cyrilzakka/clinical-trials huggingface dataset:
Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer

Survivorship Care Planning may improve overall well-being and quality of life of colorectal and lung cancer survivors

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of an Advanced Practice Nurse (APN) driven Survivorship Care Planning (SCP) intervention for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) survivors.

SECONDARY OBJECTIVES:

I. Development of the infrastructure and strategy for a larger comparative intervention study.

OUTLINE:

Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of stage I, II, or III CRC or NSCLC
* Able to read and understand English
* Able to read and/or understand the study protocol requirements, and provide written informed consent
* Diagnosis of CRC or NSCLC
* Within three months of completing primary treatment (surgery, chemotherapy, radiation, or chemoradiation)
* Without recurrent or new primary cancers
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* History of clinically active allergic conjunctivitis
* Agree to return for all required visits
* Agree to avoid disallowed meds

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates
Effect of Probiotic Supplement on Bowel Function

The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion Criteria:

* Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

Primary Objective:

To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.

Secondary Objective:

To assess the safety and tolerability of SAR342434.

The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)

* Screening: 2 to 28 days (D -28 to D -2)
* Treatment period 1 - 3: 2 days (1 overnight stay)
* Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
* End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.

Eligibility Criteria:
Inclusion criteria:

* Male or female subjects with diabetes mellitus type 1 for more than one year.
* Total insulin dose of \< 1.2 U/kg/day.
* Fasting negative serum C-peptide (\< 0.3 nmol/L).
* Glycohemoglobin (HbA1c) ≤ 9%.
* Stable insulin regimen for at least 2 months prior to study.
* Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
* Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.
* Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Nutrition Intervention Among Stem Cell Recipients: Post Hospital Discharge

Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated with severe gastrointestinal toxicity, commonly compromising patients' food intake, nutritional status and functioning level. Malnutrition has been associated with worse functional status, reduced survival, increased rate of infections, complications, hospitalizations, and therapy toxicity in oncology patients.

To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The proposed study is a single center, prospective, RCT with a parallel design that aims to assess the impact of a nutrition intervention on the nutritional and functional statuses of SCT recipients 100 days post SCT.

This study is a single center RCT with a parallel design. It aims to improve the SCT recipients' nutritional status and QoL and reduce the associated morbidities. Results of the study can guide the recommendations for the medical and nutritional outpatient assessment post SCT.

During the pre-SCT workup, patients will be invited to participate in the study. Around discharge from the hospital, recruited patients will be randomized to a control or an intervention group based on permuted block random sampling. Patients in the Nutrition Intervention group (NIG) will receive a tailored diet plan from the dietitian as well as regular outpatient follow-ups measuring and reinforcing compliance. Patients in the Control Group (CG) will receive usual care; they will only be assessed in the nutrition clinics upon referral by the medical team. The body composition, Quality of Life (QoL), Physical Activity (PA) level, nutrient intake, functional status and nutritional status of both groups will be evaluated at regular intervals during the hospital stay and post discharge through the Patient Generated Subjective Global Assessment (PGSGA), Body Impedance Analysis (BIA), handgrip strength, Functional Assessment of Cancer Therapy -Bone Marrow Transplantation (FACT-BMT), PA questionnaire and Karnofsky scale. Moreover, patients' food intake will be analyzed for its micronutrient and macronutrient content to assess the changes in nutrient analysis in the peri-transplantation phase. When applicable, BIA and Computed Tomography (CT) tests will be compared for their agreements.

Considering a power of 80%, an attrition rate of 30% and a difference of 40% between the NIG and CG groups, 52 patients need to be recruited in the study. Analysis will be done based on 'intention to treat' and 'per protocol' analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to the adult BMT service at AUBMC
* Allogeneic or autologous SCT
* Malignant or non-malignant indication for SCT

Exclusion Criteria:

* Patients who pass away before day +100
* Patients who miss 2 assessment points
The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

The aim of this study is to evaluate the potential of endogenous cortisol and cortisone metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal transplant recipients. If the blood concentrations of immunosuppressants can be predicted successfully, this new probe may take place of current drug monitoring post transplantation.

Immunosuppressive agents, including cyclosporine A, tacrolimus, and sirolimus, have been widely used to improve the outcome of organ transplantation. The need for frequent and specific monitoring of drug concentrations remains essential, since the therapeutic dosing and pharmacokinetics show great variability among recipients. However, this may be time and cost consuming. Indeed, cyclosporine A, tacrolimus, and sirolimus are all metabolized by CYP3A, consisting with the metabolic characteristic of endogenous cortisol and cortisone. Hence, the present study is designed to determine if the endogenous cortisol and cortisone metabolism can be used as an noninvasive probe for immunosuppressants pharmacokinetics in Chinese renal transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Chinese adult patients who had undergone their first renal transplantation； All patients received an immunosuppressive regimen containing immunosuppressive agents, mycophenolate mofetil, and corticosteroids; All patients had normal liver and renal function.

Exclusion Criteria:

* an acute rejection episode or infection; multiple organ transplantation; taking any other medications known to interact with immunosuppressive agents, with exception of calcium-channel blockers; abnormal findings on physical examination or laboratory tests.
High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy

The investigators aim to investigate the effect of high-intensity training in patients with facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise without muscle damage.

Clinical trials have in recent years demonstrated that aerobic exercise, are both effective and safe in patients with facioscapulohumeral muscular dystrophy. Previous studies have tested exercise at moderate intensity. No studies have so far investigated whether high-intensity-training (HIIT) exercise can increase fitness, or the training will cause muscle damage. However, we know that patients with facioscapulohumeral muscular dystrophy do not get increased muscle damage after a single exercise at high intensity.

Investigators aim to investigate whether patients with facioscapulohumeral muscular disease may increase their fitness and improve their functioning in everyday life without muscle injury in a time-saving high intensity training.

To investigate whether HIIT is safe and effective, three groups of participants are included. Two training groups, one group of patients and another with healthy matched subjects. The training is done on an ergometer-bike three times a week for 8 weeks. One weekly training will be supervised. The training consists of an interval training program (10-20-30). The third group is a none-training control group of patients. This group will undergo the same tests as the two training groups.

To investigate wether participants would continue HIIT training after 8 weeks of supervised training, the two training groups, one group of patients and one group of healthy matched subjects, are tested after additional 8 weeks of home based optional training.

To investigate wether patients with muscular dystrophy facioscapulohumeral will perform unsupervised HIIT training and whether it will be as effective as the supervised training, the control group of patients who did not train the first 8 weeks, is instructed to do home based HIIT for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Facioscapulohumeral muscular dystrophy or
* healthy matched control, matched for age, gender, BMI and activity level.

Exclusion Criteria:

* More than 1 hour cardiac exercise weekly before inclusion.
* Pregnant or breastfeeding women.
* Physical or mental condition, which could influence the results.
* Participating in other studies, which could influence the results.
* Physical or mental condition, which prevent participating in the study protocol.
Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis

The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosed with scalp psoriasis by dermatologist
3. Has scalp psoriasis Involve ≥ 10% of total scalp area and also has clinical signs, or a previous diagnosis, of psoriasis on the trunk and/or limbs
4. Total severity of scalp psoriasis should be graded in mild to very severe according to Investigator's Global Assessment score (IGA)
5. Clinical signs (redness, thickness, scaliness) should be scored as "Moderate" for at least 1 sign and "slight" on each of the other two signs
6. All participants agree to participate in the study and already complete and sign consent form

Exclusion Criteria:

1. Treated with these medications before including in the study

   * Topical corticosteroid for scalp psoriasis (except emollients and shampoo) within 2 weeks
   * Very potent topical corticosteroids for psoriasis on other area or Narrow band Ultraviolet B (NB-UVB) within 2 weeks
   * Oral psoralen plus Ultraviolet A (PUVA) or oral medication (Methotrexate, Acitretin, Cyclosporine) within 4 weeks
   * Biologic agents or concomitant medication that could affect scalp psoriasis (Beta- blockers, Antimalarial drugs, Lithium ) within 6 months
2. Has skin infection or atrophic skin on the scalp
3. Has history of allergic reaction or hypersensitivity to 0.25% Desoximetasone
4. Female participants with pregnancy or in lactation period
5. Participants who unable to come for follow-up visits at hospital
6. Participants with other underlying disease e.g. diabetes mellitus, hypertension, thyroid disease
7. Vulnerable subject e.g. illiterate person
Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)

The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes


Eligibility Criteria:
Inclusion Criteria:

* A confirmed clinical diagnosis of SMS with a prior positive genetic test result as indicated by a parent/guardian
* Informed consent from the patient or the legal guardian/assent provided by the individual with SMS, when possible
* Male or female between the ages of 6-50 years of age
* History of sleep disturbances
* Willing and able to comply with study requirements and restrictions

Exclusion Criteria:

* Failure to confirm diagnosis of SMS by molecular cytogenetic methods and/or DNA-based mutation analysis of the RAI1 gene
* Totally blind with no light perception
* Institutionalized or living in an assisted living facility
* Unwilling or unable to follow medication restrictions (medications that affect sleep or melatonin secretion) or unwilling or unable to sufficiently wash-out from use of a restricted medication
* Any medical condition, as determined by the clinical investigator that would make it unsafe for blood draws (e.g., anemia, blood clotting disorders, anxiety, etc.)
* Any other sound medical reason as determined by the clinical investigator
Early BOTOX After Spinal Cord Injury

The investigators would like to improve our understanding of how early intervention with the use of bladder chemodenervation can preserve bladder function in those with a new SCI. Although detrimental cystometric and tissue changes are known to occur, often within 3 months after SCI, the investigators seek to document the time course of these changes and the range of severity of those changes in both those participants that receive prophylactic treatment and those who do not.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-65 years of age at time of SCI.
* English speaking
* Recent SCI (within 20 weeks of injury).
* Documentation of a spinal cord injury at T6 or higher, American Spinal Injury Association Impairment Scale (AIS) level A or B as designated on initial (72 hour) AIS exam.
* Ability for subject to comply with the requirements of the study.
* Written informed consent obtained from subject.

Exclusion Criteria:

* Inability to return to research site (Harborview Medical Center) for follow-up studies after initial hospitalization.
* Acute (as part of concurrent hospitalization) or history of bladder surgery (urethral or prostate surgery acceptable) or injury.
* Inability to provide informed consent.
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Incarcerated in a detention facility or in police custody.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Active medical problems precluding the safe conduct of urodynamics, bladder chemodenervation, bladder biopsy (e.g., evidence of active bladder infection, ruled out by urine culture prior to procedures)
* Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
* Cardiovascular instability
Personalized Therapy of Patients Suffering From Rare Genodermatoses

Rare skin diseases are generally defined as serious life-threatening, progressive chronic diseases of the skin that occur extremely rarely (i.e., 5 in 10,000 people are affected). More than 80% are hereditary. In most cases, late diagnosis and the lack of therapeutic strategies also contribute to severe disease progression. Therefore, new therapeutic options are urgently needed and with them knowledge of the underlying mechanisms of disease development.

The aim of this project is to better understand disease mechanisms and to identify new pathways and drug targets that will improve patient care or therapy. In order to investigate the mechanisms of disease development, it is necessary to isolate biological material, i.e. blood and affected skin tissue from patients. For this purpose, adults 18 years of age and older with a congenital rare skin disease are included. We take blood and (lesional) skin biopsies from patients to perform immunoprofiling, as well as cell biological studies with the patient's cells. The risk for the patients is low, as only peripheral blood and skin biopsies are taken. Potential risks include bruising and pain as well as infection, postoperative bleeding, wound infection or delayed wound healing, pain, and scarring.

The samples are pseudonymized and stored with the pseudonym only. Cells and skin samples are only preserved with the prior consent of the patient.


Eligibility Criteria:
Inclusion Criteria:

* age of 18
* rare disease is known or suspected
* patent consent

Exclusion Criteria:

* none
A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization.
* Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria:

* Subjects with a history of hypersensitivity or allergy to or any component of the study product.
* Subject with history of irritation or sensitivity to pediculicides or hair care products.
Fragility and Programmed Cardiovascular Surgery (EcoSarco)

Objectives: To characterize textural ultrasonographic biomarkers of the brachial biceps musculature, wrist flexors, quadriceps and anterior tibial muscle that allow the recognition of the muscular and functional status of patients undergoing programmed cardiovascular surgery and relate them to mortality, hospital stay and functionality results after the intervention.

Design: A first phase of cross-sectional observational study and a second phase of longitudinal observational prospective study. Participants: Patients with programmed cardiovascular surgery to aortic valve replacement Outcomes: Sociodemographic and anthropometric variables, severity and clinical risk scales, disability, fragility and quality of life scales, nutritional status and textural muscular biomarkers with ultrasonography.

Expected results: strong association between ultrasound muscle biomarkers and ICU and hospital stay, disability, fragility and quality of life after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Waiting list patients with cardiovascular surgery scheduled for aortic valve refill

Exclusion Criteria:

* Urgency while waiting list
* Patients with no evaluation by presurgery committee
* Previous diagnosis of neuropathies, radiculopathy, polyneuropathy congenital or acquired or pathologies with muscular affectation
Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033

The purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 30-40 kg/m2

Exclusion Criteria:

* Women of childbearing potential