cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy.

The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy. Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study.

Overall objective:

The efficacy of Degarelix as a treatment for HRPC will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Prior trial of total androgen blockade
* Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide).
* Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan
* ECOG ≤ 2
* Age ≥ 18 years
* Serum testosterone of ≤ 50 mg/dl
* PSA ≥ 2.0 ng/ml
* White blood cell count ≥ 3000/mm3
* Platelets ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 x upper limits of normal
* Bilirubin ≤ 1.5 x upper limits of normal
* Alanine transaminase ≤ 1.25 x upper limits of normal
* Estimated life expectancy of at least 12 months
* Able and willing to sign informed consent

Exclusion Criteria:

* Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur)
* Known allergy to GnRH agonists or antagonists
* Previous treatment with Degarelix
* Major surgery within 4 weeks of registration
* Grade ≥ 3 peripheral neuropathy
* Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome
* Acute deep vein thrombosis or pulmonary embolism
* Taking anti-arrhythmia medication
* Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years.
* Prior orchiectomy for prostate cancer
* PSA \> 100 ng/mL
Effect of Caffeine on Time to Anesthetic Emergence After Laparoscopic Cholecystectomy : Randomized-controlled Trial

A faster emergence from general anesthesia has a double medico-economic impact by reducing the risks of complications and optimizing the performance of surgical units. No drug has been retained for its ability to actively accelerate anesthetic emergence by antagonizing hypnotics. Thus, the aim of this study was to examine the effect of caffeine on the time to emerge from sevoflurane anesthesia for laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* American society of Anesthesiologists (ASA) I and II patients, aged older than 18 years old and scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Patient with an allergy to caffeine citrate and analgesics used during postoperative period, those with severe renal or hepatic failure, those who refused to participate in addition to patient with heart rhythm disorder, seizure disorder, hypertension, alcoholic or psychiatric illness
Cold Therapy in the Treatment of Exercise-induced Muscle Damage

Subjects were randomly placed in five groups: (1) single exposure at 5°C in cold water immersion, (2) single exposure at 15°C in cold water immersion, (3) multiple exposures at 10°C in cold water immersion, (4) whole body cryotherapy (WBC) at 110°C and (5) passive recovery (control group). The single exposure groups performed cold water immersion immediately after exercise-induced muscle damage (EIMD) for 20 minutes. The multiple exposures group performed cold water immersion immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes. The WBC group remained in the cabin immediately after EIMD for 3 min. The control group was not exposed to treatment after the EIMD protocol. The subjects were asked to visit the laboratory on seven occasions. The first visit was the familiarization of the subjects with experimental procedures and their anthropometric assessment. One week after familiarization, on visit two, volunteers performed the exercise-induced muscle damage (EIMD) protocol and they were allocated to one of experimental groups. Indirect markers of muscle damage and inflammatory responses were evaluated at baseline (pre), immediately post, 24h, 48h, 72h, 96h, and 168h following the EIMD protocol by measuring anterior thigh muscle swelling, isometric knee extensors peak torque, knee extensors muscle soreness, countermovement vertical jump and blood sample analyzes.

To avoid circadian influences, subjects were asked to visit the laboratory always at the same time of day. Volunteers were asked to not perform any vigorous physical activities or unaccustomed exercise during the experiment period. In addition, they were instructed not to intake medications or supplements during the study.

Eligibility Criteria:
Inclusion Criteria:

* College students were eligible for inclusion.

Exclusion Criteria:

* Exclusion criteria included a history of eccentric quadriceps exercise in the past 3 months
* A history of quadriceps muscle tear
* Neurological disease involving the lower limbs
* Current lower-limb musculoskeletal injury and thigh skinfold thickness \>20 mm..
* Participants with potential vascular problems which cold therapy is contraindicated (eg, diagnoses of diabetes or Raynaud's disease) were also excluded
The Effect of Chemotherapy on Lactate Threshold in Cancer Patients

It is important to assess patients' fitness for major cancer surgery which carries a high risk of mortality. Patients with poor heart and lung function have a higher risk of death after major cancer surgery. Cardiopulmonary exercise testing, CPET, is an objective measure of patients' fitness. Most patients, before surgery to resect their cancer, undergo a period of chemotherapy. Chemotherapy often regresses the cancer but also has adverse effects on cell function. Our hypothesis is that chemotherapy alters patient fitness, as assessed by CPET, prior to major cancer surgery. Participating patients will undergo fitness testing by CPET before and after their chemotherapy, prior to their surgery.

Purpose: To evaluate the effects of chemotherapy on pre-operative fitness of patients prior to major cancer surgery.

Design: Patients will act as their own case-control.

Patients will be consented at the earliest available opportunity following the decision that they have surgically treatable disease and they consent to pre-operative NAC. Consent for the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is our current standard practice, prior to commencing neoadjuvant chemotherapy. As part of the assessment, they will have pulmonary function testing (static lung volumes, lung diffusing capacity),and a nutritional assessment using bioimpedance measurements. They will then undergo 3 cycles of NAC lasting a total of 6 weeks, as is standard current practice at our institution. At "visit 2", approximately four to six weeks following chemotherapy and just prior to planned surgery the CPET and other assessments will be repeated. This is also current standard practice at our institution.

Data from visit 1 and visit 2 will be compared in a paired manner. A statistician will be consulted to assess the degree of normality of the data, the statistical tests to use, and for power calculations. At no point will any treatments be postponed or changed solely for the purposes of collecting data for the research. 12 months survival will be assessed as an outcome variable.

Eligibility Criteria:
Inclusion Criteria:

* Consenting patients with surgically resectable oesophageal and gastric cancers referred to a tertiary NHS referral service who are deemed by their clinician to be suitable for pre-operative neoadjuvant chemotherapy(NAC)prior to their planned surgery.

Exclusion Criteria:

* Patients with cancers deemed to have surgically non-resectable disease, patients refusing chemotherapy, patients unable to perform cardiopulmonary exercise testing (CPET) due to other coincident illness or conditions (e.g. arthritis), patients refusing surgery, patients withholding consent. Patients unable to give informed consent due to mental incapacity. Prisoners will be excluded. Patients in whom haemoglobin drops by \>2g/dl between Visit 1 and visit 2.
An Open, Non-randomized Pilot Study on the Effect of Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma With an Uncontrolled Intraocular Pressure of 30 mmHg and More

Increased intraocular pressure (IOP) has been identified as the most important risk factor for the development and the progression of glaucoma. Data from large interventional studies have shown that a decrease of IOP is associated with a reduced risk of progression of the disease. This underlines the importance of a potent and save IOP lowering therapy. The introduction of preservative free tafluprost offers a new treatment possibility using a potent topical prostaglandin analogue without the disadvantages of a co-administered preservative. The current study seeks to investigate the effect of an 8 week therapy with preservative free tafluprost on intraocular pressure in patients with ocular hypertension or primary open angle glaucoma having an IOP of 30 mmHg or more.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Diagnosed primary open angle glaucoma and an IOP of 30mmHg or more in at least 1 eye at visit 1 at 8 am
* Patients with ocular hypertension as defined as an IOP of 30mmHg or more and normal findings in the visual field and the optic nerve head

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks before the screening visit
* Severe visual field loss as defined as an MD of -15 or worse
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
* Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
* Wearing of contact lenses
* Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants
* Ocular infection
* Ocular surgery in the 6 months preceding the study
* Pregnancy, planned pregnancy or lactating
* Contraindication against the use of topical prostaglandin therapy
Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.


Eligibility Criteria:
Inclusion Criteria:

* Elective TEVAR or TAVI
* Over 18 years old

Exclusion Criteria:

* Recent acute myocardial infarction
* Recent stroke or TIA
* Post or pending organ transplantation
* Active peptic ulcer disease
* Recent gastrointestinal bleed
* History of bleeding diathesis or coagulopathy or contraindications to antiplatelet or anticoagulant therapy.
* Permanent pacemaker or ICD
* History of atrial fibrillation
* Moderate or severe allergy to iodinated contrast not amenable to predmedication
* Renal failure
* Unable to safely undergo MRI
* Enrollment in another study
Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer

The study outlines a clinical prospective protocol consisting of preoperative chemoradiation in locally advanced rectal cancer, without elective pelvic nodal irradiation. The proposal to exclude lateral spaces from the target volume is based on the assumption that the radiological evidence of recurrence in the lateral lymph nodes is shown to be below 5%. In the study all patients underwent an accurate pre-treatment work-up including total body CT, pelvic MRI and 18-fluorodeoxyglucose PET/CT, in order to include patients without evidence of disease in lateral lymph nodes. The primary endpoint of the study was the reduction of gastrointestinal toxicity; secondary endpoints were the pathological complete response (pCR), the local control (LC) rate, the overall survival (OS) and the disease-free survival (DFS).

Patients affected by histologically proven rectal cancer were considered for enrollment in a prospective protocol that included preoperative CRT and surgical treatment. All patients underwent pre-treatment work-up (clinical examination, pancolonoscopy with biopsy, total body CT scan, pelvic MRI, and whole body 18-fluorodeoxyglucose PET/CT scan). Eligible patients had primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes. Additional eligibility criteria included performance status as well as liver, kidney, and bone marrow function that allowed for long-course CRT, older than 18 years, and no distant metastases.

Eligibility Criteria:
Inclusion Criteria:

* Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes
* No distant metastases

Exclusion Criteria:

* Evidence of disease in lateral lymph nodes
* Distant metastases
High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) HF-study

The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).

Deep sedation performed during the ERCP technique associates an increased risk of decrease in Sat02%, hypercapnia and airway obstruction with consequences ranging from interruption or suspension of the technique to complications that may put the patient's life at risk .

High flow devices (HF) due to the pressurization capacity of the airway and the reduction of anatomical dead space will favor a better gas exchange compared to low flow devices (LF), which will manifest clinically with a reduction in episodes of decrease of Sat02% and a decrease in carbon dioxide levels.

The main objective of the study is to demonstrate that the use of high flow devices (HF) decreases the episodes of desaturation (defined as Sat02 ≤ 90% measured through pulse oximetry) that occur during the performance of ERCP under deep sedation compared to Low flow devices (LF) with equal Inspiratory oxygen fraction (Fi02) in both cases.

The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).

Eligibility Criteria:
Inclusion Criteria:

* Patients Age over ≥18 years. Willing to participate

Exclusion Criteria:

* None
New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle

This study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female.

. Lateral clavicle fracture lead to sever pain and affect on shoulder movement . This prosthesis will compensate the lost part of the clavicle due to fracture to return the patient to the daily living activity without pain.

This prosthesis will reconstruct the missed part of the clavicle.

Eligibility Criteria:
Inclusion Criteria:

* Female has right lateral part comminuted fracture clavicle .

Exclusion Criteria:

* Male patient
* Cancer bone patient.
* Pregnant
* Left lateral part comminuted fracture clavicle
The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years

Patients presenting with signs of infection 48 hours of intubation

Exclusion Criteria:

* Patients with documented bronchiectasis

Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.

Patients with creatinine clearance less than 30ml/min.
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

* Two weeks Duloxetine 60 mg Open-Label Period
* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
* One week Double-Blind Down-Taper Period

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia
* Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
* Duloxetine must have been prescribed for the treatment of Fibromyalgia
* Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
* At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

Exclusion Criteria:

* Suicidal risk
* History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
* Myocardial infarction and/or stroke within the prior 6 months
* Systolic blood pressure \> 160 mm Hg or mean diastolic blood pressure \> 100 mm Hg at Screening (Visit 1)
* Substance abuse
* Pulmonary dysfunction
* Severe renal impairment
* Active cardiac disease
* Liver disease
* Uncontrolled narrow-angle glaucoma
* Autoimmune disease
* Cancer
* Inflammatory bowel disease
* Unstable endocrine disease
* Prostatic enlargement
* Female patients who are pregnant or breastfeeding
Development and Clinical Application of Two New Genetic Deafness Gene Diagnostic Kit

The purpose of this study is to develop and applicate two new genetic deafness gene diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.

1. For the pathogenic gene of Waardenburg syndrome and large vestibular aqueduct syndrome, based on the second-generation sequencing technology, the investigators develop multiplex PCR system for these two hereditary deafness gene diagnostic kit.
2. Using CNVplex high-throughput gene copy number detection technology to analyse Warrdenburg syndrome pathologic gene. CNVs analysis for Warrdenburg deafness syndrome develop special testing system / kit achieve SNP / CNVs detected simultaneously, as a supplementary means of genetic testing in clinical deafness.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Waardenburg syndrome
* Clinical diagnosis of large vestibular aqueduct syndrome

Exclusion Criteria:

* Could not be able to exsanguinate
Distress, Anxiety and Psychosexual Health in BOT

The aim of this study is to assess the prevalence of distress, anxiety and psychosexual anguish in patients diagnosed with borderline ovarian tumor (BOT) compared to controls confronted with surgical treatment for benign ovarian tumors.

Appropriate surgical care is primordial for the patient after diagnosis of a BOT. Taking into account the good prognosis and long live expectancy caregivers should also be concerned about non-oncological complains during the follow-up to guarantee the overall well-being of the patient.

Women diagnosed with gynaecological cancer are likely to face additional consequences beyond those common to all cancer patients.

Not surprisingly, previous research shows that women affected by gynaecological cancer are likely to suffer significant physical and psychological morbidity. Studies including women of all ages with gynaecological cancers indicate higher levels of psychological distress, including clinical levels of anxiety, depression and posttraumatic distress disorder as well as greater decrements in body image and more sexual problems than in other types of cancer. High levels of distress were reported up to four years following the diagnosis.

Longitudinal studies addressing the prevalence of psychological distress, anxiety or psychosexual health during follow up in BOT patients are lacking. Due to the connotation between sexuality and internal genitals, diagnosis of the BOT and following surgery are possibly negatively influencing each other. Large prospective or randomized control studies are unachievable due to the low prevalence of BOT and limited recurrences or death.

Identification of the presence of psychological morbidity, including anxiety and depression is clinically useful because, unlike most demographic and clinical factors, psychological illness and psychosexual complaints are modifiable.

The study material consists out of two main parts of questionnaires.

A first questionnaire addressing the distress and anxiety consists of validated questionnaires:

* Hospital Anxiety and Depression Scale (HADS),
* Body Image Scale (BIS),
* Perceived Stress Scale (PSS).

And a second questionnaire concerning psychosexual health, built up out of validated questionnaires;

* Female Sexual Function Index (FSFI),
* Female Sexual Distress Scale - Revised (FSDS-R),
* European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QOL) questionnaire designed to measure the QOL of patients with ovarian cancer (EORTC QLQ-OV28) (only questions 50-58)
* EORTC Sexual Health Questionnaire (EORTC SHQ-C22) for assessing sexual health in cancer patients (only the part concerning women).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis and surgery for benign or borderline ovarian tumors.
* \>18 y.

Exclusion Criteria:

* Known former psychological morbidity evaluated by the investigators.
* History of another cancer type.