cyrilzakka/clinical-trials huggingface dataset:
AttachMent Preterm in the Loire Infant Follow-up Team

The purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

Whether they are born at term or prematurely, from birth, children seek contact with caregivers and establish privileged relationships with them. These attachment relationships are gradually established and, from the end of the first year, interindividual differences can be observed according to temperament, quality of interactions with adults and responses to children's needs for proximity and comfort.

Prematurity is a situation that can disrupt parent-child interactions. The physiological characteristics of the premature infant attenuate and distort his/her stress signals. Visual interactions are shorter, alertness is more labile and reactivity is less clear than that of babies born at term. In such situations of stress and trauma, maternal sensitivity and responsiveness can be affected. In addition, changes in the quality of mother-child interactions have been reported, with more controlling maternal behavior. This maternal trend has been associated with behavioral disorders in children, such as eating disorders or lack of interest in social communication. More frequent disruptions of maternal caregiving associated with relational withdrawal in the child have also been shown in the case of prematurity.

We hypothesize that the experience of establishing relationships with parents in a context of extreme prematurity can alter the development of secure attachment representations in the child and that maternal representations and their possible interactions with prematurity factors prevent or contribute to the development of insecure or disorganized attachment in the child. We also hypothesize that disorganized attachment representations are associated with somatic, environmental, affective, and neurodevelopmental complications (motor, cognitive and behavioral).

Eligibility Criteria:
Inclusion Criteria:

* Children born in the neonatal reanimation department of Angers and Nantes University Hospitals
* Extrem preterm infants (term of birth less than or equal to 28 weeks of amenorrhea)
* Children included in the regional monitoring network for vulnerable newborns (Réseau Grandir Ensemble en Pays de la Loire, RGE)
* Children with a follow-up consultation at age 3 scheduled as part of the classic RGE follow-up on the Angers and Nantes University Hospitals
* Informed consent dated and signed by the parents or the holder of the parental authority
* Affiliated to a Social Security scheme

Exclusion Criteria:

* Child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year RGE follow-up evaluation
The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy

The aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.

Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
* Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
* Understanding simple commands and signing the consent form

Exclusion Criteria:

* Presence of equinus deformity
* Situations that may prevent assessments or communication
* Lack of cooperation during work
* Presence of surgery that may affect assessments, such as joint freezing
* Presence of botulinum toxin administration in the last 6 months
* Development of an allergic reaction on the skin to the tape
Molecular Profiling of Metastatic Cancer in Pleural Effusion and Ascites

Cancers are among the most frequent leading causes of death in Taiwan, and many of them show their respective unique epidemiological and pathophysiological features in Taiwanese population. One of the distinguishing features of cancers includes their potential to metastasize outside the primary tumor. Pleural cavity and peritoneum are two of the most frequent sites of metastases when serosal surfaces are involved. The prognoses of such patients are extremely poor with a median survival of months. The understandings of cancer biology of tumor metastasis demand more in-depth studies at the molecular and cell levels. Studies based on cell culture are excellent approaches for this purpose as the cell culture provides a relevant and renewable model for studying the pathological and molecular changes underlying human malignant tumors.

Due to their easy accessibility, pleural effusions and ascites are two important clinical sources of metastatic cancer cells, which upon isolation, permit comparative studies between the biology nature of primary tumor and metastatic ones. In this study, we will try to isolate cancer cells from human malignant effusions, said to be pleural effusions and/or ascites. We will establish phenotypic alterations along the progression of malignant tumors with serosal metastasis, with special emphasis on expression of some proteases, laminin receptors and transcription factors involved in the process of invasion and metastasis. We would also perform clinical correlations, including tumor type, staging, status of lymph node metastasis and histopathological differentiation and grading, etc.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients
* pleural effusion or peritoneal effusion

Exclusion Criteria:

* infected and fever patients
* anticoagulant treatment patients
* patients don't attend this study
A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment

The purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.

Title:

Xerostomy treatment in patients with Sjogren's syndrome in Chile :A double blind control trial comparing orally Pilocarpine drops and Artificial Saliva

Authors:

Cristian Vera Kellet, Mirtha Cifuentes Mutinelli. Affiliations: Pontificia Universidad Catolica de Chile

BACKGROUND Sjogren's syndrome (SS) is characterized by diminished exocrine secretions with the resultant xerostomia and xerophthalmia due to slowly progressive infiltration of lacrimal and salivary glands by inflamatory cells.

OBJECTIVE: To assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, doubleblind, controlled trial.

SUBJECTS AND METHODS After providing written informed consent, 72 patients with primary or secondary SS and clinically significant dry mouth and dry eyes will be randomized to receive either 5-mg pilocarpine drops, or artificial saliva 3 times daily for 12 weeks. Global evaluation and subjective responses of patients will be assessed by questionnaires with visual analog scales or categorical checkboxes. All patients will be submited to anxiety and psicological test before and after 12 weeks. Whole-mouth salivary flow and lacrimal flow will be measured using Schirmer test.

Eligibility Criteria:
Inclusion Criteria:

* Patiens over 18 years, with primary or secondary Sjogren's Syndrome and xerostomia.

Exclusion Criteria:

* Patiens with cardiac, pulmonary, renal, gastric diseases,
* Patients with diabetes, glaucoma, Multipleesclerosis,
* Pregnant women.
Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy

Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol.

Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written informed consent
* Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic criteria.
* Patients with severe non proliferative or early proliferative diabetic retinopathy
* Visual acuity of the treated eye \>= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70 letters Early treatment Diabetic Retinopathy Study)
* Visual acuity of the contralateral eye \>= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35 letters Early treatment Diabetic Retinopathy Study)
* Patients with a central macular thickness of 350 μm or less on Spectral Domain - Optical Coherence Tomography
* Patients with national health insurance cover
* Patients over 18 years old

Exclusion Criteria:

* Uncontrolled diabetes in the previous 6 months with intensive insulin therapy (glycated haemoglobin \> 11).
* Uncontrolled hypertension.
* Florid diabetic retinopathy floride.
* Macular oedema due to causes other than diabetic retinopathy or in a context of vitreomacular traction.
* History of intravitreal treatment with anti-angiogenic agent or corticosteroids within the 12 previous months.
* History of treatment with laser in panretinal photocoagulation or focal laser on the treated eye.
* History of eye surgery or laser capsulotomy within the previous 6 months
* History of renal failure requiring dialysis or kidney transplantation for diabetic nephropathy.
* Contra-indication for Tropicamide or Neo-synephrine
* History of uncontrolled glaucoma or hypertonia
* Patient with aphakia
* Adult under guardianship
* Pegnant or breast-feeding women
Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers

The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.

A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)


Eligibility Criteria:
Inclusion Criteria:

1. Males or females who met the inclusion/exclusion criteria, females who are not pregnant nor nursing, and who agreed to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
2. Healthy HIV negative adult volunteers
3. Age ≥18 and ≤60 years
4. BMI ≥18.5 and BMI ≤29.9 kg/m2
5. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
7. Intake of drugs with a long half-life (\>24 hours) within at least one month prior to study drug administration and during the trial
8. Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
10. Current smoker
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
13. Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
14. Excessive physical activities (within one week prior to study drug administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator
16. Inability to comply with dietary regimen required by the protocol
17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
18. Pregnant or lactating females
A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 50 years of age.
* Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
* Weight ≥ 50 kg.
* Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam.
* Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease.

Exclusion Criteria:

* Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder.
* Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST).

Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.

After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.

The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.


Eligibility Criteria:
Inclusion Criteria:

* minimum age 18
* able to understand participant information and cooperate at the neurological examination
* uncomplicated treatment with spinal cord stimulation for at least 3 months
* pain in only one extremity
* treatment effect in only one extremity

Exclusion Criteria:

-
Distinct Sources of Supplementary Protein in the Resistance Exercise Training-induced Adaptations

This is a randomized controlled trial aimed to investigate the effects of different supplementary protein sources on muscle adaptations to resistance exercise. Young, healthy, recreationally active participants consuming an omnivorous diet with protein intake within recommended dietary allowance (RDA) (i.e.; 0.8-1.0 g.kg-1. d-1) will be recruited to undergo a 12-wk supervised resistance training program in combination with the intake of three 15-g daily doses (45g. d-1 total) of either a mixed plant- (i.e.; soy and pea protein) or animal-based (i.e.; whey protein) protein in drink form as a supplementary source of protein to their main meals of the day (i.e.; breakfast, lunch, and dinner). Before (PRE) and after (POST) the 12-wk intervention, participants will be assessed for body composition by dual-energy X-ray absorptiometry (DXA), muscle cross-sectional area (ultrasound) and fiber cross-sectional area (muscle biopsy), and maximal isotonic strength (1RM). Training consists of a resistance training (RT) program individually supervised by a researcher blinded to treatment in a laboratorial setting. Assessments will also be conducted in a blinded fashion.


Eligibility Criteria:
Inclusion Criteria:

* Physically active (according to the International Physical Activity Questionnaire (IPAQ)
* Absence of any chronic condition that could preclude participation in a RT program or physical testing
* Habitual protein consumption within RDA ≥ 0.8 ≤1.0 g.kg-1. d-1

Exclusion Criteria:

* Prior history of anabolic steroids use, current or previous (≤ 3 m)
* Use of ergogenic or protein-based supplements, current or previous (\< 1 y)
* Engagement in energy-restricted diets
Diagnostic Accuracy of MR in Myositis

A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.

Idiopathic inflammatory myopathies are a heterogeneous group of conditions characterised by skeletal muscle inflammation leading to proximal muscle weakness, often with tenderness, and occasionally dermatological manifestations. Diagnosis is clinical and is based on the Bohan and Peter criteria which comprises clinical examination, serological markers, electromyography (EMG) and muscle biopsy. This has relatively poor sensitivity and specificity. Muscle biopsy in particular has a false negative rate of 10-15% and is invasive. Clinical criteria also lack the discriminatory power to differentiate between recurrent (or breakthrough) myopathy and myopathy secondary to treatment with corticosteroid.

Magnetic resonance (MR) imaging has the advantage of being non-invasive, and is able to discriminate between different tissues, and to identify areas of inflammation. The aim of this study is to assess the effectiveness of MR sequences in the diagnosis of myopathy, monitoring of treatment response, and in differentiating between breakthrough myopathy and steroid-induced myopathy.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient referred for an MR scan with a suspected clinical diagnosis of myopathy.

Exclusion Criteria:

* Patient unable or unwilling to have an MR scan.
* Standard MR exclusion criteria will apply.
Chronic Migraine Prophylaxis: Ultrasound-Guided Greater Occipital Nerve Block Versus Medical Treatment

The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.

Primary headache disorders, particularly migraine and tension-type headache (TTH) are common worldwide and commonly result in widespread and substantial disability. Chronic migraine (CM) is defined as "headache occurring on 15 or more days per month for more than 3 months which has the features of migraine headache on at least 8 days per month".

The prevalence of CM in the general population is about 2%. It negatively affects emotional and family relationships, education, economic status, and general health. Migraine headaches might become quite severe and incapacitating for patients and management can be challenging even in experienced clinics.

Prophylactic interventions may include pharmacotherapy, behavioral therapy, physical therapy and other strategies. Management often requires the simultaneous use of these different therapeutic modalities. Once the headaches become refractory to conventional pharmacologic management minimally invasive techniques such as peripheral nerve blocks are feasible for pain relief and help to decrease the frequency of the attacks.

Preventive medications for chronic migraine treatment are less well studied than they are for episodic migraine. In addition, some trials evaluating treatment of chronic migraine are limited by one or more methodologic problems, such as small size, concomitant use of other prophylactic medications and/or lack of a specific headache diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old.
2. Both sexes.
3. Patients with chronic migraine.

Exclusion Criteria:

1. Age less than 18 years.
2. Patients with medication overuse headache.
3. Patients who had used acute pain medications within 24 hours prior to the study visit.
4. History of injury to the area of the GON.
5. Any prior adverse reactions to local anesthetics.
6. Patients with impaired sensation in the occipital area.
7. Any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.
Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, Cologuard and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health
* ≥1 UCSD Health System health visit within the last year
* Resides in San Diego or Imperial County
* Currently not up to date with CRC screening
* Insured by private, public or other health insurance.

Exclusion Criteria:

* Up-to-date with screening
* Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.
* Prior history of colectomy
* Lack of health insurance
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (\< 1% FVIII)
* 30-45 years of age
* Previously treated subject (\> 100 Exposure days to any FVIII)
* On-demand therapy with any FVIII

Exclusion Criteria:

* No history of inhibitor
* No planned elective orthopedic surgery during the study duration (13 months)
* No severe concomitant disease
* No history of anaphylactic or other severe reaction to previous FVIII treatment