cyrilzakka/clinical-trials huggingface dataset:
Treatment Recommendations for Patients With ADHD TDApp2

The purpose of this study is to compare the recommendations made by TDApp2 with those by relevant clinical practice guidelines in children/adolescents with ADHD.

Clinical practice guidelines (CPG) allow optimizing medical decisions and health care based on the best evidence available. Nevertheless, CPGs have several limitations. First, many GPC are outdated shortly after their publication. Second, CPG recommendations are often not applicable to many patients treated in clinical practice. Most CPGs do not make recommendations for complex patients with comorbidities. Another limitation is that patients involvement in CPGs development is still poor. To overcome these limitations, study investigators developed TDApp, an eHealth tool to formulate decentralized, participatory, individualized and automated pharmacologic treatment recommendations for patients with Attention Deficit Hyperactivity Disorder. TDApp was initially tested in a clinical sample of ADHD patients (https://clinicaltrials.gov/ct2/show/NCT04228094), but, as it was the first human use, treatment recommendations were kept hidden to the clinicians until the last patient enrolled completed study participation. This safeguard was implemented to avoid potential misguidance. After completing this study, the investigators developed a new iteration of TDApp (TDApp2) that can also recommend non-pharmacological interventions.

In this study, the investigators aim to assess TDApp2: an eHealth tool that formulates participatory, participatory, explainatory and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder. The recommendations made by TDApp2 will be compared with those made by relevant clinical practice guidelines in children/adolescents with ADHD.

A 6-week, one group, open label study will be conducted. Tirty-two children/adolescents aged \< 18 yo with ADHD and their parents will use TDApp. The treatment recommendations made by the TDApp2 will be compared to those made by relevant CPG (American Academy of Pediatrics CPG, Canadian ADHD Resource Alliance (CADDRA) GPC, National Institute for Health and Care Excellence (NICE) GPC, the Australian ADHD Professionals Association guideline, and the Spanish GPC). As the study will be carried out in Catalonia (Spain), the primary comparison will be performed vs. the Spanish CPG. Also, TDApp2 recommendations will be compared with the actual treatment prescribed by the clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6-17 yo
* Meeting DSM 5 criteria for ADHD
* Requiring treatment initiation for ADHD or requiring a treatment change

Exclusion Criteria:

* Patients who are receiving treatment for ADHD and who are well controlled with it
* Patients who do not have a suitable electronic device for TDApp2
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium

To evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and multi-knot interrupted sutures.


Eligibility Criteria:
Inclusion Criteria:

* patients with primary pterygium

Exclusion Criteria:

* eye surgery history
* acute ocular surface imflamation
* patients with coagulation or diabetes mellitus
Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)

This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, and it also validates several new techniques for measuring social behavior. mSITE blends brief in-person psychotherapy with a context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct a randomized clinical trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions in comparison to a therapist and device matched condition. The investigators will changes in outcome measures at baseline and Weeks 8, 18, and 30. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary informed consent to participate and capacity to consent; Age 18 to 65;
* Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;
* Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
* Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).

Exclusion Criteria:

* Prior CBT in the past 2 years;
* Greater than moderate disorganization on the PANSS (P2- Disorganization item \>5);
* Alcohol or substance dependence in past 3 months based on the diagnostic interview;
* Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);
* Unable to adequately see or manually manipulate a phone;
* Resident of an integrated housing facility that also provides treatment services.
Spiration Valves Against Standard Therapy

VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.


Eligibility Criteria:
Inclusion Criteria:

* Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
* Subject has air leak present on at least the 5th day following origination.

Exclusion Criteria:

* Subject has air leak only on forced exhalation or cough
* Subject has sepsis
* Subject has pneumonia
* Subject has Acute Respiratory Distress Syndrome (ARDS)
* Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
* Subject has undergone a bone marrow transplant
* Subject has a primary pneumothorax
* Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
Tc99m Macroaggregated Albumin Bronchial Artery Study

This is a single-arm, single-center, prospective pilot study to perform bronchial artery Tc-99m-MAA infusion to determine the predicted whole lung versus lung tumor dosimetry of a possible intra-arterial radioembolization.

This study is a prospective, single-arm pilot study for patients presenting with hemoptysis from lung cancers. Prior to a therapeutic bronchial artery embolization (standard therapy), Tc99m-MAA will be administered to the bronchial artery and an imaging will be obtained to determine the distribution of MAA.

The primary objective will be quantification of Tc99m-MAA uptake within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. Dosimetry will be reported for each patient, as well as range and mean with standard deviation. Additional activity calculation methods and reporting metrics may additionally be used. Non-statistical comparison will be made to literature-reported external-beam radiation dose-related tumor response and adjacent-organ toxicities to develop a preliminary assessment of the potential for efficacy and anticipated safety-profile of Yittrium-90 bronchial artery radio-embolization.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age and older
* Patients with known active lung cancer with a history of prior hemoptysis presenting for bronchial artery embolization will be considered.
* Patients must be presenting for secondary prophylaxis of hemoptysis
* Willing and able to understand and sign a written informed consent document.
* Willing and able to undergo all study procedures.

Exclusion Criteria:

* Patients with current active hemoptysis
* Any acute or chronic inflammatory disease or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results.
* If female, not of childbearing potential or negative serum β-human chorionic gonadotropin pregnancy test prior to radiotracer injection.
* If female, not nursing.
* Subjects who have exclusion criteria that would prevent them from receiving a CT scan or fluoroscopy, or administration of contrast.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin
Needle Puncture Point During Central Venous Catheterization With Ultrasound Guidance

In this observational study, we will measure the shortest distance from the cricoid cartilage level to the puncture site of the introducer needle when anesthesiologists perform central venous catheterization.

After anesthesia induction and tracheal intubation, we will prepare central venous catheterization for patients requiring it. After anesthesiologists who are blinded to this study perform central venous catheterization, an investigator measured the shortest distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery under general anesthesia
* requirement of central venous catheterization

Exclusion Criteria:

* disagreement for participation
Effects of Food Cooking on Diabetes-2 Risk Factors

The aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.


Eligibility Criteria:
Inclusion Criteria:

* women, healthy between 20 and 50 y
* BMI between 25 and 40 kg/m2
* weight circumference over 88 cm

Exclusion Criteria:

* weigh changes within the last 2 months more than +/- 3 kg
* Physical activity more than 8 h per week
* smoking
* medications and supplements
* being vegetarian or vegan
* pregnancy or breast feeding
* postmenopause
* chronic disease
* previous gastric bypass surgery
* blood donation within the last 3 months
* Involvement in other clinical trials
* allergic to paraaminobenzoic acid
Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion after a single subcutaneous dose of \[3H\]-semaglutide in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, based on an assessment of medical history, physical examination, ECG (electrocardiogram) and vital signs, as determined by the investigator
* Age between 45-64 years (both inclusive) at the time of signing inform consent
* Body mass index (BMI) between 20 and 30 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Donation of any blood or plasma in the past month or in excess of 100 mL within the 3 months preceding screening, or surgery or trauma with more than 100 mL blood loss within the 3 months preceding screening
* Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2, Day 1
* History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
* Smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

The purpose of this study is to determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis

Part 1: To observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte Part 2: Pharmacokinetics of thymosin alpha 1 for sepsis

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent from the patients or their next of kin for patients unable to consent
2. Age ≥18 yrs
3. Presence of sepsis/ septic shock according to sepsis 3.0

Exclusion Criteria:

1. Pregnant or lactation period.
2. Age \<18 yrs
3. Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.
4. History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation;
5. Acute pancreatitis with no established source of infection.
6. Not expected to survive 28 days because of end-stage diseases.
7. Participation in another clinical trial.
The Effect of Ketamine on Postoperative Cognitive Dysfunction.

Available evidence suggests that there is no significant difference in the incidence of postoperative cognitive dysfunction POCD when general anaesthesia and regional anaesthesia are compared\[13, 14\]. To the knowledge of the investigators , no studies are examining the effects of ketamine on cognitive outcomes in the setting of spinal anesthesia.

Thus, the purpose of this study was to compare the cognitive status, as assessed by the SPMSQ, of elderly patients undergoing orthopaedic surgery under spinal anaesthesia before and after ketamine administration. The authors hypothesized that patients receiving ketamine would exhibit better cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for orthopaedic surgery under spinal anaesthesia.
* ASA physical status I to II.

Exclusion Criteria:

* Patients with a history of psychosis, schizophrenia, nephropathy, uncontrolled blood pressure, uncontrolled hepatic disorders, or allergy to ketamine.
* Patients With moderate to severe depression according to Yesavage abbreviated Geriatric Depression Scale,
* Patients presented with postoperative delirium or required medications other than study drugs.
* Ketamine administration is contraindicated.
Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19

Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.


Eligibility Criteria:
Inclusion Criteria:

* Patients are being considered for discharge to independent care
* Participant is willing and able to give informed consent for participation in the study.
* Patient with independent, stable, gait
* Patient is alert, attentive, coherent, and calm
* Male or Female, aged 18 years or above.

Exclusion Criteria:

* Minor injuries
* Elective surgery patients
* Post-operative patients at discharge
* Requires supplemental oxygen
* Shortness of breath at rest (i.e. Borg or Numerical Rating Scale \>=2)
* Unstable angina
* Patients on long-term-oxygen therapy
* Pregnancy as stated by patient
* Oxygen saturations \< 95% on room air
* Resting heart rate \> 100 bpm
* Resting respiratory rate \> 25 bpm
* ECG with signs of acute ischemia in patients where an ECG has been requested by the treating clinician
* National Early Warning Score of 5 or more
* Nursing home residents, or those being transferred to a nursing home or similar care facility
Central Venous Pressure Change With Volume Challenge in Patients With Hemodynamic Instability

We conducted this study to assess the value of early change in central venous pressure (CVP) in predicting fluid responsiveness in mechanically ventilated patients.

In patients with shock a primary goal of treatment is to restore and maintain organ perfusion, for which an adequate cardiac preload is required. Apart from the situations in which hypovolemia is evident and a favourable response to fluid administration will be seen, clinical and biological parameters often fail to predict hypovolemia. Inappropriate use of volume expansion carries out the risk of generating volume overload and pulmonary oedema. Consequently, reliable predictors of fluid responsiveness are needed especially in the early phase of cardiocirculatory deterioration. In the clinical setting, different static and dynamic indices have been shown to be useful indicators of cardiac preload. Central venous pressure (CVP) is widely used to measure right ventricular preload in patients requiring invasive hemodynamic monitoring. However, the use of the CVP is much criticized because CVP poorly predicts cardiac preload and volume status. However several decades ago, Weil and Henning proposed the fluid challenge technique, based on the 2-5 rule using CVP. There is a method for guiding volume repletion based on measurements of the patient's response to fluid load. This method has not been validated in the prediction of fluid responsiveness. We therefore conducted a prospective study that in all patients we measured CVP change and stroke volume variation (SVV) after administration of fluids. Patients were classified as fluid responders when their SVV is \>10% after volume expansion and non-responders if SVV is ≤10%.

Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated patients
* acute circulatory failure defined by the need of vasopressive drugs (dopamine \>5µg/kg/per minute or norepinephrine) with signs of tissue hypoperfusion (e.g., altered mental state, mottled skin, urine output below 0.5 ml per kilogram of body weight per hour during at least 2 h).
* admission serum lactate level more than 2.5mmol/L

Exclusion Criteria:

* severe hypoxemia defined as a ratio of arterial oxygen pressure to fraction of inspired oxygen \[PaO2/FiO2\] \< 100 mmHg
A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer

The IPTLD QoL Broad Study.

A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cancer,
* age older than 18 years,
* requesting IPTLD and nutrition therapy

Exclusion Criteria:

* diagnosis other than cancer,
* age younger than 18 years,
* requesting conventional chemotherapy
Reducing Reconsolidation of Trauma Memories With Propranolol

The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Suffer from chronic PTSD for at least 6 consecutive months;
* Obtain a score of 33 or more on the Impact of Events Scale-Revised:
* For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;
* Accept to not commence taking new medications on a regular basis during the study.

Exclusion Criteria:

* Hypotension;
* Cardiac rhythm below 55 beats per minute;
* Medical conditions that contraindicates the administration of propranolol;
* Previous adverse reaction to, or non-compliance with, beta-blockers;
* Current use of medication that may involve potentially dangerous interactions with propranolol;
* Any medication that can have an impact on cardiac rhythm;
* Women who are breast feeding;
* Past or present bipolar disorder or psychosis,
* Present substance abuse or dependence, suicidal ideation;
* Participating in psychotherapy other than support psychotherapy;
* An average score above 20 on the Dissociative Experience Scale.
Influence of Transcranial Direct Stimulation Current on Motor Learning of Young Adults

Motor learning occurs with structural and functional modifications in neural networks that meet a certain demand. The improvement of performance in diverse activities is a measure of learning, as well as the generalization and transference of this capacity. Transcranial direct current stimulation (tDCS) is a modulation technique of brain activity that modifies cortical excitability, causing changes in motor evoked potentials that influence motor learning. Modifications similar to the long-term potentiation, essential for learning processes, have also been described after applying tDCS. The primary motor cortex is the area of stimulation where there is more robust evidence in favor of increased motor learning. PURPOSE: to investigate the effects of anodic tDCS on the learning of sequential finger movements in young and healthy individuals.

Thirty-six young healthy individuals, right-handed, with no deficits that difficult the performance of the procedures will participate in the study. These individuals will be randomly divided into an experimental group that will perform the motor training of a sequential task of fingers simultaneously to the anodic tDCS on the contralateral motor cortex the trained hand and a control group that will perform the same training simultaneously the stimulation placebo (simulated in the same region of the experimental group). The training will consist of 8 blocks with 300 repetitions of sequential finger movements performed with only the right upper limb. The speed and accuracy of sequential movements will be used as a measure of performance. These measures will be performed prior to training, immediately after, 48 hours, 7 days, and 28 days after trained hand training (TH) for assessment of short and long term learning. In addition, performance evaluations (1) of the reverse-trained sequence in TH will be performed to evaluate the generalization; (2) of the trained sequence in left hand (non-trained) to evaluate the intermanual transfer; and (3) trained sequence in TH in double-task condition to evaluate automaticity. Appropriate statistical methods will be used to identify inter- and intra-group differences.

Eligibility Criteria:
Inclusion Criteria:

* Young subjects aged between 18 and 35 years, right-hand (evaluated by the Edinburgh Inventory), of both genders, attending the third grade in a private university.

Exclusion Criteria:

* Individuals using central nervous system drugs with uncorrected visual and / or auditory disorders who have any neurological, psychiatric, or orthopedic diseases and who have differentiated finger, musician or typist skills will be excluded.

Due to the electrostimulation procedure, individuals who use hair chemistry, individuals who have a metallic implant on the head or a pacemaker, and who have scars in the region to be stimulated will also be excluded.