cyrilzakka/clinical-trials huggingface dataset:
Exploratory Drug Interaction Study Between SMIs and DOACs

The main objective of this study is to investigate the effect of small molecule inhibitors (SMIs), used in targeted therapy for tumours, on direct oral anticoagulants (DOACs).

Patients who receive anticoagulant therapy in the form of a direct oral anticoagulant (DOAC) and simultaneously receive anti-cancer targeted therapy with a small molecule inhibitor (SMI), potentially have an increased risk on thromboembolic complications and bleeding events due to interfering drug-drug interactions. Some SMIs influence CYP3A4 and/or p-glycoprotein (p-gp) for which DOACs are substrates. In this study, the effect of theoretically relevant SMIs on the pharmacokinetics, efficacy and safety of DOACs in patients with solid tumours will be investigated. For this purpose, plasma concentration analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a solid tumour
* 18 years of age or older
* Patients receive or start treatment with an SMI-DOAC combination, that may cause a clinically significant DDI at the level of CYP3A4 and/or P-gp, based on the SmPC
* Combined use of a DOAC-SMI combination is expected to be continued at the same dose for at least three weeks
* The DOAC is used for at least seven days and the SMI has already been used for at least 21 days at time of blood collection to ensure steady-state
* Patients receive a DOAC at maintenance dose

Exclusion Criteria:

* Unable to understand the information in the patient information letter
* Any concurrent medication beside the SMI and DOAC that is known to strongly inhibit or induce CYP3A4 or P-gp
* Patients who are pregnant or lactating
A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

This trial is conducted in Europe. The aim of this clinical trial is to investigate the effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 30.0-40.0 kg/m2
* Stable body weight (below 5 kg body weight change during past 3 month)
* Fasting plasma glucose below 7.0 mmol/L

Exclusion Criteria:

* Presence or history of cancer or any clinically significant cardiac, metabolic, renal, gastrointestinal, hepatic, endocrine, dermatological, haematological, or psychiatric diseases or disorders, considered by the Investigator to have influence of the results of this trial
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Current or history of treatment with medications that may cause significant weight gain, within 12 months prior to screening
* Use of weight lowering pharmacotherapy within the last 3 months prior to trial start
* Previous or scheduled (during the trial period) surgical treatment for obesity
* Diagnosed type 1 or type 2 diabetes
* Smoking habitually as judged by the Investigator
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods if not sterile or post-menopausal
Predictive Value of SFlt-1/PlGF Ratio for the Diagnosis of Cardiovascular Disorders in the Puerperium: Pilot Study

The goal of this clinical trial is to identify a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks postpartum) by making use of a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data. The goal is to create a score that allows the clinician to identify those expectant mothers who at discharge are at increased risk of developing cardiovascular/hypertensive disorders.

At the time of recruitment, patients will be adequately informed about the purpose and modality of the study and will sign an informed consent form for participation in the study. On the first postpartum day, on the occasion of the blood tests included in the normal care routine, the patients will undergo measurement of circulating levels of angiogenic factors (soluble fms-like tyrosine kinase, sFlt-1; placental growth factor, PlGF), already used in pregnancy for predicting the risk of early and late preeclampsia. Marker assay kits will be provided free of charge by the company DASIT. Prior to collection, systolic and diastolic blood pressure will be measured by manual sphygmomanometer in supine position after at least 15 minutes of rest.

Anamnestic, clinical and laboratory data regarding pregnancy, childbirth and puerperium will be collected.

A diary for recording blood pressure values in the puerperium will be provided on the same occasion. The patient will be instructed in home blood pressure monitoring which should take place twice a week for the next 6 weeks after delivery. Return of the diary containing the pressure data will be done by e-mail. Postpartum hypertension is defined according to ACOG criteria as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. If altered blood pressure values are found, the patient will be invited to go to the emergency department or to her primary care physician and treated according the usual clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 44 years
* Single pregnancy
* Understanding and obtaining informed consent

Exclusion Criteria:

* Language misunderstanding
* Twin pregnancies
* Inability to comply with study arrangements (e.g., inability to home recording of blood pressure values)
Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.

OBJECTIVES:

Primary

* Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.

Secondary

* Evaluate local recurrence at 5 years.
* Evaluate aesthetic results.
* Evaluate quality of life using the QLQC30 and BR23 questionnaires.

OUTLINE: This is a multicenter study.

Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of intraductal breast cancer requiring a wide local resection
  * Diagnosis of infiltrating ductal breast cancer within range
  * Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment
* No multicentric tumor
* No gigantomastia
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No patients subject to a measure of legal protection or unable to express consent
* No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the diseased breast
* No prior adjuvant treatment
* No concurrent participation in another clinical research study
Neuromuscular Training Improves Single-Limb Stability

Pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (ACL) injuries would improve single-limb stability in young female athletes. Healthy female high school athletes will participate in this study. Single-limb postural stability for both lower extremities will be assessed with Stork balance test, Star Excursion Balance Test for Dynamic Balance and Single leg stance test for static balance. Participants will be included through convenient sampling. Informed consent will be taken from all the participants.

In this Controlled single-group pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (ACL) injuries would improve single-limb stability in young female athletes. Current study hypothesized that neuromuscular training would result in an improvement of postural stability, with the greatest improvement taking place in the medial-lateral direction. Healthy female high school athletes will participate in this study. Single-limb postural stability for both lower extremities will be assessed with Stork balance test, Star Excursion Balance Test for Dynamic Balance and Single leg stance test for static balance. Participants will be included through convenient sampling. Informed consent will be taken from all the participants. Those individuals who will match the inclusion and exclusion criteria will be a part of the study. The neuromuscular training program will consist of three 90-minute training sessions per week for 6 weeks. Following the completion of the training program, each subject will be re-evaluated to determine change in total, anterior-posterior, and medial-lateral single-limb stability.

Eligibility Criteria:
Inclusion Criteria:

* Age will range from 13-20
* Female participants
* Individuals with Postural instability and Impaired balance will be included.

Exclusion Criteria:

* Any malignancy
* Infection
* Systemic illness
* Trauma
Physiological Effects of Soccer Heading

There is growing concern for the resulting neurological and physiological outcomes from repeated head impacts in sports that do not manifest into traditional concussion symptoms. Specifically, there is evidence of immediate physiological deficits following controlled soccer heading. This study will compare the physiological changes of adolescents completing a set of soccer headers to those randomized to a set of soccer kicks to evaluate the effect of repetitive head impacts.

There is limited data relating head impact biomechanics to neurological outcomes in humans. Concussion occurs from rotational loading of the head giving rise to diffuse stresses and strains in the brain tissue leading to autonomic and physiological dysfunction. Repeated head loading is common in contact sports and an integral part of soccer. It is unknown whether the same biomechanical forces from lower severity head impacts such as typical soccer heading cause temporary physiological deficits as well. Advancement of objective physiological function assessment devices allow measurement of neurological effects in the absence of diagnosed concussion. Recent soccer heading studies have evaluated neurophysiological changes pre- and post-repetitive heading. These studies have found conflicting results for the effect on neurocognitive performance immediately following a bout of heading, but consistent changes were observed in measures of vestibular balance, ocular function, and neurochemical biomarkers.

Soccer heading biomechanics studies showed that females experienced higher severity head loading, and in equivalent sports such as soccer and basketball, females have higher concussion rates. This study will compare the physiological changes of male and female adolescents completing one of two soccer heading paradigms to those randomized to kicking to evaluate the effect of repetitive head impacts. This study will relate biomechanical measures of head loading with physiological function changes associated with repeated head impacts, and compare sex-differences in biomechanical measures and physiological changes.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 13 to 18.
* Actively participating on a competitive soccer team.
* At least 1 year of soccer heading experience.
* Parental/guardian permission (informed consent) and child assent.

Exclusion Criteria:

* Subject sustained a concussion or spinal injury within the past 6 months or still has active symptoms from a previous injury.
* Inability to exercise because of lower-extremity orthopedic injury or significant vestibular or visual dysfunction.
* Currently taking medications that can affect autonomic function.
* Plays exclusively the goalkeeper position and does not regularly head the ball.
* Parental/guardian permission (informed consent) not obtainable or not provided.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Subject has fixed orthodontia on upper teeth.
* Cannot understand English.
The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma

The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 \& PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed pathological diagnosis of aggressive PTCL
* Age 18-65 years old
* Achieving CR or PR after first-line therapy

Exclusion Criteria:

* Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.
Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy

Solid tumors have the tendency to spread to other organs in around 26% of cases, with many cases involving the bone causing severe bone destruction and pain that reduces patients' quality of life. Palliative radiation therapy is used as a standard of care to decrease cancer-related bone pain, as it has been proven to provide pain relief in many patients, either partially or totally, within only a few weeks. However, some patients experience worsening of bone pain especially within the first 10 days after radiation therapy, this is called bone pain flare, and its incidence is estimated to be around 40%. This pain flare tends to further reduce these patients' quality of life considering their main illness, which necessitates its prevention or alleviation.

Non-Steroidal Anti-inflammatory Drugs (NSAIDs) which are a key component of the World Health Organization (WHO) analgesic options used to alleviate cancer pain have not had a good share of published trials in the prevention of bone pain flares.

In this light the investigators aim to conduct a double-blinded, placebo-controlled randomized controlled trial to investigate the effectiveness of NSAIDs, specifically Proxen, in preventing bone pain flares after palliative radiotherapy, and as a secondary endpoint they will compare the quality of life and side effects experienced by patients in either group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Primary Solid tumor (Any type of solid tumor)
* Painful bone metastases which are otherwise uncomplicated (no fracture and no neurologic symptoms due to nerve impingement or compression)
* Baseline pain score on a numeric rating scale (0-10) of at least 2
* Stable dose and schedule of narcotic medications prescribed

Exclusion Criteria:

* Hematologic malignancy
* Previously irradiated bone
* Current use of steroids
* Current use of NSAIDs which cannot be stopped before randomization
* Contraindications for NSAIDs (hypersensitivity, PUD, prior GI bleed, CKD, HTN, HF, AERD/asthma)
* Contraindications for PPIs
Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma

To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.

To explore the 2 year PFS of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by reduced-dose radiation and cisplatin. The enrolled patients will receive 2 cycles of TPF regimen induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be delivered by 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. If radiographic SD/PD or EBV DNA\>0 after induction chemotherapy, the patients will receive a total of 70 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

The included patients will be treated with 2 cycles of TPF regimen induction chemotherapy and 60Gy IMRT combined with cisplatin concurrent chemotherapy. The TPF regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-Fu 3750mg/m2 civ120h, with a total of two cycles. Concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. The third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after IMRT finished.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of NPC(WHO II or III).
2. Stage III（8thAJCC/UICC staging system) and pretreatment EBVDNA\<4000opies/ml.
3. Aged 18-70 years。
4. ECOG = 0-1。
5. HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L.
6. ALT,AST\<2.5 fold of ULN；TBIL\<2.0×ULN。
7. CCR≥60ml/min or Cr\<1.5×ULN。
8. Signed informed consent

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Age \<18 or \>70years.
3. Treatment with palliative intent.
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
5. Pregnancy or lactation.
6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.


Eligibility Criteria:
Inclusion Criteria:

* Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
* Fasting TG ≥ 500 mg/dL at Screening
* Willing to follow diet counseling per Investigator judgment based on local standard of care
* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Active pancreatitis within 12 weeks prior to first dose
* Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
* Acute coronary syndrome event within 24 weeks of first dose
* Major surgery within 12 weeks of first dose
* Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
* Uncontrolled hypertension
* Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
* Uncontrolled hypothyroidism or hyperthyroidism
* Hemorrhagic stroke within 24 weeks of first dose
* Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol
Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis

The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.


Eligibility Criteria:
Inclusion Criteria:

* Active disease (inflammatory signs, erythrocyte sedimentation rate \[ESR\], C-reactive protein \[CRP\])
* Stable condition
* Stable basic treatments
* Morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (\>/=) 45 minutes

Exclusion Criteria:

* All contra-indications for glucocorticoids
* Pregnancy
* Concomitant treatment with biologics
* Intra-articular injections or synovectomy within the previous 4 months
Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.

To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine

Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Woman of age 18-60
* Pregnant woman in outdoor patient department and emergency

Exclusion Criteria:

* patient. with history of hypersensitivity to opioids,
* ketamine or bupivacaine
* History of cardiovascular disease,
* Hypertension,
* psychosis,
* antepartum hemorrhage,
* cord prolapse,
* fetal distress
Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss.

An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Adults (age ≥ 18 years on the test date)
* Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
* German native speakers
* Willingness and ability to perform all tests required for the study

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Allergy against silicon (ear mold casting mass)