cyrilzakka/clinical-trials huggingface dataset:
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)

The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.

All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12.

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an approved Informed Consent Form (ICF);
* Willing and able to return for scheduled treatment and follow-up examinations;
* Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction;

Key Exclusion Criteria:

* Any ocular conditions which could affect the stability of the IOL in either eye;
* Traumatic or congenital cataract;
* Pregnancy or planned pregnancy during the study period;
* Medications that may confound the outcome or increase risk to the subject;
* Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject;
* Other protocol-specified exclusion criteria may apply.
Clinical Evaluation of the Photoallergy Potential of Atralin Gel

To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.


Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy volunteers
* 18 years of age and older

Exclusion Criteria:

* Less than 18 years of age
Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources.

The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission.

Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy.

This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of CD, UC, or IBD-unspecified
* Initiating anti-TNF therapy for IBD within 2 weeks of baseline/randomization
* Other non-anti-TNF IBD medications must remain stable during the treatment period with the exception of tapering of corticosteroids.
* Recent (within 6 months) objective evidence of active IBD on colonoscopy along with elevated inflammatory markers (C-reactive protein \>8 mg/L or fecal calprotectin \>150 mcg/g)
* Current disease activity defined as a Harvey Bradshaw index \> 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index \> 2 at baseline (week 0) for UC subjects.
* Fecal Calprotectin level \>150 mcg/g

Exclusion Criteria:

* Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
* Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
* Known intolerance or hypersensitivity to oral vitamin D3 supplementation
* Plasma 25(OH)D \> 60 ng/mL
* Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
* Serum calcium \>11 mg/dL
* History of hyperparathyroidism
* History of renal calculi or chronic kidney disease
* Initiation of anti-TNF treatment for extra-intestinal symptoms alone
* Evidence of untreated infection (e.g. Clostridium difficile)
* History of chronic pancreatitis
* History of cystic fibrosis
* History of gastric bypass
* Presence of stoma or J-pouch
The Sapheon Closure System Feasibility Study

This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.

Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to

1. demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
2. demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
3. demonstrate the satisfactory performance of the Sapheon™ Closure System device components.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females ≥21 years of age but \<76 years of age.
* Venous reflux disease in the GSV diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
* Candidate for surgical closure of a segment of the GSV.
* CEAP classification of C2, C3 or C4.
* Ability to walk unassisted.
* Life expectancy of at least 18 months.
* Weight \>110 lbs. (50 kg).
* Ability to attend follow-up visits.
* Ability to understand the investigational nature of the treatment, and to provide written informed consent.

Exclusion Criteria:

* Previous surgical procedure (surgical, thermal, or chemical ablation) associated with the venous segment to be treated.
* Diameter of index vein (Supine) \<3mm or \>12 mm in any segment.
* Tortuous GSV, which in the opinion of the Investigator will limit catheter placement.
* Local or systemic infection.
* Insulin dependent diabetes.
* Leg obesity impairing the ability to gain access to the treatment leg, and/or apply sufficient compression for treatment.
* Documented history of superficial or deep thrombophlebitis.
* Varicosities secondary to pelvic or abdominal tumor.
* Significant arterial insufficiency; demonstrated by absence of ankle pulse.
* Known sensitivity to the cyanoacrylate (CA) adhesive or positive reaction just prior to surgery (by injecting a small peripheral vein with the agent). The Study surgeon will judge the need for the injection and the subject's reaction to the injection on clinical grounds.
* Formal duplication of the saphenous trunk in the index vein (Accessory GSV segments allowed).
* Hypercoaguable state.
* Presence of incompetent perforators in the treatment length.
* History of right ventricular failure.
* Significant femoral or popliteal vein insufficiency.
* BMI \>35
* Additional procedures in the treatment leg likely required within the six months after the investigational procedure.
* Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
* Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the Investigator may prevent safe participation or otherwise render the subject ineligible for the Study.
Pharmaceutical Care of Patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services

Design and Procedure:

The design is a randomised controlled multi-centre pilot study. 18 community pharmacies located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an intervention group. These pharmacies recruited eligible patients out of their clientele and invited them to take part in the study. Participants were visited at home by the pharmacist and home-based medication reviews were conducted. The survey form has been developed by the research team and comprised amongst others items to adherence, adverse effects, drug intake, storage and quality of life. Thereafter all data were analysed by the pharmacist with a newly developed document called "analysis guide" aiming at the detection of drug related problems. Pharmacists of the intervention group discussed the results with the family doctor of the patients and the patients and tried to solve the drug related problems. This procedure was not undertaken in the control group.

Six months later a second medication review was carried out in both groups.

Study hypothesis:

Pharmaceutical care reduces the overall number of drug-related problems of elderly patients with diabetes and impairments in mobility.

Aim:

The purpose of this study is to show that pharmaceutical care reduces the overall number of drug-related problems of elderly diabetes-patients with impairments in mobility and leads to both an improved health status and an improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* impairment in mobility
* age of 65 years or older
* four or more long-term medications
* diabetes
* at least one of the following co-morbidities: hypertension, obesity, hypercholesteremia, hyperlipidemia, coronary heart disease, cardiac insufficiency, angina pectoris, peripheral vascular disease

Exclusion Criteria:

* patient lives in a home for the aged or a residential care home for the elderly
* terminal renal failure, dialysis
* moderately or severe dementia or other severe cognitive impairments
* terminal diseases (e.g. cancer)
* nursing service if the medicine is directly administered to the patient
Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.


Eligibility Criteria:
Inclusion Criteria:

* patient with benign lesions who requires left hemihepatectomy
* Child-Pugh classification of A to B
* American Society Of Anesthesiologists (ASA) grading of I to III
* a body mass index of between 18 and 35
* willingness to participate in the study
* able to understand the nature of the study and what will be required of them

Exclusion Criteria:

* pregnant or lactating women
* unwillingness to participate
* Child-Pugh classification of C
* ASA grading of IV to V
* with condition of acute inflammatory,fever or diabetes mellitus
* with autoimmune disease or immunodeficiency
* taking drugs that affect the immune system
Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Clinical studies have demonstrated a link between staphylococcal skin colonization and the pathogenesis of AD, but the implication of bacterial virulence factors remains largely uncharacterized. Finally, AD is often associated with herpes simplex skin infections. The aim of this project is to investigate the role of staphylococcal toxins in the exacerbation and maintenance of atopic skin inflammation and in the occurrence of infectious complications such as eczema herpeticum.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate AD (SCORAD between 25 and 50) or severe AD (SCORAD\> 50)
* Skin lesions in the forearms
* Free subject, without neither guardianship, wardship nor subordination
* Patient with Social Security
* Informed and signed consent by the patient after clear and loyal information on the study

Exclusion Criteria:

* Age \< 18 year-old
* Patients with mild AD (SCORAD \< 25)
* Patients without skin lesions in the forearms
* Patients treated with dermocorticoid or calcineurin inhibitor for less than two weeks
* Patients under systemic treatment : Methotrexate, Ciclosporin, Mycophenolate Mofetil, Azathioprine, general corticosteroids for less than 4 weeks
* Patients under biological treatment : Dupilumab for less than 5 half-lives
* Patient without Social Security
* Pregnant and nursing women
Comparison of Physical Fitness, Walking Speed, Reaction Time In Older Adults With and Without Mild Cognitive Impairment

The aim of the study is to compare physical fitness, walking speed and hand reaction time measurements in older adults with different cognition levels according to the Montreal Cognitive Assessment Scale (MOCA).


Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older
* Volunteering to participate in the study
* 10 meters independent walking
* Being diagnosed with mild cognitive dysfunction
* Not being diagnosed with cognitive dysfunction
* Having received five years of basic education

Exclusion Criteria:

* Having had an upper or lower extremity surgery in the last 6 months
* Having a health problem that prevents completing the tests in the study
Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT

To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation

53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?

Eligibility Criteria:
Inclusion Criteria:

1. Intubated patients age between 18 years old and 80 years old
2. Duration of controlled mechanical ventilation≥ 24 h
3. Patients ready to wean from mechanical ventilation
4. Informed consent

Exclusion Criteria:

1. Pregnant women
2. Patients with malignant tumor
3. High paraplegia, neuromuscular lesions
4. Thoracic deformity, diaphragmatic hernia
5. Patients with ECMO
6. Patient participated in another interventional trial before enrollment
Autologous Fibroblast Transplantation in Facial Deformities

Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.

Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.

Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product

Eligibility Criteria:
Inclusion Criteria:

* Available and willing to attend all follow-up visits.
* Age \> 18 years.
* Able and willing to give informed consent.

Exclusion Criteria:

* Known allergy or sensitivity to collagen fillers
* The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
* Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
* The subject has received autologous fat transfer in the last 6 months.
* Subject is suffering from facial Kaposi's sarcoma.
* The subject has active skin diseases or inflammation on or near the area of injection
* positive HIV, HBV, HCV
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients


Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before any study assessment is performed
* Male or female patients ≥ 18 to 65 years of age
* Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

* Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
* A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Recipient with anti-HLA donor-specific antibody (DSA)
Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients

This is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of LifeLiver (an Extracorporeal Bio Artificial Liver). The study will recruit approximately 40 acute or acute-on-chronic liver failure patients.

Patient should have acute or acute-on-chronic liver failure and be registered in KONOS (Korean Network for Organ Sharing) system as a candidate of liver transplantation. Patients who meet the eligibility criteria will be assigned to control group or experimental group. Experimental group patients will receive LifeLiver treatment in addition to the best supportive care for the disease.

Primary Objective:

1. To evaluate the efficacy of LifeLiver in terms of a comparison of 30 day-survival rate between control group and experimental group. (after patient's KONOS (Korean Network for Organ Sharing) registration date)

Secondary Objective:

1. To compare a median value of 2 week-survival rate and duration of survival between both study groups
2. Survival analysis respect to each group of patients divided according to the KONOS status
3. To investigate safety and change of overall efficacy indicators in terms of Glasgow Coma Scale, West Heaven Criteria for hepatic encephalopathy, MELD (Model for End-stage Liver Disease) score, blood ammonia, inflammatory cytokine

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age
* Acute or acute-on-chronic liver failure patients who is waiting for liver transplantation (KONOS liver transplant emergency grade 2 or 3)
* Hepatic encephalopathy grade II or above
* The following laboratory values must be documented within the screening period:

  * INR (international normalized ratio) 2.0 or above
  * Serum ammonia 56 micromole/L or above
  * Total bilirubin 5mg/dL or above
  * Body weight 45kg or above
* Patient who can not expect effective treatment or prolonged survival
* Patient or patient's legal representative willing to provide informed consent and commit to study procedures

Exclusion Criteria:

* Patient who has contraindication to plasmapheresis
* Severe hypotension (systolic blood pressure 80mmHg or less)
* Platelet \< 15,000/mm3
* Contraindications to liver transplantation (sepsis, severe heart disease, uncontrollable hemorrhage, irreversible brain damage)
* Cerebral hemorrhage
* Positive HIV infection
* Serious or life-threatening hemorrhage just before initiation of the study
* Patients with high gastrointestinal bleeding tendency (a history or suspicion of gastrointestinal bleeding within last 3 months)
* Hepatocellular carcinoma patient with 7 (or more) tumors or a 6cm (or larger) diameter single tumor
* Pregnant or lactating women
* Antibiotics (beta-lactam family) hypersensitive and streptomycin, amphotericin B sensitive patients
* Patients with inappropriate condition to participate the study under investigator's judgement
Effects of Manual vs Instrument-assisted Manipulation on Electromyographic Activity and Sympathetic Nervous System

This study evaluates the effects of manual and instrument-assisted cervical manipulation on electromyographic activity and sympathetic nervous system. Subjects were divided in four groups, one group was submitted to a manual cervical manipulation, other group was submitted to an instrument-assisted cervical manipulation, other group was submitted to a sham manipulation and another group served as control.

The manual manipulation was applied over C3/C4, as the participants were positioned in supine with the cervical spine in a neutral position. Slight ipsilateral side flexion and contralateral rotation were introduced until tension was perceived in the tissues at the contact point. A high-velocity, low-amplitude thrust manipulation was directed upward and medially in the direction of the subject's contralateral eye.

The instrument-assisted manipulation was applied using a handheld Activator IV Adjusting Instrument. Contacts were made firm enough to prevent slipping of the rubber tip but not so firm as to load the spring, in consistence with customary clinical use of the instrument. The spring was then loaded by means of the instrument's trigger mechanism, and the impulse was delivered in an anterosuperior direction, over the posterolateral aspect of the vertebra on the right lamina-pedicle junction of C3.

The sham manipulation to the right C3/C4 segment was administered using the same 'set-up' as for the manual manipulation; however, once the barrier was engaged, the head was re-positioned to neutral with no thrust applied. The control group individuals were positioned supine for the same twenty minutes as the other groups and they received no manual contact.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic individuals
* Age above 18 years.

Exclusion Criteria:

* Presence of cervical pain
* History of surgery and/neck trauma
* Osteoporosis
* Current use of anticoagulant therapy
* Presence of dizziness and/or vertigo
* Pregnancy
* Cancer
* Any other contra-indication to spinal manipulation.