cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer

The general aim of the present study was to assess the safety and tolerability of intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re) -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc - labelled hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled hMAb BIWA 4 and to propose a safety dose for phase II development.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmation of squamous cell carcinoma in the head and neck
* Patients destined for surgery by means of neck dissection (Part A) or :
* Patients with either local and/or regional recurrent disease for which curative treatment options were not available or distant metastases. The tumor deposits had to be measurable either clinically or by one or more radiological technique (s) (CT, MRI, bone scintigraphy). Because RIT was expected to be more effective in smaller size tumor deposits, patients with lesions measuring \> 3 cm in greatest dimension were preferred (Part B)
* Patients over 18 years of age
* Patients younger than 80 years of age
* Patients who had given 'written informed consent'
* Patients with a life expectancy of at least 3 months
* Patients with a good performance status: Karnofsky \> 60

Exclusion Criteria:

* Life-threatening infection, allergic diathesis, organ failure (bilirubin \> 30µmol/l and/or creatinine \> 150 µmol/l) or evidence of a recent myocardial infarction on ECG or unstable angina pectoris
* Pre-menopausal women (last menstruation \<= 1 year prior to study start)

  * Not surgically sterile (hysterectomy, tubal ligation) and
  * Not practicing acceptable means of birth control, (nor not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
* Women with a positive serum pregnancy test at baseline
* Chemotherapy or radiotherapy within 4 weeks before inclusion in the study
* White blood cell count \< 3000/mm³, granulocyte count \< 1500/mm³ or platelet count \< 100000/mm³
* Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male, age at least 18 years at the time of signing informed consent
* History of more than 150 exposure days to any factor VIII products
* Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records

Exclusion Criteria:

* Known history of factor VIII inhibitors
* Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method
* Known congenital or acquired coagulation disorders other than haemophilia A
* Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial
National Survey on Infiltrative Breast Cancer

The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women\> or = 18 years old
* Women with newly diagnosis of infiltrative breast cancer
* Agree to take part in this study

Exclusion Criteria:

* Women with other malignant tumor (except in situ cervical carcinoma or treated basal cell carcinoma)
* Women with in situ ductal carcinoma or in situ lobular carcinoma
Ballooned Intercostal Drain Trial

This study is designed to assess whether a new type of chest drain reduces the number of drains that fall out of or are accidentally removed from the chest cavity (usually requiring another drain to be inserted), without causing any increase in discomfort or other side-effects.

Chest drains are an essential part of the treatment for patients with fluid or air around the lung, which usually causes breathlessness. Draining the fluid or air relieves symptoms and allows investigations to be carried out that can identify a cause for why the fluid or air is there. Chest drains are difficult to secure in place, and sometimes fall out despite the best possible care. This study tests a modified drain that has a small balloon near the end which, when inflated inside the chest cavity, should make it much harder for the drain to fall out of the chest. This was tested in a small pilot study, with encouraging results. The current study is comparing a group of patients treated with the new ballooned drain against a group treated with the standard drain, with patients equally but randomly allocated to each group. The chest drain has been through rigorous laboratory testing and has been CE marked for human use.

All patients requiring intercostal drainage for clinical reasons will be offered entry into the study, unless, in the view of the treating physician, blunt dissection is required. No other screening assessments will be required, other than the ability to sign the informed consent form.Patients who have provided signed informed consent will then proceed to the study protocol. Patients will be randomised to undergo either standard ICT insertion (usual clinical care) or insertion of the study drain using standard clinical policies and procedures at each participating centre.

Once a patient has been identified for the trial and has signed the informed consent form, baseline details will be entered into a dedicated web-based programme accessible at all sites, and patients will be allocated 1:1 to either usual care or to the study drain.

All subsequent care will be as per best clinical care for all patients in both arms of the study. The only additional assessments over and above usual care will be the collection of pain scores. Pain will be rated by the patients on a visual analogue scale (VAS) on up to 4 occasions - insertion, 24 and 72 hours post insertion, and at drain removal.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>16 years
2. Able to give written informed consent
3. Requiring intercostal tube drainage for clinical reasons

Exclusion Criteria:

1. Inability to provide written informed consent
2. Requiring blunt dissection for intercostal tube insertion
3. Haemothorax
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions

Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference , Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fasting Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years (inclusive both)
* Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* Inability to communicate or co-operate.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of pre-existing bleeding disorder.
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* HIV, HCV, HBsAg positive volunteers.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* Participation in any study within past 3 months,
* History of alcohol or drug abuse.
* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study. Positive to Breath alcohol test.
* Positive to breath alcohol test.
* Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.
* Pulse rate less than 60/minute or more than 100/minute.
* Oral temperature less than 95°F or more than 98.9°F.
* Respiratory rate less than 10/minute or more than 20/minute.
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* Recent History of kidney or liver dysfunction.
* Volunteers suffering from any psychiatric (acute or chronic) disorder.
* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
Effects of Remote Patient Monitoring on Heart Failure Management

The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.

Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.

Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Heart Failure (NYHA Class II-IV)
* Out-patients attending the University Health Network Heart Failure Clinic
* English-speaking and able to read English
* 18 years old or over

Exclusion Criteria:

* Awaiting heart transplantation
* Not expected to survive over a year (as determined by their cardiologist)
* Unable to read text on a mobile phone due to vision disability
* Unable to self-care due to anxiety, depression, or decreased cognitive function
* Lack of manual dexterity to accurately press buttons on the mobile phone
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed Study 339-14-001
* Patients who have signed the informed consent form for Study 339-14-002

Exclusion Criteria:

* The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)
* The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator
Impact of the CommunityRx Program on Health, Service Utilization and Costs

The CommunityRx system generates patient-centered e-prescriptions for community services (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive community resource database. Based on a patient's diagnoses, a HealtheRx will be printed automatically at the end of the ambulatory care visit and will provide patients with a customized map and/or list of places in their community that provide health and social services as well as contact information for a local community health worker who can provide limited case management support. The CommunityRx program aims to promote: 1) better healthcare, 2) better health, and 3) lower cost. The purpose of this research is to systematically evaluate the impact of CommunityRx on health outcomes as well as health care service utilization and total cost of care for Medicaid, Medicare and other beneficiaries. The investigators hypothesize that beneficiaries who participate in the CommunityRx intervention will experience better healthcare, better health and lower total cost of care.


Eligibility Criteria:
Inclusion Criteria:

* Intervention group eligibility: Patients receiving ambulatory care at a clinical site connected to CommunityRx who live in the CommunityRx geography. Control group eligibility: Patients receiving care at a clinical site connected to CommunityRx who live outside the CommunityRx geography.

Exclusion Criteria:

* Patients receiving care at a clinical site not connected to CommunityRx.
Moving Well for Total Knee Arthroplasty (TKA)

The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA).

Moving Well is a behavioral intervention, guided by peer coaches, that aims to improve mental and physical preparation for patients planning to undergo total knee arthroplasty (TKA) and improve postoperative recovery and outcomes. Peer coaches are patients who themselves have had TKA due to advanced osteoarthritis (OA) of the knee and have been trained and certified to become peer coaches.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have their primary TKR (one knee or both knees) scheduled in 8 weeks or more
* Be willing to participate in the Moving Well (intervention) arm or Staying Well (attention control) arm
* Are willing to work with a coach
* ≥ 50 years of age
* Speak English
* Have access to the internet, computer, and a working phone
* We will prioritize the recruitment of subjects with low socioeconomic status defined as being a beneficiary of Medicaid or no insurance and an underrepresented racial/ethnic group (Hispanic/Black).

Exclusion Criteria:

* Non-English speakers
* The intervention will first be delivered in English to ensure feasibility with the content before adapting the material for patients who speak other languages.
* TKR was a result of a septic joint or revision (implant malfunction)
* Unable to exercise (e.g., bed bound or wheelchair bound)
* Have had contralateral TKR or other joint replacement surgery (hip, shoulder) within the past 5 years
* If they have RA or other connective tissue disease: Lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, polymyalgia rheumatica.
Rosuvastatin in Treating Women With Cardiovascular Complications Who Are Undergoing Chemotherapy For Breast Cancer

This randomized pilot clinical trial studies rosuvastatin in treating women with cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for breast cancer

OBJECTIVES:

I. Evaluate the feasibility of administering Rosuvastatin to breast cancer patients undergoing treatment with anthracyclines, paclitaxel, cyclophosphamide, and trastuzumab for breast cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive rosuvastatin orally (PO) once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

Women receiving therapy for breast cancer without a history of cardiovascular disease An low-density lipoprotein (LDL) cholesterol level of less than 160 mg per deciliter (3.4 MMol per liter) Willingness to participate for the duration of the trial (3 months) Written informed consent Triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter)

Exclusion Criteria:

Previous or current use of lipid-lowering therapy Current use of postmenopausal hormone-replacement therapy Evidence of hepatic dysfunction (an alanine aminotransferase level that was more than twice the upper limit of the normal range) Creatine kinase level that was more than three times the upper limit of the normal range Creatinine level that was higher than 2.0 mg per deciliter (176.8 umol per liter) Diabetes Uncontrolled hypertension (systolic blood pressure \> 190 mm Hg or diastolic blood pressure \> 100 mm Hg) Uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5 times the upper limit of the normal range) Recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study Exclude patients with inflammatory conditions such as severe arthritis, lupus, or inflammatory bowel disease, and patients taking immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids Pregnant women are excluded from participation in this study
Emervel for the Correction of Lower Face Wrinkles & Folds

This study is designed to

1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment
3. evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
4. evaluate aesthetic improvement, by subject and treating investigator assessments
5. evaluate subject satisfaction
6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment
7. evaluate marionette lines (MLs) severity, by treating investigator assessment
8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
9. evaluate all adverse events reported during the study.


Eligibility Criteria:
Key Inclusion Criteria:

1. Seeking correction of bilateral NLFs: severe (i.e., bilateral WSRS = 3-4) or moderate (i.e., bilateral WSRS = 2-3) AND bilateral MLs: severe (i.e., WAS = 3-4) or moderate (i.e., WAS = 2-3).
2. Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
3. Intent to undergo optimal correction of bilateral NLFs and MLs. Optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject.

Key Exclusion Criteria:

1. Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.
2. Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.
3. Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.
4. Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.
5. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
6. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
7. Known/previous allergy or hypersensitivity to gram-positive bacterial proteins.
8. Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
9. Other condition preventing the subject from entering the study in the treating investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Characteristics and Outcomes of Childhood Moyamoya in the UK

This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes.

The study ahs 3 components:

1. Patient identification via the British Paediatric Surveillance Unit, and the 21 collaborating centres
2. Record review/patient interview to determine clinical features \& outcomes
3. Centralised review of imaging data to ascertain radiological phenotypes

Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis of moyamoya

Exclusion Criteria:

* Refuse consent
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 70 years of age
* Body mass index between 18.0 and 35.0 kg/m²
* Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
* Has diffuse cutaneous SSc, defined as mRSS \>0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
* Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤5 years
* Meets at least 1 of the following based on duration since SSc onset:

  * \<2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥15 and ≤45 at screening
  * ≥2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥20 and ≤45 at screening, and either:

    * RNA polymerase III negative, or
    * Evidence of recent disease progression as defined in the protocol
* FVC \>50% predicted
* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)

Exclusion Criteria:

* Has any of the following complications:

  * Left ventricular failure
  * Pulmonary arterial hypertension
  * Renal crisis within previous 6 months
  * Gastrointestinal dysmotility within previous 3 months
  * Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
* Current rheumatic disease other than SSc that could interfere with assessment of SSc
* Lung disease requiring continuous oxygen therapy
* Evidence or suspicion of active or latent tuberculosis
* Active Crohn's Disease or ulcerative colitis