cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment

This is a prospective study of up to 30 subjects designed to assess the safety and effectiveness of a non-ablative fractional laser combination wavelength treatment for general resurfacing of photoaged skin. All study subjects will be treated on the whole face with the CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. Subjects will be treated with a consecutive series of four (4) treatments spaced 1 month apart, along with follow-up study visits at one (1) and three (3) months after final treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. 18 to 65 years of age.
3. Written and oral informed consent must be obtained.
4. No more than Mild (I) to Moderate (II) classification on Glogau Photodamage Scale.
5. Fitzpatrick skin types I-VI.
6. Fitzpatrick wrinkle \& elastosis scale class I-II, score 1-6 (fine wrinkles and mild elastosis).
7. Ability to read, understand and sign the informed consent form.
8. Agree not to take any new medications (unless prescribed by the study investigator) or undergo any other procedures that may potentially treat photodamaged skin (any other aesthetic treatments) during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding, or planning to become pregnant during the study. 2 History of any type of allergic reaction to lidocaine. 3. Recent and/or active localized or systemic infections. 4. Diagnosis/possibility of actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g. skin cancer, active infections, cold sores, open wounds, rashes, burns, inflammation eczema, psoriasis).

5. Predisposition to keloid formation or excessive scarring. 6. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, scleroderma, and/or systemic infections.

7. Known sensitivity to light or photosensitizing agents/medications are being taken.

8. Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout course of the treatment.

9. Use of retinoids less than 2 weeks prior to or during the study to completion.

10. Individuals undergoing Accutane™ treatment or drugs in a similar class. 11. Having skin that is still recovering from a cosmetic procedure: such as a chemical peel, or mechanical peel, or laser resurfacing within the previous 6 months.

12. Having had Botox injections, neurotoxin injections, or dermal fillers (such as collagen) within the past four months.

13. Sunburn and/or recent sun exposure on the treatment area in the last 2 weeks.

14. Subjects must agree to seek the advice of their medical doctor regarding any known or suspicious skin condition before laser treatment.

15. Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.

16. Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Exercise and Nutritional Rehabilitation in Patients With Cancer

In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care".

However there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given.

This trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial.

40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician.

To minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control).

Measurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).
2. Outpatient
3. ≥18years
4. Karnofsky score ≥ 60
5. Prognosis greater than 3 months
6. Able to complete trial based assessments
7. Under care of community services at Marie Curie or St Columba's Hospices
8. Ability to comply with trial protocol
9. Ability to provide and have capacity to consent
10. Agree to attend trial centre for trial related activity (St Columba's Hospice)

Exclusion Criteria:

1. Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)
2. Using enteral nutrition (NG or similar) or parenteral nutrition
3. Co-enrolment in drug trials
4. Inability to swallow
Stimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit

This project has 2 phases. Phase 1: diagnostic test study, to evaluate the efficacy of the variation of pupillary size (PDR) to detect pain in ICU patients regarding to Behavioural Pain Scale (BPS) and ESCID (Conductual Scale Pain Index). Phase 2: controlled and aleatorized clinical trial to evaluate efficacy in PDR monitoring after painful assessed minimum stimulus with the best diagnostic efficiency on phase 1, as a need of analgesia indicator tool.

The sample will be patients over 18 years, sedated and mechanically ventilated, with an initial BPS of 3, RASS between -1 and -4, not able not to communicate , with inform consent signed. Exclusion criteria will be: ophtalmologic pathology and administration of drugs interfering pupillary reflexes. Measurements before/during pain/non-pain situations, aspiration of secretions and calibrated intensity stimulus through the pupilometer Algiscan. The investigators will study association between pain according to BPS/ESCID and pupillary dilatation according to pupillometry and percentage of patients with pain and preanalgesia according to pupillometry and standard clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years.
* Analgosedated patients under mechanical ventilation.
* Unable to communicate (verbal or motor).
* Patients with initial BPS of 3, and RASS from -1 to -4.
* Familiar prior informed consent.

Exclusion Criteria:

* Patients treated with muscle relaxants.
* Severe Critical Polyneuropathy.
* Pupillary reflex affectation in diabetic patients (diabetic papillopathy,glaucomatous optic neuropathy) or any other pathologies like Adie´s Syndrome, Argyl-Robertson pupil.
* Patients with tansmisible ocular infections.
* Patients with possible injury of the third carnial nerve (Horner´s syndrome) due to injury to the brainstem, cervical cord, cancer of the upper lobe the lung, dissection of the carotid and/or cluster headache.
* Acute cerbrovascular conditions with Glasgow Coma Scale less than 6, or increased intracranial pressure, or pontine base infarction.
* Drugs that interfere with the pupillary reflex (clonidine, dexmedetomidine, metoclopramide, tramadol, droperidol, ketamine, nitrous oxide).
* Patients under metoclopramide, if given 10 minutes prior the measurement of the pupillary reflex (PDR).
* Patients during the first 24 hours after Cardiac Arrest (CRP).
* Severe unestable comorbidity with doses of norepinephrine\> 0.6 microg/kg/min and/or dobutamine\>10 microg/kg/min or drenalin any doses.
* Patients with untreated pheochromocytomas.
* Refuse to participate in the trial.
Duration of Follow-Up Counselling on Smoking Cessation Outcomes

Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Current smokers among outpatients, including hospital employees, who provide informed consent for enrollment in the smoking cessation program

Exclusion Criteria:

* Subjects who decline smoking cessation or who do not provide informed consent
* Subjects who are participating or will be participating in other smoking cessation programs within the next six months
* Subjects who are currently using smoking cessation medications
* Subjects who cannot be followed up for at least six months, for instance, subjects who would be resigning and going overseas within the next six months
* Subjects with language limitations that would impede completion of self-administered questionnaires
* Subjects who are difficult to communicate with over the telephone (e.g. having speech or hearing problems)
* Subjects with cognitive impairments that would impede counselling and follow-up
* Subjects with no telephone number
* Subjects who are too sick to receive smoking cessation counselling
* Subjects with limited life expectancy (e.g. metastatic cancer)
Effects of CCM-therapy in Patients With Heart Failure

The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure.

The OPTIMIZER III System is indicated for use in patients greater than 18 years of age with symptomatic heart failure due to left ventricular systolic dysfunction despite appropriate medical therapy. The study will gather additional data on the effect of CCM treatment with the objective of determining the impact of CCM on the composite of heart failure hospitalizations and mortality in the low ejection fraction (EF \< 35%) and mildly reduced ejection fraction (35 ≤ EF ≤ 45) heart failure population. The study will also assess the impact of CCM on exercise tolerance (six minute hall walk test, 6 Minute Walk Test) and quality of life (Minnesota Living With Heart Failure Questionnaire, MLWHFQ) in these same populations.

Eligibility Criteria:
Inclusion Criteria (treatment group):

* Any subject who receives an OPTIMIZER system implant and provides informed consent

Exclusion Criteria (treatment group):

* None

Inclusion Criteria (control group):

* Symptomatic heart failure (NYHA Class 2, 3 or 4) despite receiving optimal medical therapy with doses of medications that are stable (no more than 50 % variation) for at least 7 days.
* EF ≤ 45%
* Signed informed consent

Exclusion Criteria (control group):

* Heart failure due to a potentially correctible cause ( e. g. valvular disease, congenital disease)
* Idiopathic hypertrophic cardiomyopathy, restrictive or constrictive cardiomyopathy, or heart failure on the basis of a known inflammatory or infiltrative disease (e. g. amyloidosis, sarcoidosis) or constrictive disease
* Active ischemia or exercise tolerance limited by angina
* Hospitalizations for heart failure which required the use of inotropic support within 14 days of enrollment
* Chronic (permanent or persistent) atrial fibrillation or atrial flutter
* Scheduled for a CABG or a PCI procedure, or has undergone a CABG procedure within 90 days or a PCI procedure within 30 days of enrollment
* Myocardial infarction within 90 days of enrollment
* Hemodialysis or peritoneal dialysis
* Prior heart transplant
* Participating in another study
Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors


Eligibility Criteria:
Inclusion Criteria:

* Kidney Failure
* Age \> 18
* Kidney transplant recipients

Exclusion Criteria:

* Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
* Kidney transplant performed more than one month from enrollment in the study
* Hyperkalemia (K\> 5.5 meqL)
Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing

This clinical trial studies engagement strategies for recruiting American Indians (AI) of Southwestern Tribal Nations for cancer genome sequencing. American Indians in the Southwest have higher rates of some types of cancer, such as cancers that arise in the liver, kidney, breast, and colon. American Indians with cancer may also live for less time than people from other population groups who have been treated for the same cancer. Damage to the cells of the body, acquired as people live, grow older, and are exposed to the environment, causes genetic changes in cells that can lead to cancer. This study may help researchers learn how these genetic changes in cells cause cancer and understand how and why cancer is arising in American Indians in the Southwest. This may help better prevent and treat cancer in the future.

PRIMARY OBJECTIVES:

The overall objective of the PE-CGS Research Center is to develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians affected by cancer (newly diagnosed cancer patients, patients undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.

The clinical trial is embedded in the Patient Engagement Unit (PEU) jointly with the Engagement Optimization Unit (EOU)

The specific objectives for the PEU are to:

1. Conduct direct participant engagement with cancer patients/survivors, community advisors, and partners to refine and optimize methods/processes;
2. Identify, recruit and consent eligible AI cancer patients/survivors;
3. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks;
4. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.

The specific objectives of the EUO are to:

1. Finalize consenting process and informed consent by direct engagement of AI cancer patients, survivors, healthcare providers, genetic counselors, consenting staff, tribal and spiritual leaders and tribal governance;
2. Determine AI cancer patients' and survivors' knowledge, attitudes, cultural beliefs, information needs, and communication preferences and practices regarding clinical genomics testing;
3. Determine AI cancer patients' and survivors' perspectives on strategies to engage and recruit participants for clinical genomics testing.

Eligibility Criteria:
Inclusion Criteria:

* The PE-CGS Research Center is only recruiting and sequencing tumors for adult-onset cancers (patients and survivors) among the American Indian Tribes, Nations, and Pueblos of New Mexico and adjacent states
* Male or female adults (18 years) or older
* Cancer patient undergoing active treatment or a cancer survivor
* Self-identify as American Indian

Exclusion Criteria:

* Cognitively impaired
* Adults unable to consent for themselves
* Individuals who are not yet adults
* Prisoners
Optical Spectroscopy for Cutaneous Cancer

1. Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner.
2. Study activities and population group: Competent adults with a clinically suspicious skin lesion who are undergoing a biopsy as part of their routine care. For those who agree to participate, the sterilized portable optical spectroscopic probe will be used to measure diffuse reflectance on the lesion of clinical interest.
3. Data analysis and risk/safety issues: The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis. A variety of correlative statistics will be explored to determine if there are relationships found that can justify a larger study

This is a pilot study to determine the optical spectroscopy characteristics of tumor in patients with cutaneous malignancies. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with numerous suspicious skin lesions who would require multiple biopsies.

Further spectroscopy measurements of the tumor site and adjacent normal tissue during therapy (chemoradiotherapy or radiotherapy) may provide useful information pertinent to tumor physiology and therapeutic effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one clinically suspicious skin lesion warranting a biopsy as part of routine care, in the outpatient clinic setting.
* Patients with previous histologically confirmed malignancy such as basal cell carcinoma or squamous cell carcinoma are eligible; however this is not required for enrollment.
* The suspicious skin lesion(s) is accessible to optical probe measurements. If patient has previous histologically confirmed malignancy of the skin, then the primary tumor site must be accessible to optical probe measurements
* Patient is able to provide written informed consent
* Patient is \>18 years of age

Exclusion Criteria:

* \< 18 years of age
* Unable to provide written informed consent
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease
* Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label
* Participant must be an adult male or female, 18-64 years of age
* Time since beginning of motor fluctuations ≤ 3 years
* The Hoehn and Yahr (H\&Y) stage \< 3 in the on-medication condition
* Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study

Exclusion Criteria:

* Previous Exposure to any device-aided therapy (DAT).
* Any condition included in the contraindications section of the approved local LDp/CDp label.
* Participants with Mini mental state examination (MMSE) score \< 24
Sprint Performance in Football Players With a Previous Hamstring Injury

Few studies indicate that sprint performance may be impaired in football players with a previous hamstring strain injury. This exploratory cross-sectional study aim to compare sprint performance between football players with and without a previous hamstring strain injury. The findings may elucidate potential indications of insufficient rehabilitation following a hamstring strain injury.

Sprint performance data will be collected using the MySprint Iphone Application.

Due to pragmatic reasons and the exploratory nature of this study the aim is to include players on a team level.

Based on the prevalence of hamstring strain injuries the expected number of cases to be included are 10-20 football players with a previous hamstring strain injury, and a corresponding 80-90 number of healthy controls.

No outcomes will be weighted (flat outcome structure).


Eligibility Criteria:
Inclusion Criteria Controls:

* Able to participate fully in regular football training and matches

Exclusion Criteria Controls:

* Self-reported hamstring strain injury resulting in loss of regular football training sessions or football matches in the preceding 12 months.
* Longstanding injury (\>6 weeks) in the lower extremities or trunk in the preceding 12 months.
* Any pain in the lower extremity, pelvis, or spine during testing

Inclusion Criteria Cases:

* Able to participate fully in regular football training and matches
* Self-reported hamstring strain injury resulting in loss of regular football training sessions or football matches in the preceding 12 months.

Exclusion Criteria Cases:

* Longstanding injury (\>6 weeks) in the lower extremities (except hamstring strain injury) or trunk in the preceding 12 months.
* Any pain in the lower extremity, pelvis, or spine during testing
Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

The objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are:

• Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life?

Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if:

• Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of SSc according to the ACR and EULAR criteria
* presence of IDU in active phase
* naïve to rehabilitation treatment for their hands and upper limbs
* written in-formed consent to participate in the study.

Exclusion Criteria:

* presence of skin lesions due to other conditions (e.g., trauma);
* pregnancy;
* infectious diseases (e.g. HIV, HBV, HCV);
* myositis;
* arthritis;
* other rheumatological diseases and immunodepression.