cyrilzakka/clinical-trials huggingface dataset:
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 \[C204\]) or Phase III trials (i.e., TMC278-TiDP6-C209 \[C209\] or TMC278-TiDP6-C215 \[C215\]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.

Eligibility Criteria:
Inclusion Criteria:

* Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
* Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
* Patient can comply with the current protocol requirements.
* The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.

Exclusion Criteria:

* Use of disallowed concomitant therapy.
* Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).
* Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis

The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.

Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.

Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.

The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.

The treatment regimen in this study will also include a basic antituberculosis therapy.

The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.

The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.

Eligibility Criteria:
Inclusion Criteria:

* Participants must sign the form of informed consent and agree to follow the protocol requirements
* Women willing to participate in the study must protect against possible pregnancy during all the study long
* Age 18-50 years
* Pulmonary tuberculosis
* HIV/AIDS
* Indication for in-patient standard antituberculosis treatment

Exclusion Criteria:

* Investigational research agents received within 30 days before the screening and participation in other clinical trials
* Immunosuppressive medications received within 6 months before the screening
* Current drug abuse for more than 3 years
* Contraindications to interferons of standard antimicrobial therapy
A Clinical Investigation to Evaluate The Orkla Corn Plaster

This is a prospective, randomized, controlled, open-labelled investigation to assess performance and safety of Orkla Corn Plaster in subject with corns. The hypothesis is that there is an improvement in the size of corns at day 28 compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form
2. \>18 years of age
3. Presence of corn(s) confirmed by Investigator
4. Corn included into investigation shall not have been subject to any other treatment 1 month prior to study enrolment.

Exclusion Criteria:

1. Pregnant or lactating women at time of enrolment
2. Subjects with hypersensitivity to salicylic acid/salicylates, polyethylene foil, acrylic adhesive, viscose/polyethylene fibers and azorubine
3. Subjects diagnosed with diabetes
4. Subjects with poor peripheral blood circulation
5. Subjects with renal dysfunction (eGFR \<60 mL/min/1.73 m2)
6. Subjects with ongoing skin disease in the area where the index corn is located.
7. Subjects with any other condition that as judged by the investigator may make follow-up or investigations procedures inappropriate
8. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment
Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

To evaluate the efficacy and safety of apatinib in treating patients with recurrent or metastatic nasopharyngeal carcinoma who failed prior platinum based chemotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )
2. Have failed for ≥1 lines of platinum based chemotherapy
3. At least one measurable lesion according to the RECIST 1.1
4. ≥ 18 and ≤ 65 years of age
5. ECOG performance scale 0-2
6. Life expectancy of more than 3 months
7. Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10\^9/L, neutrophils ≥ 1.5×10\^9/L, serum transaminase \< 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase\< 5×the ULN), creatinine clearance rate \> 60ml/min.
8. Signed and dated informed consent.

Exclusion Criteria:

1. Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR and PDGFR
2. Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
3. Any factors that influence the usage of oral administration
4. Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
5. Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
6. Within 3 months before the first treatment occurs myocardial infarction, unstable angina pectoris, cardiac angioplasty or stent implantation
7. Within 1 months before the first treatment received surgical operation and the wounds were not healed
8. Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed
9. Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.
10. Preexisting serious accompanying disease which may bring great risk or influence the patient's compliance( uncontrolled hypertension, grade III - IV cardiac insufficiency, severe arrhythmia -QTc duration between 500 m/s, severe liver and kidney insufficiency :urine protein+ +, 24 hours urinary protein \> 1.0 g, mental illness.)
11. history of organ transplants
12. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

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A Psoriasis Plaque Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis

The purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin D analogues using a psoriasis plaque test design


Eligibility Criteria:
Inclusion Criteria:

* Subjects having understood and signed an informed consent form.
* Either sex
* Age 18 years or above
* All skin types and any ethnic origin
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk.

Exclusion Criteria:

* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
* Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation
* Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:

  * Potent or very potent (WHO group III-IV) corticosteroids
  * PUVA or Grenz ray therapy
* Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:

  * WHO group I-II corticosteroids (except if used for treatment of scalp psoriasis)
  * Topical retinoids
  * Vitamin D analogues
  * Topical immunomodulators (e.g. macrolides)
  * Anthracen derivatives
  * Tar
  * Salicylic acid
  * UVB therapy
* Subjects known to be non-responder to topical vitamin D analogues (e.g., known history of no improvement or worsening of psoriasis with e.g., calcipotriol, calcitriol or tacalcitol when used according to current SmPc)
* Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
* Subjects with current participation in any other interventional clinical, based on interview of the subject
* Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
* Subjects with known or suspected hypersensitivity to component(s) of the investigational products
* Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia
* Subjects with known severe hepatic and/or severe renal insufficiency
* Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
The Digital Version of Holistic Healthy Life Education(e2HLE)

The digital version of Holistic Healthy Life Education" (e2HLE) is a holistic, person-centric, multi-component and lifestyle modification intervention that we developed, alongside the WHO integrated care for older people (ICOPE) model and a home-based self-monitoring bio-signals system "Hera Leto". This randomized controlled trial aims to evaluate the effectiveness of e2HLE intervention for achieving weight loss and enhancing self-care and intrinsic capacity (i.e. psychological and mental wellbeing, vitality and nutritional health) as well as improving cardio-metabolic profiles (e.g. blood pressure and lipid profile) compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* aged 50 years old or above,
* able to use internet and tablet;
* education level of primary or above;
* understand Chinese and speak Cantonese;
* have central obesity (waist circumference: male \>90 cm, female \>80 cm) and two of the following: (a) hypertension (systolic blood pressure ≥130 or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), (b) hyperglycemia (fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) or (c) previously diagnosed type 2 diabetes), (d) hyperlipidemia (triglyceride concentrations ≥150 mg/dL (1.7 mmol/L), or treatment for this lipid abnormality); HDL cholesterol;40 mg/dL (1.03 mmol/L) in males and 50 mg/dL (1.29 mmol/L) in females, or treatment for this lipid abnormality), (e) BMI over 23; and chronic pain or bad mood caused by the psychosomatic disorder for no less than six months
* have at least 2 of the following distressing symptoms due to psychosomatic or pain and stress symptoms, including physical and mental agitation, feeling tired, often crying, feeling angry/depressed, feeling isolated from family and friends, feeling great stress, insomnia, health is worse than before.

Exclusion Criteria:

* non-Chinese nationality or can't speak Cantonese;
* participating in any cancer treatment;
* will leave Hong Kong within a short period or the next three months;
* participating in another experiment; living in or planning to live in a facility-care home;
* cognitive difficulties (SPMSQ score equal to or lower than 4);
* taking medications such as estrogenic, synthetic glucocorticoids, anti-steroids, and antiepileptic drugs which may affect cortisol levels.
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
* No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
* Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
* Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
* Eastern Cooperative Oncology Group Performance Status 0-1
* Adequate organ function

Exclusion Criteria:

* Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
* Prior treatment with a selective estrogen receptor degrader (SERD)
* Treatment with any investigational therapy within 28 days prior to study treatment
* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
* Pregnant or breastfeeding
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.

This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected men and women at least 18 years of age
* On stable HAART for previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
* Fasting triglycerides \> 150 mg/dl and \< 1,500 mg/dl
* Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
* Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke
* Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use 2 methods of barrier contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for \> 1 year
* Ability to provide consent

Exclusion Criteria:

* Plasma HIV-1 RNA \> 10,000
* Previous history of atherosclerotic disease or diabetes mellitus
* Change in HAART regimen over three months prior to study entry
* Change in lipid lowering therapy within 2 months
* On chronic anticoagulants such as heparin or coumadin
* On fish oil, omega 3 supplements, or Omacor currently or during the past month
Risk Factors for Persistent Postural-Perceptual Dizziness Development

The primary aim of this study is to determine whether the prevalence of neuroticism, anxiety and body vigilance is higher in patients diagnosed with PPPD compared to those who suffered a vestibular insult but did not develop PPPD and healthy controls. An increased prevalence of one or more of these factors may identify them as risk factors in the development of PPPD. The secondary aim is to understand how PPPD affects quality of life.

The diagnosis persistent postural-perceptual dizziness (PPPD) entered the 11th edition of the World Health Organization's International Classification of Diseases (ICD-11 beta draft) in 2015 following a consensus document on its diagnostic criteria created by the Behavioral Subcommittee of the Committee for the Classification of Vestibular Disorders of the Bárány Society (CCBS) between 2010 and 2014. The ICD-11 describes it as follows: "Persistent non-vertiginous dizziness, unsteadiness, or both lasting three months or more. Symptoms are present most days, often increasing throughout the day, but may wax and wane. Momentary flares may occur spontaneously or with sudden movement. Affected individuals feel worst when upright, exposed to moving or complex visual stimuli, and during active or passive head motion. These situations may not be equally provocative. Typically, the disorder follows occurrences of acute or episodic vestibular or balance-related problems, but may follow non-vestibular insults as well. Symptoms may begin intermittently, and then consolidate. Gradual onset is uncommon." In a previous systematic review of the literature, the authors discuss the pathophysiology and management of PPPD, including certain psychological risk factors. Anxiety has been suggested to play a pivotal role in the maladaptation cycle of PPPD in part by increasing body vigilance and both neuroticism and a pre-existing anxiety disorder have been suggested as predisposing factors for the onset of this maladaptation cycle. Such risk factors may allow the prediction of who might be at risk of developing PPPD after an acute vestibular injury and thus benefit from early treatment.

As PPPD is a relatively new diagnosis, to date there is no study that comprehensively confirms the prevalence of anxiety, neuroticism and/or increased body vigilance in sufferers specifically. It is important to determine this in order to guide further research into treating and potentially preventing its onset.

Eligibility Criteria:
Inclusion Criteria

* Must have diagnosis of PPPD based on the CCBS criteria
* Aged under 18 years old
* Able to provide informed consent Exclusion Criteria
* No confirmed/firm diagnosis of PPPD
* Aged \<18 years old
* Unable to provide informed consent
* Current clinically significant illness that could confound the study results