cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose

Uncontrolled study

Eligibility Criteria:
Inclusion Criteria:

* Outpatient males or females 12 to \<18 years of age
* General good health with a documented history typical for recurrent herpes labialis
* Prodromal symptoms or active lesions suggestive of a recurrent episode of herpes labialis (i.e. having had cold sores in the past) , with onset not exceeding 24 hours until the time of study drug administration

  * Adolescents participating in Pharmacokinetics (PK) part of the study may be enrolled without an active herpes labialis recurrence or with onset of signs/symptoms of a recurrent herpes labialis episode longer than 24 hours before study drug administration, All adolescents participating in the pharmacokinetics assessments must fast for at least 8 hours prior to Visit 1 and be willing to fast for an additional 2 hours after study drug administration

Exclusion Criteria:

* Use of other investigational drugs within 30 days of enrollment
* History of hypersensitivity to famciclovir or penciclovir
* Inability to swallow tablets
* Body weight less than 40 Killograms (kg)
* History of malabsorption, unless a condition like celiac disease is stable and well controlled, previous gastrointestinal surgery or radiation therapy that could affect drug absorption or metabolism, or any condition that could interfere with drug absorption, distribution, metabolism, or excretion
* Known renal insufficiency (calculated creatinine clearance \<60 \[Milliliters/Minutes\] mL/min)
* Known severe hepatic impairment (Child-Pugh Class C)
* Significant skin disease such as atopic dermatitis or eczema that would interfere with assessment of oral/labial lesions
* Known to be immunocompromised or are receiving systemic or using topical immunosuppressive agents (including corticosteroids, tacrolimus and picrolimus) within 30 days of enrollment
* Concomitant use of probenecid
* Pregnant or nursing (lactating) females
* Females of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders

Self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (SUD). The Satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop healthier ways of relating to themselves and others. It offers a range of techniques to enhance self-esteem, challenging negative belief systems, and promote personal growth. The aim of the study is to investigate the acceptability and preliminary efficacy of the Satir model on self-esteem, mental health, and family function among individuals with SUD in China. The study will adopt a mixed-method approach. The quantitative phase will employ a randomized control trial (RCT) utilizing a pre-post study design. The qualitative phase will involve conducting semi-structured individual interviews.The data will be analyzed by using SPSS software package (IBM SPSS statistics version 26.0). The individual-interview will be analyzed by using the six-phase thematic analysis. The study has the potential to advance knowledge in the field of drug rehabilitation interventions, inform evidence-based practice, and improve the wellbeing and outcomes of individual with SUD. It can contribute to the ongoing efforts to address the complex challenges associated with substance use and support individual on their trajectory to recovery.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 or above;
2. are able to speak, read, and write Chinese;
3. are willing to participate in the study and share their experience of the intervention with the research group;
4. have informed consent to participate in the study.

Exclusion Criteria:

1. have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder;
2. have a diagnosed memory and cognitive impairment;
3. are undergoing psychotherapeutic or psychopharmacologic treatment;
4. are participating in similar studies.
Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.

The goal of this study is to examine whether a brief personalized fatigue-mitigation lifestyle coaching (PFMLC) for emergency medicine residents on overnight shifts would minimize the negative effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices.

Eligibility Criteria:
Inclusion Criteria:

* Stanford Health Care (SHC) Emergency Medicine residents (PGY 1 to 4)
* Scheduled to work at least 3 consecutive overnight shifts at SHC Emergency Department.

Exclusion Criteria:

* Non-Stanford Health Care (SHC) Emergency Medicine residents
* Stanford Health Care (SHC) Emergency Medicine residents who are not rotating in Stanford Emergency Medicine Department
Family Promoting Positive Emotions Pilot Study

Anhedonia is characterized by loss of interest or pleasure. The proposed pilot study would be the first to test an innovative, neuroscience-informed intervention in mothers reporting depressive symptoms and stress to enhance positive emotionality with the goal of preventing anhedonia and associated emotional disturbances in their children. This study will recruit dyads (mothers and their children) for the intervention.

Anhedonia, characterized by loss of interest or pleasure, is a primary symptom of depression. Depression is increasingly prevalent and can cause significant impairments in life functioning. Given the increased presence of stress during COVID-19, there is a significant need for interventions that can prevent the development of anhedonia and depression. This study examines a neuroscience-informed positive emotion intervention to determine its effects on preventing anhedonia and associated emotional disturbances in dyads of children and their mothers. Participants will be randomized to either receive the positive emotion intervention for 8 sessions for 8 weeks with a clinician or the self-administered written information condition. Depressive symptoms, anhedonia, stress and other internalizing disorders will be assessed at baseline, and at the end of the intervention.

Eligibility Criteria:
Inclusion criteria for mothers:

* Age 18 and older who report at least subthreshold current depressive symptoms (\> score of 8 on the Patient Health Questionnaire) and moderate COVID-19-related stress
* Can read and speak in English.
* Have access to a computer with a videoconferencing platform.

Inclusion criteria for children:

* Age 8-12 years who can participate with their biological mother who is 18 years or older that meets the above criteria.
* Can read and speak in English.

Exclusion criteria for mothers:

* Current substance use disorder.
* Intellectual disabilities.
* Diagnosis of mania or bipolar disorder.
* Diagnosis of a psychotic disorder (e.g., schizophrenia).
* Visual or hearing impairments that interfere with completing study measures and sessions.

Exclusion criteria for children:

* Diagnoses of autism spectrum disorders or developmental disorders.
* Intellectual disabilities.
* Diagnosis of mania or bipolar disorder.
* Diagnosis of a psychotic disorder (e.g., schizophrenia).
* Currently experiencing depressive symptoms.
* Visual or hearing impairments that interfere with completing study measures and sessions.
* Offspring of mothers who have previously participated in the study with another biological child.
Effects of LDX on Functioning of College Students With ADHD

The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) completed a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).

Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30, 50, \& 70-mg LDX per day). Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic Statistical Manual of Mental Disorders 4th edition-text revision (DSM-IV-TR) criteria for ADHD based on self- and parent-report using questionnaires and clinical interview

Exclusion Criteria:

* significant cardiac condition based on medical history and/or physical examination
* significant substance abuse based on self-report and toxicology screen at intake
* significant symptoms of major depressive disorder, bipolar disorder, or thought disorder based on initial diagnostic interview
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil

The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease
* On Memantine
* Caregiver who is willing to accompany the patient to all clinic visits

Exclusion Criteria:

* Unstable medical illnesses or significant hepatic or renal disease
* Other primary psychiatric or neurological disorders
Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy

The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy.

A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.


Eligibility Criteria:
Inclusion criteria :

* a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;
* age over 18 years;
* no distant metastases and/or disease progression;
* at least 25 scheduled radiation treatments (5 weeks);
* ability to read, write, and speak French.

Exclusion criteria :

* uncontrolled cardiac, hypertensive or pulmonary diseases,
* uncontrolled insulin-dependent diabetes mellitus,
* neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation
* abnormal electrocardiogram.
Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases

: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes \[1\]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy between 01/01/2011 and 31/12/2014
* Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)

Exclusion Criteria:

* Non IBD indication of antiTNFα treatment
Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER

During this IIT, the MSOT (Multispectral Optoacoustic Tomography ) Acuity Echo will be used to scan participants with Peripheral Arterial Disease assess MSOT Multispectral Optoacoustic Tomography (single-wavelength and hemoglobin-related parameters) in the Tibialis Anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization (LER ).

Primary aim of the study ist the Comparison of the difference between oxygenated, deoxygenated hemoglobin and oxygenation in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization.


Eligibility Criteria:
Inclusion Criteria:

* • Written consent of the participant after being informed

  * Adults above 18 years
  * Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

Exclusion Criteria:

* • Participants with previous LER on the same leg

  * Participants less than 18years
  * Pregnancy
  * Participants with tattoos in the scan area
  * Participants with no clinical indication for interventional LER
  * Missing consent form
Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

An increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute.

This randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. We hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted to the ICU
* Expected length of stay in ICU \> 3 days
* Mechanically ventilated, which enables indirect calorimetry
* Have central venous catheter wherein TPN can be administered
* Written proxy consent obtained (proxy consent defined as consent from two doctors, who are independent of the trial)
* Must be able to understand Danish

Exclusion Criteria:

* Contraindications to use enteral nutrition
* Contraindications to use parenteral nutrition, eg. hypersensitivity towards fish-, egg or peanut protein, or any of the active substances in the PN products
* Receiving a special diet
* Burns \> 10% total body surface area
* Severe hepatic failure (Child-Pugh class C) or severe hepatic dysfunction: Bilirubin ≥ 50 µmol/l (3 mg/dl) + alanine aminotransferase ≥ 3 times upper reference value
* Traumatic brain injury
* Diabetic ketoacidosis
* Hyperosmolar non-ketotic acidosis
* Known or suspected hyperlipidemia
* BMI below 17 or severe malnutrition
* Pregnancy
* The clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent
Scapular Kinematics of Young Swimmers

The aim of this study was to (a) compare the scapular kinematics of asymptomatic swimmers and healthy non-athletes and to (b) compare the scapular kinematics of the dominant and non-dominant shoulders in asymptomatic young swimmers.

This cross-sectional study included 27 volunteered asymptomatic young swimmers (mean age: 12.7 yrs) with at least 3 years of experience in a professional swimming club and 22 healthy non-athletes (mean age: 11.5 yrs). 3D scapular kinematics were evaluated at 0°, 30º, 60º, 90º, and 120º with the electromagnetic tracking system during bilateral arm elevation and lowering on the scapular plane. The differences in the scapular kinematics of the dominant and the non-dominant side in both groups were analyzed with 2 by 8 Mixed Model ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Absence of shoulder pain in the last 6 months,
* No discomfort in the shoulder joint during swimming,
* Use of symmetrical breathing patterns in training competitions

Exclusion Criteria:

* Participants with a history of upper extremity injury (dislocation, fracture, muscle strain, etc.),
* Pain in clinical tests (Hawkins and Neer),
* Those who did not attend training regularly.
Gene Therapy for Pleural Malignancies

This Phase I study will evaluate the safety of two doses of BG00001 at different doses and intervals. Eligible subjects will have:

* malignant pleural mesothelioma, or
* pleural effusions who have progressed through at least one prior therapy or have refused therapy

BG00001 is given twice through a catheter in the pleural space.

Ad.hIFN-β (BG00001) is a replication-defective recombinant adenoviral vector containing the human interferon-beta (hIFN-β) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of intrapleural (IP) Ad.hIFN-β in subjects with pleural malignancies either metastatic or pleural mesothelioma.

Five dose levels will be studied:

* Dose levels 1, 2, and 3 will be given on Days 1 and 15
* Dose levels 4 and 5 will be given on Days 1 and 8

Eligibility Criteria:
Inclusion Criteria:

* must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma
* must have evaluable disease
* must have ECOG performance status of 2
* must have pleural space involved with tumor accessible for pleural catheter
* must have FEV1 \> 1 liter or 40% of predicted value
* must have completed radiotherapy and/or treatment with chemotherapy, cytotoxic, or immunologic agents 4 weeks prior to dosing with BG00001
* concurrent Tarceva is allowed if patients has been on a stable dose for at least three months and has not had serious adverse events
* patients on stable dose of hormone may continue use of hormone
* patients on stable dose of Tarceva for 3 months and without complications may remain on Tarceva

Exclusion Criteria:

* malignant pleural effusions secondary to lymphoma
* rapidly re-accumulating, symptomatic malignant pleural effusions that require immediate mechanical or chemical pleurodesis for palliation
* untreated brain metastases
* use of concurrent systemic steroids or immunosuppressants
Anxiety and Sexual Malfunction Functions in Infertile Pcos Women

Polycystic ovary syndrome (PCOS) is a common hormonal disorder in females in reproductive age associated with signs and symptoms as amenorrhea or oligomenorrhea, obesity,infertility acne and hirsutism tism that mostly Reduce self steem and having negative impact on physical and sexual quality of life , the management of signs and symptoms should result in improvement in the quality of life


Eligibility Criteria:
Inclusion Criteria:

- Age:20-40 Married infertile

Exclusion Criteria:

* any other diseases could affect quality of life
Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis

To explore the therapeutic effect of Shenxiao Yuning Decoction on albuminuria and the improvement of traditional Chinese medicine syndrome in patients with stage III diabetic kidney disease with Qi and Yin deficiency and blood stasis syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for albuminuria in type 2 diabetic nephropathy, persistent albuminuria, and 2 consecutive urine microalbumin/creatinine (ACR) \>30mg/g within 3 months;
* The glomerular filtration rate eGPR ≥ 60ml/min/1.73m2, and is required to remain stable during the trial (eGFR decreases ≤25% from the beginning of screening to the second week of follow-up);
* Those who are consistent with the syndrome of diabetes and kidney disease, deficiency of Qi and Yin and blood stasis;
* Gender is not limited, age is 18-75 years old, BMI≤45 kg/m2;
* Glycated hemoglobin (HbA1C) 6-11%, fasting blood glucose (FPG) ≤15 mmol/L;
* Systolic blood pressure/diastolic blood pressure (SBP/DBP) ≤180/100 mmhg (sitting);
* Those who have complete medical records, voluntarily participate in this clinical study, and sign the informed consent form.

Exclusion Criteria:

* Pregnant and lactating women;
* Acute complications of diabetes such as hypoglycemic coma, diabetic ketosis, lactic acidosis, etc. have recently occurred;
* Those combined with heart failure and myocardial infarction; combined with infections, immune diseases, and malignant tumors; combined with liver diseases (ALT, AST or ALP levels exceed three times the upper limit of normal);
* Male serum creatinine (SCr) ≥1.50 mg/d1 (114.4 μmol/L), or female serum creatinine ≥1.40 mg/dl (106.8 μmol/L);
* Those who are combined with other kidney and renovascular diseases, or those who have other causes such as excessive exercise, heart failure, febrile infections, or urinary tract infections that lead to elevated urinary microalbumin;
* Those who have used nephrotoxic drugs and antioxidants, or used systemic glucocorticoid therapy in the past 2 weeks;
* Those undergoing dialysis or kidney transplantation;
* History of bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within 2 years;
* Persons with drug contraindications: pregnant or lactating women, allergic constitutions, and those allergic to the drugs used in this study;
* Those who are unable to cooperate due to severe mental illness or mental disorder;
* Those who have not signed the informed consent form.