cyrilzakka/clinical-trials huggingface dataset:
Brain Maturation and Sleep

In this study, the investigator evaluates whether there are age-specific diurnal changes in markers of cortical plasticity in children, adolescents and adults. The question will be investigated by the quantification of brain metabolites and structural brain volumes using magnet resonance imaging (MRI) and electrophysiological markers using sleep encephalography (sleep EEG). In a second step, it will be tested how these markers of cortical plasticity change depending on a modulation of sleep by applying tones during deep sleep.

Given that children and adolescents undergo entirely different maturational processes (children show an increase, adolescents a decrease in synapse density) larger diurnal changes in children are expected compared to adolescents concerning brain metabolites and structural markers. These cortical changes in synapse density are thought to be reflected in electrophysiological markers in the sleep EEG (children show a higher slow wave activity, adolescents a reduced slow wave activity). With the modulation of the deep (slow wave) sleep by playing short, low volume tones, the investigators want to test if there is a causal relationship between slow wave sleep and markers of cortical plasticity.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 8 to 30 years of age,
* good general health Status
* right-handedness,
* Written informed consent after participants' information

Exclusion Criteria:

* sleep disorders (insomnia, sleep disordered breathing, restless legs syndrome)
* sleep complaints in general
* irregular sleep-wake rhythm
* daytime sleep
* travelling across a time zone within the last month
* diseases or lesions of the central nervous system
* psychiatric diseases
* learning disability
* skin allergy or very sensitive skin
* acute pediatric disease
* pregnancy
* drug and medication use and abuse
* nicotine use
* high caffeine consumption (\>2 servings/day (\>160 mg caffeine); including coffee, tea, white and dark chocolate, coca cola, energy drink)
* Alcohol consumption in children and adolescents under 16 years
* high alcohol consumption in adults (\> 1 standard serving/day (\>14 mg Alcohol))
* high alcohol consumption in adolescents aged 16 years and above (\> 3-4 Standard servings per week)
ALY688-SR in Generally Healthy Overweight or Obese Adults

First in human study of ALY688-SR administered as a subcutaneous injection

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,

Exclusion Criteria:

* Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia
Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness

The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness

Limited studies have been done on the BAHA in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. The findings of the limited number of studies to date on the BAHA with single sided deafness demonstrate that the BAHA improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the BAHA to have at least satisfactory benefit. But conflicting findings have been obtained regarding whether the BAHA improves the ability to locate the source of a sound. Additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity.

This investigation will show whether the previously reported BAHA benefits at one month post BAHA sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post BAHA sound processor fitting. This long-term investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect on localization abilities.

Subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the BAHA.In order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Adult-onset deafness
2. Deafness is unilateral - complete or near complete

Exclusion Criteria:

1. the presence of a developmental disorder or mental retardation;
2. history of drug abuse;
3. psychiatric disease;
4. inability to follow instructions or to participate in follow-up appointments
5. inability to use the BAHA
6. lack of osseo-integration -
Lower-limb Strength and Flexibility Program on Prevention of Falls in the Community-dwelling Elderly

Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling elderly.

To estimate the effect of strength and flexibility training with elastic band on community-dwelling elderly gait, balance, and functional performance. All subjects received a home exercise program with low resistance elastic band training. All subjects were assessed for functional assessment, balance and gait analysis at initial and after training.

Eligibility Criteria:
Inclusion Criteria:

* elder living in community
* age \> 65 years old

Exclusion Criteria:

* no walking ability before fall
* conscious change or disease induce fall
* impaired cognition
Change of Intramedullar Pressure After Implantation of Hip Prothesis

It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this issue.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing hip replacement with cemented and non-cemented femoral component

Exclusion Criteria:

* ASA IV
* Patient with periprosthetic fractures
* Patient with hip replacement revision
Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)

The main objective of this study is to analyse the effectiveness of the FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.

This is a two-arm RCT focused on the potential efficacy of the multicomponent program FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

The main objective of this RCT was two-fold: (a) To analyse the effectiveness of a 12-week multicomponent treatment as an add-on to Treatment (FIBROWALK) as Usual (TAU) to improve functional impact (primary outcome), as well as pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) compared to TAU; and (b) to explore the baseline differences between responders and non-responders in terms sociodemographic and clinical characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. fulfil the 2010/2011 American College of Rheumatology (ACR) FM diagnostic criteria. The diagnosis was verified by a rheumatologist (MA) of the CSSSU
2. adults \> 18 years old, and
3. provide written informed consent.

Exclusion Criteria:

1. To have a terminal illnesses or programmed interventions that might interrupt the study.
2. No stringent eligibility criteria were established due to the naturalistic nature of the RCT. Excluding patients with lower education or comorbidities might have turned away many patients from our RCT who would otherwise be eligible, that is we put emphasis on external validity. All recruited patients were considered capable of following the multicomponent therapy if they were allocated to it. Lack of adherence to drugs or home activities was not an exclusion criterion given the nature of our trial and we analysed data from all participants who underwent random allocation. Treatment allocation was performed by the clinical trials unit in accordance with computer-generated randomisation sequences.
Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Positive urine drug test
Genetics of Schizophrenia

Genetic etiology in schizophrenia is widely accepted. However, many chromosomal sites were shown to characterize the families of patients with schizophrenia. This is probably due to the high genetic heterogenity of this illness. Thus, it is important to investigate the genetic factor in relatively genetically homogenous populations. Many studies have indicate that Ashkenazy Jews show relative gentic homogenity. Indeed, the genes responsible for most Mendelian disorders of Jewish peoples have been identified. The study will apply genome-wide mutation screening methods to identify candidate allells in subjects of Ashkenazi Jewish ancestry with multiplex schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18+;
2. Meet DSM-IV criteria for Schizophrenia;
3. At least one first-degree relative who Meet DSM-IV criteria for Schizophrenia;
4. Can sign the informed consent form.

Exclusion Criteria:

1. Patients suffering from terminal or incurabale disease;
2. Minors, incompetents
Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments (COVID-19-LAT)

This survey is performed to examine if during the Covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics

In the current legislativ context notably the Clayes Leonetti law, a very large majority of ICU (Intensive Care Unit) patients die with the establishement of a procedure for the limitation and cessation of therapeutics (LAT). During a viral pandemic, medical resources can be saturated, limiting reflexive abilities in favour of binary decisions. This sorting of patients leads to LAT that could be performed without the elementary modalities stated by the law. Thus, arbitrary medical decisions made alone could expose patients to unjustified " loss of luck ". Increasing the resources mobilized during a pandemic must not make us forget the quality of care provided for the benefit of quantity. In therefore seems legitimate to keep the LAT modalities to ensure our ethical principles. No work in the literature based on actual facts explores the impact of a pandemic on compliance with and maintenance of ethical principles and the legisltaive framework, in particular as regards the procedures of the application of LAT.

The purpose of this study is to assess whether the terms of the LAT are being complied during a pandemic for patients with or without Covid.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized major patient
* Infected or not with Covid-19
* having a management with a LAT defined by an anticipated or factual restriction of a therapeutic resource ( organ replacement, specific treatment) while his or her state of health requires or may require it, leading or not a death. The patient's death occurs either after a cariac massagewhich corresponds to a maximum management with therapeutic failure or within the framework or in the context of brain death, in these cases there is no LAT ; either without cardiac massage and in this case there is de facto a LAT wether or not it is performed according to legisltaive procedures. All patients who die will beclassified according to this diagram for the inclusion criterion. For surviving patients, an analysis of the record in search of LAT elments will be performed. In the absence of LAT elment in the record, i twill be considered that the patient did not have LAT and therfore will not be included.

Exclusion Criteria:

None
Effect of Raisins on Cognitive Function in Healthy Older Adults

Objective:To assess the effect of an intervention based on including 50 g of raisins (sultanas) daily in the diet for 3 months on improving cognitive performance, cardiovascular risk factors and inflammatory markers in a population of older adults without cognitive impairment.

Methodology: Randomised two parallel-group clinical trial. Population: 80 patients between 70 and 80 years of age will be included, selected from primary care clinics in Salamanca and Zamora.

Measurements and intervention: Participants included in the study will have a baseline visit and two evaluations visits at 3 and 6 months where cognitive performance (attention, executive functions, verbal memory, working memory and language) will be assessed using a brief neuropsychological battery; quality of life, using the WHOQol- AGE and EUROQOL-5D questionnaire; blood pressure; glycaemia; body composition, using an impedancemeter; and different markers of inflammation, interleukin (IL) 6, IL-1 and tumour necrosis factor alpha (TNF); and different markers of inflammation, interleukin (IL) 6, IL-1 and tumour necrosis factor alpha (TNF-α).

Participants will be randomised using the Epidat 4.0 programme into 2 groups (control group and intervention group) with a ratio of 1:1. Both groups will be instructed to continue with their usual dietary pattern without changing their habits during the study period.

Those in the control group will not receive any amount of raisins to their usual diet. The participants in the intervention group will receive 50 g of raisins and instructions on the time of day to take it (at night). The duration of this intervention will be 3 months. The daily nutritional intake of this amount of raisins is as follows: 146 kcal; 0.25 g of fat; 34 g carbohydrates of which 34 g sugars; 1.3 g protein; 1 g fibre. The total polyphenol content of total polyphenols from 50 g of raisinas is approximately 532,5 mg (phenols explorer database).


Eligibility Criteria:
Inclusion Criteria:

* People of both sexes aged between 70 and 80 years.
* The score on the Mini Mental State Examination (MMSE) must be greater than or equal to 24 points.
* Self-employed to attend the centre where the study is carried out.
* Signature of the informed consent form.

Exclusion Criteria:

* Coronary or cerebrovascular atherosclerotic pathology.
* Diabetes mellitus
* Grade II or higher heart failure.
* Moderate or severe chronic obstructive pulmonary disease.
* Advanced renal or hepatic disease.
* Severe mental illness.
* Oncological disease under treatment diagnosed within the last 5 years or terminal condition.
* Morbid obesity (IMC ≥ 40 kg/m2).
* Intolerance and/or allergy to any of the grape components.
* Any other circumstance at the criterion of the researchers.
An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects

The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population.

* Part A will compare the PK of oral digoxin alone and in combination with an IV infusion of rolapitant.
* Part B will compare the PK of an oral dose of sulfasalazine alone to the PK of an oral dose of sulfasalazine in combination with an IV infusion of rolapitant
* Part C will compare the PK of an oral dose of the Cooperstown Cocktail (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan) alone and when given in combination with an IV infusion of rolapitant.

Eligibility Criteria:
Main Inclusion Criteria:

* Subjects must be healthy males or females aged 18 to 55 years (inclusive)
* Female subjects (of childbearing potential) must have a negative pregnancy test at Screening and on Day -1
* Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) before Visit 1 and to continue its use during the study and for at least 30 days after the final dose
* Subjects must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥50 kg at Screening
* Subjects must be capable of understanding the informed consent after the risks and benefits of the study have been explained; subjects must be able to sign a written informed consent and be willing to comply with the protocol requirements
* Subjects must be in general good health as determined by the Investigator based on pre-study medical and surgical history, physical examination \[PE\], and clinical laboratory tests

Main Exclusion Criteria:

* Subjects who have participated in another investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, before the time of the first study dose
* Subjects who have a history of relevant allergies (including asthma, food, or drug allergies) as determined by the Investigator
* Subjects who have had significant blood loss, or have donated or received ≥1 units (450 mL) of blood, within 30 days before the first study dose
* Subjects who have a history of hypersensitivity to rolapitant IV or any of its excipients or who have participated in a previous rolapitant study within 6 months prior to administration of the first dose of study drug (Day 1)
* Subjects with poor venous access and/or cannot tolerate venipuncture
* Subjects with a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject
* Subjects who have a history of hypersensitivity to sulfasalazine (Part B only).
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma

This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma.

A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with Advanced/Metastatic Hepatocellular Carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years
* Histologically or cytologically confirmed HCC (with the exception of fibrolamellar carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis)
* Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
* Metastatic or locally advanced meeting ANY of the criteria below:
* HCC not suitable to receive local therapy
* Disease recurred or was refractory to last therapy (local or systemic)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks

Exclusion Criteria:

* More than 2 prior systemic treatments for HCC
* Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor
* Presence of hepatic encephalopathy within 4 weeks of 1st dose
* Uncontrolled massive ascites
* High likelihood of bleeding
Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome

The purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiotherapy treatment of cervix cancer patients results in improvement for disease specific survival, tumor response and local control.

Definitive radiotherapy is the treatment of choice for patients with locally advanced cervix cancer. Low pre-therapeutic values of the intratumoral pO2 are associated with significantly worse therapeutic outcome and the blood hemoglobin levels correlate positively with the intratumoral pO2. Successful augmentation of hemoglobin levels by way of transfusion leads to improvement of therapeutic results. Therefore, a pre-therapeutic transfusion therapy is carried out routinely at a number of hospitals; however this therapy is due to its cost and risks limited to patients with an initial hemoglobin level of \< 10 g/dl. To avoid transfusions and to increase patients wellbeing, the efficacy and tolerability of erythropoietin was tested, when administered to increase the lowered hemoglobin levels in tumor patients. The question is, whether or not it is possible, to regularly raise the blood hemoglobin levels in patients with carcinoma of the cervix by administering erythropoietin. If a normal (\>12 g/dl) or rather an upper-normal (\>14 g/dl) hemoglobin level is reached, then the tumor oxygenation and thus also the response to radiation could be positively influenced. The objective of this study is to improve the response and control rates as well as the disease free survival rates in female patients with primary carcinoma of the cervix within the scope of the curative radiation therapy. The test hypothesis is that by administering erythropoietin the hemoglobin levels are increased and through this increase the response of the tumor to radiation therapy will be improved.

Comparison(s): A prospective, randomized, multi-centric group of female patients treated with Erythropoietin is compared to a parallel stratified control group receiving no treatment.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven cervix cancer (FIGO stage I-IVA)
* Age of 19-80 years
* initial blood level of hemoglobin \<= 14 g/dl
* patients who gave their informed consent

Exclusion Criteria:

* Karnofsky-Index \< 50 %
* known intolerance of erythropoietin
* FIGO stage IVB
* blood transfusion within the last four weeks
* neoadjuvant chemotherapy
* previous radiation therapy of the abdomen
Atkins Diet for Difficult-to-Control Headaches in Teenagers

This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache improvement.

Patients are placed on the diet and followed with various measures for 3 months. If the diet is helpful it is continued. Patients are still being enrolled as of 9/6/06.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12-19
* Minimum 15 headaches/month for at least 3 months
* Tried 2 preventative medications previously

Exclusion Criteria:

* Prior use of the Atkins diet for more than 1 week
* Pregnancy
* Significant heart or kidney disease
* Dangerously underweight
* Using acute pain medications more than 11 days in the past month
* Medications being changed