cyrilzakka/clinical-trials huggingface dataset:
Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histological or cytological diagnosis of neoplasm
* No effective standard therapeutic options
* ECOG performance status of 0-2
* ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
* Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
* Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria:

* Concurrent malignancies
* Women who are pregnant or lactating
* Evidence of symptomatic brain metastases
* Receiving concomitant anticancer therapy (excluding supportive care)
* Requires palliative radiotherapy at time of study entry
* Unable to tolerate conditions for radionuclide imaging
* Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20
The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery

The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile would be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since these disorders contribute to an impact on morbidity / mortality in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 50 years.
* Be submitted to cardiac surgery by sternotomy and with the use of cardiopulmonary bypass (CPB).
* American Society of Anesthesiologists classification 1, 2,3 and 4.

Exclusion Criteria:

* Patients undergoing reoperation.
* Patients undergoing heart transplantation.
* Patients using vasopressor agents and / or ionotropic continuous preoperatively.
* Patients with prior endotracheal intubation and consequently Ventilatory Assistance Mechanics.
* Patients with documented psychiatric disorders.
* Patients with previous cognitive disorders.
* Patients with a history of alcohol or drug abuse.
* Patients with a history of cerebrovascular accident (CVA) with less than 3 months.
Diabetic Retinopathy Candesartan Trials

The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including secondary prevention studies of diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included.
* Duration of diabetes for \> 1 year and \< 15 years with stable diabetic therapy within last 6 months.
* Patients with untreated resting mean sitting SBP \< 130 mmHg, mean sitting DBP \< 85 mmHg and with retinal photograph grading level 10/10 (on ETDRS severity scale).

Exclusion Criteria:

* Patients with the following conditions are excluded from participation in the study:
* Cataract or media opacity of a degree which precludes taking gradable retinal photographs
* Angle closure glaucoma, which precludes pharmacological dilatation of the pupil
* History of retinopathy
* History or presence of clinical significant macular oedema (CSME)
* History or evidence of photocoagulation of the retina Other retinal conditions which may mask assessment, eg, retinal vein occlusion
* Positive micral dipstick test
* Presence of secondary diabetes
* Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception
* Need of treatment with ACE-inhibitor
* Haemodynamically significant aortic or mitral valve stenosis
* Known renal artery stenosis or kidney transplantation
* Hypersensitivity to study drug
* Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator
Work and Vocational AdvicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care

Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain.

The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective?

WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis.

Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs).

The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work.

Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and over
* currently in paid employment (full or part time)
* current absence from work of at least two consecutive calendar weeks but not more than six continuous months
* received a fit note
* access to a mobile phone that can receive and respond to SMS text messages
* able to read and write English
* able to give full informed consent
* willing to participate.

Exclusion Criteria:

* Long-term work absence defined as over six continuous months
* pregnancy or on maternity leave
* patients presenting with signs or symptoms indicative of serious illness requiring urgent medical attention ('red' flags)
* severe mental health problems (e.g. severe depression with risk of self-harm, exacerbation of schizophrenia or bipolar disorder, cognitive impairment or lack of capacity)
* high vulnerability (e.g. palliative stages of illness, recent bereavement, dementia).
Bioavailability of Resveratrol From Vineatrol30 Extract Incorporated Into Micelles

To enhance the oral bioavailability of the antioxidants trans-resveratrol and trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was incorporated into micelles. A single dose, single blind, two arms crossover trial was conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and compared between formulations. Tolerability of the dose was also controlled by safety parameters in plasma.


Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers with blood chemistry values within normal ranges

Age: 18-35 years

BMI: 19-25 kg/m2

Exclusion Criteria:

Pregnancy or lactation

Alcohol and/or drug abuse

Use of dietary supplements or any medications, except contraceptives

Any known malignant, metabolic and endocrine diseases

Previous cardiac infarction

Dementia

Participation in a clinical trial within the past 6 weeks prior to recruitment

Smoking

Physical activity of more than 5 h/wk
A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin

Exclusion Criteria:

Exclusion Criteria:

* Patient not presenting with the associated signs of an exacerbation
* Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
* Patient requiring hospitalisation in intensive care
Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

Immunotherapy is a new therapeutic approach used in non small cell lung cancer in a late stage.

VOC analysis could allow to identify biomarkers of early response to immunotherapy. The study of VOC could help in the optimisation of immunotherapy prescription in lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* patient aged \> 18 years old
* patient with metastatic non-small cell lung cancer with marketing authorisation criteria for immunotherapy
* preserved overall condition (Performans Status 1)
* signed informed consent
* patient with healthcare insurance

Non Inclusion Criteria:

* patient with oxygen therapy or invasive ventilation
* patient unable to perform a slow vital capacity
* systemic corticosteroid therapy more than 10 mg per day of prednisone equivalent
* previous treatment with immunotherapy
* dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance)
* Patient deprived of liberty by judicial or administrative decision
Pharmacokinetics of FDL169 in Healthy Female Subjects

To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female subjects.

This is a two-part study.

Part 1:

Part 1 of the study is a single-dose, dose-escalation, study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state. Up to five doses will be assessed.

Part 2:

Part 2 of the study is a multiple-dose study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy female subjects aged 18 to 55 years inclusive and of any ethnic origin with a body mass index (BMI) of \> 19 and \< 30 kg/m2. Body Mass Index = Body weight (kg) / \[Height (m)\]
2. Subjects must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP (unless they are of non-child bearing potential).

Exclusion Criteria:

1. Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
2. Subjects who have any renal or clinically significant cardiac, renal or hepatic disease at Screening.
3. Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (with the exception of Gilbert's syndrome or asymptomatic gallstones), endocrine or immunologic disease at Screening.
4. Have an abnormal twelve-lead ECG or an ECG with abnormality considered to be clinically significant in the opinion of the Investigator or an ECG with a single QTcB \> 450 mSec.
5. Subjects with a positive urinary drugs of abuse screen or positive alcohol screen at Screening or Day -1.
6. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \> 21 units.
7. Subject with history of HIV or positive human immunodeficiency virus, hepatitis B or hepatitis C results.
8. Donation of 500 mL or more of blood within the previous 3 months.
9. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and FDL Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
10. Smoking or use of tobacco products or substitutes equivalent to \> 15 cigarettes/day.
11. Any subject who is pregnant or nursing.
Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome

In this modern era, Text Neck is a new term used to describe neck pain and associated damage caused by continuous flexed posture due to excessive use of smartphones for a long time. The term text neck was first introduced by Dr. Dean L. Fishman, who is US based chiropractor. Text neck can also be described as overuse syndrome caused by repetitive stress on neck due to prolonged flexion. There is coordinated work between cervical spine and surrounding structure such as muscles, ligament, nerves and bones. In addition, any nerve compression at cervical spine leads to radiating pain in neck, shoulder and arm. Previous literature reported use of cell phone is very common in population of 18 to 44 years of age. Seventy nine percent (79%) population have smartphone with them all the time. Technology has become essential part of modern lifestyle. Sustained flexed posture forces the head to exert weight on neck of varying degrees. Weight of neutral head is 10 to 12 pounds and increases 6 times 1 inch forward movement of head. Children are at higher risk because of their large head size. This study will be a Randomized clinical trial with objective to reduce neck pain and disability in patients with text neck syndrome. Two groups will be designed, in one group ElDOA (n=20) and in other group post facilitation technique (n=20) will be applied. Patients will be recruited into two groups by consecutive sampling by non-replacement lottery method with equal no. of chits. Patients will be assessed by Numeric pain rating scale (NPRS), Neck disability index (NDI), smartphone addiction scale before and after treatment. Both groups will receive heating pad as common treatment first after that group A will be treated with ELDOA and group B will be treated with Post-facilitation. Session of 6 weeks with 3 days per week will be conducted. After that post treatment assessment will be done.


Eligibility Criteria:
Inclusion Criteria:

* • Neck pain without unilateral UE symptoms

  * Age 18-35 years
  * Subjects using Phone since past 1 year
  * Neck disability index (NDI) score \>10 points
  * Participants able to understand and fill the questionnaire in English

Exclusion Criteria:

* • Subjects having any congenital cervical condition

  * Subjects having traumatic cervical condition such as whiplash injury within the past 6 weeks
  * History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  * Subjects with cervical radiculopathy
Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes

Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Recently developed mirofidelity (MIFI) catheter has mini-electrodes that can record local eletrogram with higher resolution. We aimed to investigate the efficacy of MIFI catheter in the ablation of paroxysmal supraventricular tachycardia compared to conventional radiofrequency ablation catheter. Enrolled patients undergo conventional electrophysiologic study. Patients with sustained supraventricular tachycardia during the study are randomized to either study group or control group. Radiofrequency ablation is performed using MIFI catheter in the study group, and conventional catheter (Blazer II) in the control group. The study endpoints are recorded immediately after ablation and there is no additional follow up or management after procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo radiofrequency ablation for paroxysmal supraventricular tachycardia or WPW syndrome with atrial fibrillation
* Give written informed consent for the study

Exclusion Criteria:

* Unable to induce supraventricular tachycardia during electrophysiologic study.
* Cognitive impairment to understand study procedure
Twice Yearly Treatment for the Control of LF

The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission.

Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.


Eligibility Criteria:
Inclusion Criteria:

* Residency in the disease endemic community for at least 12 months
* Willingness to provide informed consent/assent
* Willingness to donate blood (per the protocol)

Exclusion Criteria:

* Recent residents (\<12 months)
* Inability to give informed consent
* Pregnant and lactating women
* Children below the age of 5.
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.

Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

Eligibility Criteria:
Inclusion Criteria:

1. Must be ≥ 18 years of age
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater

Exclusion Criteria:

1. Previous hernia repair
2. Emergent surgery
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
5. Active skin pathology
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class \> IV
10. Enrolled in another clinical trial
11. Site personnel directly involved with this trial
12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
20. Breastfeeding