cyrilzakka/clinical-trials huggingface dataset:
INNO-206 in Patients With Small Cell Lung Cancer (SCLC)

The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.

This is a phase II, open-label, prospective, multicenter, single-arm study of INNO 206 in adult patients with recurrent extensive small cell lung cancer sensitive to first-line platinum-based therapy. The primary objective of the study is to determine the objective overall response rate. Secondary objectives include evaluating the treatment-related toxicities in this patient population and determining the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients.

Eligibility Criteria:
Inclusion Criteria:

* Be ≥18 years old.
* Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at the time of enrollment into the study.
* Have responded to first-line platinum-based chemotherapy, but progressed or relapsed ≥60 days after completion of first-line therapy.
* Have measurable disease defined by RECIST.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
* Have an estimated life expectancy of ≥4 weeks.
* Be male or non-pregnant, non-lactating female patients. Patients who are fertile must agree to use an effective barrier method of birth control to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication.
* Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).
* Have adequate organ function.

Exclusion Criteria:

* Are pregnant or lactating.
* Have received prior anthracycline therapy.
* Have participated in any investigational drug study within 30 days prior to study entry.
* Have received radiotherapy within 2 weeks of treatment in this study.
* Have not recovered from acute toxicity of all previous therapy prior to enrollment.
* Have a history of a malignancy other than SCLC. Exceptions to this include: curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix, or prior low-grade, localized prostate cancer (Gleason score ≤6); or a history of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.
* Have symptomatic central nervous system (CNS) metastases.
* Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure ≥NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances, etc.) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
* Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
* Have received radiotherapy with \>25% involvement of the bone marrow within 6 weeks prior to study start.
* Have a known hypersensitivity to doxorubicin, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N-acetyltryptophane.
A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis

The effects of n-3 LC-PUFA-supplemented dairy products on inflammation and immunological parameters, biomarkers of oxidative stress, serum lipids, and disease activity were determined in patients with rheumatoid arthritis (RA).

Recent studies suggest that n-3 LC-PUFA may improve cardiovascular and inflammatory diseases.

As a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination in the Clinic for Rheumatology (Internal Medicine III, Friedrich Schiller University, Jena). The RA was diagnosed according to the 1987 revised criteria of the American Rheumatism Association (ARA). Severity of disease activity was evaluated by using the disease activity score DAS 28.

Forty five subjects (43 f, 2 m) were randomly divided into two groups to carry out a double-blind, placebo-controlled cross-over study.

The study consisted of two investigation periods of 12 weeks, with an eight-week washout period in between. Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils with high amounts of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linoleic acid (ALA). The daily dose of n-3 FA amounted to 2.4 g, consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA. The placebo products were commercial dairy products with comparable fat contents.

Venous blood and 24h urine were collected at the beginning and at the end of each period. The DAS 28 score was assessed at the beginning and the end of each period, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Clear diagnosis of Rheumatoid Arthritis
* Patients receiving nonsteroidal anti-inflammatory drugs (NSAID) or corticosteroids (max. 15 mg/d) or both were eligible if dosage had been stable for at least 4 weeks before day 1 of the study and remained below this limit throughout the study
* Patients on disease-modifying antirheumatic drugs (DMARD) had to be on a constant dosage for at least 8 weeks before and throughout the study

Exclusion Criteria:

* Subjects with gastrointestinal or metabolic diseases, alcohol abuse, taking dietary supplements (e. g. fish oil capsules), known allergies or foodstuff indigestibility
* patient's request, serious infections, inadequate control of arthritis symptoms (over 50% increase of the number of swollen or tender joints), reinstitution of therapy with DMARD, or if patient compliance with the study protocol was doubtful.
Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability

Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in the treating pain and severe functional disability in acute LBP patients.

58 patients with acute LBP and severe disability with an Oswestry Disability Index(ODI) of 60% or higher were randomly allocated and divided into 2 groups. The experimental group was treated with MSAT and the control group was treated with intramuscular injections of diclofenac(NSAID). All administrations were limited to 1 session, and comparisons were made of measurements before and after treatment. Primary outcomes were measured by the NRS(numerical rating scale) of back pain in active movement. Secondary outcomes were measured by the NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC) etc. Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Acute LBP(with or without leg pain), with onset within past 4 weeks
* Severe disability as assessed by an Oswestry Disability Index of 60% or higher
* Age between 20 and 60
* Given consent to lumbar MRI
* Voluntary participation with written consent given to study consent form

Exclusion Criteria:

* Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
* Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
* Progressive neurologic deficit(s) or concurrent severe neurological symptoms
* Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
* Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
* Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
* During pregnancy or suspected pregnancy
* Subjects considered unsuitable for clinical trial by the researcher
Personalized Tidal Volume in ARDS (VT4HEMOD)

Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.

Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.

The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)


Eligibility Criteria:
Inclusion Criteria:

1. Age greater then 18 years old
2. ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
3. invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
4. use of sedation and neuromuscular-blocking agents
5. arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
6. central venous catheter implanted in the superior vena cava territory
7. esophageal balloon
8. Computed tomography planned by attending physician

Exclusion Criteria:

1. Previous inclusion in current study
2. Acute cor pulmonale
3. ECMO
4. Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min
5. Pneumothorax or bronchopleural fistula
6. Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
7. Contra-indication of transport to imaging facility
8. Intracranial hypertension
9. Tricuspid or pulmonary mechanical valve
10. Tricuspid or pulmonary infective endocarditis
11. Pace maker with intracardiac leads
12. Right ventricle tumor
13. Complete left bundle block
14. Intrathoracic metallic device
15. COPD
16. Cardiac arrythmia
17. Vesical pressure \> 15 mm Hg
18. Lower limb amputation
19. Inferior vena cava thrombosis
20. Patient under an exclusion period relative to participation to another clinical trial
21. Patient under a legal protective measure
22. Patient not affiliated to social security
23. lac of patient/representative consent
24. Pregnancy
25. Breast feeding
Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study

Acupuncture is used extensively by patients worldwide for a variety of illnesses. While research is beginning to show effectiveness in clinical pain, the mechanisms underlying how these effects are evoked are poorly understood. Experimental models in healthy human volunteers can more closely control the variables of acupuncture needling and begin to separate out the relative contribution of specific components of needling and needle stimulation. By examining acupuncture's effects on experimental inflammatory models with well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how acupuncture produces its clinical effects. We propose to establish a model which could be used as a template to examine the individual components contributing to acupuncture's clinical effects on inflammation and pain. We hypothesize that acupuncture will have analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well as a model of heat pain testing which activates central sensitization.

Twenty healthy human volunteers will participate in a crossover study with active acupuncture and sham acupuncture interventions. They will be tested for their minimal erythemal dose (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the lower leg. Background information will be collected which could affect individuals' sensitivity to pain such as anxiety and depression, as well as their expectations regarding acupuncture treatment.

The following day they will return for the first experimental day. A measurement with Laser Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be performed using a computer controlled thermode both on and off the ultraviolet B lesion. On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal summation of heat pain.

Next, a licensed acupuncturist will perform either true electroacupuncture or sham electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler and heat pain testing will be repeated. The difference between pre-acupuncture and post-acupuncture measurements will represent the acupuncture -induced analgesic and anti-inflammatory effects.

Participants will return for another ultraviolet B exposure adjacent to the first, and will receive whichever sham or true acupuncture intervention was not performed on the first study day.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-70

Exclusion Criteria:

* Clinically relevant systemic diseases such as psychiatric, neurological, and dermatological conditions interfering with the collection and interpretation of study data
* Chronic or recent use of medication potentially interfering with pain processing (except oral contraceptives)
* Intake of analgesics within the two days prior to study
* Participation in other research studies within the previous 30 days
* Having previously received acupuncture treatments
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
* Evidence of an activating RET gene alteration in the tumor and/or blood
* Measurable or non-measurable disease
* Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50
* Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days
* Adequate hematologic, hepatic and renal function.
* Ability to receive study drug therapy orally or via gastric access
* Willingness of men and women of reproductive potential to observe conventional and effective birth control

Exclusion Criteria:

* Major surgery within two weeks prior to planned start of LOXO-292
* Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292
* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
* Clinically significant active malabsorption syndrome
* Pregnancy or lactation
* Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292)
* Uncontrolled symptomatic hypercalcemia or hypocalcemia
* Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension
* Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor\[s\])
Nutritional Tolerance and Safety of a Tube Feeding Formula

This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, enteral formula in medically stable adults, who currently require or will require to be enterally fed.

In patients unable to meet energy and protein requirements orally, enteral nutrition (EN) often serves as the sole source of nutrition for long-term tube fed individuals in varied care settings. EN formulas are designed to meet patients' macronutrient needs as well as vitamin and mineral needs with the overall objective of establishing and maintaining quality of life and further preventing undesirable outcomes that are associated with malnutrition. Some individuals who might benefit from a formulation with real food ingredients have not been able to do so because they need a more concentrated, higher calorie formula. Compleat® 1.5 is a calorically dense real food containing nutrition formula. This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, plant-based enteral formula with real food ingredients, Compleat® 1.5, in medically stable adults, who currently require or will require to be enterally fed.

Eligibility Criteria:
Inclusion Criteria:

1. Medically stable, enterally tube-fed adults with a feeding tube diameter of at least 8 French OR medically stable, adults assessed to require enteral feeding initiation with a feeding tube diameter of at least 8 French (2.6 mm).
2. Aged 18 years or older at the time of screening visit.
3. Currently tolerating or determined to tolerate enteral feeding and eligible for feeding with a 1.5 kcal/mL formula, as per PI discretion.
4. Requires or will require enteral tube feeding to provide 90% or more of their daily nutritional needs without the use of modular(s) for at least 14 days.
5. Participant or their Legally Authorized Representatives (LAR) is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary informed consent (or assent, if capable), carry out all study-related procedures, and communicate effectively with the study staff.

Exclusion Criteria:

1. Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
2. Currently using the study formula
3. Any medical condition or contraindicated medications deemed exclusionary by the PI as determined by medical/medication history at the time of screening visit.
4. Any condition, in the opinion of the PI, that would contraindicate use of the study formula (e.g., need for severe fluid restriction, allergy to formula ingredients, etc.).
5. Participation in another interventional clinical study between 30 days prior to screening visit until the end of study.
6. Any condition or abnormality that, in the opinion of the QI, would compromise the safety of the participant or the quality of the study data.
7. Unable to obtain informed consent.
Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis

This trial aims is to assess and compare treatment effect of microwave thermolysis and botulinum toxin A for axillary hyperhidrosis with focus on longevity. The investigators also aim to assess patient satisfaction and adverse reactions in relation to treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent
2. Subject is 18 years of age or older
3. A unilateral HDSS score of 3 or 4 for each axilla
4. A gravimetric measurement of at least 50 mg/5 min for women and 100 mg/5 min for men in at least one axilla. The contralateral axilla should not be below 40 mg (women) and 80 mg (men).
5. Women of childbearing potential must be confirmed not pregnant by a negative u-HCG prior to study treatment and must use a safe contraceptive method at baseline.

Exclusion Criteria:

1. Subjects with generalized hyperhidrosis
2. Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
3. Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
4. Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
5. Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
6. Breast tissue in the axillae
7. Treatment with Isotretinoin within the past 6 months
8. Axillary laser or IPL treatment within the past 6 months
9. Botulinum toxin-injections in the axillae within the past 12 months prior to baseline
10. Known allergies to botulinum toxin, iodine, lidocaine or adrenaline
11. Prior axillary surgery
12. Limited motion in the shoulder joint or neurologic deficit in upper limb
13. History of diseases resulting in muscle weakness (ALS, Lou Gehrig's), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise
14. Axillary lymph node enlargement or -removal or lymphedema in either upper limb
15. History of hidradenitis suppurativa or history of reoccurring infections/abscesses
16. History of breast cancer
17. Electronic device implant
18. If female; lactating, pregnant or planning on becoming pregnant during the study
19. Non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)