cyrilzakka/clinical-trials huggingface dataset:
Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain

Cancer related pelvic pain can be debilitating and difficult to treat. Superior hypogastric plexus neurolysis (SHPN) is considered to be an option for adequately relieving pain, with fewer side effects and improving the quality of life

The superior hypogastric plexus (SHP) is one of the paravertebral sympathetic ganglia, located in the lower border of the L5 vertebra and upper part of the sacrum in the retroperitoneal space. It is considered as a continuity of the celiac plexus and the lumbar sympathetic ganglia. It is related to the bifurcation of the aorta and the ureters. The SHP has a sympathetic connection (both efferent and afferent fibers) with splanchnic nerves and aortic plexus. It innervates the viscera of the pelvis, including the urinary bladder, ureters, sigmoid colon down to the anal canal, and upper vagina SHP blockade can be performed either by ultrasound (US), fluoroscopic, computed tomography (CT) and Magnetic resonance imaging (MRI) techniques and it is conducted through anterior (transabdominal) or posterior (lateral, paramedian, oblique, transdiscal, or transvaginal) approaches These different imaging modalities and approaches have been described for SHPN to make it easier, safer and more accurate and satisfied to the patients

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years old of both genders with cancer-related pelvic pain,
* poor pain control or severe side effects with opioid therapy,
* ≥ 4 on a numeric rating scale (NRS) of pain that ranged from 0 (no pain) to 10 (extreme pain).,
* American society of Anesthesiology Physical Status class I and II,
* positive diagnostic block day before the procedure by injecting a local anesthetic (0.25% bupivacaine 10 ml)
* Body mass index ˂ 30 were included in this study.

Exclusion Criteria:

* patient refusal,
* local or systemic sepsis,
* coagulopathy,
* unstable cardiovascular and respiratory diseases,
* previous neurological deficits,
* history of psychiatric disorders,
* history of drug abuse,
* distorted local anatomy,
* those who were allergic to the used medications were excluded from the study.
Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)

The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.

To study the effect of ocrelizumab on cortical lesion accumulation in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Patient participating in the ORATORIO study
* MRI scans available at baseline
* Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 2D/3D T1-WI at baseline

Exclusion Criteria:

- None
Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]

The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
* Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
* With the intention to be treated with Dysport®

Exclusion Criteria:

* The subject has already been included in this study
* Participation in an interventional trial
* Suffering from anterocollis or retrocollis as primary component
Impact of BRAFV600E Intratumor Heterogeneity in Thyroid Cancer Treated With Tyrosine Kinase Inhibitors

* Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer (DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase inhibitors (TKI) with specific activity against BRAF in metastatic radioiodine-resistant DTC (MRR-DTC) are ongoing. Very recently it has been demonstrated that DTC often consists of a mixture of tumor cells with wild-type and mutant BRAF. The subclonal occurrence of BRAFV600E in MRR-DTC could disable the therapy with BRAF targeted TKI and be responsible of the frequent defeats of this treatment. A therapeutic strategy based upon BRAF inhibitors in tumors bearing subclonal BRAFV600E could be initially successful hitting the tumor cells expressing the oncogene, and after the initial tumor growth arrest and/or shrinkage, the oncogene negative cells insensitive or less sensitive to the treatment, could restart the growth of the tumor causing the progression of the disease and the escape from the clinical response.
* Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF inhibitors in the treatment of MRR-DTC.
* Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E by pyrosequencing or other quantitative assay. If available, synchronous metastases and post-therapy metachronous metastases will be analyzed as well. The clinical response will be determined according to RECIST, and the association with the percentage of BRAFV600E alleles will be evaluated. Attention will be paid to the possible difference of BRAFwild-type/BRAFV600E ratio between primary tumors and synchronous metastases, primary tumors and post-therapy metachronous metastases, and between responsive and resistant synchronous tumor lesions.


Eligibility Criteria:
Inclusion Criteria:

* subjects any sex any age with metastatic or unresectable thyroid carcinoma treated with tyrosine kinase inhibitors
* evidence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
* availability of study end points including best response, duration of response, and time to disease progression (based on RECIST), clinical progression, or death
* availability of tumor tissue samples, frozen or formaldehyde fixed-paraffin embedded from block, genomic DNA already extracted from tumor tissue

Exclusion Criteria:

* concurrent Hashimoto's thyroiditis
Symbenda Post-Marketing Surveillance (PMS)

This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.


Eligibility Criteria:
Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.

This study will be conducted as complete surveillance method; subjects who meet the inclusion/exclusion criteria and administrate Symbenda for the first time after conclusion of agreement will be enrolled.

Inclusion Criteria:

Patients who meet the following criteria will be eligible for inclusion in the study:

1. Patients with approved indication for Symbenda in Korea
2. Patients who have verbal or written consent for use of personal and medical information for the study purpose Investigators will refer to approved indications and contraindications regarding inclusion criteria.

Exclusion Criteria:

Investigators will refer to approved indications and contraindications regarding exclusion criteria.
Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)

The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of citalopram 40 mg in these patients.

Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD:

1. Will increase the rate of resolution of symptoms with citalopram 40 mg.
2. Show the combined product to be safe and tolerable.

Patients are scheduled to receive study medication for eight weeks and a final follow-up check will be carried out 28 days after completing the study.

All patients will receive active citalopram from baseline and will be randomised to receive either active pipamperone or a placebo equivalent for eight weeks during which time they will attend for 6 study visits.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* 18-65 years inclusive
* Suffering from a moderate to severe MDD as defined by DSM IV with an existence of depressed mood and loss of interest/anhedonia for at least four weeks and no longer than six months for the current episode
* Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI) version 5.0.0.
* Clinical global impression - severity scale (CGI-S) rating of at least four and a minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screen and baseline
* A non-psychotic state
* Where appropriate, male patients should agree to use barrier contraceptive measures (condoms) during the course of the study and for three months after the last dose of medication

Exclusion Criteria:

* Premenopausal females not using adequate contraceptive measures
* Considered by the investigator to be a significant risk of suicide or scoring 5 or more on the MADRS question 10
* Significant other psychiatric illness which would interfere with trial assessments - co-morbid generalised anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis
* Significant physical illness which would interfere with trial assessments
* Reduced hepatic function
* Epilepsy
* History of cardiac dysrhythmia
* Alcohol intake above accepted UK ranges
* Recent (1 week) antidepressant (except for fluoxetine - 4 weeks and St John's Wort or MAOI's - 14 days), benzodiazepine or any other psychotropic medication ingestion including lithium or other mood stabilisers
* Resistant depression defined as having failed to respond to

  * Two previous antidepressants at an adequate dose ingested for at least 4 weeks during the current episode
  * To an augmentation therapy with an atypical antipsychotic drug
* Electroconvulsive therapy (ECT) for the current episode
* Formal psychotherapy or alternative treatments for one week prior to or during the study
Pros and Cons of Telemedicine in Diagnosis and Management

Telemedicine "healing at a distance" Telemedicine has many advantages especially in time of pandemics for both doctors and patients, low cost and easily accessibility. Pandemics especially COVID 19 has radically change the medical team thoughts about the telemedicine. It can decrease the exposure of the medical team to infection and expected by some of the medical team to be very beneficial if done in good and legal manner. Although, telemedicine has many advantages, also has many disadvantages and medicolegal problems, breakdown in the relationship between medical teams and patients, mis diagnosis or wrong treatment. There are many legal and ethical aspects of telemedicine.

Telemedicine "healing at a distance" Telemedicine has many advantages especially in time of pandemics for both doctors and patients, low cost and easily accessibility. Pandemics especially COVID 19 has radically change the medical team thoughts about the telemedicine. It can decrease the exposure of the medical team to infection and expected by some of the medical team to be very beneficial if done in good and legal manner. Although, telemedicine has many advantages, also has many disadvantages and medicolegal problems, breakdown in the relationship between medical teams and patients, mis diagnosis or wrong treatment. There are many legal and ethical aspects of telemedicine. These include the medical responsibilities, the confidentiality and privacy of the patients can not be maintained, the jurisdictional problems. Shortage of medical practitioners and specialists, shortage of internet facilities, low education levels in some patients all are problems facing the telemedicine in developing countries. The evolution of telemedicine poses a series of legal problems ranging from the profiles on the subject of authorization and accreditation to those concerning the protection of patient confidentiality, the definition and solution of which, in the absence of specific regulatory provisions, is mainly left to the assessment of compatibility of the practices adopted so far, with the general regulatory framework.

This research will be done to clarify the role of telemedicine, and if it has a share hand or the upper hand if compared with traditional medicine.

Eligibility Criteria:
Inclusion Criteria:

* doctors of all specialty
* Patients
* police man and who work in law

Exclusion Criteria:

* No exclusion criteria
Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers

Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.

To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in healthy volunteers, all participants in this open-label study will be asked to record their fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement. Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1 and 29.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to record urine volume and fluid consumption over 3 days.
* Written consent to participate in the study.

Exclusion Criteria:

* Disease or comprehension problems (language) that affect the accurate collection and measurement of urine levels over 3 days.
* Taking diuretic drugs, teas, herbal supplements, or systemic corticosteroids.
* Chronic nephropathy (such as glomerulonephritis, analgesic nephropathy, interstitial nephritis).
* Pregnancy or lactation.
* Psychiatric disorders that include suicidality.
* Surgical intervention in the 3 months prior to enrollment or scheduled surgery during the study.
* Known chronic diseases such as dementia, progressive systemic diseases.
* Known alcohol and/or drug addiction.
* Known allergies to goldenrod or birch leaves.
* Participation in one or more other clinical trials in the last 30 days
Variations of the Lung Compliance During Extracorporeal Circulation and Post Operative Pulmonary Complications

the decrease in thoracopulmonary compliance after cardiac surgery is well known . The investigators hypothesize that the major factor determining pulmonary outcome after cardiac surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that this alteration is due to CBP itself through pulmonary blood emptying.

compliance is the compliance calculate when thorax is closed, the pulmonary compliance is the compliance calculated when thorax is opened After operation chest X-ray are daily done and blood samples as needed. Were recorded death, time of extubation,duration of non invasive ventilation,of Intensive Care Unit stay and of total hospital stay, troponin peak, lactates, blood gases, ionogram and count.Variations of compliance is analyzed through one factor paired Anova or Wilcoxon paired test. Decrease of compliance and respiratory complications are analyzed through binomial logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for standard aortic
* mitral or coronary surgery

Exclusion Criteria:

* emergency operation
* no complete preoperative echocardiography
* surgery needing multiple table position changes
* unstable cardiac or respiratory condition
* difficult patient needing multiple care and/or special attention
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

Approximately 42 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* Willing to participate and sign an informed consent form
* Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
* Willing to use two forms of contraception during the study
* Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
* Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Exclusion Criteria:

* Currently pregnant or breast-feeding
* Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
* Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
* Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
* Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
* Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Symptoms Based Awareness Confirmation Study - CoMiSS Validation

The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children.

Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.

The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and investigate if the CoMiSS tool could be an alternative to the open challenge test needed to confirm the diagnosis of Cow Milk Protein Allergy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female infant aged up to 6 months old
* Has been fed exclusively on cow's milk infant formula for at least one week
* Has CMPA symptoms that have been present for at least one week, and that developed within the first two months of starting cow's milk infant formula
* In the opinion of the investigator, requires a two week elimination diet with Amino Acid Formula (AAF).
* Had a gestational age at birth of 37 to 42 weeks
* Had a birthweight of 2500 g to 4500 g
* Informed consent signed by both parents, liable parent or legal guardian (if applicable).

Exclusion Criteria:

* Has ever received either an extensively hydrolysed infant formula or an AAF prior to enrolment
* Has a fever above 38.5°C at enrolment
* Has ever experienced a medically diagnosed serious anaphylactic reaction
* Use of antibiotic drugs at enrolment. Infants may be enrolled if antibiotics have been stopped at least 7 days prior to enrolment. (Antibiotic treatment can be initiated during the study if an infant develops a condition after enrolment that requires antibiotic treatment).
* Infant with a health condition or family situation that makes the infant unsuitable to participate in the trial according to the opinion of the investigator
* Infant or infant's carers are unable to comply with trial procedures
* Currently participating or has participated in another clinical trial within 4 weeks prior to trial start.
Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men

To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Body weight at least 50 kg and Body Mass index \>18.5 and \< 30 kg/m2
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination
* Use of contraception.

Exclusion Criteria:

* The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit
* The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).

Other protocol defined inclusion and exclusion criteria do apply
The Oncopanel Pilot (TOP) Study

The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes.

The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.

Somatic mutations in solid tumors represent an established means of characterizing malignancies for prognostic, diagnostic and therapeutic purposes. Mutations in EGFR, KRAS, BRAF, and KIT and PDGFRA genes direct therapy in patients with advanced lung, colorectal, melanoma, and GIST tumors, respectively. Known or novel mutations in other genes may also be of clinical significance but are not identified by current genotyping offered to BC Cancer Agency (BCCA) patients. Furthermore, numerous candidate genes have been implicated as potential prognostic and predictive biomarkers in patients with solid tumours. As such, the Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The following clinically relevant set of genes and exons are included in the Oncpanel: KRAS, EGFR, BRAF, NRAS and HRAS, PIK3CA Signal Transduction Pathway Genes, RAS-RAF-MEK-MAPK Pathway, HER2, IDH1 and IDH2, ALK, TP53, c-KIT, STAT1\&3 and PDGFRA. Additional testing on the tumour material will also include analysis of specific gene variants associated with adverse events or response to therapy.

Numerous studies have documented the presence of circulating tumour DNA (ctDNA) among patients with advanced and early stage malignancies (20-22). The ability to diagnose standard cancer mutations with a blood-based assay (a "liquid biopsy") has not yet been established but presents obvious advantages. The emergence of "resistance" mutations arising in the metastatic tumor or throughout the course of therapy is well documented (21, 22). A blood biopsy may represent more accurate determination of the tumor's genetic features than archival DNA specimen. Adequate tissue specimens can be difficult to obtain from some patients with diagnosed malignancies, particularly lung cancer. A blood biopsy may represent a less invasive and timelier means of diagnosing both standard and translational cancer mutations.

Eligibility Criteria:
Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:

* Advanced colorectal cancer and eligible for standard KRAS testing,
* Advanced non-small cell lung cancer and eligible for standard EGFR testing,
* Advanced melanoma and eligible for standard BRAF testing,
* Gastrointestinal stromal tumors (GISTs) eligible for standard c-KIT and PDGFRA testing,
* Being considered for potential eligibility in clinical trial.