cyrilzakka/clinical-trials huggingface dataset:
Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of [14C]-BIBR 953 ZW Intravenously or [14C]-BIBR 1048 Oral Solution in Healthy Male Volunteers

The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS and BIBR 953 ZW in man.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent from each subject in accordance with the regulatory and legal requirements of the UK
* Age between 30 and 55 years of age
* Body Mass Index (BMI) of between 18.5 and 29.9 kg/m²

Exclusion Criteria:

* Any of the findings from the medical examination (including BP, pulse rate and ECG) deviated from normal or were of clinical relevance
* History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of relevant orthostatic hypotension, fainting spells and blackouts, or volunteers with diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the principal investigator
* History of any bleeding disorder including prolonged or habitual bleeding
* History of other hematologic disease
* History of cerebral bleeding (e.g. after a car accident)
* History of craniocerebral trauma
* Intake of drugs with a long half life (≥ 24h) within 1 month prior to administration
* Any drugs which may have had an influence on the results of the trial within 10 days prior to administration or during the trial
* Any volunteers who had participated in another trial with an investigational drug within 3 months ( 4 months if the drug was a new chemical entity) prior to administration or during the trial
* Exposition to radiation in the previous 12 months (i.e. serial x-rays, CT scan or barium meal)
* Smoker
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 12 weeks prior to administration or during the trial
* Any excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of familial bleeding disorder
* Platelets \> 150 x 10-9 /l
* Unable to defecate at least once a day every two days
Ischemic Postconditioning in STEMI Patients Treated With Primary PCI

In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI

Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon known as reperfusion injury.

In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured region applied after initial reperfusion, has been shown favorable with different modalities such as biomarkers, echocardiography and cardiac magnetic resonance.

However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was allowed and this might have impaired postconditioning, since thrombectomy itself creates reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in favor of postconditioning.

iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect of iPOST without thrombectomy compared to conventional PCI on the development of heart failure and death in STEMI patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Acute onset of chest pain with \< 12 hours duration
* STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.
* TIMI flow 0-1 in infarct related artery

Exclusion Criteria:

* Potential pregnancy
* Refusal to participate
* OHCA without subsequent consciousness despite ROSC
* Thrombectomy considered unavoidable
Testing the Effectiveness and Safety of a New Prototype of a Passive Industrial Exoskeleton for Back Support

This research will provide data on evaluation of the effectiveness and safety of using a passive exoskeleton designed to reduce the negative impact of static and dynamic loads associated with body tilts, lifting and holding weights on the musculoskeletal system of workers. To evaluate a passive industrial exoskeleton for back support, a protocol was developed in which individual production operations will be modeled.

This research will recruit 9 valunteers. During a 4-hour laboratory visit, each subject will perform three identical experimental tests: one test without an exoskeleton and two tests using two different modifications of the exoskeleton prototype. To avoid sequence bias, the test order will be randomized (balanced). Two types of labor operations will be simulated. One operation will consist in lifting the load, which is 20% of the volunteer's body weight, from a height of 14 cm to a surface with a height of 70 cm, the frequency of lifting is 1 time in 30 seconds. The second operation is holding a cargo weighing 5 kg in a forced working position (tilt of the body more than 30 °) for 1 minute, after which rest will follow for 1 minute, and then the work will be repeated. Both types of work will be performed for 105 minutes, then a break of 15 minutes, then 105 minutes of work. Heart rate, blood pressure, ECG (Custo) will be monitored. An ergospirometric device (Metamax) will be used to collect muscle activity data (Trust-M, Myoton), inertial sensors (Trust-M) will be used to evaluate the biomechanics of movements. In addition, questionnaires will be filled out for a subjective assessment of the use of exoskeleton prototypes (local discomfort scale, exoskeleton properties assessment questionnaire).


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals (based on medical screening)

Exclusion Criteria:

* musculoskeletal system diseases
* musculoskeletal injuries
* health deviations at the time of the study
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors

To determined what dose of topotecan can be safely given with daily pazopanib.

A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors

Eligibility Criteria:
Inclusion Criteria -

* signed, written informed consent.
* at least 18 years of age.
* ECOG performance status 0 or 1.
* Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy.
* able to swallow and retain oral medications.
* females are eligible to enter and participate in this study providing adequate established contraception is being practiced.

Exclusion Criteria

* had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
* received an investigational drug within 30 days or 5 half-lives (whichever is longer).
* received prior treatment with pazopanib/investigational anti-angiogenic compounds.
* presence of uncontrolled infection.
* pregnant or lactating.
* poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg.
* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.-
* arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months.
* any unresolved bowel obstruction or diarrhea ? Grade 1.
* received an allogeneic bone marrow transplant.
* known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan.
* any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study.
* psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy

The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* All total laparoscopic hysterectomies performed by a single surgeon
* Both benign and malignant cases
* Completed laparoscopically
* Intracorporeal vaginal cuff suturing

Exclusion Criteria:

* Robotic hysterectomies
* Pelvic infection within 30 days before surgery
* Conversion to laparotomy
A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

To find out more information on how treating impotence with vardenafil in comparison to placebo affects the quality of life (QoL) of men and their partners. Subjects will receive 10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their 'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected via questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Males with erectile dysfunction for more than six months according to the NIH Consensus Statement (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance)

  * Stable, heterosexual relationship for more than six months
  * Documented written Informed Consent, from both the patient and his partner, after receiving adequate previous information and prior to any study specific procedures.
* An ED-EQoL score \< or = 15.- An IIEF score \< or = 25.

Exclusion Criteria:

* Presence of penile anatomical abnormalities (eg. penile fibrosis or Peyronie's disease) that would significantly impair erectile function.
* History of radical prostatectomy. - Retinitis pigmentosa.
* History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.- Unstable angina pectoris.
* History of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia within the prior 6 months.
* Atrial tachyarrhythmia (eg. atrial fibrillation/flutter) with a heart rate of \>100 beats per minute at screening.
* Child-Pugh class B liver disease or liver function abnormalities.
* Clinically significant chronic haematological disease or bleeding disorder
* History of significant peptic ulcer disease within one year before Visit 1
* Resting hypotension (a resting systolic blood pressure of \<90 mm Hg) or hypertension (a resting systolic blood pressure \>170 mm Hg or a resting diastolic blood pressure \>110 mm Hg).
* Symptomatic postural hypotension within the six months of Visit 1.
* Uncontrolled diabetes mellitus (haemoglobin A1c \> 12%).
* Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine).
* Patients who are taking anticoagulants, with the exception of anti-platelet agents.
* Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens.
* Patients who are taking the following inhibitors of cytochrome P 450 CYP 3A4: potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica

In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Aged from 18 to 65 years
* Affiliated or benefit from an insurance regimen
* Patient with a sciatic answering to the definition
* Discal sciatica more than 15 days and less than 6 months
* Discal hernia (scan or RMI)
* Negative BHCG and normal coagulation parameters

Exclusion Criteria:

* History of lumbar surgery
* Spinal infiltration of corticoids in 30 days before inclusion
* Iode allergy
* Anticoagulation therapy, unbalanced type 2 diabetes, instable HTA
* Motor loss \< 4 (muscular testing)
* Sphincter disorder (cauda equida syndrome)
Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder

The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB.

The main questions aimed to be answered are:

What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 with clinical diagnosis of idiopathic OAB
* Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
* Able to understand the procedures, advantages and possible side effects
* Willing and able to complete the voiding diary and QoL questionnaire
* The strength of pelvic floor muscles 3/5 and more

Exclusion Criteria:

* Women with stress urinary incontinence
* History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/PTNS) within 6 months
* Pregnancy or intention to become pregnant during the study
* Current vulvovaginitis or urinary tract infections or malignancy
* Anatomic or posttraumatic malformations/skin disorders of medial plantar nerve region on inner foot that cannot allow to apply the electrodes
* More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
* Cardiac pacemaker, implanted defibrillator
* Previous urogynecological surgery within 3 months
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of post-void residual volume more than 100 ml
Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs

This is a prospective randomised controlled comparative study comparing bone transport through induced membrane (BTM) and conventional bone transport (BT) in management of bone defects in infected non united fractures of long bones of lower limbs (femur, tibia) as regard clinical, functional outcomes and possible complications.

A prospective randomised controlled study was conducted at Ain shams university hospitals. A total of 30 patients with infected non united fractures of long bones of lower limbs (femur and tibia) were divided randomly into 15 patients treated by bone transport through induced membrane technique (BTM) (Group A) and 15 patients treated by conventional bone transport technique (BT) (Group B)

Eligibility Criteria:
Inclusion Criteria:

* Sex: both sexes.
* Age:18-60 yrs old.
* Lesion: tibial or femoral bone defects (\>4 cm)
* Defects resulting from infected non-united fractures

Exclusion Criteria:

* Pathological and congenital defects
* Aseptic traumatic bone defects
* Defects less than 4 cm
* Multiple defects Pediatric age group
Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

All participants in the REVIVE trial will be randomized (1:1) at the time of study entry to receive azithromycin prophylaxis or placebo for 28 days and will be followed for 24 weeks to determine the primary outcome measure. Total follow up duration will be 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Documented HIV infection
3. CD4 count criteria:

   i. CD4 count ≤ 100 cells/mm3 within past 4 weeks; or

   ii. Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or

   iii. Documented CD4 count ≤ 100 cells/mm3 if ART-naive
4. Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment

Exclusion Criteria:

1. Contraindications to azithromycin:

   i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or

   ii. Personal or family history of QT-prolongation
2. Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)
3. Off-label azithromycin prophylaxis or requirement for prolonged (\> 7 days) azithromycin (or macrolide) therapy
Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.

OBJECTIVES:

* Assess the response rate and toxicity of oral etoposide and radiotherapy in children with newly diagnosed high stage medulloblastoma.
* Compare the response rate and toxicity of these patients to historical control patients registered on POG #9031.
* Estimate the 2-year event-free survival and overall survival of these patients.
* Evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin, cyclophosphamide, and vincristine following craniospinal irradiation in these patients.

OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).

Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically diagnosed advanced (high grade) childhood medulloblastoma
* Residual disease of at least 1.5 cm2 in size on MRI or CT scan OR
* Evidence of CNS or extraneural metastases

PATIENT CHARACTERISTICS:

Age:

* 3 to 21

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* SGPT less than 5 times normal
* Bilirubin less than 1.5 mg/dL

Renal:

* Creatinine less than 1.7 mg/dL OR
* Creatinine clearance greater than 70 mL/min

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior corticosteroids allowed

Radiotherapy:

* No prior radiotherapy

Surgery:

* Not specified
Clinician-Collected Versus Patient-Collected Cervical Pap Smears

The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.

Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.

The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.

Eligibility Criteria:
Inclusion Criteria:

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding

Exclusion Criteria:

* Age \<18 years (not recommended for Pap Smear)
* Known pregnancy
* Women who have had a total hysterectomy (cervix removed)
* Women with vaginal bleeding
* Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands