cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Mechanism of Augmentation of Cognitive Behavioral Therapy With Transcranial Alternating Current Stimulation(tACS) for Obsessive-Compulsive Disorder (OCD)

This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Alternating Current Stimulation (tACS) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by electroencephalography (EEG).

The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT (ERP) combined with tACS over the prefrontal cortex (mPFC) in treatment of OCD patients. 120 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into three groups (ERP+active tACS, ERP+sham tACS stimulation and waiting list). All patients except those in the waiting list will be received 10 sessions of individual CBT in a two-month period, including 8 sessions of concurrent tACS with ERP (tACS+ERP). Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive EEG at each point. The current study aims to explore whether the administration of online tACS together with ERP (tACS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.

Eligibility Criteria:
The investigators recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and exclusion criteria were also applied:

Inclusion Criteria:

* 18-60 years old,
* With at least 9 years of education
* Y-BOCS score ≥16
* No history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary)
* Medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study
* No previous exposure to ERP or tACS

Exclusion Criteria:

* History of serious medical, neurological illness or other psychotic disorders other than OCD
* OCD symptoms are severe, preventing the patient from completing the required assessment and examination
* Serious suicide risk
* Women who are pregnant or planning to become pregnant
* Currently taking antiepileptic medication
* Clinically significant physical illnesses or laboratory test abnormalities that have clinical significance
Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease

The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42 levels in the CSF, and b) cognitive function in people with mild to moderate Alzheimer' Disease (AD).

The purpose of this study is to test the effects of long-term therapeutic doses of formoterol, on a) cerebrospinal fluid CSF tau levels, and A-beta amyloid protein 40/42 levels, and b) cognitive function: NE-ergic neurons undergo significant degeneration in AD. This system plays a significant role in cognition. Recent studies have indicated that increasing NE levels in the brain would significantly improve microglia migration and clearance of A-beta amyloid protein 40/42 levels in mouse models of AD. The investigators plan to test whether long- term daily treatment with inhaled formoterol solution would improve the structure and function of hippocampal neurons in AD. Study Design: Randomization and initiation of experimental treatment: All participants will be given formoterol daily for 52 weeks. The active regimen will be initiated as (20 micro gram, BID). The dose will be decreased if there is evidence of side effects, including cardiac or respiratory alteration changes, gastro-intestinal disturbances or neurological issues.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 50-85,
* Mild-to-moderate AD (NINCDS/ADRDA criteria for probable AD will be used to establish AD diagnosis).
* MMSE 16-26.

Exclusion Criteria:

* Non-AD dementia or significant neurological disease such as Parkinson's disease, stroke, brain tumor,multiple sclerosis, seizure disorder, focal brain lesion, or head injury with loss of consciousness.
* Hypothyroidism, congestive heart failure (New York Heart Association Class III or IV), significant extrapyramidal symptoms on neurological examination, serum creatinine\>1.3 mg/dl, significant arrhythmias or conduction defect abnormalities on ECG,
* Use of another beta2 adrenergic drug within the last 2 months.
* Residence in a long-term care facility.
* Evidence of any significant clinical disorder or laboratory finding that renders the person unsuitable for receiving an investigational new drug.
* Known hypersensitivity or prior exposure to formoterol.
* Active asthma or family history of asthma.
Broadband Amplification as Tinnitus Treatment

* The effect of broadband amplification was tested in a double-blinded crossover study
* Its effect was compared to an active placebo treatment
* An improvement in tinnitus distress was found after use of broadband amplification
* No effect was found on the tinnitus loudness

This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.

Eligibility Criteria:
Inclusion Criteria:

* Chronic tinnitus
* hearing thresholds (\<=25 dB HL) up to 2000 Hz and hearing loss at frequencies above 2 kHz
* inexperienced hearing aid user

Exclusion Criteria:

* objective or pulsatile tinnitus
* Ménière's disease, otosclerosis, stapedectomy, stapedotomy or tympanoplasty
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation

Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Non-mechanical ventilation patients with expected ICU stay time \>24h
* People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);

Exclusion Criteria:

* pregnancy；
* can not get pain score from patients
* allergy to drugs
* ....
Honey in Idiopathic Dilated Cardiomyopathy

Background: Honey, as a natural product produced by honey bees, has anti-oxidant, anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that honey might have positive effects on cardiovascular diseases.

Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2 to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly assigned into two equal groups: the honey group and the control group. In the honey group, honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional treatment of IDC. The patients in the control group received only their standard treatment, without honey. The main outcome measure was the percent change in the ejection fraction (EF) and the fraction shortening (FS) shown in echocardiography.

Background: Honey, as a natural product produced by honey bees, has anti-oxidant, anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that honey might have positive effects on cardiovascular diseases.

Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2 to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly assigned into two equal groups: the honey group and the control group. In the honey group, honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional treatment of IDC. The patients in the control group received only their standard treatment, without honey. The main outcome measure was the percent change in the ejection fraction (EF) and the fraction shortening (FS) shown in echocardiography. Patients in each group were subjected to history taking, clinical examination and investigations, including ECG and echocardiography at baseline and end of the study. Patients continued their standard treatment during the study. The honey used in the study was subjected to physicochemical analysis before use, and it was kept in closed containers away from light until the time of administration.

Eligibility Criteria:
Inclusion Criteria:

1. Echocardiographic diagnosis of dilated cardiomyopathy (DCM), based on the presence of left ventricular enlargement and systolic dysfunction with an ejection fraction \<45%.
2. The echocardiographic findings included left ventricular dilatation and systolic dysfunction, with or without mitral regurgitation

Exclusion Criteria:

1. Other types of cardiomyopathy
2. Systemic or chronic illness, including cancer, endocrine disorders and sepsis
3. Children with diabetes mellitus
4. Ischemic heart disease diagnosed by coronary angiography or a history of myocardial infarction
5. Systemic hypertension with a blood pressure \>170/100 mm Hg -
Methods of Assessing Fitness and Physical Capacity

Aerobic fitness is an important part of sport training preparation for wheelchair rugby players. Currently, there are some test protocols on arm crank ergometer for spinal cord injury people. However, wheelchair propulsion seems to be better and more specific movement to assess aerobic fitness in wheelchair rugby player. Thus, this pilot study was designed to determine the reliability of the aerobic fitness test protocol on a wheelchair ergometer for wheelchair rugby players.

Methods Ten wheelchair rugby players (C5/6 = 4, C6/C7 = 3, C7/th1 = 1 all with incomplete lesions, cerebral palsy (CP) = 1; dysmelia = 1; mean age = 32,90 yr. ± 5,17; body mass = 70,04 kg ± 12,53; body height = 177,70 cm ± 18,64) participated in the aerobic fitness test on the Lode Esseda wheelchair ergometer (LEM Software 10.12, Groningen, Netherlands). This test involved different considering players' International Wheelchair Rugby Federation (IWRF) class (class 0.5 = 4 players, classes 1.0-1.5 = 6 players, and classes 2.0-3.5 = 8 players) increments of workload every minute at constant velocity of 4.5 km/h. Peak oxygen uptake (V̇O2peak l/min, V̇O2peak ml/kg/min), minute ventilation (VE), and the test time achieved were collected (Cortex Metamax). The load \[N, Watts\] from the last fully achieved level in the test was noticed. Participants repeated the aerobic fitness test twice with 24h break. Each player had 10 minutes warm-up before the test. Differences (T-test for independent groups or Wilcoxon test) and correlations (Pearson test or Spearman test) between results from the first and the second repetition of the test (fully achieved load level in the test) were calculated to establish reliability. The intra-class correlation coefficients (ICC) and standard error of measurement (SEM) were added. The significance level was set at p\<.05

"the Lode Esseda" is the name of a wheelchair ergometer.

Eligibility Criteria:
Inclusion Criteria:

- wheelchair rugby players - elite athletes, national team athletes

Exclusion Criteria:

- not healthy participant
Nurse-led Pain Education Clinical Trial in Chronic Pain Patients

Chronic pain is a multidimensional problem that consequently requires interventions on multiple levels. Pain education by physicians is one of the interventions that shows promising results in patient reported outcomes. It is however unclear if nurse-led chronic pain education could be equally effective on pain attitude and behavior in chronic pain patients. The aim of this clinical trial is to investigate the effects of a nurse-led consultation with chronic pain patients on pain attitude and patient satisfaction compared with regular care without nurse specialist intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* dutch speaking
* first time consultation

Exclusion Criteria:

* Palliative care patients
* Patients with dementia diagnosis
* Urgent referral to the pain clinic by other physicians
Study of LY3154207 in Healthy Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of 19 to 32.0 kilogram per meter square (kg/m²)
* Are 18 to 50 years old, inclusive, at the time of screening

Exclusion Criteria:

* Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
* Are unwilling to refrain from consuming caffeine- or xanthine-containing food and drink from 48 hours prior to admission and while resident in the CRU
* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
* Have participated in a \[14C\]-study within the last 4 to 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of 1 other previous \[14C\]-study within 6 to 12 months of this study (if the previous studies' radiation exposure is not known) or a maximum of 2 other previous \[14C\]-studies within 4 to 12 months of this study
* Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)
Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.

The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers.

The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.

Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation
* The patient has signed the informed consent form
* No LAA previous ablation procedure
* No valvular disease
* LVEF ≥ 35% prior to recruitment
* Age ≥ 18 years

Exclusion Criteria:

* LVEF \< 35 %
* Hyperthyroidism or hypothyroidism
* Mental or physical illness incapacitation
* Planned cardiac procedure
* Non-controlled hypertension
* Terminal renal failure or dialysis
* Class IV of the NYHA
* Age ≥ 75 years
* Life expectancy \< 2 years
* Atrioventricular block
* Pregnancy
Triple Recipient Strategy Using Split, Domino, and Auxiliary Techniques

The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients".

The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients". Three recipients had hepatitis C cirrhosis, argininemia, and hepatocellular carcinoma (HCC), respectively. The investigators performed SLT in the first two recipients (an adult and a child), with the donor liver coming from a female who died of severe head trauma. The right lobe of the child, as the "domino liver graft", was transplanted to the postoperative HCC patient, whose left lateral lobe was preserved after tumor resection. All recipients were discharged from the hospital. During the 12 months of follow-up, all three recipients remained alive.

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* argininemia
* hepatocellular carcinoma

Exclusion Criteria:

* Patients who do not require an allogeneic liver transplantation.
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.

Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants who are:

  1. 500 to 1250 grams at birth
  2. \< 30 weeks gestational age
  3. 5 to 14 days of age (inclusive) at the time of entry
  4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)

Exclusion Criteria:

1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
3. Subjects who are dependent on right to left shunting to maintain the systemic circulation
4. Preterm infants who received prior iNO therapy
5. Use of another investigational agent
Small Volume Simethicone Before Gastroscopy: Any Benefit?

A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.

Excessive bubbles or foam during gastroscopy is a common problem which can cause significant hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and contribute to poor patient tolerance during the scope.

Simethicone, with or without N-acetylcysteine, has been extensively evaluated to improve mucosal visibility. However, the volume of simethicone preparation and the timing of ingesting this solution before gastroscope varied significantly across different studies. In general, it appeared that a larger volume of simethicone solution, given earlier before the gastroscopy, may yield better results. However, allowing a patient to ingest a large volume of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent Taiwanese study published in 2014 \[1\] showed that the subgroup with 100mg of simethicone in just 5ml of water, did achieve a good total mucosal visibility score, if the solution was ingested more than 30 minutes before the gastroscope. This may be because a longer time allows the simethicone to coat more of the mucosa. However, this study did not compare this preparation against a placebo.

In Changi General Hospital, many gastroscopies are done daily with no premedication. Also, there is no protocol for premedication before gastroscopes. This study hopes to prove that a low volume of simethicone solution, given at an ample time (more than 30 minutes) before the scope, can significantly improve overall endoscopy performance compared to no premedication at all.

Eligibility Criteria:
Inclusion Criteria:

* Planned for an elective diagnostic gastroscopy by the attending gastroenterologist
* Age of at least 21 years old
* Mentally competent and able to provide informed consent

Exclusion Criteria:

* Category A patients (incarcerated prisoners)
* adults who are unable to give their own informed consent due to lack of mental capacity
* suspected gastrointestinal bleeding
* suspected impacted foreign material
* suspected gastric outlet obstruction
* suspected esophageal obstruction
* history of dysphagia
* known hypersensitivity to simethicone
* previous gastrectomy