cyrilzakka/clinical-trials huggingface dataset:
Cephalosporin Hypersensitivity

Background :

Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.

Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).


Eligibility Criteria:
Inclusion criteria:

- Patients with one or more ST and DPT tests to cephalosporins

Exclusion criteria:

- Patients refusing to take part in the study
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.


Eligibility Criteria:
Key Inclusion Criteria

* Age ≥ 16 years
* Advanced unresectable or metastatic sarcoma

  * Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS)
  * Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors)
* Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
* Measurable disease by RECIST 1.1
* Adequate hematologic, renal, hepatic function
* Adequate creatine phosphokinase
* ECOG performance status ≤ 1
* Left ventricular ejection fraction (LVEF) \>= institutional lower limit of normal (LLN)
* Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment

Key Exclusion Criteria

* Prior therapy with PARP inhibitor, including olaparib
* Prior therapy with trabectedin
* Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
* Pregnant or breastfeeding women
* Known hypersensitivity to trabectedin or olaparib
* Other exclusions per protocol
Glybera Registry, Lipoprotein Lipase Deficient (LPLD) Patients

Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by loss-of function mutations in the LPL gene, leading to the inability to produce functionally active lipoprotein lipase (LPL). LPL is the key enzyme in the metabolism of triglyceride (TG)-rich lipoproteins (chylomicrons (CM) and very low-density lipoproteins (VLDL)). LPLD results in extremely high concentrations of circulating TG-rich lipoproteins.

No drug therapy for LPLD is currently available. Clinical management of LPLD patients consists of severe dietary fat restriction and the use of medium-chain triglycerides to substitute for normal dietary fats.

Alipogene tiparvovec (Glybera®) received marketing authorisation from the European commission on 25 October 2012. Glybera® aims to correct lipoprotein lipase deficiency sufficiently to decrease the morbidity and lower the risk of inherent complications of LPLD, in adult patients genetically diagnosed with LPLD.

The Glybera Registry is designed to collect the long-term safety and efficacy data of GLYBERA®

All patients treated with GLYBERA®, in a clinical trial and when GLYBERA® was commercially available who are currently participating in the LPLD Registry (Long term follow up of safety and efficacy in LPLD), will be asked to continue their participation in this Glybera Registry to collect long-term safety and efficacy data.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with GLYBERA®, either during their participation in a clinical trial or in the commercial setting till October 25th, 2017 (= expiration date of Marketing Authorization of GLYBERA®), and
* Who are currently participating in the LPLD Registry

Exclusion Criteria:

* None
Mind Body Therapy During Geriatric Rehabilitation

The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary methods that can improve the care of elderly people who had suffered an acute illness. The aim of this prospective study is to assess the effect of mind-body therapy(including guided imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and physical rehabilitation in geriatric patients.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatients,age 18 and above.
2. Getting standard rehabilitation therapy
3. Can fill an informed consent.

Exclusion Criteria:

1. Medically unstable patients (uncontrolled heart failure,rapid AF, severe infection, constant need of oxygen therapy).
2. Demented patients who are unable to fill an informed consent
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO

Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high

Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous Extracorporeal membrane oxygenation (VV-ECMO).

Methods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March 2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of patients treated with PPV, number of PPV-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.

Eligibility Criteria:
Inclusion Criteria: patients with COVID-19 induced severe ARDS accepted for and treated with VV-ECMO in Denmark

-

Exclusion Criteria:

* none
Laparoscopic Colectomies In Management of Colonic Cancers

The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .

This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.

In Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.

Sample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program

Eligibility Criteria:
Inclusion Criteria:

* Patients had to present histologically confirmed cancer( right and left) colon.
* All grades of cancer will be included.
* Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.

Exclusion Criteria:

* Locally advanced disease with invasion of adjacent important organs.
* Acute bowel obstruction or perforation from cancer.
* Pregnant ladies.
* Rectal cancer and transverse colon cancer.
Better First Aid With First Aid Training and Dispatcher Central Instructions?

The study evaluates the effect of a first aid course on first aid skills compared to no training. The study also evaluates the effect of first-aid instructions given by emergency dispatch central over mobile phone on first aid performance to no instructions.

Half the participants will perform first aid in two scenarios prior to first aid training. Half the participants will perform first aid in two scenarios 4 to 5 months after attending a first aid course. Half the participants (overall) will receive first aid instructions by mobile phone during the scenarios.


Eligibility Criteria:
Inclusion Criteria:

* Students in high school/college

Exclusion Criteria:

-
Periapical Lesions and Immediate Implants

The aim of this case-control study is to evaluate the success and survival rates of dental implants immediately placed into extraction sites in the presence of periapical pathology.

The main questions it aims to answer are:

What were the survival and success rates of implants immediately placed into extraction sockets of teeth with chronic periodical lesions.

A retrospective analysis was performed based on the evaluation of certain clinical and radiographic parameters 12 months after prosthetic function of these implants.

In 25 patients (13 men, 12 women), certain clinical and radiological parameters were retrospectively evaluated with particular interest in survival and success rates of the implants (total of 30 implants, 21 in the maxilla, 9 in the mandible) placed immediately to extraction sites of teeth with chronic periapical lesions. These parameters included mobility and the presence or absence of chronic pain, probing depth, gingival index, radiographic measurements of crestal bone loss on mesial and distal aspects of the implants.

Eligibility Criteria:
Inclusion Criteria:

* To have 1 or more teeth with a chronic periapical lesion that requiring extraction.
* The chronic periapical lesion should be determined as an asymptomatic periapical radiolucency with a diameter ranging between 4 and 8 mm.
* The patients undergoing tooth extraction must have been treated with an immediate implant placement procedure.
* At the time of extraction and implant placement, the neighboring teeth must have had healthy periodontal and periapical status.

Exclusion Criteria:

* Age younger than 18 years
* Any systemic disease or medication that might compromise osseointegration, bone or soft tissue healing
* Smoking
* Purulent exudate during the extraction
* Severe deficiency of soft and/or hard tissue in implant region
* Pregnancy
* Lactation
* History of chemotherapy or radiotherapy
* Severe parafunctional habits
Prevention of Incontinence-associated Dermatitis

Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.

Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged and direct contact of the skin with urine and/or stool. It may occur in all age groups but elderly and care-dependent incontinent people are often affected by this type of inflammation. Promotion of continence, use of absorbent products and structured skin care are recommended to prevent and/or treat IAD. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. Currently, there is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory randomized controlled trial in incontinent elderly nursing home residents and geriatric patients will be conducted. In the two intervention groups, a film-forming or a lipophilic skin protection product will be applied in addition to standardized skin care regimens. Every other day, investigators will perform skin inspections, including instrumental skin measurements to quantify erythema for a total study period of n= 14 days. IAD- related pain and itch will be assessed. A total of n= 210 nursing home residents and geriatric patients in Berlin, Germany, aged over 65 years, who are affected by urinary and faecal incontinence without signs of severe IAD will be included.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients or residents being incontinent of urine and stool
* Expected minimum length of stay of 14 days at the care facility
* Intact skin with no clinical signs of IAD OR
* intact skin with early clinical signs of IAD (IAD category 1A)
* Written informed consent

Exclusion Criteria:

* Residents/patients at the end of life
* Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area
* Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)
* Known hypersensitivity or allergy to silicones and/or topical leave-on products
* Topical treatments in the IAD area.
Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study

Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs. Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities. This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered collaboratively with the YMCA.


Eligibility Criteria:
Inclusion Criteria:

≥ 50 years of age

* Accelerometer wear time ≥10 hours on at least 4 days in a 7 consecutive day period between baselines
* Self-report of \<140 minutes of MVPA per week in 3 months prior to baseline AND accelerometer recorded \<100 minutes of MVPA between baselines
* Mini-Mental State score ≥ 24 if indicated
* Independent self-ambulation
* Provides consent and is willing to participate in data collection activities

Exclusion Criteria:

* Pregnancy
* Unwilling or unable to participate in study activities
* Current or upcoming participation in educational programs similar to those under study
* Medical restrictions to increasing Moderate Vigorous Physical Activity (MVPA)
* Terminal illness
* Contraindications to mindfulness practice
The Effects of Microgravity on Human Sperm

It has been described that microgravity affects cellular and molecular structures. Cell membrane, cytoskeleton, cytoplasm and nucleus have been found to be sensible to gravitational changes. Alterations in the male and female reproductive systems have also been reported in mouse and other animals. The effects of microgravity on human reproductive cells remain unknown.

The main objective of this experimental study is to investigate the effect of simulated microgravity in human male reproductive cells under in vitro conditions. Induced microgravity conditions will be obtained with a smaller single-engine aerobatic aircraft that can provide parabolic flights.

The main parameters to be analyzed are: sperm motility, vitality, DNA fragmentation and apoptosis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men)
* Who accepted to take part in the study
* Who gave their written informed consent
Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch

The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch

Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* post-traumatic conditions of the upper limbs
* tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands
* cardiac arrhythmias
* circulatory or peripheral varcular disease
* aortic valve disease
* myocardiopathy
* other cardiovascular diseases
* pregnancy
* kidney disease
* diabetes
* neurotic disorder
* haemostatic disorders
* use of blood-thinning drugs
Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures

The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.

Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients.
* Any race
* Older than 18y
* Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.
* Any type of proximal humeral fracture according to the Neer or AO classification system.
* Patient should have received non-operative treatment.

Exclusion Criteria:

* Patients younger than 18 y.
* Patients with multiple other fractures.
* Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.
Balance Confidence and Kinesiophobia in Parkinson's Disease

31 patients aged 50-80 years diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stages 1-3) and 31 healthy volunteers. At the start of the study, sociodemographic data for all participants will be recorded. To assess the mental and functional status of Parkinson's disease patients, the Mini-Mental State Examination (MMSE) and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Balance confidence levels will be assessed using the Activities-specific Balance Confidence Scale-6 (ABC-6), overall balance using the Berg Balance Scale (BBS), fear of falling using the Falls Efficacy Scale (FES), and kinesiophobia levels using the Tampa Scale of Kinesiophobia (TSK).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic Parkinson's Disease by a neurology specialist.
* Modified Hoehn-Yahr Staging Scale classification between stages 1-3.
* Mini-Mental State Examination (MMSE) score of 24 or higher.
* Age between 50-80 years.
* Volunteered to participate in the study.

Exclusion Criteria:

* Use of medications, apart from routine Parkinson's disease treatments, that could affect balance or muscle strength.
* Presence of neurological or musculoskeletal conditions other than Parkinson's disease.
* Refusal to participate in the study.
* Presence of psychiatric disorders.
* Presence of cognitive impairments.
Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia

Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. This project aims to compare the efficacy and safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2 g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were determined at the beginning and the end of the study. The efficacies of three groups are compared, and the characteristics of better responders are analyzed.

We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on cognitive functions.The side effect assessments are also performed every 3 weeks. Side effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects, Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale. Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry , urine analysis, and EKG, will be checked at baseline and the end of week 12.

To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be checked at baseline and the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* The participants fulfill the criteria of schizophrenia according to the
* Diagnostic and Statistic Manual, fourth edition (DSM-IV).
* The participants remain stable schizophrenic symptoms and receive stable antipsychotic regimens at last 8 weeks before enrollment.
* The participants agree to participate in the study and provide informed consent.

Exclusion Criteria:

* History of alcohol or substance dependence, history of epilepsy, head trauma or CNS diseases, history of major, untreated medical diseases, mental retardation, pregnancy or lactation