cyrilzakka/clinical-trials huggingface dataset:
Testicular Cancer and Aerobic and Strength Training

The present study examine the effects of an aerobic and strength training program on cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the participants will receive the exercise program and the other half will receive one individual lifestyle counseling session. The investigators hypothesize that TC patients in the exercise group will have less reduction in cardiorespiratory fitness during chemotherapy treatment compared to patients in the control group.

Testicular cancer (TC) patients receiving chemotherapy often experience troublesome side-effects during and after treatment. Both aerobic and strength exercise have showed beneficial effects on side-effects during and after treatment in other cancer diagnosis. Knowledge of the effects of physical exercise during and after chemotherapy in TC patients is insufficient and studies are needed. The primary aim is to examine the effects of physical exercise on cardiorespiratory fitness in TC patients during chemotherapy. Secondary aims are to examine the effects of physical exercise on other secondary health outcomes during and three and twelve months after chemotherapy.

The present study is a randomized controlled trial comparing a tailored exercise program consisting of aerobic and strength training during chemotherapy to a control group receiving one individual lifestyle counseling session during the first chemotherapy cycle. The TC patients will be included and assessed before the first cycle of chemotherapy and further assigned to either a exercise group or a control group. The intervention will last for 9 or 12 weeks (depending on the number of bleomycin, etoposide, cisplatin (BEP)/etoposide, cisplatin (EP) cycles received) and it will consists of two-three one-hour sessions per week mostly supervised by a personal trainer. All variables will be assessed pre- and post-intervention, and at three and 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* testicular cancer with seminoma or non-seminoma
* stage II-IV
* referred to chemotherapy (3-4 BEP (bleomycin, etoposide and cisplatin)-cycles or 4 EP (etoposide and cisplatin) -cycles) with/without retroperitoneal lymph node dissection (RPLND)
* satisfactory Norwegian Language skills
* signed informed consent

Exclusion Criteria:

* severe brain and lung metastasis (reduced lung function)
* heart and lung diseases that contraindicate exercise testing and the supervised exercise program without adjusted actions according to American College of Sports Medicine (ACSM)'s guidelines)
* physical and mental conditions of a severity that complicates the ability for exercise testing and the supervised exercise program
The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy

This study observes the efficacy and side effects of 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. 3D-printing non co-planar template is made individually which guides the implantation of Iodine-125 seed into the tumor and ensures the accuracy of the position.This study collects the data of patients with pelvic recurrent rectal carcinoma who underwent 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed implantation from 2015 to 2018. We evaluate the dose that covers 90% target volume(D90),the volume that 100% prescription dose covers(V100) and other dosimetric parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy in Peking University Third Hospital
* histological proven recurrent rectal cancer
* inoperable local recurrent cases
* previous external beam radiotherapy, incapable of re-irradiation
* expected life span\>3 months

Exclusion Criteria:

* serious medical illness
* unable to tolerate anesthesia
* blood coagulation dysfunction
Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers

1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for 4.5 days at the same doses twice daily versus placebo and to use the study results for bridging with Caucasian data.
2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations.
3. Clinical safety of ivabradine versus placebo.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years and Korean
* Nonsmoker or smoke less than 5 cigarettes per day
* normal dietary habits
* BMI ranging from 18 to 25 kg/m2
* good physical and mental status, determined by the investigator
* vital signs in resting condition within range: SBP 100-139 mmHg, DBP 50-89 mmHg
* Normal ECG

Exclusion Criteria:

* Participate any other trial in the last 3 months prior to the study
* History of major psychiatric, medical, surgical disorders
* Acute, or chronic disease
* History of hypersensitivity to at least one drug
* History of alcoholism or positive alcohol breath test
* Positive drug screening results
* known positive serology for HIV1, HIV2, hepatitis B or C
* blood donor within the last 3 month of the study
* regular use of sedatives, hypnotics, tranquillisers
Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis

Study design:

Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model: Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.

Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.

Primary outcome measures:

* Lower extremity functional scale
* Visual analogue scale
* Range of motion
* Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December 2012 Estimated study completion date: June 2013 Estimated primary completion date: December 2013

The study include:

200 knees, 50 knees will have single injection of Crespine gel, and 50 knees will have single injection of 2 ampules of Intragel, also 50 knees will have single injection of Crespine plus gel and 50 knees will have single injection of Monovisc The patient will be randomized to Crespine gel or to Intragel, and Crespine Plus gel or to Monovisc

Inclusion Criteria: patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading were included.

Exclusion Criteria: patients with autoimmune illnesses, active inflammation or infected processes, anticoagulant, and known allergy to hyaluronic acid.

Target parameters:

* Lower extremity functional scale
* Visual analogue scale
* Range of motion
* Kellgren and Lawrence class grade

Eligibility:

Ages Eligible for Study: 20 years to 70 years Genders Eligible for Study: both Accepts Healthy Volunteers: no

Criteria

Inclusion Criteria:

* Age of patients between 20 and 70 years
* patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading

Exclusion Criteria:

* Autoimmune illnesses
* Active inflammation or infected processes
* Anticoagulant
* Known allergy to hyaluronic acid.

Eligibility Criteria:
Inclusion Criteria:

* Age of patients between 20 and 70 years
* patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading

Exclusion Criteria:

* Autoimmune illnesses
* Active inflammation or infected processes
* Anticoagulant
* Known allergy to hyaluronic acid.
Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)

Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI).

All patients with urodynamically proven SUI, who have failed/declined conservative therapies will be informed about the study.

They will be invited to attend a screening/baseline visit. At this visit, they will be asked to perform a standardised 1 hour pad test. Their medical history will be checked and they will undergo a clinical and vaginal examination, pregnancy test and dip stick urinalysis. If their 1 hour pad weight is \>2g and they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. They will receive detailed instructions for performing a 24 hour pad test, and will be asked to keep a 3 day voiding diary. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF).

Patients will then undergo 3 outpatient treatment visits. The timing of visits will be approximately 1 month apart. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment. Patients will receive 3 treatments in total.

Patients will be invited to attend a follow-up visits 3, 6, 12 and 18 months after the 3rd treatment and asked to complete the 1 hour pad test, 24 hour pad test, 3 day voiding diary and ICIQ-SF questionnaire.

At the 18-, 24- and 30-month follow up, they will be given an option to receive additional single session of non-ablative Er:YAG laser treatment. At each visit, and during additional visit after 36 months, they will be asked to complete all of the tests (1 hour pad test, 24 h hour pad test, 3 day voiding diary and ICIQ-UI SF).

Eligibility Criteria:
Inclusion Criteria:

* Adult Female, 18 years of age or older
* Clinical and urodynamic study (UDS) diagnosis of Stress Urinary Incontinence
* No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training

Exclusion Criteria:

* Pre-existing bladder pathology including prior radiation treatment
* Pregnancy
* BMI\>35
* Radical pelvic surgery or previous incontinence surgery
* Urinary tract infection or other active infections of urinary tract or bladder
* SUI III (VLPP \> 60 cm H2O)
* Any form of pelvic organ prolapse (POP) stage 2 or greater, according to POP-Q
* Diagnosis of urge incontinence
* Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
* Incomplete bladder emptying
* Vesicovaginal fistula
* Faecal incontinence
* Unwillingness or inability to complete follow-up schedule
* Unwillingness or inability to give Informed Consent
* Failure to comply with diary requirements during extended baseline period
Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC).

Thanks to recent technological advances in high definition display systems, three dimensional VATS (3D) has been developed in an attempt of overcoming some optical limits of two dimensional (2D) VATS.

In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage NSCLC.

Video-assisted thoracic surgery (VATS) is widely employed for pulmonary lobectomy in early stage non-small-cell-lung-cancer (NSCLC). Indeed, VATS is thought to represent an optimal minimally invasive surgical option which is deemed superior to conventional thoracotomy since it enables smaller incisions with no rib spreading thus minimizing both postoperative pain and hospital stay.

For over than three decades, several thoracic surgeons adopted VATS for anatomical lung resection using two-dimensional (2D) display systems. However, a 2D image lacks depth of perception which may negatively affect surgical manoeuvring.

Three dimensional (3D) display systems for VATS can offer superior magnified vision of the surgical field and better perception of depth during surgical manoeuvring potentially shortening learning curve, which may thus overcome some optical limitations of 2D systems.

In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage (stage I-II) NSCLC. For this purpose we compared three ergonomical domains: exposure, instrumentation and maneuvering with the aid of a scoring scale entailing analysis of 5 main technical steps: vein, artery bronchus, lymph node and fissure score.

The evaluation process of the five surgical steps was carried out by 4 thoracic surgeons who individually scored all recorded operations.

Eligibility Criteria:
Inclusion Criteria:

* Clinical NSCLC early stage (stage I-II).
* Both forced expiratory volume in one second (FEV1) and diffusion capacity of carbon monoxide (DLCO)\>60%
* Both predicted postoperative (PPO) FEV1 and PPO DLCO \>35%
* American Society of Anesthesia (ASA) score\<=2
* Body mass index (BMI) \>18 \<28

Exclusion Criteria:

* Clinical NSCLC stage\> II
* History of Neoadjuvant chemotherapy or radiotherapy
* Radiologic evidence of extensive pleural adhesions.
* Age \<18 or \>80 years.
* Patients with previous pleurodesis or thoracotomy in the affected hemithorax.
* Patients who will undergo surgical lung resection other than lobectomy.
* Patients with severe comorbidity contraindicating lobectomy.
* Patients refusal or noncompliance to general surgery and one-lung ventilation.
Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain

This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain. Patients who have been diagnosed with failed back surgery syndrome (FBSS) will receive a stimulator device for treatment of their pain.


Eligibility Criteria:
Inclusion Criteria:

* Appropriate Freedom SCS candidate as affirmed by study investigator
* Candidate has a stable spine not suitable for further surgery as confirmed by physician
* 18 years of age or older (no upper age limit)
* Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back
* At least 6 months since last surgical procedure on the spine
* Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain)
* Pain duration of at least 6 months
* Expected lifespan of at least two years
* Able to comply with study requirements
* Gives informed consent for study participation

Exclusion Criteria:

* A consistent VAS score of 100 over the past 24 hours as established at Visit 1
* A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy)
* Pregnant or planning to become pregnant
* Known or suspected substance abuse within the last 2 years
* Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion
* Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events)
* Documented allergy to Freedom SCS material components
* Co-existing pain condition or participation in another clinical study that could confound the results of this study
* History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:

1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain?
2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis?
3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis?

Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18.
2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
3. Stage II or III disease.
4. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Creatinine clearance \<30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
2. Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
3. Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers

GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry powder containing either lactose alone or lactose and cellobiose octaacetate. However, future dry powder GW685698X formulations will contain lactose and magnesium stearate. This study will be the first administration of this new GW685698X dry powder formulation in man and will provide safety and tolerability data to support the further development of this formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers,
* Aged 18-65
* Male and females (females of non-child bearing potential or who meet the contraception criteria).
* BMI - 19-31 kg/m2

Exclusion Criteria:

* History of breathing problems
Adrenomedullin Effect on Migraine Without Patients

AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).

AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).

A pilot study on healthy volunteers were conducted to determine tolerable dose of adrenomedullin to the main study.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* 50-100 kg
* migraine without aura according International Headache Classification Disorders 3rd edition

Exclusion Criteria:

* Tension-type headaches more than 5 days a month on average over the past year.
* All other primary headache forms.-
* Headache later than 48 hours before the start of the trial.
* Daily intake of medicines of all kinds except oral contraception.
* Taking any medicine later than 4 times the plasma half-life of that drug (on the day of the trial), except oral contraception.
* Pregnant or breastfeeding women.
* Headache on the day of the trial or later than 48 hours before the administration of the trial drug / placebo
* Migraines within 3 days before the trial date.
* Anamnestic information or clinical signs (on the day of inclusion):
* Hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 100 mmHg)
* Hypotension (systolic blood pressure \<90 mm Hg and / or diastolic blood pressure \<50 mmHg)
* Cardiovascular diseases of all kinds, including cerebrovascular diseases.
* Anamnestic or clinical signs of mental illness or abuse.
* Patients with glaucoma or prostate hyperplasia
* Anamnestic or clinical signs of illness of any kind that the investigating physician considers relevant for participation in the trial.
Effect of Perioperative Sivelstat Administration for Liver Resection

It is reported that sivelstat improved and preserved the postoperative renal function in the orthopedic management. Moreover because sivelstat reduced the migration of neutrophil, it improved acute lung injury. During liver resection, Pringle maneuver, clamping the hepatoduodenal ligament, was performed. Pringle maneuver causes reperfusion injury of the liver. We have a hypothesis that sivelstat prevent the warm shock of reperfusion injury of the liver by Pringle maneuver.

Whether the incidence of postoperative morbidities, such as liver failure, renal failure, or congestive heart failure, was reduced by administration of perioperative sivelstat.

Eligibility Criteria:
Inclusion Criteria:

* liver disease which surgical management was indicated

Exclusion Criteria:

* weight loss greater than 10 per cent during the previous 6 months, signs of distant metastasis, or of respiratory, renal or heart disease