligibility Criteria:
Inclusion Criteria:

* acute dyspnea
* crackles on lung auscultation,
* hypoxemia,
* right-sided signs.

Exclusion Criteria:

* no exclusion criteria
Comparison of High Versus Low Bicarbonate Hemodialysis

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months

Exclusion Criteria:

* Use of oral alkali within the previous month
* Hospitalization within the previous month
* Inability to provide written informed consent
* Plans for kidney transplant in the next 2 months
* Planned change in phosphate binder therapy within the next month
* Pregnancy, or planned pregnancy in the next 2 months
A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison

The clinical data from all except the first 20 cases who underwent our novel transaxillary thyroidectomy were collected retrospectively, while the data from patients who underwent conventional open thyroid lobectomy by same surgeon during the same period were used as a control.


Eligibility Criteria:
Inclusion Criteria:

1. The patients with benign or malignant thyroid disease require lobe thyroidectomy;
2. The patient had cosmetic requirements and agreed with transaxillary thyroidectomy;
3. Benign lesions with the largest diameter ≤5 cm;
4. Differentiated thyroid cancer(DTC) meets the following conditions at the same time: ①The maximum diameter of the primary lesion is \<2.5 cm; ②There is no extraglandular invasion or only minimal external invasion of the anterior thyroid capsule or minor invasion of the sternum thyroid muscle;

Exclusion Criteria:

1. the patients had poor compliance and could not be reexamined regularly;
2. There was a history of neck or thyroid surgery;
3. The patients require total thyroidectomy or lateral neck dissection.
Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.

This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality.

The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB.

The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Sign written informed consent;
* With extensive small cell lung cancer;
* Previously received first-line standard chemotherapy, with treatment response of CR or PR;
* Can tolerate the radiotherapy process;
* Be over 18 years old
* Life expectancy ≥ 12 weeks;
* With the Eastern Cancer Cooperative Group (ECOG) score 0-1
* After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation.

Exclusion Criteria:

* Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis;
* Pregnancy or breastfeeding;
* Any other conclusive medical, psychiatric and/or social reasons determined by the researcher;
* Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study;
* Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.
Endoscopy for Bleeding Situations in Surgical Patients

Retrospective analysis of surgical patients with relevant gastrointestinal bleeding situations and indication for endoscopy for bleeding

We performed an analysis of all adult, surgial patients with indication for emergency endoscopy because of relevant gastrointestinal bleeding situations. A retrospective analysisof the incidence, causes, endoscopic findings and therapy and the outcome of bleeding situations during a 24-mounths interval in the years 2017, 2018 and 2019 was performed at our tertiary centre. Informed consent was obtained from all participants. Patient records as well as database were analyzed for therapy-specific items.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the University Hospital of Tübingen Department of General, Visceral and Transplantation Surgery with gastrointestinal bleeding situations

Exclusion Criteria:

* younger patients
* patients without indication for emergency endoscopy for bleeding situations
Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery

Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to single-port robotic gynecologic surgery which has incision site at umbilical area. Patients will randomly assigned to two groups, RSB group and Control group. Each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.

Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be proceeded. Patient of Control group will be proceeded the surgery after induction of anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively. If a patient complains pain more intense than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Robotic single-port gynecologic surgery
* American society of Anesthesiologists (ASA) physical status classification I-II
* Age: 21-60

Exclusion Criteria:

* Gynecologic cancer operation
* History of previous abdominal surgery
* Allergy to local anesthetics(ropivacaine)
* Opioid tolerance
* Coagulopathy
* Infection at the needle insertion site
* Difficulty to cooperating
Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD

The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Adolescents, ages 13-18
* Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder.

Exclusion Criteria:

* Adolescents who are pregnant.
* Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk.
* History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders.
* Currently on other psychotropic medications from which discontinuation would present a significant risk.
* A current episode of major depressive disorder or a diagnosis of bipolar disorder.
* Diagnosis of dependence for any substance other than marijuana.
* Adolescents with a full-scale IQ below 80.
Study of Infantile Lower Limb Malformations and Deformities

The skeletal defects of the lower limbs in pediatric age encompass various congenital and acquired conditions that alter bone structure. These alterations can be symmetrical or asymmetrical, with potential consequences such as deformities, short stature, and disability. These condictions may impact not only on the physical and the mental function of the children, but also on their family context.

Management often requires a multidisciplinary approach for early diagnosis and treatment. Deformities are heterogeneous and necessitate a personalized therapeutic plan.

Currently, in pediatric orthopedic surgery there is a lack of an instrument capable of evaluating all these aspects.

The advancement of computer-assisted surgery and artificial intelligence could improve treatment customization and involve patients and families in therapeutic decision-making to prevent complications. This study aims to provide support for clinical practice to promote a systematic, comprehensive, and sequential evaluation of lower limb deformities in developmental age, from which epidemiological data and evidence on treatment approaches used in major referral centers can be extrapolated.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years at the time of initial orthopedic evaluation
* Diagnosis of congenital or acquired musculoskeletal deformity to one or both lower limbs
* Presence of informed consent to participate in the study

Exclusion Criteria:

* Refuse to participate in the study by the patient or parent/legal guardian
* Patients with mild paramorphisms not associated with functional limitations
An Observational Study to Investigate Clinical Usefulness of OROS Hydromorphone in Korean Cancer Patients

This study aims to collect clinical information and to examine the usefulness and safety of ORal Osmotic System Hydromorphone in Korean cancer patients. The decision to treat patients with drug is as per physician discretion and that doses are determined based upon approved labeling recommendations and physician discretion.

The primary purpose of this observational study is to collect clinical data on cancer pain control using OROS (ORal Osmotic Active System) hydromorphone and to investigate the clinical usefulness of OROS hydromorphone for Korean cancer patients. Information on the effectiveness of cancer pain control and any adverse events reported by those patients using OROS Hydromorphone will be reported. In addition, clinical usefulness of OROS hydromorphone will be evaluated through assessing sleep disturbance due to pain, breakthrough pain, and end-of-dose failure before and after the study drug administration and examining the patient's satisfaction with study drug and the investigator's global assessment. This is a multi-center, open-label, prospective, exploratory, and observational study with approximately 770 patients. Efficacy endpoints will be analyzed to examine the difference between before and after the treatment. Since this is an observational study under the condition of routine practice, OROS Hydromorphone dosage should be adjusted at the discretion of the investigator, based on patient response. It is recommended that the dosage be conservative at first and adjusted appropriately considering the adverse events and analgesic effect for all the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are in need OROS hydromorphone to relieve cancer pain

Exclusion Criteria:

* Patients with serious gastrointestinal diseases that may interfere with oral analgesic effects, such as dysphagia, vomiting, absence of periastalsis, intestinal obstruction, and/or severe strangulation, in which case the absorption and passage of orally-administered medication may be unduly influenced