cyrilzakka/clinical-trials huggingface dataset:
Study of a Nutritional Supplement for Healthy Aging

The main aim of this clinical trial is to learn if a nutritional supplement improves health status from a nutritional point of view in an active and healthy elderly population. It will also study about the improvement of anthropometric variables, vitality, quality of life and mood, as well as biochemical and metabolic changes produced after the intervention.

The main questions it aims to answer are:

* Does a nutritional supplement improve the general nutritional status?
* What health parameters improve most clearly after taking the supplement? Researchers will compare a nutritional supplement to a placebo (a look-alike substance that contains no interest nutrients) to see if the nutritional supplement works to improve health status from a nutritional point of view.

Participants will:

* Take a nutritional supplement or a placebo every day for 8 weeks.
* Visit the clinic once every 4 weeks for checkups and tests
* Keep a diary of their symptoms and the degree of adherence to taking the nutritional supplement.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 65 and 80 years of age, inclusive.
* Body mass index (BMI) less than 35 kg/m2.
* Subjects must have a cultural level, general physical and psychological conditions that allow the understanding, monitoring and development of the study.
* Agree to voluntarily participate in the study and provide their informed consent in writing, complying with the procedures and requirements of the study.

Exclusion Criteria:

* People allergic to soy or lactose, as the supplement contains traces.
* Severe diseases or relevant functional or structural abnormalities of the digestive system: inflammatory bowel disease.
* Surgical interventions of the digestive system with permanent sequelae such as resections (gastroduodenostomy...)
* Presenting any type of serious or chronic or systemic disease such as: infections that cause impairment of the general condition, cardiovascular diseases, cardiac arrhythmias, stroke, neoplasia, severe kidney disease, liver disease...
* Recent fracture in the last 3 months (strength training).
* Subjects who present some type of cognitive and/or psychological impediment, Alzheimer's, depressive pathology, etc.
* Pharmacological treatment that affects the study variables recently prescribed, without a stable dose prescribed.
* People with diabetes of any type.
* Intake of any type of nutritional supplement that includes vitamin D, folic acid, vitamin B6, vitamin B12, calcium, iron, zinc or proteins, in the last 3 months.
* Being on any type of special diet and/or high alcohol consumption (more than 14 units in women and 20 units in men per week).
* Subjects in whom poor collaboration is expected or who, in the opinion of the researcher, have difficulties in following the procedures of the study.
* Lack of commitment (in the opinion of the researcher) to the intervention, suspicion of non-compliance, or real difficulties in following the development of the study.
Dose Response of Epinephrine

Epinephrine is the principal physiologic defense against hypoglycemia in type 1 and longer duration type 2 DM. Despite this, it is unknown how epinephrine regulates in-vivo endothelial function and atherothrombotic balance in humans. The specific aim of our study will be to determine the dose response effects of the key ANS counterregulatory hormone epinephrine on endothelial function, fibrinolytic balance and pro-atherogenic inflammatory mechanisms in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* healthy controls age 18-55 yr.
* Body mass index \>21 kg · m-2

Exclusion Criteria:

* Pregnant or breastfeeding women
* Subjects unwilling or unable to comply with approved contraception measures
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Subjects with a history of severe, uncontrolled hypertension, heart disease, cerebrovascular incidents
* Current tobacco use
* Subjects with any known allergies to any of the study medications being used

Physical Exam Exclusion Criteria

* Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
* Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmia)
* Pneumonia treatment or hospitalization within 2 weeks prior to enrollment (study visit)
* Hepatic failure / jaundice
* Renal failure
* Cerebrovascular accident occurrence or hospitalization within 4 weeks prior to enrollment
* Fever greater than 38.0 degrees C

Screening Laboratory Tests Exclusion Criteria

* Hematocrit lower than 32 %
* White blood cell (WBC) count lower than 3 thou/ul or greater than 14 thou/ul
* Liver function tests: serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) greater than twice upper limit of normal range
* Alkaline phosphatase greater than 150U/L
* Total bilirubin (TBil) greater than 2 mg/dl
* Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2
* Positive human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
* Any abnormal cardiac response during multi-stage exercise test (if over 40 years of age)
Physical Exercise Program for Family Caregivers of Dependent Patients

This estudy evaluates the effects of physical exercise program on health related quality of life (HRQoL), pain and physical fitness in family caregiver.

Justification: Research indicates that the dependent patient caregiver´s have physical, psychological and social repercussions, as consequence of the care that they provide. From Primary Health Care there is a "caregiver care program" to prevent and palliate this situation, consisting mainly in education programs in care and psychotherapy. There is controversy about the effectiveness of these programs, being necessary to develop new therapeutic strategies.

Objectives: to determine the effects of a physical exercise program, adressed by the primary health care physioterapist, on health related quality of life (HRQol), pain and physical fitness in dependent patient caregivers included in the " caregiver care program" of a basic health area.

Methodology: randomized clinical trial, with control group (GC = 32) and intervention group (GI = 36), double blind and pre and post-intervention evaluation. The GC received the usual program of the " caregiver care program". The GI also carried out a multi-component exercise program for 12 weeks, with 3 weekly sessions realized in group and monitored by physiotherapists. The outcomes variables are measured by Quality of life (SF-36), Burden (Zarit), anxiety (Goldberg Ansiety Questionanaire), depression (Yesavage Questionnaire), pain intensity (EVA), disability (Roland Morris) and physical fitness (battery of fitness tests). Patients evaluator and Outcomes Assessor are masked.

Applicability of results: If the physical exercise program, carried out from the primary health care physiotherapy, improves the HRQol, pain and physical fitness, this intervention could be an effective therapeutic strategy in the "caregiver care programs". Furthermore the proposed intervention is simple, reproducible and requires few resources.

Eligibility Criteria:
Inclusion Criteria:

* Status as family caregiver and to be incluided in the "Caregiver care Program".
* Provided care to family dependent al least 6 months.
* Accept to participate in the study and sign the informed consent.
* No changes in medication for at least 3 months prior to study entry.

Exclusion Criteria:

* People whith associated pathologies that make it impossible to perform physical exercise program (moderate-intensity exercise).
* To be incluiding in other family care program
* Participation in any regular physical activity program.
* To have a formal caregiver to care for the dependent family member
The Effect of Hypnobreastfeeding Education Given to Primiparas

Primiparous pregnant women may need support regarding the breastfeeding process because they have not had breastfeeding experience before. Hypnobreastfeeding is one of the education-based interventions used in this field. According to the results of the power analysis, at least 104 pregnant women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Pregnant Introduction Form", "Breastfeeding Myths Scale", "Breastfeeding Expectations Scale-A" and "Prenatal Breastfeeding Self-Efficacy Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the primiparous pregnant women in the experimental group.

Primiparous pregnant women may need support regarding the breastfeeding process because they have not had breastfeeding experience before. Negative breastfeeding stories and misinformation can affect beliefs, attitudes, and fears about breastfeeding. Education-based interventions provided by health professionals can be beneficial in reducing false beliefs and myths about breastfeeding, reducing breastfeeding-related fears/anxious expectations, and increasing breastfeeding self-efficacy. Hypnobreastfeeding is one of the education-based interventions used in this field. This study aims to evaluate the effect of hypnobreastfeeding education given to primiparous pregnant women on breastfeeding myths, breastfeeding expectations and breastfeeding self-efficacy. According to the results of the power analysis, at least 104 pregnant women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Pregnant Introduction Form", "Breastfeeding Myths Scale", "Breastfeeding Expectations Scale-A" and "Prenatal Breastfeeding Self-Efficacy Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the primiparous pregnant women in the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnant women,
* Singleton pregnancy,
* Those with 28-32 weeks of pregnancy,
* Those who can read and write Turkish,
* Those who volunteered to participate in the study

Exclusion Criteria:

* Those with communication disabilities,
* Those with psychiatric and mental illnesses,
* Those who have an obstacle to breastfeeding,
* Those diagnosed with risky pregnancy,
* Those who have previously attended a birth preparation class,
* Those who receive breastfeeding-related training and consultancy
Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.

EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information. This study will analyze whether the freezing time influences the diagnostic yield in CB of mediastinal lymphadenopathies. Additionally we will evaluate the influence of the number of biopsies on the diagnostic yield.

Eligibility Criteria:
Inclusion Criteria:

* At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy
* Age between 18 and 90 years
* Written informed consent after participant's information

Exclusion Criteria:

* Age \< 18 and \> 90 years
* Lacking ability to form an informed consent (including impaired judgement, communication barriers)
* Contraindication against bronchoscopy (e.g. co-morbidities)
* Mediastinal abscess or cyst
* Extraordinary blood supply of the lesion visualized by EBUS bronchoscope
* INR \> 1.5 or Thrombocytes \< 100 G/l
* Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed)
* Anticoagulation with NOAC within 48 hours before biopsy
* Pulmonary lesions suspicious of lung carcinoma
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass surgery.

Coronary vascular disease manifested by narrowing of the coronary arteries is one of the more common manifestations of atherosclerotic vascular disease. The clinical manifestations of coronary artery disease include death, angina pectoris, myocardial infarction, congestive heart failure and arrhythmia. Restoration of circulation to the heart may be undertaken using a variety of techniques including angioplasty, stenting, and bypass grafting.

Approximately 359,000 patients underwent coronary bypass procedures in the U.S. in 1999. Long term studies have observed an incidence of vein graft occlusion at 19% at 1 year, 25% at 5 years and 50% by 15 years after operation for an overall rate of 2.5% per year after the first year of observation. The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia, myocardial infarction and death.

CGT003 is a novel therapeutic that is under investigation as a treatment to prevent vein graft failure. It acts by inhibiting the transcription factor, E2F, which is activated in response to injury such as that which occurs when thin-walled vein grafts are exposed to the pressures of the arterial circulation. Blockade of E2F inhibits smooth muscle cell proliferation and redirects the vein graft remodeling that occurs within the first several days after implantation towards medial hypertrophy and strengthening of the medial layer and blunts formation of neointima. Inhibition of neotinimal formation coupled with expansion of the media should result in a decreased risk of the accelerated atherosclerosis and consequent vein graft failure over several years.

Eligibility Criteria:
PATIENTS MUST:

* Have coronary artery disease and be scheduled to undergo a coronary artery bypass (CABG) procedure that is to include at least two segments of autogenous vein (sequential grafts do not count as two separate grafts).
* Be between 18 and 80 years old.
* Have a documented negative serum pregnancy test for all women of childbearing potential.
* Be using an acceptable method of birth control if of reproductive potential.
* Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form.
* (If one of the first 2400 patients enrolled) have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form for the Angiography population.
* Note: Patients who are to receive an arterial bypass to the left anterior descending artery in addition to the two vein grafts required by the protocol ARE eligible for this study.
* Note: Patients ARE eligible for enrollment regardless of whether the planned procedure is to be on or off cardiopulmonary bypass pump.
* Note: Patients who do not wish to undergo elective Angiography at one year SHOULD NOT be enrolled in the first 2400 patients.
Compassionate Use of Campath-1H in Treating Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval.

PURPOSE: Compassionate use of Campath-1H in treating patients who have refractory prolymphocytic leukemia or chronic lymphocytic leukemia.

OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic leukemia or chronic lymphocytic leukemia.

OUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified
Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study

the purpose of this study was to compare standard trabeculectomy to the Ex-PRESS mini glaucoma shunt implantation under a scleral flap in eyes with open-angle glaucoma.In this report, we describe the results of a prospective, randomized trial in which subjects with bilateral primary open-angle glaucoma underwent the two procedures in fellow eyes.Design: Prospective, randomized clinical trial.

Participants: 15 subjects with bilateral primary open-angle glaucoma Methods: Subjects underwent the two procedures in fellow eyes. Safety and efficacy were evaluated for up to two years.

Main Outcome Measures: Mean IOP and surgical success rates. Results: Mean IOP was similar in Ex-PRESS and trabeculectomy eyes at all time points except month 9, when Ex-PRESS eyes had lower mean IOP (13.2 mmHg vs 16.5 mmHg, respectively; p=0.025). Percent IOP reduction was also similar at all time points except postoperative day 1, when trabeculectomy eyes were lower (75.5% vs 65.8%, respectively; p=0.003), likely due to a higher rate of early hypotony in trabeculectomy eyes versus Ex-PRESS eyes (47% vs 7%, respectively). Complete (without medications) and qualified (with or without medications) successes were more common at all IOP cut-off values in Ex-PRESS eyes than trabeculectomy eyes at last visit (p=0.015, p=0.015 respectively). Postoperative complications were uncommon in both groups, but trabeculectomy eyes required more postoperative interventions than Ex-PRESS eyes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were at least 18 years of age and
* Had medically uncontrolled primary open-angle glaucoma requiring incisional surgery for reduction of intraocular pressure in both eyes.
* Subjects with prior cataract or failed filtration surgery in either eye were eligible to participate if surgery occurred at least 3 months prior to enrollment.

Exclusion Criteria:

* Any form of glaucoma other than primary open-angle glaucoma;
* History of or active uveitis; or
* Any ocular abnormality that would prevent accurate assessment of intraocular pressure
Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.

The project will investigate the feasibility of a physiotherapy intervention for patients diagnosed with deep vein thrombosis for whom a physiotherapy intervention is not currently part of clinical practice in Denmark. Specifically, the project will investigate if an early-initiated physiotherapy intervention for patients who are admitted acutely with first-time deep vein thrombosis (DVT), can be carried out and is experienced as valuable for the patients.

This study aims to investigate whether it is possible for patients diagnosed with DVT to complete early mobilization combined with progressive walking during their hospitalization and the first month after discharge.

This study is twofold. Part one is a clinical cohort study and will investigate the feasibility using quantitative outcomes. Part two is a qualitative study using interviews to investigate the patients' experiences with and attititudes towards a physiotherapy guided intervention of early mobilization combined with progressive walking during their hospitalization and one month after discharge to their own home.

If the physiotherapy intervention is deemed feasible and acceptable, a future randomized controlled trial will investigate the effect of the intervention on quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or above
2. First time lower extremity DVT
3. Hospitalized at the Emergency Department

Exclusion Criteria:

1. Patients without a Danish social security number
2. Terminal patients
3. Patients who do not understand or speak Danish