cyrilzakka/clinical-trials huggingface dataset:
European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients

The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies.


Eligibility Criteria:
RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES

INCLUSION CRITERIA:

Participants must meet the following inclusion criteria to be eligible.

* Male or Female (age over 55 years). Females must be non-child-bearing potential. Male patients with female partners of child-bearing potential should use effective contraception for the duration of the Study.
* A diagnosis of probable Alzheimer's disease established in accordance with the National Institute of Neurological and Communicative Disorders and Stroke /Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) classification.
* Severity of dementia of mild to moderate as assessed by the Mini-Mental State Examination (MMSE) score of 12-24.
* Patients must be living in the community living with or have at least daily visits from a responsible carer. The carer should be capable of assisting with the patient's medication, and prepared to attend with the patient for assessment.
* Written consent should be obtained from the patient and responsible carer.

EXCLUSION CRITERIA

Patients will not be eligible to participate in the study if they meet any of the following criteria:

* Primary, secondary or pseudodementias other than probable Alzheimer's disease.
* Clinically significant and/or uncontrolled condition or other significant medical disease.
* If taking medication for symptoms of dementia, the patient must be stable on therapy and have been taking these for a minimum of 3 months prior to enrolment.
* Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity.
* Non-steroidal or steroidal anti-inflammatory agents. However, patients stable on low dose aspirin (upto 300mg/day) for at least 3 month prior to enrolment will be eligible.
* Taking anti-oxidant supplements.
* Active smokers of tobacco.
* Considered to be malnourished (body mass index \<19).
* Patients in whom a lumbar puncture is contra-indicated.
The Early Predictors for Developing Type 2 Diabetes Mellitus in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease(COPD), characterized by persistent airflow limitation, associated with an progressive chronic inflammatory response of the lung to noxious particles or gases, can lead to dyspnea and limited mobility and influence the life quality of patients severely. Type 2 diabetes mellitus(T2DM), as a common complication of COPD, has got more attention in comprehensive control of COPD. Stress response and metabolic disorder are more likely to happen in COPD patients with T2DM in high level inflammation status, which decrease the drug efficacy, increase the risk of acute exacerbation of COPD, complications and mortality.

Both COPD and T2DM are chronic inflammatory disease with long term, there is close relationship in occurrence and development of each other, and the patients with severe COPD are more likely to develop T2DM. Monitoring the acute inflammation maker of C reactive protein (CRP) and IL-6(interleukin-6) is the most useable way to predict the inflammatory status and condition of COPD patient with T2DM, however the chronic inflammation maker is lacking. Neutrophil-to-Lymphocyte ratio(NLR), platelet-lymphocyte ratio (PLR) and lymphocyte-monocyte ratio (LMR) , the new, cheap and easy-tested chronic inflammatory markers, have got great research in early predicting the tumor such as nasopharyngeal carcinoma, soft tissue sarcoma and small-cell lung cancer,among them, NLR has manifest promising application in predicting insulin-resistance. However the value about NLR,PLR and LMR to predict the T2DM in COPD patients remain unknown and many articles related to NLR and COPD are retrospective.

The investigators attempt to analyze the risk factors and predict value of NLR,PLR and LMR about developing T2DM in COPD patients with prospective method.

All the subjects will experience the follow-up every six months, accompanying the monitoring of fast blood glucose (FBG). The complete follow-up will span three years. The follow-up for one patient will stop early when its FBG≥7.0mmol/L which indicates the patient has developed new T2DM.

The subjects will be divided into two groups according to whether patients develop T2DM at the end of each follow-up, namely, COPD patients with T2DM and COPD patients without T2DM

Eligibility Criteria:
Inclusion Criteria:

* The patients diagnosed with stable COPD but no T2DM between April 2017 to April 2020 at Zhu Jiang Hospital of Southern Medical University, will be included.

The diagnosis of COPD is according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Report.

T2DM diagnosis in accordance with the diagnostic criteria of WHO1999.

Exclusion Criteria:

* Patients will be excluded if they have other chronic or acute respiratory disease except COPD, such as bronchiectasia, lung tumor, interstitial pneumonia and hydrothorax; bilateral pulmonary multiple bullae; with metabolic disease such as T2DM, hyperthyroidism or hypothyroidism; questionnaire and laboratory dada was incomplete; with infection.
Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia

To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4 months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV risk reduction counseling (EDRC).

The Specific Aims of the proposed study are:

1. To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4 months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV risk reduction counseling (EDRC).
2. To better characterize patients with co-occurring ATS and heroin dependence (with regard to disturbances of mood, impulse control, executive functioning and patterns of drug use during MMT) and to evaluate the effects of atomoxetine on mood, impulsivity, and executive functioning (including attention, concentration, memory, and decision-making characteristics).
3. To provide training in drug abuse treatment, HIV prevention and treatment, and drug abuse clinical research to drug abuse clinical researchers and clinicians in Kota Bharu, Malaysia.

Eligibility Criteria:
Inclusion Criteria:

* Meet Opioid and Amphetamine-type stimulant (ATS)dependence, as assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM-IV) (SCID) and documented by opioid-positive and ATS positive urine tests.
* Report at least 2 or more days per week of ATS use over the past month.

Exclusion Criteria:

* Hypersensitivity to atomoxetine;
* Current use of a monoamine oxidase inhibitor (MAOI) or use within the preceding 2 weeks;
* Suffer from narrow angle glaucoma; pheochromocytoma; severe cardiovascular disorder; liver enzymes greater than 3 times the upper limit of normal; liver failure or acute hepatitis;
* Pregnancy or breast feeding;
* Current suicide or homicide risk;
* Current psychotic disorder or major depression;
* Inability to understand the protocol or assessment questions.
* A physician reviews the results of all baseline assessments and laboratory and other medical tests (CBC, chemistries, liver enzymes, HIV and Hepatitis B and C, EKG, chest x-ray), takes a medical history, and performs a physical examination in order to confirm the patient's eligibility for the study.
Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnostic of PSPS-T1/2 with leg pain and back pain,
* Patients older than 18 years
* 6 months with pain
* Visual Analogue Scale score \>7
* Spanish native language

Exclusion Criteria:

* Previous surgeries in abdominal area
* Pregnant or lactating
* Severe fractures or pathologies
* Spine structural deformity
* Neurologic or psychiatric issues.
Licorice and Home Blood Pressure

Out-of-office blood pressure is more strongly associated with cardiovascular risk than office blood pressure. Licorice is known to raise blood pressure, but no previous studies have measured the effects on home blood pressure. The aim of this study is to analyze the association between licorice intake and home blood pressure.

Healthy volunteers will be invited to participate in a randomized, non-blinded, cross-over study. Participants will be randomized to either of two groups with a 1:1 allocation ratio, stratified by sex. Intervention will be sweet licorice and control will be salty licorice. A run-in period of 1 week will be followed by a 2-week intervention/control, a 2-week washout period, another 2-week control/intervention period and again a 2-week washout period. Home blood pressure will be measured continuously, and blood samples (including potassium and aldosterone) will be collected every two weeks. Analyses will be made comparing baseline characteristics of the two groups, intervention/control and washout period results of the two groups to look for potential carry-over effects, and finally comparing intervention and washout period results respectively to the baseline data to look for the effects of licorice.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 30 years

Exclusion Criteria:

* known hypertension, cardiovascular disease, kidney disease, liver disease, hormonal disease, peanut allergy, eating disorder or headache disease (including tension headache and migraine)
* known alcohol abuse or drug abuse (including cannabis and anabolic steroids)
* treatment with hormonal drugs (including oral contraceptives
* known intolerance to licorice intake
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.

This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.

Eligibility Criteria:
Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
2. Willing and able to give informed consent

Exclusion Criteria:

1. Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
2. Any subject in Study KRX-0502-304 SAP who early terminated from the trial
3. Any subject who participated in Study KRX-0502-304 but declined EAP
4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
5. History of malignancy in the last five years
6. Previous intolerance to KRX-0502 (ferric citrate)
7. Intolerance to oral iron-containing products
8. Absolute requirement for oral iron therapy
9. Absolute requirement for Vitamin C (multivitamins \[Nephrocaps, Renaphro, etc.\] allowed)
10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
11. Inability to tolerate oral drug intake
12. Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
13. Inability to cooperate with study personnel or history of noncompliance
14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
Endometrial Injury In Recurrent Implantation Failure

The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.

This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

Eligibility Criteria:
Inclusion Criteria:

* Women under the age of 40 who met the RIF definition
* Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL

Exclusion Criteria:

* Patients with congenital uterine anomalies
* Patients with Asherman's syndrome
* Patients with uterine cavity distorted by myoma or endometrial polyps
* Patients with confirmed endometriosis or endometrioma
* Patients with BMI of \<18.5 and \>29.9
Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique

The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

During immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. Pain-reducing methods (Buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. Studies using the Helfer Skin Tap Technique and ShotBlocker Technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited.

Therefore, this study aims to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Born between 38 and 42 weeks of gestation,
* Between 2 and 4 months old,
* Applying to the family health center for KPA (Conjugated Pneumococcal Vaccine) application,
* No congenital anomalies, birth asphyxia or any chronic disease

Exclusion Criteria:

* Born prematurely or postmaturely
* Not between 2 and 4 months old
* Those who come to the family health center for the administration of other vaccines other than the KPA (Conjugated Pneumococcal Vaccine) application administered via IM route.
* Those with congenital anomalies, birth asphyxia or any chronic disease
Equine-assisted Therapy and Anorexia Nervosa

Background: Severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. Equine-assisted therapy could provide additional therapeutic benefits.

Objectives : The investigators aimed to explore the effects of equine assisted therapy on the experience of adolescents with severe anorexia nervosa.

Méthods : Using a qualitative approach based on Interpretative Phenomenological Analysis, the investigators conducted semi-structured interviews with nine participants who had taken part in equine-assisted therapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* having participated in at least 2 equine-assisted therapy sessions
* being or having been hospitalised between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)
* ICD 10 diagnosis F50.0/ F.50.1
* female gender
* age between 13 and 25
* fluent French
* consent (including parents if minor participant)

Exclusion Criteria:

* having been under the care of C. Lepy (resident) during hospitalisation at the Institut Mutualiste Montsouris (Paris)
* refusal to participate on the part of the participant or the holder of parental authority.
tDCS on Precuneus in MCS: Repeated Stimulations

In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).

Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.

Researchers expected to see an improvement of the CRS-R total score at the end of the anodal session and that this improvement persists for 5 days.

Eligibility Criteria:
Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma or vegetative state
* patients \< 1 months after the acute brain injury
* patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)
The MOTS (Medication Overuse Treatment Strategy) Trial

There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.


Eligibility Criteria:
Inclusion Criteria

* Adults, at least 21 years of age
* Chronic Migraine - diagnosed according to ICHD3beta criteria
* Medication Overuse - diagnosed according to ICHD3beta criteria
* Willingness to be randomized to either of the two treatment arms
* Willingness to maintain a headache diary
* Plan for follow-up care with the clinician
* No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.

Exclusion Criteria

* Younger than 21 years of age
* Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
* Not willing to be randomized to either of the treatment arms
* Not willing to maintain a daily headache diary
* Not planning on follow-up care with the clinician
* In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
* Prisoners
* Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
Development of Ketoacidosis During the Perioperative Period: an Observational Study 'The DKAP Study'

Rationale:

During perioperative period, prolonged starvation, surgical stress, acute complications (e.g. infection) and medication changes all promote ketone generation, therefore increasing the risk of ketoacidosis. At present, there is no literature concerning the ketone production in patients undergoing cardiac surgery, regardless of the diabetes status.

Objectives:

The objectives of this study are to explore the change in blood ketone level during the perioperative period in patients with and without diabetes, to observe the incidence of perioperative ketoacidosis, and to investigate therapy and outcome of patients with perioperative ketoacidosis.

Study procedures On the first day of admission, all the patients scheduled for cardiac surgery with an on-pump procedure will be asked for a consent for anonymous using of their information. Patients giving permission will be screened for participation in this study, and those fulfil the inclusion/exclusion criteria will be included for further research.

Blood ketone will be measured with StatStrip Glucose/Ketone Meters (Nova biomedical, United Kingdom) using sample leftover from blood gas analysis. No extra blood draw is needed. The levels of ketones will be measured at four time points:

1. Beginning of surgery;
2. The moment the cardio-pulmonary bypass machine takes over the circulation.
3. After the decoupling of the Cardio-pulmonary bypass machine
4. At the end of surgery.

Diagnosis of ketoacidosis is based on criteria mentioned. Epidemiology characteristics and perioperative variables will be extracted from electronic medical records.

Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Inclusion Criteria

* Aged eighteen years or older
* Scheduled for open heart surgery

Exclusion criteria

* Diagnosed with type 1 diabetes mellitus or latent auto-immune diabetes in adults
* Recently used sodium glucose transport co-enzyme 2 (SGLT-2i's) within 2 weeks before surgery)
* History of recurrent ketoacidosis (two times or more within three months)
* Emergency surgery
* (Suspected) pregnancy