cyrilzakka/clinical-trials huggingface dataset:
Double-Blind Naltrexone in Kleptomania

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 21-75
2. current DSM-IV kleptomania.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
2. history of seizures
3. myocardial infarction within 6 months
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
5. clinically significant suicidality
6. current or recent (past 3 months) DSM-IV substance abuse or dependence
7. illegal substance within 2 weeks of study initiation
8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline
9. initiation of a psychotropic medication within 2 months prior to study inclusion
10. previous treatment with naltrexone
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.
Effect of Pulse Oximeter Device on Measured Perfusion Index Values

The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.

Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult Volunteer

Exclusion Criteria:

* Post-traumatic upper limb conditions affecting finger perfusion
* Injuries or diseases of the skin of the fingers
* Any acute phase of any disease
Hypothermia in the Trauma Patient - When do Trauma Patients Get Cold?

The purpose of this study is to analyze changes in core body- and skin temperature during pre-hospital and early in-hospital treatment of multi-traumatized patients. The researchers want to investigate when trauma patients get cold and to what extent.

Hypothermia is a common finding in severely traumatized patients. Decreases in core temperature during the course of initial evaluation and resuscitation are common, and can contribute to poor outcomes in multi-traumatized patients.

In this study the temperature will be recorded continually with multiple skin probes and an ear-probe from the site of the accident to arrival in the intensive care unit (including time in primary surgery, if any).

Eligibility Criteria:
Inclusion Criteria:

* trauma patient with a ISS 9 or above.

Exclusion Criteria:

* \<12 years old
Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay

Currently, drugs commonly used for antiplatelet are aspirin and clopidogrel when encountering stroke or coronary heart disease. In this study, we would use VASP assay and thromboelastograph with platelet mapping assay kit to evaluate the antiplatelet resistance in general population and the relationship between clopidogrel and proton pump inhibitor.

This study intent is to search the standard to diagnose of the antiplatelet drug resistance and to discover the prevalence of drug resistance in Taiwanese population in Taiwan. The trial will enroll at least 30 healthy people after fulfilling the investigation questionnaire. All the participants will receive antiplatelet drugs in two separate period and measured the efficacy by VASP assay and thromboelastograph with platelet mapping assay. The health volunteer will receive clopidogrel and different types of proton pump inhibitor to see the interference of antiplatelet efficacy between each drug.

Eligibility Criteria:
Inclusion Criteria:

* 30 Healthy people, without major systemic disease, not under medication treatment

Exclusion Criteria:

* Systemic disease, under medication control with NSAID, anticoagulants, taking antiplatelet drugs before entering trial, Chinese herb, pregnant or breast feeding woman
Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients

The aims of this three-year study are to explore the protective and risk factors of resilience in colorectal cancer patients, and examine the effect of the resilience model-based care plan in reducing fear of recurrence and GI symptom distress and improving quality of life in newly diagnosed colorectal cancer (CRC) patients.

Develop and evaluate the effect of a resilience model-based total care plan on reducing fear of recurrence and GI symptom distress and improving quality of life (QOL) in this population.

Eligibility Criteria:
Inclusion Criteria:

* patients with stage I to III colon cancer.

Exclusion Criteria:

* patients with cancer other than colon cancer or have cancer recurrence.
Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.

The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of \[14C\] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male subjects
* Ages 18-50 years
* Body weight of at least 110 lbs (50kg)
* BMI of 18 to 32 kg/m\^2
* non-smoking

Exclusion Criteria:

* Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
* gastrointestinal disease including gastrointestinal surgery
* constipation or irregular bowel movements
Pramipexole to Target "Anhedonic Depression"

The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤75.
2. Diagnosis of unipolar depression; bipolar disorder in depressive phase or dysthymia.
3. Symptoms of depression; Total-score ≥ 18, measured by Montgomery-Åsberg Depression Rating Scale (MADRS).
4. Symptoms of anhedonia; Total-score \< 27, measured by Dimensional Anhedonia Rating Scale (DARS).
5. Ongoing treatment with at least one antidepressant drug ≥ 4 weeks without major changes in dosage. Patients with bipolar disorder must have a mood-stabilizing drug treatment.
6. Must sign an informed consent. -

Exclusion Criteria:

1. Ongoing pregnancy, breastfeeding or planning for pregnancy.
2. High suicidality assessed by the researcher with medical degree.
3. Ongoing substance use disorder (last 12 month).
4. Diagnosis of psychosis.
5. Ongoing involuntary psychiatric treatment.
6. History of Impulse-control disorder or current ADHD diagnosis.
7. Diagnosis of Intellectual disability, dementia, or other circumstances leading to difficulties to understand the implications of participating in the study and to give informed consent.
8. Diagnosis of renal failure (eGFR \< 50 ml/min/1,73 m2 ) or severe cardiovascular disease (defined as symptoms of heart failure NYHA class 2).
9. Recently committed to psychotherapy (during the last 6 weeks) or planning for psychotherapy during the participation of the study.
10. Ongoing ECT-treatment.
11. Other diseases, disorders or medical treatments that according to the researchers might influence the results of the study or increases the risks of the study. Such as Parkinson's disorder, liver failure, cancer not in remission (for at least over a year).
12. Confirmed or suspected allergy to the active substance or excipients of the drug used in this study.
13. Committed to other trials
14. Other reasons that according to the researcher might prevent the subject to fulfill the obligations of the study. For example insufficient drug compliance. -
SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction, characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs), versus other types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

Introduction:

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs) versus other type drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

Methods:

* Study Design: Retrospective cohort study or cross-sectional study.
* Participants: 60 patients with ICI-induced SJS/TEN and 100 to 500 patients with other drug-induced SJS/TEN.
* Data Collection: Detailed medical records were reviewed to extract information.
* Statistical Analysis: analysis using appropriate statistical tests (e.g., t-test, chi-square test).

Results:

Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

Conclusion:

We discuss the clinical implications of the findings, potential mechanisms underlying the observed differences, and the relevance to patient management. Summarize the main findings and their significance for clinical practice. Emphasize the need for tailored treatment approaches based on the type of drug causing SJS/TEN.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SJS/TEN induced by any drugs
* Have the immune-related cutaneous adverse events

Exclusion Criteria:

* Incomplete medical records
* Unknown the specific culprit drugs
Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child

Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy.

Hypothesis: the administration of probiotics during infancy has no effect on future dental health.


Eligibility Criteria:
Inclusion Criteria:

* Child participated in the probiotic milk intervention study in early 2000
* Child lives now within 100 km from Turku

Exclusion Criteria:

* Child has a chronic illness affecting dental health
* Child lives now outside 100 km from Turku
Umbilical Cord Blood Therapy for Children With Global Developmental Delay

This open-label study aims to evaluate the safety and efficacy of umbilical cord blood therapy for children with global developmental delay.

Global developmental delay (GDD) is a subset of developmental disabilities defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.

Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.

Eligibility Criteria:
Inclusion Criteria:

* Global developmental delay
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical instability including pneumonia or renal function at enrollment
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Uncontrolled persistent epilepsy
* Not eligible according to the principal investigator
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain

Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain \& ENT clinic visit

Exclusion Criteria:

* age \<18 or \>80
* pregnant women
* economically disadvantaged (not able to afford clinic visits/treatments)
* decisionally impaired (unable to obtain informed consent)
* has allergy to bupivacaine
* unable or unwilling to participate plans to participate in another clinical study at any time during this study
Early Versus Late Extubation in Myasthenia Gravis Patients

MYASTHENIA GRAVIS (MG) is an autoimmune disease characterized by varying degrees of muscle weakness and fatigability worsened with exertion and relieved with rest。Thymectomy plays an important role in the management of these patients because a consistent association between myasthenic and thymic pathology has been recognized.The need for prolonged mechanical ventilation in these patients after thymectomy is determined by their preoperative condition and various perioperative risk factors. Leventhal et al proposed a preoperative scoring system to predict the need for postoperative mechanical ventilation in myasthenic patients undergoing thymectomy based on the following 4 criteria: duration of MG, chronic respiratory disease, dose of pyridostigmine, and vital capacity. However, some investigators discovered that the Leventhal criteria may not be the sole benchmark and that other criteria such as severity of myasthenia,history of myasthenic crisis, and presence of thymoma may be more important in predicting the necessity for prolonged mechanical ventilation after thymectomy. Naguib et al described multivariate determinants of the need for postoperative ventilation after thymectomy in MG patients predominantly on the basis of pulmonary function tests. In addition, the prevalence and presentation of MG may be variable among different ethnic groups. However, there are very few large studies investigating the determinants of prolonged mechanical ventilation after thymectomy. The authors describe the parameters associated with prolonged mechanical ventilation after trans-sternal thymectomy at their institution.

Perioperative variables collected from the patient records were demographic data, duration of the disease,severity of the disease based on Osserman's classification, antiacetylcholine receptor (AChR) antibody positivity, preoperative drug therapy, history of preoperative myasthenic crisis, technique of anesthesia, drugs used for anesthesia, perioperative complications, and duration of postoperative mechanical ventilation. Even though the MG classification by the Myasthenia Gravis Foundation of America is widely accepted,disease severity was graded according to the Osserman and Genkins classification preoperatively as per the authors' institutional protocol.

Eligibility Criteria:
Inclusion Criteria:

* myasthenia gravis patients after thymectomy

Exclusion Criteria:

* not extubation
The Interaction Between Metformin and Acute Exercise

Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated.

It is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of acute physical activity with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.

Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo treatment in a double-blinded way. Following a treatment run-in period of 17 days, two experimental days (one with acute exercise and one without acute exercise), separated by one week, will be performed in each subject.

This registration concerns a sub-study of another study which has previously been registrered at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this registration have not previously been registered.


Eligibility Criteria:
Inclusion Criteria:

* Glucose-lowering-medication naïve T2D and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (PG) in the 75-g OGTT (7.8-11.0 mmol/L) and/or HbA1c (39-47 mmol/mol)
* Caucasian
* BMI \> 25 but \< 40 kg/m2
* Low to moderate physically active (≤90 min of structured physical activity/week)

Exclusion Criteria:

* Pregnancy
* Smoking
* Glucose-lowering treatment
* Treatment with steroids and other immunomodulating drugs
* Contraindication to increased levels of physical activity
* Liver disease (ALAT elevated more than 3 times above upper normal limit, or reduced levels of the liver function markers albumin and KF II+VII+X)
* Renal insufficiency (eGFR\<60 ml/min)
* Prior history of lactic acidosis
* HbA1c \>55 mmol/mol and/or 2-hPG in the 75-g OGTT \> 15 mmol/L
Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS

Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG 3350 + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium ascorbate and ascorbic acid (PEG-ELS).

Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.

Looking at the Incidence of Hyponatremia With Two Commonly Prescribed Purgatives for Colonoscopy-Polyethylene Glycol 3350 With a Sports Drink (PEG-SD) Compared to Polyethylene Glycol 3350 With Electrolyte Solution (PEG-ELS)

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older scheduled for elective outpatient colonoscopy: 8am - noon.

Exclusion Criteria:

* Unable or unwilling to consent
* Pregnant
* Breast feeding
* Significant psychiatric illness

  -\> 50% colon resection
* Bowel obstruction
* History of hyponatremia (Serum sodium \<135 mmol/L)
* End stage renal disease on dialysis
* History of chronic kidney disease (other than kidney stones)
* Decompensated cirrhosis, including:

  * History of bleeding due to portal hypertension (varices, gastropathy, etc) within 3 months
* Hepatic encephalopathy (not controlled with medications) within 3 months
* Clinical presence of ascites
* Active cardiac disease
* Recent myocardial infarction (\<4weeks)
* Unstable angina
* Congestive heart failure NYHA Functional Class Stage III or IV
* Stage III: Marked limitation of activity. Less than ordinary activity (e.g. walking short distances, 20-100 m) causes fatigue, palpitations, dyspnea. Comfortable at rest.
* Stage IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Exclusion Criteria (post-enrollment), from baseline labs:

* Serum creatinine \> 1.5 mg/dL
* Serum potassium \< 3.3 or \> 5.5 mmol/L
* Serum sodium \< 135 mmol/L or \>150 mmol/L
* Serum calcium \< 8.0 or \> 11.0 mg/dL
A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer

Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Non metastatic cancer
* 1 month post chemotherapy/radiation treatment (hormone treatment okay)
* Diagnosis of Primary or Secondary Insomnia

Exclusion Criteria:

* Presence of another sleep disorder
* Presence of another Axis I diagnosis (not in remission)
* Inability to attend at least 5 out of the 8 treatment sessions
* Randomization Refusal
* Previous participation in CBT-I or MBSR
* Shift work