cyrilzakka/clinical-trials huggingface dataset:
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
* Minimum of 1.5 x 10\^6 CD34+ cells/kg cryopreserved and to be transplanted.

Exclusion Criteria:

* Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
* Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
* Congestive heart failure as defined by New York Heart Association class III or IV.
* History of or current diagnosis of pancreatitis
* Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
* Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or alanine aminotransferase (ALT) greater than 3x upper limit of normal per the institutional guidelines)
* Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon monoxide (DLCO) less than 50% of predicted.
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).


Eligibility Criteria:
Key Inclusion Criteria:

* Part A, B, and C: Healthy Volunteers

  * Female subjects must be of non-childbearing potential
  * Between the ages of 18 and 55 years, inclusive
  * Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight \>50 kg
* Part D: Subjects with CF

  * Heterozygous for F508del and an MF mutation (F/MF)
  * FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
  * Body weight ≥35 kg

Key Exclusion Criteria:

* Part A, B and C: Healthy Volunteers

  * Any condition possibly affecting drug absorption
  * History of febrile illness or other acute illness within 5 days before the first study drug dose
* Part D: Subjects with CF

  * History of clinically significant cirrhosis with or without portal hypertension
  * History of solid organ or hematological transplantation
  * Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply
Pharmacokinetics of Sufentanil After Epidural Administration

Sufentanil is an opioid analgesics used in all groups of patients. It has one of the strongest effects among analgesic drugs. Sufentanil is widely-used because of its very quick onset, short duration of action, and better hemodynamic stability in patients compared to other opioids. Most of the pharmacokinetic studies described intravenous administration of sufentanil. The drug can also be epidural administrated (especially continuous epidural infusion) in low concentration with local anesthetics (ropivacaine or bupivacaine) for epidural analgesia. Epidural analgesia offers effective pain relief not only during the surgery, but also postoperatively. The combination of two drugs provides their additive effect and can reduce doses required for pain relief, then decreases the number and severity of adverse events. The study aims to describe the pharmacokinetics of epidural sufentanil used perioperative in adult patients after abdominal surgery to adjust the dosage if necessary.

The patients qualified for abdominal surgery were enrolled in the study. All patients were premedicated with oral midazolam (7.5 mg). Epidural cannulations were placed by anesthesiologists before general anesthesia. The catheters' placement procedure was conducted under local anesthesia and according to the local protocol for the infections' prevention. The epidural infusion (solution of 0.2 % ropivacaine 5 ml with 25 to 50 mcg sufentanil in 50 ml of 0,9% NaCl) was started with a 5 mL bolus of the mentioned solution a few minutes before skin incision. The continuous infusion was maintained throughout the surgery at the rate of 3-12 mL/h. The patients were induced into general endotracheal anesthesia according to a standardized protocol, with propofol 1-3 mg/kg, fentanyl 1-2 mcg/kg, and rocuronium bromide 0.6 mg/kg. Anaesthesia was continued by using sevoflurane or desflurane MAC 1 to maintain mean arterial pressure with a value of +/- 20% of the original value. The postoperatively patients were monitored in the PACU (Post Anesthesia Care Unit) for 1 hour and then transferred to the intensive care unit or surgical unit according to their clinical status and co-morbidities. Whole blood samples (2.0 ml) were collected to measure sufentanil concentrations - during the epidural infusion and up to 72 hours after its cessation. Vital parameters (e.g. blood pressure, saturation, heart rate, respiratory rate, and pain score) were monitored at regular intervals. The epidural sufentanil and ropivacaine infusion were continued after surgery as long as was necessary.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years,
* qualifications for abdominal surgery,
* ASA I-III

Exclusion Criteria:

* proven allergies to sufentanil,
* lack of written confirmed consent of a patient
Non-inferiority Bioavailabilty Study of 3 Silicon-rich Supplements

The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.

The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.

Participants: 5 healthy men over 18 years old, with normal serum creatinine levels. Treatment consists of one product consumption every week, and measuring postprandrial response at 0, 30, 60, 90, 120, 180, 240 and 360 min, in blood, and urine in two periods of three hours each.

The statistical analysis will follow the principles specified in the guidelines of the ICHE and CPMP/EWP/908/99 ICHE Points to Consider on Multiplicity Issues in Clinical Trials.

Eligibility Criteria:
Inclusion Criteria:

* Adults men or women (\>18 years old)
* With normal serum creatinine levels.
* Written informed consent provided before the initial screening visit.

Exclusion Criteria:

* Suffering from chronic diseases
* Suffering from intestinal disorders
* Consuming silicon supplements in the 7 days prior to inclusion in the study.
* Consuming medicines containing silicon in the 7 days prior to inclusion in the study.
* Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
* Failing to follow study guidelines.
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System

This project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the Brazilian Unified Health System to generate genomic and phenotypic data for the Brazilian Ministry of Health's National Precision Genomics and Health Program, called Genomas Brasil, as well as to collect data on the population's ancestry.

In Brazil, the most frequent types of neoplasm are prostate cancer in men and breast cancer in women. Understanding the molecular variants in tumors, which result from mutations and variants that occur during carcinogenesis, can affect treatment response and disease prognosis and is an important target of oncology research. Detecting hereditary genetic syndromes also helps in oncological follow-up, allowing prediction of the risk of new neoplasms. This project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the Brazilian Unified Health System to generate genomic and phenotypic data for the Brazilian Ministry of Health's National Precision Genomics and Health Program, called Genomas Brasil, as well as to collect data on the population's ancestry.

Eligibility Criteria:
Inclusion criteria for breast cancer patients (Arm 1):

* Women aged ≥ 18 years;
* Brazilian nationality;
* After review at the Hospital Moinhos de Vento, confirmed histological diagnosis of breast carcinoma with overexpression of HER2 (classified by immunohistochemistry as 3+ or 2+ with positive in-situ hybridization) or triple-negative (estrogen and progesterone receptors \<1% and no overexpression of HER2);
* Clinical stage II or III for HER2-positive and I, II and III for triple-negative patients - American Joint Committee on Cancer (AJCC) 8th edition;
* HER2- positive patients: must undergo neoadjuvant chemotherapy plus trastuzumab in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel), combined with trastuzumab, or a non-anthracycline option consisting of taxane (docetaxel or paclitaxel) combined with carboplatin and trastuzumab;
* Triple-negative patients: must undergo neoadjuvant chemotherapy without immunotherapy in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel) with/ without platins (carboplatin ou cisplatin) or a regimen without anthracycline (taxane with/without platins)
* Patients must provide written informed consent prior to inclusion

Inclusion criteria for patients with prostate cancer (Arm 2):

* Men aged ≥ 18 years;
* Confirmed histological diagnosis of prostate adenocarcinoma;
* AJCC 8th edition clinical stage IV;
* Patients must provide written informed consent.

Exclusion criteria for Arms 1 and 2:

* No available paraffin-embedded tumor tissue for genomic analysis;
* Inability to collect blood for genomic evaluation.
Ultrasound Guidance for Intravenous Cannulation in Emergency Department Patients.

A randomized trial of the use of ultrasound by emergency physicians in the placement of intravenous catheters in emergency patients who are found to have difficult intravenous access (defined as two failed attempts by nursing staff).


Eligibility Criteria:
Inclusion Criteria:

* patients requiring an IV in the emergency department and who have two failed attempts by nursing staff

Exclusion Criteria:

* emergent need for IV access
A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants

This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of high-dose omega-3 PUFA supplementation in patients with dyslipidemia who carry a specific "unfavorable" genetic variant in the FADS1/FADS2 gene cluster. The study will compare lipid profile improvements and inflammatory markers between two cohorts: (1) homozygous (or high- risk) carriers of the FADS1/FADS2 variants and (2) non-carriers (wild-type). Investigators hypothesize that individuals with these variants will show a more pronounced reduction in triglyceride levels and inflammatory markers following high-dose omega-3 supplementation due to their diminished endogenous synthesis of long-chain PUFAs.

Dyslipidemia is a key risk factor for cardiovascular disease, often characterized by elevated triglycerides, low HDL cholesterol, and/or high LDL cholesterol. Genetic variants in the fatty acid desaturase genes FADS1 and FADS2 can alter the conversion of shorter-chain polyunsaturated fatty acids into longer-chain forms (EPA, DHA), leading to suboptimal endogenous production of these beneficial fatty acids. Omega-3 supplements, especially EPA and DHA, have been shown to lower triglycerides and modulate inflammatory pathways. This study examines whether high-dose omega-3 supplementation (2-4 g/day) confers greater benefit for carriers of certain "unfavorable" FADS1/ FADS2 polymorphisms, potentially optimizing cardiovascular risk reduction in this genetically defined subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol).

  * On stable lipid-lowering therapy (e.g., statins) or lifestyle regimen for at least 4 weeks prior to enrollment, if applicable.
  * Willingness to undergo genetic testing for FADS1/FADS2 variants. For the FADS Variant Cohort: confirmed homozygous (or high-risk) polymorphisms in FADS1/FADS2.
  * For the Non-Variant Cohort: confirmed wild-type FADS genotype.

Exclusion Criteria:

* Use of prescription omega-3 products or high-dose fish oil supplements within 4 weeks prior to enrollment.
* Known hypersensitivity to fish or fish oil products. Significant renal or hepatic impairment, uncontrolled thyroid disease, or other comorbidities that may confound results.
* Pregnancy or breastfeeding.
* Inability or unwillingness to comply with study procedures.
NINDS CRC Chronic Migraine Treatment Trial

The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate is becoming the standard treatment among headache specialists. Experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. No randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine.

The goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. In the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. Participants will be followed for six months.

Eligibility Criteria:
Inclusion Criteria:

* History of chronic migraine for at least 6 months
* Age ≥ 18 years and age of migraine onset 60 or younger
* EKG performed in the last 12 months

Exclusion Criteria:

* Prior neuro-imaging suggesting secondary structural causes of headache
* Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder
* Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)
* History of kidney failure or nephrolithiasis
* A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control
* Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month
* Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol
* Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months
Metastatic Gastric Cancer FFCD 03-07

The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.

To compare the effectiveness of two different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.

Eligibility Criteria:
Inclusion Criteria:

* age = 18 years old
* patients carrying a adenocarcinoma of the stomach or cardia histologically proven
* locally advanced tumour which may not be treated surgically or metastatic tumour
* the patients having a stenosante tumour responsible for a disphagy had to have a tumoral ablation or a prosthesis or a probe of food,
* measurable lesions according to criteria RECIST (specify measurement by spiral scanner of largest diameter of with less the one lesion of size higher than 1 cm) or appraisable but nonmeasurable (lesions \< 1 cm, ascite, pleural effusion...)
* general state WHO \< 2
* absence of insufficiency cardiac or coronary symptomatic
* absence of previous chemotherapy other that auxiliary stopped since more than 6 months
* filled questionnaires QLQ C30 and STO-22
* PNN = 1500/mm3, haemoglobin ≥ 10g/dl, plates= 100 000/mm3
* creatinin ≤ 110 micromol/l
* bilirubin ≤ 35 micromol/l

Exclusion Criteria:

* disphagy or intestinal obstruction incompatible with a treatment per os or by a probe of food
* pregnant or nursing woman
* previous of cardiac toxicity to the 5FU or to the anthracyclines
* radiotherapy less than 3 weeks before inclusion, whatever the site
* other evolutionary cancer threatening the short-term life
* metastasis cerebral or méningée known (without obligation to seek it)
* impossibility of regular follow-up for psychological, social, family or geographical reasons
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia

The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a novel highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML).

The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily.

Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of at least 2 recommended dose levels for expansion selected from Part 1.

In both Part 1 and Part 2, participants will receive continuous daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2, C1D8, C1D15, and C1D16, followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter.

Approximately 100 participants could be enrolled in this trial, including up to 60 participants in Part 1 (dose escalation), including optional backfill cohorts, and approximately 40 participants in Part 2 (randomized dose expansion).

All participants will receive active trial intervention.

At least 4 dose-level cohorts may be evaluated in Part 1; at least 2 dose levels may be evaluated in Part 2.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female participants ≥ 18 years of age at the time of signing the informed consent
* Have an ECOG performance status score of 0 to 2
* Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase
* Have received treatment with active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance
* Prior treatment with asciminib may be allowed
* Adequate organ function, as assessed by local laboratory

Key Exclusion Criteria:

* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701
* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)
Neuromodulation and Language Acquisition (Project Stage Ia)

The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.

Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether a mixed d1/d2 dopamine agonist (pergolid) or cholinergic neuromodulation (rivastigmine) or a general centrally arousing substance (modafinil) will yield a learning enhancement comparable to using levodopa in healthy subjects.

Our results show that the dopamine agonist pergolide impaired learning in healthy subjects compared to placebo, whereas cholinergic neuromodulation had no effect.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* 20-35 years old
* Right handedness
* Left language dominance (as assessed by functional transcranial Doppler ultrasonography \[fTCD\])

Exclusion Criteria:

* Neurological/psychiatric/metabolic/cardiac disorders
* Asthma
* Known allergic reactions to one of the experimental drugs
* Other drugs affecting the central nervous system
* Leisure drug ingestion during the past 4 weeks (urine test)
* Smoking cessation during the past 2 weeks
* \> 6 cups of coffee or energy drinks per day
* \> 10 cigarettes per day
* \> 50 grams of alcohol per day
Low Level Laser Therapy for Better Wound Healing

Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy.

Outcome: Pain score \& would healing at discharge, 1 months \& 3 months

After surgical suture application of low level laser therapy of ca. 72 Joules / cm2.

Evaluation at discharge, after 1 months \& 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Caesarean section or perineal tear grade 1-4 or episiotomy
* competent in German language

Exclusion Criteria:

* no caesarean section or birth without perineal tear grad 1-4 / episiotomy
* No consent given