cyrilzakka/clinical-trials huggingface dataset:
Head and Neck Cancer Rehabilitation: the CaRe Feasibility Study

Introduction: As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate a number of negative health consequences of head and neck cancer and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes in head and neck cancer populations are lacking.

Purpose: To evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world, standard practice setting.

Methods and analysis: In this single-arm prospective feasibility study, survivors of head and neck cancer (n=29) will undergo a 10-week multi-modal exercise programme. The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre. Participants will be aged 18 or older and have completed treatment with curative intent.

Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes will examine physical function and quality of life measures. In addition, the acceptability of the programme will be assessed through patient feedback.

Ethics and dissemination: Ethical approval is pending from the St. James's Hospital and Tallaght University Hospital Research and Ethics Committee. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses and relevant clinical groups.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Over 18 years old
* In the first two years after treatment for head and neck cancer
* Medically fit to participate in low to moderate physical activity

Exclusion Criteria:

* Individuals with moderate or severe cognitive impairment
* Pregnancy
* Receiving treatment in the palliative setting
Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program

Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.

This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.

This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. Willing to be randomized
3. Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
4. Age 50+

Exclusion Criteria:

1. Hospice enrollee or life-threatening illness
2. Active cancer treatment
3. Neurologic disease linked to falls risk, such as Parkinson's
4. Unable to ambulate indoors
5. High likelihood of moving in next 6 months
Inhaled Steroids and Control of Severe Asthma

Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI)

Objectives: To explore if inhalative fluticasone application by means of the AKITA technology would result in a better symptom control in patients with severe persistent asthma as compared to inhalative application of fluticasone by a conventional MDI.

Study design: open label, cross-over (one AKITA, one MDI arm)

Patients: 20 Patients with severe persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Severe persistent asthma bronchiale with diagnosis according to the criteria of the Global Initiative for Asthma (GINA) executive summary
* Treatment with at least inhaled corticosteroids (ICS) and long acting b agonists (LABA)
* Evidence of inflammatory triggered form of asthma with at least one of the following:
* sensitization to typical aerogenous allergens
* increased Serum IgE levels
* Eosinophilia in peripheral blood
* Proven Eosinophilia in sputum differential (\> 3%) in the previous 2 years
* at least 2 exacerbations of asthma within the previous 24 months leading to unscheduled presentation at a health care provider and/or systemic corticosteroid
* Signed informed consent
* Requirements of the local ethics committee are met

Exclusion Criteria:

* Acute exacerbation of asthma within the last 6 weeks Rtot \> 350% predicted capillary pO2 \< 60mmHG, pCo2 \> 50mmHG near fatal asthma or anaphylaxis in history
* Age ≤ 18 and \> 80 years
* Active smoking or \> 15 pack-years former smoking
* Oral steroid treatment with a prednisolon-equivalent dose exceeding 10 mg per day
* Pregnancy, nursing females
* Female without use of effective contraceptive method
* Treatment with investigational drugs over the past 30 days or during the course of the trial
* Severe and uncontrolled gastroesophageal reflux disease
* Ongoing psychiatric disorder
* Treatment with systemic corticosteroids for any reason other than asthma
* Other active lung diseases
* Medical history of other uncontrolled diseases 3 months prior randomization (e.g. infections, coronary heart diseases and metabolic diseases)
* Any history of malignancy requiring ongoing treatment and/or limiting life-expectancy
* Clinically significant abnormalities in electrocardiogram (ECG) or laboratory exams
* Asthma related to non-steroidal anti-inflammatory drug (NSAID)
* Insulin dependent diabetes mellitus
* Cataract
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer

The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.

Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.

Eligibility Criteria:
Inclusion Criteria:

1. No less than 18 years old
2. Karnofsky Performance Status over 60
3. Life expectancy more than three months
4. Pathological diagnosed as pancreatic epithelial cell carcinoma
5. Recurrence after surgery or unresectable
6. No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months
7. Measurable lesions (by CT or MRI)
8. No serious mental disorders
9. Adequate organ and bone marrow functions
10. No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation)
11. No other malignant tumor history
12. Informed consent and willing to participate in this study

Exclusion Criteria:

1. Received immunosuppressants or glucocorticoid treatment
2. Uncontrolled severe infection or unhealed wound caused by suppurative inflammation
3. Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months
4. Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value
5. Other malignant tumor history
6. Transaminase\>2.5ULN or bilirubin\>3ULN or creatinine \>1.25ULN
7. Pregnant or lactating women
8. Obvious bleeding tendency
9. Participated other clinical trails in 1 month
10. Other unsuitable conditions: HIV infection, intravenous drug abusers, etc
Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis

Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20% of symptomatic patients.

Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates forms of diseases and antibiotic therapy in the postoperatory of these patients remains under discussion. However in the beginning, AC presents itself as an steril process, the obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis, as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a significant factor associated with total, as well as infectious, operative complications. Regarding this, for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the best treatment after LC in patients with mild and moderate cholecystitis without intraoperative complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. In the other hand, others do not prescribe antimicrobial treatment after surgery in these selected patients.

There is controversy regarding the postoperative treatment with antibiotics in patients with mild and moderate cholecystitis and all the evidence about this topic.

Therefore, investigators decided to conduct a prospective randomized study in patients undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. The patients will be randomized to receive AMC or placebo after surgery. With this study investigators intend to prove that are no clinical differences in postoperative outcomes between patients treated with AMC and placebo.

The primary aim of the trial is to assess that there are no benefits in the use of postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy was performed.

Double blind randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years old
* Patients with diagnose of mild or moderate acute cholecystitis.
* Underwent laparoscopic cholecystectomy on Italian Hospital of Buenos Aires

Exclusion Criteria:

* They refuse to participate from the trial or the process of informed consent.
* Have known allergies or hypersensitivity to Mosapride or lactose (used for placebo).
* Patients with severe cholecystitis
* Patients with moderate cholecystitis who presents liver abscess, gallbladder abscess, cholangitis or bile peritonitis.
* Intraoperative findings like liver cancer, liver metastases, common bile duct stones or gallbladder carcinoma.
* Patients with conversion to laparotomy
* Previous treatment with antibiotics for more than five days.
* Patients with active oncological diseases, AIDS, diabetes, transplanted.
Evaluating Whole Foods Supplementation on Cognition

A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age and older
* English speaking
* Not living in a skilled or intermediate care level nursing facility
* No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
* A Mini-Mental State Exam (MMSE) score ≥ 23

Exclusion Criteria:

* A cognitive deficit greater than that indicated according to the MMSE score
* A clinical diagnosis of AD and/or related disorders
* A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
* Bleeding disorders
* Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
* Gastrointestinal disorders causing impaired absorption of the study supplements
* Insulin-dependent diabetes
* Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure
* Hematologic or oncologic disorders treated with chemotherapy in the previous two years
* Active chemotherapy or radiation treatment for cancer
* Current cigarette smoking
* More than three major medical or psychiatric hospitalizations in the past year
* Diagnosis of a terminal illness
* A T score \> 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
* A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)
* Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit
* Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine
* Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants
* Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial
* Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are male or female aged 18-55 years at the time of signing the informed consent form.

Exclusion Criteria:

* Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.
Psychosocial Effect of HPV Positivity

The use of HPV testing in cervical screening has raised concerns about the effect of a positive HPV result on women's psychological well being. This is a nested psychosocial study of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects of educational intervention on such impact. Potential participants are identified among those who have joint the COCY trial. Participants will be randomized into two groups, namely the control group or intervention group. The control group participants will receive their smear results and an HPV leaflet by post. The intervention group will receive the leaflet and a counseling session on HPV. Self-administered questionnaires will be used to assess participants' psychological condition at the receipt of the smear results and at two months afterward. It is hypothesized that the level of emotional distress measured at smear result notification will be greater than that at two months afterward for all participants. Furthermore, participants in the intervention group will have lower psychological distress than those in the control group at two months after the receipt of their smear results.


Eligibility Criteria:
Inclusion Criteria:

1. Ethnic Chinese women who have enrolled in the COCY trial, and whose smear results are normal cytology with HPV positivity
2. Women who are willing to attend colposcopy
3. Literate in the Chinese language
4. Have given a verbal consent to participate in this study

Exclusion Criteria:

* Women who are unable to provide a consent to participation.
Sleep and Vascular Health Study

Habitual short sleep duration (\< 7 hours/night) increases the risk of cardiovascular disease (CVD) and all-cause mortality. Yet most adults, especially emerging adults (i.e., 18-25 years) do not achieve the National Sleep Foundation recommendation of 7-9 hours of sleep each night. Additionally, the American Heart Association recently included sleep duration in the "Life's Essential 8". This recent development emphasizes the importance of sleep and the need to advance our understanding of how sleep impacts cardiometabolic health (CMH), particularly in emerging adults, a population whose CVD risk trajectory is malleable. Specifically, emerging adulthood is a critical age window when age-related loss of CMH accelerates. Based on my previous work and others, both self-reported and objective measures of poor sleep (e.g., duration, variability) are linked to early signs of elevated CVD risk in emerging adults, such as microvascular dysfunction and elevated central blood pressure (BP), which precede the development of hypertension.

The investigators aim to address the knowledge gap on whether sleep extension is a viable strategy to improve CMH in emerging adults with habitual short sleep duration. A prior study demonstrated the feasibility of sleep extension to improve BP and perceived sleepiness in predominantly normotensive emerging adults (18-23 years). Even without hypertension, reductions in BP are generally beneficial for CMH. The research hypothesis is that sleep extension (one extra hour in bed per night) will improve CMH and health behaviors in emerging adults who self-report \< 7 hours of sleep per night. The primary aim is to determine if sleep extension is effective in improving BP. Investigators will assess CMH after habitual sleep (2 weeks) followed by a 2-week sleep extension intervention in 60 emerging adults (\~30 female).

Eligibility Criteria:
Inclusion Criteria:

* 18 - 25 years old
* self-report sleeping less than 7 hours a night on average
* free from metabolic disease
* free from liver disease
* free from pulmonary disease
* free from cardiovascular disease

Exclusion Criteria:

* blood pressure higher than 140/80 mmHg
* BMI greater than 35 kg/m2
* use of blood thinners
* history of sleeping disorders
* no severe food allergies or eating disorders
the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake

safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine

Based on the previous studies, the research choose the patients with different iodine intake,and improve our original Chinese Herbs thyroid III formula, in order to provide the patients the best individual treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* patient with thyroid diseases

Exclusion Criteria:

* not meet the diagnostic criteria,women with pregnancy or lactation ,drug allergy ,need surgery
Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver with Echinococcosis

The objective of the study is to determine the presence of germinal elements of echinococcosis in the liver parenchyma next to and in the thickness of the fibrous capsule of hydatid cysts.


Eligibility Criteria:
Inclusion Criteria:

* Presence of primary or recurrent liver echinococcosis disease requiring surgical treatment
* Cyst diametr \>5 cm;
* Performing one of the surgical treatment of liver echinococcosis with intraoperative sampling of part of the fibrous capsule with or without adjacent liver tissue for research;
* Signed informed consent of patients for inclusion in the study;

Exclusion Criteria:

* Liver echinococcosis with cysts less than 5 cm in diametr;
* Presence of severe concomitant disorders
Electrical Stimulation to Promote Recovery in Bells Palsy

A feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.

Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current ES on patients with Bell's palsy and factors predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of bell's palsy (diagnosed in the last 30 days)
* IF younger than 60 years of age must have complete paralysis on one side of face or both
* IF older than 60 years of age paralysis must be present but CAN be incomplete.

Exclusion Criteria:

* Paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or trauma.
* Younger than 60 years old with INCOMPLETE paralysis.
* Non English speakers
* Pacemaker or deep brain stimulator
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).

This is a global, randomized, Phase I/II study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary food effect of single-agent ITU512 in adult healthy participants, and safety, tolerability, PK, PD, and efficacy of ITU512 in adolescent and adult patients with sickle cell disease (SCD). The study consists of a first-in-human Phase I study (Part 1) in healthy participants, and a Phase II study (Part 2) in patients with SCD.

Part 1 will comprise of Part 1A, Part 1B, and Part 1C. Part 2 may include an extension part.

Eligibility Criteria:
Key Inclusion Criteria:

Part 1 (Healthy participants)

* Healthy male participants and female participants of non-childbearing potential between 18-55 years of age
* In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laboratory tests
* Participants must weigh at least 50 kg at screening and first baseline (admission) and must have a body mass index (BMI) within the range of 18.0-32.0 kg/m2 inclusive.

Part 2 (Sickle Cell Disease)

- Male and female participants with a diagnosis of sickle cell disease

Key Exclusion Criteria:

Part 1 (Healthy participants)

* QTcF ≥ 450 msec (as a mean value of triplicates)
* History of arrhythmias
* History of significant illness which has not resolved within two (2) weeks prior to initial dosing
* Women of child-bearing potential (WOCBP)

Part 2 (Sickle Cell Disease)

* Current use of hydroxyurea/hydroxycarbamide (HU/HC)
* QTcF ≥ 450 msec (as a mean value of triplicates)
* History of arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply.