cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis

The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient with active retinal vasculitis (involving arteries or veins) as a manifestation of non-infectious ocular inflammatory disease; fundus must be viewable with wide-field FA in the study eye
* If both eyes are involved, both are eligible for inclusion in the study
* Patients already on non-steroidal immunosuppressive therapy may continue on this during the study, but the dose must not be increased or decreased within 6 weeks of initiating the trial
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under age 18
* Patients who are pregnant (must be ruled out in women of child-bearing age)
* Active infectious ocular or systemic disease
* Patients with active infectious ocular or extraocular disease
* Patients with history of malignancy, except for dermatologic entities of basal or squamous cell carcinoma which have been completely excised or removed previously
* Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction
* Patients with known hypersensitivity to Acthar
* Patients on other non-steroidal systemic immunomodulatory medications with dose adjusted sooner than 6 weeks prior to study drug administration
* Patients currently on or recently treated with (within 6 weeks) systemic corticosteroid
* Patients with periocular or intraocular injections of medications administered to help control inflammation sooner than 6 weeks prior to study drug administration
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator, or contraindicated, including but not limited to, patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin. Administration of live or live attenuated vaccines is contraindicated in patients during the entire duration of the study and for one month prior
Clinical and Economic Evaluation of Neurocognitively-Enhanced Online Cognitive Behavioural Therapy

To evaluate the clinical efficacy of online cognitive behavioural therapy supplemented with online neurocognitive remediation therapy to improve mood and cognition, decrease relapse rates and optimise work and occupational functioning.

Depression is the most prevalent mental disorder with high relapse rates. Direct costs to Europe represent 1% of its total economy. Following usual treatment, mood improves or fully recovers but cognitive deficits often persist, preventing full return to normal social function. These deficits worsen with repeated depressive episodes and are a significant predictor of relapse. Preventing depression relapse remains one of the biggest therapeutic challenges in the field. While effective short-term therapies, such as cognitive behavioural therapy (CBT), exist, all are associated with high relapse rates. Online neurocognitive remediation therapy (oNCRT), by its potential to rehabilitate impaired cognition in depression, offers an innovative solution to this mental health problem.

This trial aims to test the effectiveness and cost-effectiveness of neurocognitively enhanced online CBT to improve mood and cognition in depression, optimise everyday functioning and prevent depression relapse over six months follow-up, using a randomised active-control parallel-groups research design. Individuals presenting with at least mild depression (n=134) are randomly assigned to one of two treatment allocations: online CBT (oCBT) or neurocognitively enhanced online CBT (oCBT+oNCRT) for 20 one-hour sessions over 5 weeks (i.e., four weekly sessions).

Before randomisation and within a week of the final allocated session, mood, attention, memory and planning abilities will be assessed. All participants will be then followed for six-months to determine if the mood and cognitive benefits of the oCBT+oNCRT are maintained with the passage of time compared to the control group (oCBT alone). Standard measures of daily functioning (e.g., work ability, occupational function) and economic cost-effectiveness data will be obtained at the same time points. Demonstrating the oNCRT effectiveness as an adjunct to CBT will contribute towards optimising connected healthcare solutions for depression.

Eligibility Criteria:
Inclusion Criteria:

* scoring a minimum of 14 on the BDI-II,
* internet access
* computer access
* English-speaking fluency

Exclusion Criteria:

* scoring less than 14 on BDI
Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study

Until now no scientific clinical evidence exists regarding the possible impact of long term endogenous androgen priming in IVF patients aligned with the Bologna Criteria, in specific the impact of priming on serum parameters correlated with the ovarian reserve, antral follicle count, and the number of retrievable follicles. Thus, this pilot-study will explore a new suggested protocol for the Bologna criteria patient developed from basic physiology, and will if successful result in a subsequent randomized controlled trial in the same subset of patients, enabling a possible paradigm shift in the treatment of poor ovarian response (POR).

A single center study pilot study in 30 IVF Bologna criteria POR patients. All patients fulfilling the ESHRE Bologna criteria will be eligible for inclusion.

Eight weeks prior to stimulation for IVF, patients will start treatment with a low dose of rhCG (Ovitrelle). At the same time daily treatment with the aromatase inhibitor daily will commence, concomitantly with GnRHa down-regulation with a depot GnRHa.

After 8 weeks, stimulation will be performed with a fixed dose of 300 IU rFSH (Gonal F, Merck) for the first 5 days in patients ≤ 34 years of age and 300 IU Pergoveris (Merck) in patients ≥ 35 years of age. The use of hCG and aromatase inhibitor will stop on the first day of stimulation.

Monitoring will be performed according to the standard procedure of the clinic. Patients will receive a bolus of 6.500 IU rhCG (Ovitrelle, Merck) for triggering of final oocyte maturation. Oocyte pick-up and embryo transfer will be performed according to the policy of the clinic. Oocyte pick-up (OPU) and embryo transfer will be performed according to standard procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 41 years
* BMI \< 30 kg/m2
* Ovarian reserve, according to the ESHRE Bologna Criteria measured within two months prior to stimulation start

Bologna criteria: At least two of the following three features present:

* Advanced maternal age (≥40 years) or any other risk factor for POR
* A previous POR (≤3 oocytes with a conventional stimulation protocol)
* An abnormal ovarian reserve test (i.e. antral follicle count \< 5-7 follicles or AMH\< 0.5 - 1.1 ng/mL)
* Poor responder if - Two previous episodes of POR after maximal stimulation (300 IU)

  * Receiving GnRH-antagonist co-treatment during ovarian stimulation
  * Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
  * Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal

A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.

Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm.

However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.

Eligibility Criteria:
Inclusion Criteria:

* Older adults between 18 and 65 years of both sexes.
* Patients residing in the provinces of Havana, Artemisa and Mayabeque.
* Voluntariness of the patient to participate in the study. Informed and written consent.
* Women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Contraindication to the performance of upper digestive endoscopy.
* Psychiatric conditions that do not favor the administration of treatment and follow-up.
* History of hypersensitivity to another similar product.
* Severe acute allergic states.
* Patients with concomitant diagnosis of esophageal tumor or other causes of infectious esophagitis.
* Present an associated chronic illness in the decompensation phase (heart disease, diabetes, hypertension, renal failure, AIDSl).
* Patients who are receiving another product under investigation.
Personalized Motor Learning in Primary Care Physiotherapy (TREAT)

Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed.

The aim of this prospective study is to evaluate the use and experiences of the card set and website designed to aid the physiotherapist in decision making with regards to motor learning. The following research question is central to this evaluation: How are the developed card set and website used and experienced by physiotherapists in primary care during the treatment of patients with neurological or geriatric conditions?

Method: Formative process evaluation.

Over the last decade many scientific articles have been published on motor learning in neurological and geriatric rehabilitation. To make the available findings comprehendible and clear for physiotherapists, a card set and website have been developed. Participating physiotherapists will use the "card set and website" in their daily practice for a period of six months. To assess the usage and experiences of therapists, digital questionnaires will be administered prior to the intervention, at 3 months, and at 6 months, along with bi-weekly monitoring. The quantitative data from the questionnaires and monitoring will be analyzed using descriptive statistics (e.g., frequency tables, means, medians, IQR, and summary figures). Additionally, an interim evaluation will take place where solutions for the main user issues will be collectively brainstormed with the participants. Finally, a consensus meeting will be held to reach the final versions of the card set and website. The nominal group technique will be used to ensure active participation from all participants and to achieve consensus on the definitive list of modifications.

Eligibility Criteria:
Physiotherapists will be eligible for inclusion when they:

* have at least one year of working experience
* are treating neurological and/or geriatric patients
* are able to attend the preparatory training provided by the researchers
Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients

Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.

Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.

Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Subacute stroke (within 1-4 weeks post stroke)
* Acute hemiparesis (Fugl-Meyer Stage \< IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist
* Aged 18-79

Exclusion Criteria:

* Absence of voluntary movement (Fugl-Meyer Stage \< III)
* Head injury or the presence of intracranial metal or intracranial lesions
* History of cranial irradiation
* History of epilepsy
* Presence of a pacemaker
* Taking anticonvulsant or neuroleptic medication
* Substance abuse
* Inability to understand instructions
OPEN Study: Pain Management Treatment Needs Interviews

Presently, there are few options for medically managing HIV-related painful peripheral sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN. However, there is a scarcity of research on psychological treatment approaches for pain management in people with HIV. This study will use in-depth semi-structured interviews to examine the needs of people with painful HIV-SN for a psychologically-based pain management treatment that may be delivered over the Internet. Interview questions will examine participants' needs in terms of treatment content and delivery format. Men and women, ethnic minorities, and people who use recreational drugs will be sampled to ensure that interview responses reflect the views of people most commonly suffering from this condition. Approximately 30 people will be recruited for the study. The interviews will be audio recorded, transcribed verbatim, and coded to identify themes. The interview responses will be used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that tailoring the treatment based on the qualitative interview responses will increase the acceptability of the treatment and will improve treatment adherence rates for a future study.

This report is independent research supported by the National Institute for Health Research (NIHR Post Doctoral Fellowship, Dr Whitney Scott, PDF-2015-08-059). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older.
* Living with HIV.
* A positive screen for peripheral sensory neuropathy, as indicated by: presence of self-reported bilateral foot pain and/or numbness in a symmetrical distribution.
* Positive screen for symptoms of neuropathic pain in the feet, as indicated by a score of greater than or equal to 3 on the patient reported outcomes section of the Neuropathic Pain Interview.
* Pain in the feet present most days for at least 3 months.
* Average pain intensity of greater than or equal to 4/10.
* Average interference of pain with daily activities is greater than or equal to 4/10.

Exclusion Criteria:

* Presence of excessive alcohol consumption, hypothyroidism, vitamin B12 deficiency, diabetes, exposure to isoniazid or chemotherapy drug treatment, or a known history of a neuropathy due to a cause other than HIV or antiretroviral treatment
* Unable to conduct interview in English.
* Current diagnosis of dementia or learning disability.
* Unwilling to provide written informed consent.
Pharmacogenomics to Improve Supportive Care Symptoms.

To understand the clinical utility of multi-gene pharmacogenetic testing in patients receiving palliative and supportive care across palliative care settings (inpatient hospital, outpatient), specifically to calculate a drug-gene interaction ratio, based on extant prescriptions paired with an individual's pharmacogenetic results.

This is a prospective, observational cross-sectional study of patients with serious and/or life limiting condition conditions, such as incurable cancer undergoing palliative or supportive care treatment at a University Teaching Hospital in England, UK. Participants will be recruited at point of referral to in-patient or outpatient palliative care services (i.e. at point of presentation with symptom control issues).

All participant study activities:

All participants will undergo testing of a panel of genetic variants relevant to drugs used in symptom control (see https://cpicpgx.org/genes-drugs/ ). This will involve collecting a 5mL blood sample (the intervention) from individuals. All participants will be consented to examination of their records within local hospitals and/or primary care to extract study relevant data (described below).

The start of follow-up will be from the date of the blood sample (the intervention). Standard demographic information including ethnicity will be collected at baseline.

Participation in study will be for the duration of being under palliative care treatment, up to a maximum of 90days from recruitment date.

All participant sample will be stored and genetic analysis will take place after the end of recruitment and health data collection.

The study team will then calculate a drug-gene interaction ratio (DGI) (i.e. The total number of genetic variation results that pair with a relevant prescribed medication for that same individual, divided by total number of individuals tested).

Eligibility Criteria:
Inclusion Criteria: Aged 18 or older; incurable, life limiting condition, clinical care provided at NNUH.

Exclusion Criteria: Lacking capacity to consent to research (unless there is an appropriate consultee)
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed.

The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume.

Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of continuous RRT and GCV treatment
* 18 years of age or older.

Exclusion Criteria:

* Concomitant treatment with acyclovir or valacyclovir.
* Patient does not give informed consent.
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 70 years, with a body mass index (BMI) of 18-30 kg/m² and body weight≥45kg.
* laparoscopic gynecologic or abdominal surgery under general anesthesia (duration≥1 hour and postoperative hospitalization ≥24 hours), with anesthesia maintained using sevoflurane and remifentanil (propofol maintenance was prohibited);
* had≥2 risk factors of PONV; expected to use postoperative opioid within 24 hours after surgery;
* American Society of Anesthesiologists (ASA) physical status class I-III.

Exclusion Criteria:

* planned intrathoracic, transplant, or central nervous system surgeries;
* diagnostic-only procedures;
* use of local/regional anesthesia (e.g., neuraxial/nerve blocks);
* postoperative intensive care unit (ICU) transfer;
* preoperative nasogastric/orogastric tube placement (from screening through 24 hours postoperatively)
* nausea, vomiting, retching, or organic disease-related emesis (e.g., intestinal obstruction) within 24 hours preoperatively; history of malignancy, epilepsy, or vestibular dysfunction;
* hypersensitivity to aprepitant;
* recent use of aprepitant/NK1 antagonists (within 2 weeks prior to randomization), antiemetics (including 5-HT3 antagonists, corticosteroids; within 1 week), strong CYP3A4 inhibitors/substrates (within 1 week), CYP3A4 inducers (within 4 weeks), or warfarin (within 2 weeks);
* clinically significant laboratory abnormalities (ALT/AST ≥2×upper limit of normal \[ULN\], total bilirubin ≥1.5×ULN, creatinine ≥1.5×ULN, hemoglobin ≤90 g/L)