cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery

The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery

Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography

Eligibility Criteria:
Inclusion Criteria:

* Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures.
* Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed
* Subject was male or female at least 18 years of age.
* Subject weighed \> or = 100 lbs (pounds).
* Subject was willing and able to comply with the protocol and able to score their pain intensity.
* Subject was in good health as determined by the investigator on the basis of medical history, physical examination, Electrocardiogram (ECG) and screening laboratory results.
* Subject had not developed a condition or complications as result of the bunionectomy procedure that would preclude their participation in the study.
* Subject was willing and able to remain at the recovery day care center for the entire 24-hour Treatment period.

Exclusion Criteria:

* Subject was pregnant or lactating.
* Subject had been on an investigational drug within 30 days prior to the initiation of study drug.
* Subject had donated blood or blood components within one month prior to study (Check-in).
* Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac.
* Subject had a known history of substance or alcohol abuse within 2 years prior to Screening.
* Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines, and barbiturates) that could not be justified by prescription use.
* Subject had a condition that would contraindicate the use of opioid analgesia (e.g., pulmonary disease or paralytic ileus).
* Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants (TCA) compounds within 1-month prior to Check-in.
* Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours prior to Check-in.
* Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics within 24 hours prior to Check-in.
Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)

The purpose of this study is to test the safety of a combination of the study drug called WST11 and PDT. Photodynamic therapy (PDT) is a type of ablation therapy (treatment which destroys tumor cells) which has been previously approved for the treatment of patients with other cancers. It works by using a drug that is given through the vein and then is activated in the tumor by light administered during endoscopy, which results in destruction of the cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older

  * Confirmed tissue diagnosis of urothelial carcinoma involving the ureter and/or renal pelvis with pathology reviewed at MSKCC
  * Residual or recurrent cancer following prior endoscopic treatment
  * Ineligible, unwilling or refusing to undergo surgical management by resection of involved kidney or ureter.
  * Karnofsky performance status ≥ 50%
  * Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted. Demonstration of the site and degree of obstruction must be documented by retrograde pyelography at the time of initial and follow up endoscopic procedures within 60 days.
  * Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) ≤4 weeks prior to treatment
  * Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2)
  * Adequate organ function defined at baseline as:

    * ANC ≥1,000/ µL
    * Platelets ≥75,000/ µL
    * Hb ≥9 g/dl
    * INR ≤1.5 (except for patients who are on full-dose warfarin)
    * Calculated creatinine clearance ≥40 ml/min (using Cockcroft-Gault method)
    * Total serum bilirubin ≤1.5 mg/dL
    * AST/ALT ≤5× upper limit of normal
  * Able to provide written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include:

  * Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months)
  * Women on hormone replacement therapy with documented serum follicle stimulating hormone level \> 35 mIU/ml
  * Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence or where the partner is sterile
* T4 tumors with involvement of the bowel or major blood vessels • Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease that, in the opinion of the study investigator, would make the patient a poor candidate for the study
Trial to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice

Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 years or older at enrolment
* Who have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor
* Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label
* Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed

Exclusion Criteria:

* Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated
* Women with a contraindication for prescription of REKOVELLE® treatment

  * Hypersensitivity to the active substance or to any of the excipients
  * Tumours of the hypothalamus or pituitary gland
  * Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
  * Gynaecological haemorrhages of unknown aetiology
  * Ovarian, uterine, or mammary carcinoma
  * Primary ovarian failure
  * Malformations of sexual organs incompatible with pregnancy
  * Fibroid tumours of the uterus incompatible with pregnancy
  * Pregnancy and breast feeding
* Women who undergo ovarian stimulation for fertility preservation
* Women placed under judicial protection, guardianship, or supervision
* Women who are considered as vulnerable population
Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
* Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
* Karnofsky performance status of greater than or equal to 50%
* Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria:

* Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
* Hematologic disorder previously associated with anemia
* Active bleeding
* Iron deficiency
* Received erythropoietic therapy within 14 days prior to randomization
* Unstable cardiac disease
* Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
* Known positive antibody response to any erythropoietic agent
* Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
* Pregnant or breast feeding
* Red blood cell (RBC) transfusion within 4 weeks of screening
* Known hypersensitivity to any recombinant mammalian-derived product
Systemic Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is obscure, therefore more insight is needed to design effective anti-inflammatory agents. Recently it has become clear that cigarette smoke-induced inflammation is not only present in the lungs but also in the blood, and that this systemic inflammation has important consequences for the clinical expression of COPD. The investigators hypothesize that healthy individuals who are susceptible to cigarette smoking demonstrate a higher and aberrant systemic inflammatory response to cigarette smoke. This susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment.

Objective:

* To study systemic inflammation in individuals who are or are not susceptible to develop COPD.
* To characterize the switch to chronicity of the systemic inflmmatory response in COPD
* To determine whether the type and severity of the systemic inflammation contributes to the clinical outcome of COPD
* To compare between subjects who are or are not susceptible to develop COPD in peripheral blood, the corticosteroid responsiveness in vitro, and to unravel underlying mechanisms.
* To study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs
* To develop new biological and clinical markers for the early diagnosis and monitoring of COPD
* To define possible mediators involved in the early induction of COPD in susceptible smokers, and to define new drug targets


Eligibility Criteria:
Inclusion Criteria:

Age ≥18 and ≤75 years

* Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 9 groups of the study population
* Physically and mentally able to undergo the total study protocol
* Written informed consent

Exclusion Criteria:

* Participation in another study
* Alpha-1-antitrypsin deficiency
* Selected grade 1-3 co-morbidity listed in the ACE-27
* Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
* Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc
* Pulmonary diseases like sarcoidosis, pulmonary fibrosis, silicosis, hypersensitivity pneumonitis, asthma
* Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc
* Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine
Staples Versus Dermabond for Closure of the Skin After Cesarean Section

Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.

Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.


Eligibility Criteria:
Inclusion Criteria:

Woman over 18 year Woman having elective caesarean section

Exclusion Criteria:

Age under 18 Woman having an emergency caesarean section
Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.

Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.

Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.

The aim of this study is to conduct a randomised, controlled, clinical trial to compare the effect of S-1 plus RFA with stent with RFA with stent in patients with unresectable cholangiocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Obtention of a written informed consent.
* Patient over 18.
* Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
* Patient with Karnofsky score ≥ 50 %
* Patient capable of fill in the quality of life questionnaire.

Exclusion Criteria:

* No written informed consent.
* Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
* Patients with porphyria or hypersensibility to porphyrins.
* Pregnant, parturient or breastfeeding women.
* Patient under 18.
A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease

This is purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease

An open-label Phase 2 study is designed to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype.

Eligibility Criteria:
Key Inclusion Criteria:

* APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
* Chronic kidney disease with persistent albuminuria

Key Exclusion Criteria:

* Organ or bone marrow transplantation
* History of cancer within past 2 years, excepted for treated non-melanoma skin cancer, stage 0 cervical cancer, or stage 1 prostate cancer
* Conditions that may alter drug absorption, e.g., history of bariatric surgery
* Type I diabetes
* Pregnant or currently nursing

Other inclusion/exclusion criteria defined in protocol apply.
A Real-World Study of Bispecific Antibodies in Multiple Myeloma

Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Patients with multiple myeloma
* Patients who received at least one administration of the following therapies: teclistamab, elranatamab

Exclusion Criteria:

- Patients opposed to the collection of their personal data
Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

Exclusion Criteria:

* None.
Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)

Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of the leaflets of the mitral valve prolapse during systole into the left atrium.

The disease is very heterogeneous and can vary from a benign disease with almost no impact on the patient's life to a severe cardiac problem with many complications and high mortality rate.

The purpose of the study is to see if the investigators can find a relation between the severity of the MVP to the exercise capacity of the patient. The investigators also want to see if they can find a difference between the exercise capacity of mild MVP patients and healthy people.

To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the subject's functions during exercise. By combining gas exchange monitoring and ECG during a controlled exercise in which the subject reaches maximal effort, the test gives information about the cardiac, the pulmonary and the metabolic functions of the subject. This information can help identify if there is a problem to perform exercise properly and more specifically if the limitation is due to a cardiac, pulmonary or metabolic problem.

Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of the leaflets of the mitral valve prolapse during systole into the left atrium.

The disease is very heterogeneous and can vary from a benign disease with almost no impact on the patient's life to a severe cardiac problem with many complications and high mortality rate .

The purpose of the study is to see if the investigators can find a relation between the severity of the MVP to the exercise capacity of the patient. The investigators also want to see if they can find a difference between the exercise capacity of mild MVP patients and healthy people.

To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the subject's functions during exercise. By combining gas exchange monitoring and ECG during a controlled exercise in which the subject reaches maximal effort, the test gives information about the cardiac, the pulmonary and the metabolic functions of the subject. This information can help identify if there is a problem to perform exercise properly and more specifically if the limitation is due to a cardiac, pulmonary or metabolic problem.

Eligibility Criteria:
Inclusion Criteria:

* MVP diagnosis
* Signing consent form (By parents if the patient is a minor)

Exclusion Criteria:

* Other congenital or acquired cardiac problems other than MVP.
* Patients with other diseases that can affect the exercise capacity.
Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer

Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a combination of ethinylestradiol and levonorgestrel (Microgynon®)

Purpose:

Eligibility Criteria:
Inclusion criteria:

* Female patients 18 years or older at screening
* Female patient is postmenopausal or surgically sterilised
* Patient with locally advanced, metastatic or locally recurrent non-small cell lung cancer with histology of adenocarcinoma
* Nintedanib (Vargatef®) is planned to be prescribed in accordance with the marketing authorisation (SmPC)
* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial

Exclusion criteria:

* Any contraindication to nintedanib (Vargatef®), ethinylestradiol or levonorgestrel (Microgynon®), as specified in the respective labels
* Use of hormone containing contraceptives (including vaginal and intrauterine devices and including hormone replacement therapy) within 30 days prior to first administration of Microgynon®
* Systemic use of drugs known to induce (e.g. rifampicin, St. John's Wort, carbamazepine) or to inhibit (e.g. azole antimycotics, macrolides) CYP3A4 within 7 days prior to first trial drug administration until last pharmacokinetic(PK)-sampling in the trial. Exception: allowed is the intake of corticosteroids as docetaxel (pre)medication
* History of major thrombotic or clinically relevant major bleeding event in the past 6 months
* Persistence of clinically relevant therapy related toxicities (i.e. \> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2) from previous chemotherapy and/or radiotherapy
* Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
* Gastrointestinal disorders or abnormalities that would interfere with absorption of the trial drugs
* Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first treatment within the trial and without complete wound healing
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
* Patients unable to comply with the protocol
* Previous enrolment in this trial