cyrilzakka/clinical-trials huggingface dataset:
Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.

Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis
* Presence of large oesophageal varices or small with high risk

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months
* High risk gastric varices
* Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any extrahepatic malignancy
* Patients with past history of variceal bleed
* Patients with non-tumor portal vein thrombosis
* Refusal to participate in the study
Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease

The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy \[C3G\] and IgA Nephropathy \[IgAN\]). In Part 1 of the study, HVs will receive either one or two doses of ARO-C3 or placebo. In Part 2 of the study, adult patients with C3G/IgAN will receive 3 open-label doses of ARO-C3. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.


Eligibility Criteria:
Inclusion Criteria (All Participants):

* Willing to provide written informed consent and to comply with study requirements
* Female participants must be non-pregnant/non-lactating
* Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. C3G and IgAN participants must have been vaccinated or willing to undergo vaccination
* All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae
* Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
* 12-lead electrocardiogram (ECG) at Screening with no abnormalities that may compromise participant's safety at discretion of investigator
* Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Males must not donate sperm during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later.
* No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the investigator, could adversely impact participant safety or study results

Inclusion Criteria (C3G and IgAN Participants):

* Diagnosis of C3G or IgAN
* Clinical evidence of ongoing disease based on significant proteinuria
* Estimated glomerular filtration rate ≥30 mL/Min/1.73 m2 at Screening and currently not on dialysis
* Must be on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Exclusion Criteria (All Participants):

* Seropositive for human immunodeficiency virus (HIV) infection,hepatitis B virus, or hepatitis C virus
* History of recurrent or chronic infections
* Uncontrolled hypertension
* Regular use of alcohol within 30 days prior to Screening
* Use of illicit drugs within 1 year prior to Screening or positive urine drug screen at Screening
* History of meningococcal infection
* History of asplenia or splenectomy
* Known contraindication or history of anaphylactic reaction to any vaccine or vaccine component or prophylactic antibiotics planned for use in the study
* Any medical or surgical condition that, in the opinion of the investigator, would expose the participant to a significant safety risk or compromise the results of the study

Note: Additional Inclusion/Exclusion criteria may apply per protocol
Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis

This is a phase 4 study to evaluate the the efficacy of second generation antihistamine on cough outcomes in cough patients with allergic rhinitis.

This is a randomized, double blind, placebo controlled trial in which a total of 78 participants who have cough (≥ 3 weeks) and symptoms of allergic rhinitis will be enrolled. Study participants will be randomly assigned to either active treatment or placebo group. The subjects in active treatment groups will be treated with daily oral bepotastine for 2 weeks, while those in placebo group will take identical-looking tablets. The efficacy of bepotastine will be assessed at the end of 2-week intervention using leicester cough questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Had a cough for at least 3 weeks (score of ≥30 mm on the VAS)
2. History or allergic rhinitis confirmed with skin prick test or serum specific IgE test AND current one or more symptoms of allergic rhinitis (runny nose, obstruction, sneezing, nasal itching)
3. Provided written informed consent
4. Were willing and able to comply with the study protocol

Exclusion Criteria:

1. Current smoker or individuals who have smoked within the past 1 month prior to study entry
2. Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum
3. Currently under allergen immunotherapy
4. 1) Allergic rhinitis or chronic rhinosinusitis under treatment with intranasal corticosteroids (INS) or leukotriene receptor antagonist (LTRA) or 2) allergic rhinitis requiring treatment with INS or LTRA
5. Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
6. Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) \< 0.7 or FEV1 % of predicted \< 80% within 1 month prior to enrollment
7. Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment
8. Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment
9. Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms
10. History of hypersensitivity or severe adverse reaction to antihistamines
11. Unable to fill in the questionnaires (blindness, unable to read)
12. Unable to provide informed consent
13. History of taking following medication within 2 weeks of the enrollment; LTRA, nasal decongestants, intranasal corticosteroids (INS), systemic corticosteroids, antitussive agents (OTCs, codeine)
Sexual Function of Trans Women After Vaginoplasty

Genital feminine affirming surgery may be an important step for transgender women. Vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and aesthetic issues.

Different techniques are available: inversion of penile skin flap for creation of the vulva. The vaginal cavity may come from scrotal skin graft, sigmoid segment, small intestine, or peritoneal flap.

Vaginoplasty has a major place in the the transgender woman pathway, but the specific evaluation of long-term sexuality has not been explored so far.

Multicentric (Lyon, FR - Lille, FR - Limoges, FR), prospective, observational study Patients who underwent vaginoplasty or revision vaginoplasty.

Main objective:

To assess sexuality after sex reassignment surgery in transgender women.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Underwent vaginoplasty or revision in Lyon South Hospital, Lille University Hospital, Limoges University Hospital, between January 2007 and December 2019
* Penile inversion vaginoplasty with scrotal skin graft

Exclusion Criteria:

* \< 18 years old
* Vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap
Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease

The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject older than 18 years.
* Subject presenting with:

  * Either field actinic keratoses (AKs) (mild to moderate, multiple and clustered AKs on a severely sun-damaged skin); or
  * Biopsy-confirmed large, or multiple (several in the same anatomical area) primary superficial BCC lesions that are macroscopically and histologically consistent with superficial basal cell carcinoma (sBCC) and have no histological evidence of aggressive growth patterns; or
  * Histologically confirmed diagnosis of Bowen's disease from a biopsy taken within 3 months
* Any subject presenting with the aforementioned lesions must not be able to be treated optimally by conventional therapies.
* Female subject of childbearing potential, using an effective birth control method (see Case Report Form) and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential
* Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
* Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.

Exclusion Criteria:

* A recurrent superficial BCC lesion that has previously been treated.
* Subject whose lesions on the selected treatment zone (including a 5 cm margin around the treatment area) have been treated with any of the following topical treatments within the specified washout period:

  * 5-FU - 3 months
  * Cryotherapy - 3 months
  * Imiquimod - 3 months
  * PDT - 3 months
  * Diclofenac sodium - 3 months
  * Surgery, radiotherapy, curettage, electrodesiccation, retinoids, dermabrasion, laser resurfacing, salicylic acid - 3 months
* A primary superficial BCC located close to or involving a scar of SCC
* Subject with known porphyria.
* Subject with target lesions on the genitals.
* Subject with known xeroderma pigmentosum.
* Pigmented lesion(s) on the treated area.
* Morpheaform lesion(s) on the treated area.
* Infiltrating lesion(s) on the treated area.
* Female subject who is pregnant, nursing or planning a pregnancy during the study.
* Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream.
* Subject who has participated in another investigational drug or device research study within 30 days of enrolment.
Risk Prediction in Type II Diabetics With Ischemic Heart Disease

The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease

In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected.

In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity.

The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).

Eligibility Criteria:
Inclusion Criteria:

* type-2 diabetes
* coronary artery disease

Exclusion Criteria:

* age \>80 years
* acute coronary syndrome
* life expectancy \<1 year
* unable to give informed consent
Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

This research trial studies protein expression in tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PRIMARY OBJECTIVES:

I. To investigate (in two stages) which proteins are overexpressed in association with 12q13-q14 amplification by applying fluorescence in situ hybridization (FISH) and immunohistochemical (IHC) assays to a panel of alveolar rhabdomyosarcomas (ARMS) cases organized into tissue microarrays.

OUTLINE:

Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.

Eligibility Criteria:
Inclusion Criteria:

* Slides of the 2006 alveolar rhabdomyosarcoma (ARMS) TMA and the 2009 ARMS/anaplastic embryonal rhabdomyosarcoma (ERMS) TMA

  * PAX3-FOXO1-positive tumors
  * PAX7-FOXO1-positive tumors
  * Fusion-negative tumors
Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence

The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in response inhibition during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using functional magnetic resonance imaging (fMRI)while smokers complete tasks designed to assess decision making and response inhibition.

Our primary hypothesis is that smoking abstinence will result in impaired response inhibition accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with these cognitive processes including frontal cortex and the ventral striatum. Abstinence may also result in performance-related increases in activation in brain regions associated with effortful processing including the anterior cingulate cortex in effort to compensate for deficits in other regions.

Participants will learn and practice a Go/No-Go reaction time task (Garavan, Hester, Murphy, Fassbender, \& Kelly, 2006) that measures inhibitory and excitatory aspects of behavioral control. During the task subjects are presented with an alternating series of Xs and Ys in the center of the screen and must press a button every time they see a Go trial (the letter 'Y' or the letter 'X') while inhibiting a response when they are presented with a No-Go trial (any interruption of the X Y alternating stream, e.g., X Y Y).

Eligibility Criteria:
Inclusion Criteria:

Smoker subjects must have

* smoked an average of 10 cigarettes per day for two continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine
* have an expired air carbon monoxide reading of at least 10 ppm.
* must be in general good health

Non-smoker subjects must have

* smoked less than 50 cigarettes in their lifetime
* have not smoked in the last six months
* have an expired air carbon monoxide reading of less than or equal to 5 ppm.
* must be in general good health.

Exclusion Criteria:

* major medical condition
* anything that would make participation unsafe (e.g., have pacemaker or other metallic implant) or uncomfortable (e.g., chronic pain)
* psychiatric condition
* suffering from claustrophobia
* current alcohol or drug abuse
* smokeless tobacco use, or use of nicotine replacement therapy or other smoking cessation treatment
Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.

Patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated (twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will receive identical chemotherapy consisting of eight weekly doses of Vincristine given with radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years.
* Histologically proven medulloblastoma, including the following variants(WHO classification - 2000): classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI - supratentorial, arachnoid of the posterior fossa or spine.
* No clinical evidence of extra-CNS metastasis
* No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy.
* Radiotherapy to start no more than 40 days after surgery.
* Ability to receive twice daily radiotherapy.
* Vital functions within normal range for their age group.
* CTC grades \< 2 for liver, renal, haematological and audiological function.
* No medical contraindication to radiotherapy or chemotherapy.
* Written informed consent (and patient assent where appropriate) according to the laws of each participating country. Written informed consent should also be sought for biological studies.
* National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies).

Exclusion Criteria:

* One of the inclusion criteria is lacking.
* Brainstem or supratentorial primitive neuroectodermal tumour.
* Atypical teratoid rhabdoid tumour.
* Medulloepithelioma.
* Ependymoblastoma.
* Large cell médulloblastoma.
* Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF).
* Patient previously treated for a brain tumour or any type of malignant disease.
* Patients who are pregnant.
* Females who are sexually active and not taking reliable contraception.
* Known predisposition to medulloblastoma e.g. Gorlin's syndrome.
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer

The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.

In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole

Eligibility Criteria:
Inclusion Criteria:

* Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant
* SWOG Performance Status 0-2
* Previously received a platinum and paclitaxel containing regimen
* Projected Life Expectancy of at least 3 months
* Adequate bone marrow function
* Adequate organ function
* Must have received at least 1 prior salvage regimen for recurrent ovarian cancer
* Recovery from acute toxicities from surgery, radiation or chemotherapy
* At least 3 weeks from last therapy

Exclusion Criteria:

* Prior fenretinide oral capsule use allowed. If prior IV fenretinide use, must contact study chair for eligibility
* Second malignancy within last 5 years
* Use of concomitant antioxidants, such as vitamin C or E
* Untreated or symptomatic brain metastases
* History of hypertriglyceride levels \> 200 mg/dl; triglyceride levels \< 200 and receiving treatment are okay.
* Use of certain medications is prohibited - contact study coordinator for information
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers

The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy as determined by medical evaluation by study physician
* Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)\^2 as measured at screening
* Weight ≥ 50 kg at screening
* Must agree to adhere to the protocol defined contraception requirements

Key Exclusion Criteria:

* Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician
* Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and \> 470 millisecond (msec) for females at screening and pre-dose
* Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician
* Received any study medicine in a clinical research study within the last 90 days
* Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers

The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in HDGECs using the radioligand \[18F\]MNI-659. The study will be a follow-up, examining HDGECs from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial PET measurement.

The HDGECs will perform 2 study visits: Visit 1 (screening) and Visit 2 (PET analysis utilizing the radioligand \[18F\]MNI-659). There will also be 2 telephone follow ups; one after Visit 1 (telephone follow-up after screening) and one after Visit 2, (telephone follow-up after PET). Study visits and telephone follow-ups will take place during a maximum of 97 days.

Eligibility Criteria:
Inclusion Criteria:

* Have participated in and completed study CHDIKI1201/PET-HD-PDE10A and are capable of providing informed consent or have a legal representative authorized to give consent on their behalf.
* Otherwise healthy according to medical history, no co-morbidity of psychotic disorders, physical examination, vital signs and laboratory assessments
* Willing to travel to Stockholm (with a companion if requested) for PET examinations
* Suitable physically and psychologically to travel to Stockholm and undergo PET examinations, as judged by the recruiting Investigator with attention given to symptoms of chorea and anxiety
* Willing to comply with the use of adequate contraceptive measures

Exclusion Criteria:

* Any disease, condition or concomitant medications that significantly compromises the function of the body systems and that, in the opinion of the Investigator might interfere with the conduct of the study or the interpretation
* Regular use of any medication prohibited by this protocol (selective or non-selective PDE inhibitors), with the exception for erectile dysfunction medication, which may be temporarily discontinued prior to the PET measurement
* History of anaphylactoid or anaphylactic reactions to any allergen including drugs and contrast media
* History of other neurological condition (including brain surgery, intracranial hematoma, stroke/cerebrovascular disorders, epilepsy), co-morbidity of psychiatric disorders
* Clinically relevant findings in hematological, biochemical testing or 12-lead ECG as determined by the evaluating physician
* Female subjects who are breast-feeding or have a positive pregnancy test at screening or at Visit 2