cyrilzakka/clinical-trials huggingface dataset:
BMS-214662 in Treating Patients With Solid Tumors

Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.

II. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.

III. Determine the nature of dose limiting toxicity of this drug in this patient population.

IV. Determine the recommended phase II regimen of this drug in these patients. V. Establish a pharmacologic and pharmacokinetic profile of this drug in these patients.

OUTLINE: This is a dose escalation study.

Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for at least 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignant solid tumor for which a standard curative therapy does not exist
* Performance status - Karnofsky 70-100%
* At least 6 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
* Bilirubin no greater than 2.0 mg/dL
* AST no greater than 2 times upper limit of normal
* Albumin at least 3.0 g/dL
* Creatinine no greater than 1.5 mg/dL
* No uncontrolled heart disease
* No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation
* Corrected QT interval no greater than 450 milliseconds
* Must not require total parenteral nutrition
* No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No signs or symptoms of acute infection requiring systemic therapy
* No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause
* No confusion, disorientation, or psychiatric illness that may preclude study
* No more than 3 prior chemotherapy regimens
* At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered
* No other concurrent antineoplastic agents
* No concurrent hormonal anticancer therapy
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
* Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug
* No drugs known to prolong the QT interval during and for 24 hours after study drug
* No concurrent therapy with known CYP3A4 substrates
* No other concurrent investigational agents
Gamified Occupational Therapy for Adolescents with Duchenne Muscular Dystrophy

This research aims to improve the quality of life, occupational performance, occupational satisfaction and emotional health of young people with Duchenne muscular dystrophy compared to the classical occupational therapy program. The findings are planned to shed light on the development of new and effective strategies in the rehabilitation of adolescents with Duchenne muscular dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Duchenne muscular dystrophy
* To be literate in Turkish
* To have scored 27 points or more on the Modified Mini Mental Test
* Having a computer, tablet and internet connection
* Volunteering to participate in the study by their parents and reading and signing the informed consent form

Exclusion Criteria:

* Having a neurological disease other than Duchenne muscular dystrophy and/or another diagnosed neurological disease accompanying Duchenne muscular dystrophy
* Having a cooperation problem that prevents completing the assessments for any reason
* Difficulty understanding and speaking the Turkish language
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

The purpose of this study is to determine whether chiropractic manipulation or medical therapy is effective in the treatment of chronic neck pain.

Neck pain is a common complaint, approximately 10% of the population have neck pain. Many modalities are used to treat neck pain, but no therapy has been found to be clearly superior. We conducted a randomized controlled study of chiropractic manipulation versus medical therapy for chronic neck pain.

Subjects (n=70) with neck pain for more than 3 months but with no evidence of radiculopathy or myelopathy were randomized. Both groups were instructed to do neck exercises and use heat daily. The chiropractic group received 12 standardized manipulations over 6 weeks. Nurses saw the medical group on the same visit schedule and received acetaminophen 1,000 milligrams four times a day as needed. Blinded observer performed all measurements. The primary outcome measure was the Neck Disability Index (NDI). Secondary measures were pain via a visual analogue scale, global via Medical Outcome Study Short Form and range of motion via Cybex electronic inclinometer.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain for more than 3 months

Exclusion Criteria:

* Cervical radiculopathy or myelopathy
* Contraindications to cervical manipulation: metastatic cancer, coagulation disorder, cervical spine abnormalities, neuromuscular disease
* Medical contraindications: uncontrolled hypertension, active coronary artery disease, history of cerebral vascular disease, alcohol or drug dependency, acetaminophen allergy
* Active litigation involving neck pain
* Medical or Chiropractic treatment within the past 3 months
Utility of Laboratory Testing for Children With Seizure in Emergency Department

Objective: To evaluate the predisposing factors associated with abnormal laboratory findings in patients who came to the emergency room due to a first seizure.

Methods: Patients were divided into separate groups based on normal and abnormal laboratory results for sodium, potassium, calcium, and glucose. The difference in age, gender, whether this was the first attack, whether there was fever, whether there were gastrointestinal symptoms, the duration and pattern of the seizure, and whether there was a seizure at the emergency department, were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age: less than 18 years old
* The patient came to emergency department due to seizure
* The patient received blood sampling including serum sodium, potassium, calcium and glucose.

Exclusion Criteria:

* The patient came to the outpatient department.
* The patient did not received blood sampling at emergency room.
* The seizure occurred after admission.
Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS

This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.

Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time.

The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline).

The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment.

Yearly assessment starting from study inclusion will be performed.

Eligibility Criteria:
Inclusion Criteria:

* active MS, according to the Lublin criteria
* disease duration \< 10 years before initiating or changing a disease-modifying therapies,
* relapse- and steroid-free for at least 1 month before MRI acquisition
* between 18-50 years old
* having given informed consent
* with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances

Exclusion Criteria:

* progressive forms of MS
Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer

RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how patients will respond to treatment.

PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs work in very young patients with cancer.

OBJECTIVES:

* Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age \< 2 years on current dosing schedules.
* Compare drug exposures and degree of pharmacokinetic variability in children \< 2 years with data obtained from published studies in older children.
* Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response.
* Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants and young children.

OUTLINE: This is a multicenter study. Patients are stratified according to age in months (0 to 6 vs 6 to 12 vs 12 to 24).

Patients receive carboplatin, cyclophosphamide, or etoposide according to the dosing regimen detailed in the clinical protocol on which the child is being treated.

Blood samples are collected from patients receiving 1 of the 3 drugs by central venous catheter periodically during treatment to measure pharmacokinetics of the specific drug. Additional blood samples are collected for DNA extraction and polymorphism analysis in CYP2B6, CYP2C9, and other metabolizing enzymes in addition to the determination of the genetic variation in multiple drug resistance.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of childhood cancer
* Receiving carboplatin, cyclophosphamide, or etoposide as standard treatment as part of a clinical study at a Children's Cancer and Leukemia Group (CCLG) center

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Single or double lumen central venous catheter in place
* No concurrent anticonvulsants, azole antifungal agents, or chronic steroid treatment
Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation

Assessment of efficacy and safety UK-390,957.


Eligibility Criteria:
Inclusion Criteria:

* Premature ejaculation as defined by DSM-IV

Exclusion Criteria:

* History of erectile dysfunction
Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)

The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.

This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose.

The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745).

Eligibility Criteria:
Inclusion Criteria:

* Adult outpatient having signed informed consent
* Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU)
* Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface®
* Patient can be followed over 12 weeks by the investigator, according to his/her practices
* Patient able to participate in the study and complete a self-questionnaire without difficulty

Exclusion Criteria:

* Hemorrhagic wound
* Cancerous wound
* Fistulous wound revealing a deep abscess
* Presence of dry necrosis partially or completely covering the wound bed
* Infected wound
* Osteitis
* Critical or acute ischemia
* Patient for whom a surgical procedure related to the treated wound is scheduled within 12 weeks following the inclusion visit
* Patient with known sensitivity to one of the studied dressings components
* Pregnant or breastfeeding patient
* Patient under the protection of justice or under guardianship or deprived of liberty
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.


Eligibility Criteria:
Inclusion criteria:

Healthy subjects:

* Male or female subject, healthy according to the investigator's judgement based on a complete medical history, including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory
* Age of 18 to 79 years at screening visit

Hepatically impaired patients as determined by a hepatologist/ gastroenterologist:

* A documented diagnosis of the impaired hepatic function, determined by hepatologist/gastroenterologist/specialist for internal medicine, must be available in the patient´s source data.
* Male or female chronic hepatically impaired patient as determined by screening results and classified as Child-Pugh A (Child-Pugh score of 5-6 points) or as Child-Pugh B (Child-Pugh score of 7-9 points). Hepatic insufficiency must be diagnosed at least 3 months before screening.
* Age of 18 to 79 years at screening visit

Exclusion criteria:

Healthy subjects:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
* Any laboratory value outside the reference range at screening visit that the investigator considers to be of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders judged as clinically relevant by the investigator
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication based on the investigator´s judgment
* Women who are breast feeding or of child-bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 3 month after administration of trial medication.

Hepatically impaired patients as determined by a hepatologist/gastroenterologist:

* Medical disorder, condition or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator or the sponsor
* Patients with significant diseases other than underlying diagnose of hepatic impairment and concomitant diseases related to it. A significant disease is defined as a disease which in the opinion of the investigator:

  * put the patient at risk because of participation in the study
  * may influence the results of the study
  * is not in a stable condition
* Surgery of the gastrointestinal tract that could interfere with the kinetics of the trial medication based on the investigator´s judgment
* Women who are breast feeding or of child-bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 3 month after administration of trial medication
Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement

It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty.

The objectives of the study are to:

1. Identify clinical practices set up for patient care
2. Assess the type and the frequency of perioperative complications
3. Look for factors, related to patients or treatments, associated with the occurrence of these complications.

The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years
* Programmed for primary hip or knee arthroplasty.
* Effective dose of anticoagulant drugs intake for more than 1 month with the intention to resume it after the intervention for ADELC cohort; no effective dose of anticoagulant drugs intake for the control cohort.

Exclusion Criteria:

* Patient non opposition
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers

Exclusion Criteria:

* Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans

This is a single-centre study over 36 months for the inclusion of 30 patients. The selection and inclusion of patients will take place according to the criterion of Medical Termination of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23 WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue will also be systematically harvested in parallel (liver and psoas muscle) for control purposes. The gonads will be subjected to molecular biology analyses destined to quantify the expression of transposons and their inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Couple or mother who has provided written informed consent
* Foetus between 10 and 37 weeks of amenorrhea (WA)
* Male foetus
* Foetus obtained following medical termination of pregnancy or voluntary termination of pregnancy

Exclusion Criteria:

* persons without national health insurance cover
* foetus presenting aneuploidy
* foetus presenting a malformation of the genital organs
Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

The study compare digestive and urinary functional outcomes following surgical management of rectal endometriosis by either colorectal resection or conservative surgery (shaving or full thickness excision of rectal nodules).

Patients managed for rectal endometriosis are randomized in two arms, and followed up for 24 months. The assessment of digestive and urinary functions is performed at 6, 12, 18 and 24 months using standardized questionnaires. Postoperative complications and improvement of endometriosis related pain are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* female
* age \>18 and \<45
* at least one digestive symptom related to deep endometriosis (pain defecation, either cyclic diarrhea or cyclic constipation, cyclic rectorrhagia)
* preoperative work up revealing a deep endometriosis nodule infiltrating the rectum (either muscular or submucosal layer, on less than 50% of rectal circumference) and measuring at least 20 mm
* affiliation to the National Social Security System

Exclusion Criteria:

* pregnant women or likely to be at the moment of the surgery
* no preoperative hypothesis of rectal involvement
* no intraoperative confirmation of the rectal involvement
* advanced rectal endometriosis involving rectal mucosa or more than 50% of the rectal circumference (preoperative assessment using rectal endoscopy or ultrasonography)
* women unable to give an informed consent (guardianship or trusteeship)
Radiological Evaluation of Radiesse Implantation in the Hands

The objective of this study is to provide a preliminary assessment of the radiographic appearance of Radiesse material that has been injected into the dorsum of the hands.

Radiesse dermal filler is radiopaque and shows no overt radiographic safety concerns in a study of 58 patients after facial implantation, with Radiesse not always visible on plain X-rays.

This Post Approval Safety study will evaluate if there are concerns after Radiesse implantation in the dorsum of hands, specifically if implantation interferes with radiological assessment by obscuring the bones of the hand.

Hands will be scored according to the 5 point Merz Hand Grading Scale (MHGS), which ranges from 0 (No loss of fatty tissue) to 4 (Very severe loss of fatty tissue; marked visibility of veins and tendons).

Eligibility Criteria:
Inclusion Criteria:

1. Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator.
2. Is at least 22 years of age.
3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.

Exclusion Criteria:

1. Was a participant in the Radiesse hands pre-market clinical study.
2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
3. Has any medical condition with the potential to interfere with the study or increase the risk of adverse events (AEs).