cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Inpatient Sleep and Activity Following Childbirth

Sleep is critical to mental and physical health following childbirth. However, patients who are hospitalized for labor and delivery may be admitted for days with significant impacts on sleep levels. Little is known about sleep and activity levels in inpatients during nighttime and daytime following childbirth and how this may affect their mental and physical health and wellbeing. If abnormalities are identified, targeted interventions may be possible to optimize recovery following delivery.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* live pregnancy
* Single or multiple gestation
* all gestational ages

Exclusion Criteria:

* Weekend delivery
* admitted to critical care
* unable to speak or understand English
* known sleeping disorder
* opioid requirement prior to admission
* long term steroids use
* significant autoimmune or neurological disease
* significant psychiatric or neurodevelopment disorder
Home Exercise Intervention in Childhood Obesity

Aim: To evaluate the impact of a physical exercise Web-based program with or without support on body composition, physical fitness and blood pressure values.

Design: Randomized Controlled Trial. Population: Obese children and adolescents.

In recent years there has been a decline in levels of physical activity (PA) in both children and adults. The promotion of PA is also a key element in the treatment of obesity, along with changing eating habits, but usually has very low levels of adherence. Active video games may be an alternative for the promotion of PA in the treatment of obesity.

The objective of this project is to evaluate the impact of a physical exercise Web-based program with or without support on Body Composition, Physical Fitness and Blood Pressure values.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese children and adolescents

Exclusion Criteria:

* Secondary obesity syndromes
* Severe obesity (z score \> 2.5)
A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously \[IV\] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 60-70 or \>70 years of age
* Cumulative Illness Rating Scale (CIRS) comorbidity score \>/=7 if patient is 60-70 years old
* Previously untreated B-cell chronic lymphocytic leukemia
* Binet stage B, C or A with progression
* ECOG performance status 0-2

Exclusion Criteria:

* Small-cell lymphoma
* Autoimmune hemolytic anemia
* Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin
* Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment
* Richter's syndrome
Mean Values of Oxidative Stress Parameters in Healthy Subjects

Determination of the mean value of oxidative stress parameters in normals and of the plasma and serum levels, resp. of malondialdehyde, glutathion and superoxide dismutase in healthy subjects.

In certain situations, free radicals can be generated in an exaggerated manner and can injure tissues and organs by interacting with lipids, proteins, or DNA. So, oxidative stress has been implicated in a large number of human diseases. To survive, the human body has developed a complex, efficient, and highly adaptive antioxidant defense system. The eye is also protected against oxidative stress by several mechanisms involving antioxidant enzymes such as catalase (CAT) and superoxide dismutase (SOD), as well as by low-molecular-weight antioxidants such as glutathion (GSH) and ascorbate.

Primary open-angle glaucoma (POAG) is a chronic, slowly progressive optic neuropathy, characterized by excavation of the optic nerve head (ONH) and a distinctive pattern of visual field (VF) defects. The disease is multifactorial in origin, so that besides more extensively investigated factors oxidative stress has also been proposed as a contributing factor in the etiology of glaucomatous optic neuropathy. Oxidative stress represents a harmful state defined by the presence of pathologic levels of reactive oxygen species (ROS) relative to antioxidant defense.

Therefore, it would be also important to determine whether there is a relationship between circulating levels of the defense parameters to oxidative stress like malondialdehyde, GSH and SOD, and the occurrence of POAG.

Since there are only the limits of variation for these defense parameters available, mean values of the plasma levels of malondialdehyde, glutathion and superoxide dismutase will be determined in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* German native speakers
* Age between 18-80 years
* Healthy without medication
* No ophthalmic disease

Exclusion Criteria:

* Any history of ocular or systemic diseases or of drug or alcohol abuse
* Any mentally impaired patient
Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks

The aim of this study is to determine whether there are any changes in the carbon dioxide partial pressure in medical staff while wearing a filtering face piece (FFP) 2 or FFP3 mask.

Furthermore, changes in the capillary oxygen partial pressure, the subjective respiratory effort and the breathing rate are measured.

In the fight against the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), the personal protective equipment (PPE) of medical staff plays a special role. Since the pathogen can be transmitted via droplets, particle-filtering half masks (filtering face piece - FFP) are a substantial part of the PPE. The current data indicate that there may be an increase in the carbon dioxide partial pressure (PcCO2) in the blood when wearing an FFP2 / 3 mask during routine medical activity.

The aim of this prospective cross-over study is to compare the PcCO2 measured by capillary blood sampling from medical staff while wearing an FFP2 or FFP3 mask. The PcCO2 determined without a mask serves as a reference value. While no mask is worn, the PcCO2, the subjective respiratory effort, the breathing rate and the capillary oxygen partial pressure (PcO2) is measured. The study participants then wear an FFP2 or FFP3 mask for one hour, and the same parameters are collected. Subsequently, the participant switches to an FFP3 or FFP2 mask, and the last measurement is conducted after one hour.

Eligibility Criteria:
Inclusion Criteria:

* medical staff working at the Vienna General Hospital
* oral and written consent to take part voluntarily in this trial

Exclusion Criteria:

* hypersensitivity / allergy against Nonylvanillamid, Nikotinsäure-beta-butoxyethylester or other component of "Finalgon Salbe"
* not Coronavirus disease-19 vaccinated
* pregnancy
* breastfeeding
Health-care Quality in Semi-intensive Care Units

The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.

Collecting data of semi-intensive care units' patients and structural data of hospitals, healthcare quality's indicators will be realized. Starting from those indicators of insuccess, specific for different kinds of patients, it will be possibile to evaluate the general level of care in each singular semi-intensive care unit. The study will least for 5 years, but at the end of every year it will be realized a report of analysis to see the results of each unit.

Eligibility Criteria:
Inclusion Criteria:

* all patients hospitalised in a semi-intensive care unit

Exclusion Criteria:

* None
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.

Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.

The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).

The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).

Eligibility Criteria:
Inclusion Criteria:

• chronic anal fissure for more than three months

Exclusion Criteria:

* medical comorbidity
* inflammatory bowel disease
* tuberculosis fissure
* HIV infected patients
Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma

The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

Eligibility Criteria:
Inclusion Criteria:

* stage IVA and IVB nasopharyngeal carcinoma
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Eastern CooperativeOncology Group performance status of 0 to 2.
* Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
* allergy to any of these three drugs
Diagnostic Performance of General Practitioners in Compression UltraSound

The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

After being informed about the study and the potential risks, all patients who have given their written consent and who meet the eligibility criteria will benefit from a 3-point compression ultrasound performed by the general practitioner before being referred for a whole-leg ultrasound with Doppler at the vascular physician.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Management by a general practitioner trained in 3-point venous ultrasound
* Suspicion of deep vein thrombosis by the general practitioner with prescription of a whole-leg Doppler ultrasound by a vascular physician. It is noted that the patient can be included from the moment the general practitioner had planned to refer the patient to the vascular physician for a suspicion of DVT, including in the absence of realization of DDimer on a low probability of DVT. It may also be included in case of positive DDimer tests.
* Signed written consent
* Patient covered by the French social security system

Exclusion Criteria:

* Whole leg ultrasound performed more than 72 hours after the initial examination
* History of homolateral deep vein thrombosis
* Patient objecting to the use of his data
* Refusal of written and signed consent
Blood Collection From Individuals With Lung Disease for Genetic Studies

This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer.

The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease. The investigators aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Must provide informed consent
* Males and females, age 18 years and older
* Lung disease proven by at least one of the following:

  * symptoms consistent with pulmonary disease
  * chest X-rays consistent with lung disease
  * pulmonary function tests consistent with lung disease
  * lung biopsy consistent with lung disease
  * family history of lung disease
  * disease of organs with know associated with lung disease
  * individuals suspected of history of lung disease based on history and/or physical examination
  * normal controls (individuals without history of lung disease) to be sampled to provide a comparison to the lung disease cohort.

Exclusion Criteria:

* Drug and/or alcohol abuse within the past six months
* Females who are pregnant or nursing
Extracorporeal SPecific IgE Removal From the Plasma of Allergic Asthma Patients (ESPIRA-study)

In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound. The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. The new adsorber can be safely used in patients. A group of patients with conventional drug treatment and no apheresis treatment serves as control.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Clinically relevant allergy to respiratory allergens confirmed by patient's history, skin-prick testing, IgE serology
* Allergic asthma (diagnosed by lung specialist)
* IgE concentration in blood at least 300 kilo Units (kU)/L

Exclusion Criteria:

* Participation in another trial within 30 days prior to enrolment
* Gravidity (pregnancy test prior to each treatment cycle)
* Intake of omalizumab
* Hepatitis or HIV or malignant disease
* Specific immunotherapy in the last 6 months
* Non-allergic asthma
* Auto-immune diseases
* Hypocalcaemia
* Intake of ACE-inhibitors (discontinuation according to half-time before treatment possible)
* Uncontrolled bleeding and coagulation disorders
* Severe cardiovascular disease
* Severe cardiac arrhythmias
* Severe systemic infection
* Unability to tolerate therapeutic apheresis procedures (hypersensitivity associated with previous apheresis sessions)
* Inadequate peripheral venous access
* Condition in which acute fluid shifts may cause congestive heart failure
* Established or suspected intra-cranial disease where fluid imbalance or pressure changes could exacerbate the disease
* Impaired renal function
* Clinically significant hypotension or borderline hypotension where a further drop in blood pressure could be harmful
Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema

The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female and/or male
* From 18 to 65 years of age
* Uniform skin color and no erythema or dark pigmentation in the test area
* ITA° \> 28 in the test area

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS, HIV-positive or infectious hepatitis
* Conditions which exclude a participation or might influence the test reaction/evaluation
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
* One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
* Insulin-dependent diabetes mellitus
* Electronic implant (e.g. pace maker, insulin pump, hearing aid, and the like) that cannot be removed during irradiation
* Documented allergies to cosmetic products and/or ingredients
* Active skin disease at the test area
* Irregularly tanned skin in the test area
* Medical history of dysplastic nevi, melanoma or other skin carcinoma
* Medical history of abnormal response to sunlight
* Regular use of tanning beds (more than 10 times within the last 6 months)
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* Usage of medication with known photo-toxic and/or photo-sensitizing potential (e.g. some antibiotics, blood pressure regulating agents and antidepressants agents; hypericum perforatum) within the last 14 days prior to the start of the study and/or throughout the entire course of the study
* Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and/or throughout the entire course of the study
* Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study and/or throughout the entire course of the study
Feasibility of an Online Exercise Community Among Individuals With Type 2 Diabetes

The aim of this study is to evaluate the feasibility, fidelity and acceptability of an 8-week high intensity online physical exercise combined with online group meetings and supported with an activity tracker in individuals with type 2 diabetes. The design of the intervention will be developed using a co-creation approach. The intervention consist of eight weeks of 30 minutes online physical exercise followed by 30 minutes of online group meeting in Microsoft Teams once a week. Outcomes includes pre-defined research progression criteria and secondary outcomes of physical and mental health and participant feedback.

The study is designed as a one-armed feasibility for the reason that the progression criteria are linked to the intervention. No blinding will be applied in the study.

The study will be carried on the Centre for Physical Activity Research, Rigshospitalet, Denmark. Reporting of the study will be following the CONSORT extension to a randomized pilot and feasibility trials.

Participants will be recruited from the Capital Region of Denmark and Region Zealand using different recruitment strategies followed by a telephone screening with the project coordinator.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Access to a device such as a computer, tablet, or a smart phone

Exclusion Criteria:

* Contraindications to exercise, for example heart conditions, complications/injuries in the locomotive apparatus
* Advised to not exercise by medical doctor
* Current participation in other intervention trials
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj

Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.

This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis.

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.

\[NCT02221258\]

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\]
* Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

* In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period