cyrilzakka/clinical-trials huggingface dataset:
Study on the Clinical Efficacy of Teclistamab

The aim of this study is to assess the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli®) in a prospective, real-life setting in Belgium.

To assess the clinical efficacy and safety of teclistamab (Tecvayli®) in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab (Tecvayli®) as the next treatment. Patients will be followed up prospectively until the end of study (24 months/2 years), or until disease progression, withdrawal of consent death or loss to follow-up, whichever occurs first. Each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab. Then, data will be collected every 3 months until the end of study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Written informed consent
* Has a diagnosis of relapsed and refractory multiple myeloma
* Has already received at least three previous treatments
* Is refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody
* Evidence of disease progression on the last line of therapy, based on determination of response by the IMWG response criteria
* Anticipated to start treatment with teclistamab per routine clinical care or has started with teclistamab treatment ≤14 days before intended screening visit

Exclusion Criteria:

* Has participated in a teclistamab trial (teclistamab or control arm) or teclistamab Single Patient Request (SPR) program
* Has started teclistamab treatment \>14 days before intended screening visit.
Bioavailability of Plant Protein Amino Acids

This study aims to inform of the mechanism of action of plant-based protein by measuring the bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation following oral ingestion) of key amino acid and metabolic products that regulate skeletal muscle protein synthesis (MPS) in humans.

Plant-based proteins contain several amino acids that are essential to signal muscle growth/repair and act as a substrate during muscle protein synthesis. However, compared to animal protein or free-amino acids, the bioavailability of certain essential amino acids may be compromised. Following selective processing (e.g. removal of carbohydrate and/or other anti-nutritive factors) food grade plant-based protein concentrates possibly confer greater bioavailability and bioactivity in vivo. This project explores the bioavailability and bioactivity of selected plant-based protein concentrates following oral ingestion in young, healthy men and women.

Eligibility Criteria:
Inclusion Criteria:

* No known intolerance to any item contained in the protein products.
* No blood borne disease risk, current illness or medication that would adversely affect participation
* No known adverse reaction to venepuncture

Exclusion Criteria:

* n/a
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer

The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.

The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of breast cancer
* Stage IV disease
* None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
* Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
* ECOG Performance Status 0-2
* Age \>18 and \< 75 years
* Left Ventricular Ejection Fraction (LVEF) \>50%
* Life expectancy \>3 months
* Signed informed consent

Exclusion Criteria:

* Absence of measurable or evaluable disease
* Life expectancy \< 3 months
* ECOG performance status \> 2
* History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
* Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
* Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
* Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 9 g/dl
* Creatinine \> 1.5 x the upper normal limits
* GOT and/or GPT \> 2.5 x the upper normal limits and/or Bilirubin \> 1.5 x the upper normal limits in absence of hepatic metastases
* GOT and/or GPT \> 5 x the upper normal limits and/or Bilirubin \> 3 x the upper normal limits in presence of hepatic metastases
* Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
* Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
* Male gender
* Pregnant or lactating women
* Refusal or incapacity to provide informed consent
* Inability to comply with follow up
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System

The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.

The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.

Eligibility Criteria:
Inclusion Criteria:

* 200 subjects at 10 clinical centers.
* All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
* All subjects are skeletally mature with spinal deformity.
* Risser score must be ≥ 3.
* Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
* Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications

Exclusion Criteria:

* Any subject who does not meet the inclusion criteria
Minocycline for the Prevention of Post-operative Intercostal Neuralgia

In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.

The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18 years or older
* Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
* Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
* Negative pregnancy test at screening for women of child bearing potential
* Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection
* Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period
* Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period

Exclusion Criteria:

* Pregnant or breast feeding
* Known allergy to minocycline and other tetracycline antibiotics
* Pre-existing neuralgic pain condition in area designated for operation
* Physical abnormality in area designated for operation
* Taking disallowed concomitant medication
* Renal insufficiency as determined by a calculated creatinine clearance of \< 60mL/min
* Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits
* Diagnosis of systemic lupus erythematosus
* Recent diagnosis of enterocolitis or colitis
* Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period
* Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
* History of major psychiatric disorder not medically controlled
Postural Balance of the Adult

Description of the geometrical configuration of the skeleton with regard to gravity line by patients suffering from spinal disorders that may induce postural troubles

In clinical routine, 3D analysis of postural balance is only made using clinical examination. When dealing with specific pathologies, in particular spine disorders, a better understanding of the balance could help better treat and prevent late complications. This prospective study aims at describing the pathologies of the musculoskeletal system using 3D reconstruction of the spine, the pelvis and the inferior limbs with regard to gravity line by patients suffering from postural trouble and defining new parameters to assess postural balance

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to social insurance
* Informed of the benefits, the risks and the conduction of the study and have given their free informed consent.

For Patients

* Medical prescription for an EOS™ exam, or for Frontal AND Lateral full-spine radiographs or for a pangonogram.

For Healthy Volunteers

* 50 years old

Exclusion Criteria:

For Patients

* Patients that neither need any EOS™ exam, nor Face \& Lateral full-spine radiographs, nor pangonogram.

For Healthy Volunteers

* Children or young adults (\<50)
* Psychiatric or neurologic deficit.
* Anterior Surgery of Spine or inferior Member
* Chronic back pain
* Recent acute back Pain
A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis

Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. The outcome of mortality reflects the caliber of ICU treatment. This is a prospective observational study that will include all patients diagnosed with sepsis for point-of-care ultrasonography within 24 hours of admission to the ICU from April 26, 2023, to March 30, 2024, and create a model that will predict 28 day outcome in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=16 yrs within 24 hour of ICU admission diagnosed as Sepsis as per Sepsis 3

Exclusion Criteria:

* USG cannot be done within 24 hour of admission to icu If USG cannot be done for 2 parameters Who do not give consent Withdrawal of active life support Do not intubate(DNI) or do not resuscitate(DNR) order at admission
Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 21 or older, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3 (see Annex 7)).
* The level of follicle-stimulating hormone (FSH) is not more than 25 milli-International unit per ml (mIU/ml) according to the screening values.
* Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the hypoactive sexual desire disorder (HSDD) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
* Current HSDD episode lasting not less than 24 weeks.
* Patients with secondary female sexual arousal disorder (FSAD) and/or female orgasmic disorder (FOD) will be eligible only if the HSDD developed before the FSAD and/or FOD and the HSDD has a more significant impact on the patient's quality of life.
* Not less than 15 scores according to the FSDS-R (Distress) Total Score.
* Stable monogamous relationship with one sexually active male sexual partner lasting at least a year. The partner is physically available not less than 50% of time during a month.
* Consent to attempt to have a sexual intercourse at least twice a month, if she has a desire.
* Consent to complete a diary every day during the screening period and assessment of the baseline state (in this period diary records must cover ≥80% days), during the therapy and subsequent follow-up.
* Consent to use adequate methods of contraception throughout the study.

Exclusion Criteria:

* Any prohibited treatments.
* Other mental disorders or psychiatric diseases.
* Score ≥ 20 according to the Beck Depression Inventory during the screening. Patients with 16 to 19 scores according to Beck's inventory may be included in the study unless, in the investigator's opinion, an actual depressive disorder is observed in the patient.
* Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium.
* Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc).
* Pregnant and nursing women or non-lactating women during the first 12 months after childbirth.
* Consumption of more than 5 portions of alcoholic drinks per week or alcohol addiction, drug addiction or drug abuse in the past. One portion of an alcoholic drink means 360 ml of beer, 120 ml of wine or 30 ml of a strong alcoholic drink.
Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer

This research trial studies the role of a substance called hyaluronic acid in causing the growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells are a type of cancer cells that may cause the cancer to spread to other parts of the body. Studying samples of blood and bone marrow from patients and animal models in the laboratory may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the bones.

PRIMARY OBJECTIVES:

I. To evaluate the hypothesis that there are more hyaluronan synthase 2 (HAS2)+ cells in patients with bone metastasis compared to patients with only local disease.

SECONDARY OBJECTIVES:

I. To evaluate the hypothesis that cells with HAS2+ and cancer stem cell (CSC)+ (cluster of differentiation \[CD\]24-/CD44+/epithelial specific antigen \[ESA\]+) cells will have the most aggressive growth in the bone, using an animal model.

OUTLINE:

Blood and bone marrow samples are collected and analyzed via flow cytometry and polymerase chain reaction (PCR). Cells are also transplanted into mice and studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy
Study of Blood and Tissue Samples in Predicting Response to Second-Line Therapy Using Erlotinib Hydrochloride or Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients with advanced non-small cell lung cancer.

OBJECTIVES:

* To evaluate the predictive value of proteomic profiling on the effect of second-line therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or docetaxel) in patients with advanced non-small cell lung cancer.
* To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras mutation).

OUTLINE: This is a multicenter study. Patients are stratified according to smoking status, performance status, proteomic profile, and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or another standard drug.
* Arm II: Patients receive standard non-chemotherapy treatment with erlotinib hydrochloride.

Serum is collected after failure of first-line therapy for proteomic analysis by matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein profile.

After completion of study treatment, patients are followed every 2 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)

  * Advanced NSCLC (stage IIIB or IV)
* Measurable disease
* Underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced NSCLC
* No clinical evidence of uncontrolled brain metastases

PATIENT CHARACTERISTICS:

* Caucasian
* ECOG performance status 0-2
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN in patients with known liver metastases)
* ALT or AST ≤ 3 times ULN (≤ 5 times ULN in patients with known liver metastases)
* Creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Able to comply with planned study procedures
* No multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
* No other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior surgery or radiotherapy
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator

Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising candidate as a functional endpoint measure for evaluating interventions to slow early progression of age-related macular degeneration (AMD). However, there is no agreement among the clinical, research and regulatory communities as to what constitutes a clinically (practically) significant slowing in RMDA. Treatments for AMD are often not considered efficacious if they do not result in a criterion level of improvement in vision. But how much change in the rate of dark adaptation constitutes a clinically significant change? Until this issue is resolved, progress in developing clinical trials on early AMD are at a standstill since there is no functional endpoint to be used in the trial. One approach to establishing clinical significance is to examine how RMDA relates to the performance of an everyday visual task under low luminance conditions, such as night driving or reading. However, such data are not yet available. The purpose of this project is to examine the relationship between RMDA and night-time driving and reading under poor illumination. This information will guide the development of a definition of a clinically significant difference in RMDA that can be used in designing clinical trials on early AMD.

The specific aims of this study are as follows:

Aim 1: To examine the association between RMDA as assessed by the rod intercept time and self reported driving difficulty and experiences during night time driving.

Aim 2: To examine the association between RMDA as assessed by rod intercept time and reading performance as assessed by the MNREAD test administered under a low light level. Reading performance will be defined in terms of maximum reading speed, critical print size (i.e., the smallest print size that supports maximum reading speed), reading acuity (i.e., the smallest print size that can be just read) and the reading accessibility index (i.e., an individual's access to text over the range of print sizes found in everyday life).

Eligibility Criteria:
Inclusion Criteria:

* age-related macular degeneration in one or both eyes, ability to follow simple instructions, licensed to drive a vehicle, can read and speak English

Exclusion Criteria:

* diabetes, retinal or optic nerve conditions other than age-related macular degeneration, neurological conditions that impair vision
Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism

Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions.

Our study was designed as a randomized, single-blind experimental clinical trial. It was planned to include 40 individuals diagnosed with bruxism in our research. Outcome measurements and assessments will be performed immediately after the participants are recruited and at the end of the 8-week program. Pain intensity, oral health quality of life, stress level and sleep quality will be assessed by self-report through questionnaires. Pressure pain threshold and muscle activation for the masseter muscle and heart rate variables measurements will be performed by physiotherapists. After completing the initial evaluations, the participants will be randomly divided into two groups. An eight-week exercise program will be applied to the control group. In the TAVNS group, in addition to the eight-week exercise program, TAVNS will be used twice weekly for 16 sessions with the VAGUSTIM device.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bruxism between the ages of 18-65,
* A history of bruxism for at least 6 months,
* Individuals with masseter muscle pain GAS≥4 at rest and during mastication

Exclusion Criteria:

* Masseter botox application in the last 6 months,
* Regular use of analgesics and anti-inflammatories that affect the OSS,
* Presence of infection or tumoral structures within intraoral structures,
* Wearing multiple ear piercings,
* With TMJ disc displacement and joint degeneration,
* Musculoskeletal problem with evidence of cervical or TMJ fracture, systemic disease, specific pathologic condition,
* Any surgical operation related to a cervical or TMJ problem,
* Less than 6 months of cervical or TMJ-related physiotherapy and rehabilitation services,
* The one with facial paralysis,
* Diagnosed psychiatric illness