cyrilzakka/clinical-trials huggingface dataset:
Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome

Confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. There are patient-specific predisposing factors and precipitating factors. Elderly people, due to their comorbidities, are more at risk. Confusion syndrome affects approximately 23% of elderly patients in the medical department, 33% in the rehabilitation department and its occurrence is preventable in 30 to 40% of cases. The health expenditure generated by its occurrence was estimated at 182 billion dollars per year by combining the expenditure of 18 European countries in 2011. The occurrence of a delirium increases the duration of hospitalization, increases the risk of falls, loss of autonomy, can lead to an impairment of quality of life at 6 months and is linked to excess mortality.

The gold standard for making the diagnosis of delirium is the use of the DSM-5 criteria, but their use is time-consuming and requires that staff be trained in their use. The 4 "A" test (tool to help identify confusional syndrome) can be used to monitor confusional syndromes; it has the advantage of being able to be taken in less than 3 minutes.

Concerning the management of a confusional syndrome, a non-pharmacological multi-component approach is recommended as first line for its prevention but there is no treatment to date. A tool to help with temporo-spatial reorientation (La Rob'Gazette) has been set up in the Medical Care and Geriatric Rehabilitation (SMRG) departments of the HUS


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 75 and over
* Hospitalized at the HUS in the SMRG department during the period from January 1, 2021 to April 31, 2023
* Passed at least a 4AT during hospitalization
* Absence of written opposition in the patient's medical file (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Exclusion Criteria:

- Presence of written opposition from the patient (and/or their legal representative if applicable) in their medical file.
NEPTUNE Match Study

NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

This is a prospective, open-label study testing the ability to effectively communicate patient-specific clinical trial matching with kidney patients and clinician investigators. The study consists of four components:

1. Recruitment of participants from the NEPTUNE observational cohort study
2. Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board
3. Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients
4. Retrospective comparison of kidney health outcomes in subjects enrolled in trials that aligned with their match vs. trial subjects with mis-aligned or unknown match alignment.

Eligibility Criteria:
Inclusion Criteria:

1. Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
2. Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).

   Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended.
3. Regular nephrology healthcare provided at a NEPTUNE study site.
4. Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match

Exclusion Criteria:

Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.

Exclusion Criteria:

1. Non-English or non-Spanish speaking
Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations

study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion

Dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.

Eligibility Criteria:
Inclusion Criteria:

* All patients should satisfy the following criteria:-

  1. An age range from 18-22.
  2. Transverse maxillary deficiency.
  3. Crossbite (unilateral or bilateral)
  4. No previous orthodontic treatment.
  5. Good oral and general health.
  6. No systemic disease/ medication that could interfere with OTM.

Exclusion Criteria:

1. History of systemic and medical illness.
2. History of extraction of permanent teeth.
3. Previos orthodontic treatment.
4. Poor oral hygiene or periodontally compromised patient.
5. Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.
Registry: TPLA for LUTS

Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic enlargement in men with transperineal laser ablation (TPLA) may offer advantages in functional outcomes and safety over current standard therapies. As the technique is relatively new, indications and outcomes for this treatment are subject of investigation. However, the technique is already applied outside clinical studies. Clinical information from these treatments can be useful for future research. The aim of this study is to collect data on patients treated with transperineal laser ablation of the prostate outside clinical trials and to provide data on safety and functional outcomes in these patients in order to improve treatment.

Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations.

Study design: This is an international prospective observational study in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.

Study population: Male patients treated with transperineal laser ablation for lower urinary tract symptoms due to benign prostatic enlargement.

Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of transperineal laser ablation for lower urinary tract symptoms measured by the time until surgical retreatment.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Presenting with lower urinary tract symptoms
* Indication for transperineal laser ablation
* Signed informed consent form

Exclusion Criteria:

* Age \< 18 years
* Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)
Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease

The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of sickle cell disease
* Age 12-21 years old
* Fluent in English (the intervention will be delivered in English)
* Participant is cognitively able to provide informed signed consent or assent
* Participant is cognitively able to follow instructions

Exclusion Criteria:

* Under 12 years of age or over 21 years of age
* Not fluent in English
* Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
* Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
Dyad Oxytocin Study (DOS)

The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls:
* Age between 18 and 75 years old
* Must have at least 4 hours of contact with the patient per week and be considered a "significant caregiver" by the patient

Inclusion criteria for patients with schizophrenia:

* Between the ages of 14 and 45.
* Patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- Not Otherwise Specified (NOS).
* Patients must be clinically stable
* No or minor changes to medications in the past week
* Patients must have a primary caregiver
* Inclusion criteria for healthy control child:
* Between the ages of 14 and 45
* Healthy control must have a primary caregiver
* Inclusion criteria for patients with autism spectrum disorder
* Between the ages of 14 and 45
* Patient must have a primary caregiver
* Patients must have a diagnosis of an autism spectrum disorder (ASD) (autism or Asperger's disorder), pervasive developmental disorder (PDD) or pervasive developmental disorder - not otherwise specified (PDD-NOS).

Exclusion Criteria:

Exclusion criteria for all caregivers:

* Female caregivers that state that they are pregnant or have a positive urine pregnancy test
* Caregivers who have significant nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy)
* Caregivers with significant psychiatric, neurologic, or medical illness
* Exclusion criteria for healthy controls:
* Healthy controls with history of psychiatric or neurological illness
* Exclusion criteria for patients with an autism spectrum disorder:
* Patients with an Intelligence Quotient (IQ) lower than 75
* Exclusion criteria for patients with schizophrenia
* Patients with severe brain trauma
Supportive Program for Mother With BPD

Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability of interpersonal relationships, self-image and emotions as well as marked impulsivity. When patients have children, they are at high risk of severe emotional and relational disturbances (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support the effectiveness of parental guidance group to reduce emotional and behavioral difficulties of children. To our knowledge there are no programs directed to mothers with BPD who received a controlled evaluation.

From experience with parental guidance, data from the observation of children of patients with BPD and psychosocial programs directed to patients BPD, we have built for preventive intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group sessions providing information (education, childcare, care specific to BPD) and promotes mother-child interactions (observation, games).

Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to mothers with a BPD in addition to a minimal intervention (diagnostic announcement and provision of health care resources) on behavior withdrawal of children at 6 months compared to a group of mothers receiving only minimal intervention.

Primary outcome: Difference at 6 months between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).


Eligibility Criteria:
Inclusion Criteria:

Mother:

* Women with children and at least one child aged 2 months to 2 years, Borderline Personality Disorder with SIDP (Structured Interview for DSM Personality Disorders)
* age above 18 years
* written consent

Child:

* ages between 2 months and 2 years,
* parental consent for research participation.

Exclusion Criteria:

Mother:

* chronic psychotic disorder, major depressive disorder, current mania or hypomania,
* legal protection,
* if no child can be included, the mother cannot be included.

Child :

•major psychomotor development disorder or psychiatric disorder according to the investigator.
Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma

30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options.

Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting cells.

The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery.
2. Histologically confirmed diagnosis of renal cell carcinoma.
3. Newly diagnosed or recurrent disease.
4. Karnofsky performance status 60-100.
5. Life expectancy ≥ 12 weeks.
6. Written informed consent of patient and/or legal guardian.
7. Must be off steroid at least two weeks prior to vaccination.
8. Hematologic and metabolic panel results will be within the parameters of the protocol.
9. Normal renal function in the kidney.
10. Adequate function of liver,lung and heart.
11. Negative pregnancy test
12. Fertile patients must use effective contraception
13. Serologically negative for HIV,HBV,HCV.
14. Syphilis serology negative
15. Patient must have no prior sensitivity to the components of the dendritic cell vaccine.

Exclusion Criteria:

1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study.
2. Presence of acute infection.
3. Inability to obtain informed consent because of psychiatric or complicating medical problems.
4. Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
5. Subjects with organ allografts.
6. Known history of autoimmune disorder.
7. Pregnancy or breast-feeding.
8. Positive for hepatitis B, C, HIV, syphilis.
9. Patients unwilling to perform a save method of birth control.
Agaricus Blazei Murill in Patients With Multiple Myeloma

Extract from the mushroom Agaricus blazei Murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. Furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. The investigators now want to investigate the effect of Agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.

Patients who are scheduled to undergo high dose chemotherapy for multiple myeloma will receive in addition in a double blinded manner 60 ml of agaricus extract or placebo once daily from the start of stem cell mobilizing therapy until one week after the end of aplasia after high dose melphalan.

Primary endpoints will be cytokine levels of degree of activation of tumor supressor genes before and after start of the investigational product.

Secondary endpoints will be treatment response and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma

Exclusion Criteria:

* None
Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)

The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms in these patients should be identified at an early stage and thereby AAA-associated mortality be decreased.

A recently published meta-analysis showed a higher prevalence of aortic aneurysm (AAA) in men requiring treatment of coronary heart disaese compared to standard population. In women, however, the prevalence was not increased. Thus, the SCAN project addresses male patients who underwent coronary artery intervention in order to screen them for the presence of an AAA using duplex sonography.

The SCAN project involves the following elements:

1. Informing the patient with cardiovascular risk factors about the clinical picture of AAA
2. An ultrasound scan of the abdominal aorta in patients with an increased risk for AAA
3. Acquisition of patient data followed by a correlation analysis for the parameters presence of AAA and cardiovascular diseases

The cohort study is part of the SCAN project which is also conducted in an similar way by Catharina Ziekenhuis Eindhoven ClinicalTrials.gov Identifier:NCT01643317.

Eligibility Criteria:
Inclusion Criteria:

* men with coronary artery intervention (PTCA/stenting)
* at least 1 risk factor for AAA (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history)

Exclusion Criteria:

* life expectancy less than 1 year
* inability to follow the instructions of the investigator (dementia, lack of time, insufficient understanding of the language)
* insufficient compliance
Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children

The main aim of this study is to investigate potential associations between maternal pre- and postnatal vitamin D level and oral health outcomes (caries and developmental defects of enamel) in their children at 7-9 years of age.

Vitamin D plays an important part in calcium absorption needed for calcification of hard tissues such as bone. Lack of vitamin D can lead to growth retardation in children and a variety of bone related problems in adulthood such as osteopenia, osteoporosis and increased risk of bone fracture. Vitamin D deficiency has also been associated with a variety of other health problems. In relation to oral health, studies have suggested that lack of vitamin D may interfere with tooth development resulting in development defects of the enamel, which in turn increase the risk of dental caries. As teeth begin to calcify around 14 weeks in utero and continue until the enamel on the last primary tooth is completed around ten months after birth, it is plausible that both pre- and postnatal vitamin D levels can have an impact on the development of the enamel in primary teeth in the offspring, which in turn may be related to the risk of developing enamel defects and dental caries. Furthermore, vitamin D may play a role in the immune system and thereby affect the oral microflora. Vitamin D could therefore also affect the risk of caries through immunological pathways. Few previous studies have investigated the associations between vitamin D and oral health outcomes, such as these.

The aim of this study is to investigate the potential associations between maternal pre- and postnatal vitamin D levels and oral health outcomes, such as caries and dental enamel defects in the offspring at 7-9 years of age.

The current study is a follow-up study of a previous study conducted in Trondheim and Stavanger, Norway. In 2007-2009 a total of 855 pregnant women participated in the Training in Pregnancy (TRIP) study, a randomised controlled trial study conducted to investigate whether exercise during pregnancy would help prevent or treat various pregnancy related illnesses. The women were included between weeks 18-22 of pregnancy and were followed-up at week 32-36 of pregnancy and at 3 months post-partum. An additional follow-up was also conducted among the participants from Trondheim at 18 months post-partum. The data collection included both questionnaires, clinical examinations and blood samples. The blood samples taken from the mothers at 18-22 weeks and 32-36 weeks of pregnancy have been analysed for levels of vitamin D, calcium, phosphate, magnesium, creatinine, albumin and PTH. In the current study, the children are invited to a dental examination, including a saliva sample. These clinical examinations will be conducted from June 2016 through to August 2017.

Eligibility Criteria:
Inclusion Criteria:

* Mother of the child participated in the main study "Training in Pregnancy"

Exclusion Criteria:

* Consent not given
Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis

The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.

A phase II, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of PRO-118 ophthalmic solution ( PRO-118 0.015% qd, PRO-118 0.015% twice daily , PRO-118 0.020% qd, PRO-118 0.020% twice daily) for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of seasonal or perennial allergic conjunctivitis.
* Age ≥ 6 years old at screening visit.
* Male or female patients.

Applicable in patients ≥ 18 years old.

* Patient has signed the Informed Consent Form (ICF) prior to any screening procedures.

Applicable in patients with age ≤ 18 years old.

* Patients Patients'parents or legal guardians signed an Informed Consent Form (ICF).
* The patients also provided written assent.

Exclusion Criteria:

* Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis).
* Any other ophthalmic medication within seven days prior to randomization.
* Patient with one blind eye.
* Visual acuity of 20/40 in any eye.
* Patients with history of active stage of any other concomitant ocular disease.
* Contraindications or sensitivity to any component of the study treatments.
* Contact lens users.
* Ocular surgery within the past 3 months.
* Women who were not using an effective means of contraception or who were pregnant or nursing.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Discontinuation criteria:

* Patients could be discontinued before the completion of the study because of use of prohibited medications, adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.