cyrilzakka/clinical-trials huggingface dataset:
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 01/05/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction

The goal of this clinical trial is to compare the effectiveness of Vestibular Rehabilitation Exercises (VRE) and General Fitness Training (GFT) in adults diagnosed with vestibular disorders. The main questions it aims to answer are:

Does VRE lead to better improvements in gaze stabilization, balance, and gait than GFT? Does GFT lead to more improvements in overall fitness than VRE? Participants will be randomly assigned to either the VRE or GFT group and will participate in 60-minute exercise sessions twice weekly for 8 weeks. Researchers will compare the improvements in the two groups to see which intervention is more effective.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 - 60 years.
* Diagnosis of a vestibular disorder confirmed by a healthcare professional.
* Able to walk unassisted for at least 10 meters.
* Able to understand and comply with the procedures of this study.
* Willing to provide informed consent.

Exclusion Criteria:

* Severe cardiovascular, respiratory, or metabolic disease that contraindicates physical exercise.
* Neuromuscular disorders that may affect balance and mobility other than the diagnosed vestibular disorder.
* History of orthopedic surgery within the past 6 months.
* Currently participating in another interventional clinical trial.
* Pregnant or breastfeeding women.
The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM.

There isn't specific Health related quality of life measure for children with DMD in French. The aim of this study is to validate the French version of the Pediatric Quality of Life Inventory 3.0 Duchenne Muscular Dystrophy module with a multicentric study. The investigators will evaluate the following psychometric properties : convergent validity, internal validity, inter-rater reliability. The investigators would like to be able to use this scientific tool in future clinical trials.

The Duchenne Muscular Dystrophy, the commonest form of dystrophy, is an X-linked, recessive neuromuscular disease, in which there is an absence of the protein dystrophin. This chronic and progressive disease leads to an inevitable loss of autonomy (muscle weakness, respiratory and cardiac failure). With better multidisciplinary care, life expectancy has increased but also morbidity. From now one, the evaluation of the quality of life of children with DMD is necessary in therapeutic trials.

Given the specificities of the disease, it seems appropriate to have a specific scale. In the literature there isn't quality of life scale specific to Duchenne Muscular Dystrophy in French version. The only specific scale that exists is the specific module PedsQLTM DMD that was validated in English version in 2012. This scale is relevant for assessing the quality of life in clinical trials and in daily clinical practice given its psychometric properties (good internal consistency close to 0.8).The main hypothesis that we formulate is to validate the French translation of the pediatric module of Duchenne Muscular Dystrophy of the PedsQL ™ 3.0 scale.

Eligibility Criteria:
Inclusion Criteria:

* Boys aged 7 to 18, with genomic Duchenne muscular dystrophy whose parents (mother and / or father) or direct grandparents do not oppose.

Exclusion Criteria:

* Inability for the child to understand the issues
* Absence of direct parents or grandparents
* Child receiving antidepressant treatment
* Non French speaking child
* Duchenne Muscular Dystrophy girls
Immune Responses After Human Subject Challenge With Sand Fly Bites

Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is to evaluate the human immune response to uninfected laboratory raised sand fly bites and select from the immune response to sand fly saliva, possible substances to use for a future vaccine to protect against the parasite leishmaniasis.

Based on travel history and possible exposure, subjects were entered into one of 2 arms, Ph. dubosqui or Lu. lutzomyia controlled sand fly repeated feedings. At baseline a pheresis was done to collect baseline cells. Subjects received sand fly bites on a q2 week schedule for 2 months followed by a q2 months schedule for one year. They had an option to extend for a late recall feeding at 18 months, when a skin biopsy was performed 48 hours after sand fly bites. Currently the study is fully enrolled and all human subject contact is complete. We (laboratory at NIAID) are studying the humoral, cellular immune responses using blood samples, and cytokine expression in the skin biopsy samples.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Plans to remain in DC area for at least one year
* willingness to participate in all study procedures
* general good health
* military health care beneficiary
* able to provide informed consent

Exclusion Criteria:

* Prior travel to geographic areas where leishmania transmitting sand flies are common
* positive antibody to sand fly saliva on screening blood test
* pregnancy
* elevated serum IgE
* history of chronic medical illness
* adult history of treatment requiring anemia
* large reactions to insect bites
* history of multiple vasovagal reactions to phlebotomy
* difficult venous access for phlebotomy
* Taking medications that could interfere with immune responses
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty

The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
* Age 50-80 year
* Patients with osteoarthritis who voluntarily participated in the project

Exclusion Criteria:

* Patients with osteoporosis
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* Patients with bilateral total knee arthroplasty
* Patients osteoarthritis with revision surgery
Experience in Predicting Decision Making for Receiving Treatment in Acute Coronary Syndrome Patients

The purpose of this study is to examine the predictability of cognitive representation, emotional responses, and hospitalization experience toward the decision to receive treatment of the acute coronary syndrome patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute coronary syndrome
* Patients who had first experience or recurrent acute coronary syndrome

Exclusion Criteria:

* Still have chest pain within 24 hours ago
* Cognition or communication disorder or having psychotic or neurologic symptoms
Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV.

Up to 40% of individuals receiving medical care for HIV meet DSM-IV criteria for co-occurring depressive disorder. Individuals with HIV and depressive disorders, compared to those with HIV alone, have been shown to have worse adherence to taking antiretroviral medication, increased HIV related morbidity and among women a higher mortality. Previous research suggests that mental health interventions may lead to improved depressive and HIV related outcomes. However because many HIV infected depressed individuals may have trouble accessing mental health services, there is an urgent need for treatment trials to assess whether treatment of depression targeting patients in urban HIV care settings will result in both improved depressive and HIV related outcomes. The goal of this project is to test the preliminary effectiveness of an adapted telephone-based, cognitive behavioral therapy (CBT) intervention targeting HIV infected depressed individuals receiving care in adult outpatient HIV clinics. A total of 60 HIV infected, depressed individuals receiving care at an urban, outpatient HIV clinic will be randomly assigned to receive either the telephone psychotherapy intervention or enhanced usual care with non-specific telephone contact. The results will provide preliminary data on whether the telephone psychotherapy intervention for HIV infected depressed individuals is effective in reducing depression. The results will also be used to determine feasibility, accessibility, and whether the intervention leads to improved retention and better satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Has a DSM-IV diagnosis of a Depressive Disorder as measured by the mood battery of the MINI
* Has a diagnosis of HIV and is receiving HIV related outpatient care at the Evelyn Jordan Center in Baltimore, MD
* Is able to speak English
* Is able to read English on approximately the 6th grade reading level or higher as measured by the Wide Range Achievement Test 4 (WRAT-4) or by self-report
* Is at least 18 years old
* Has access to a telephone

Exclusion Criteria:

* Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale
* Shows signs of serious psychiatric pathology that might either be due to an organic etiology other than HIV, or would generally not be considered treatable solely with psychotherapy, or for whom participation in this protocol might be considered dangerous or unethical
* has a history of serious suicide attempts or is severely suicidal (has ideation, plan, and intent) determined by the MINI
* Patients in psychotherapy are excluded because it is confounded with the study treatments
Clinical Impact of Dedicated MR Staging of Ovarian Cancer

The only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. Aim of this study is to determine the performance of DW-MRI for predicting whether complete CRS can be achieved.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
* Age \>18 years
* Written and signed informed consent
* WHO 0-2
* Able to read and write Dutch

Exclusion Criteria:

* Patients with contraindications for MRI
* Patients with contraindications for CRS
* Known additional malignancy
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children

This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children 2 months to 5 years of age scheduled to receive vaccination

Exclusion Criteria:

* Contraindications to Vaxem™Hib Korean Prescribing information
Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.

Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.

It is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. The patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. Bispectral index (BIS) monitoring guided the anesthesia by setting target BIS range value between 40 and 60. Anesthetics were adjusted to reached that. Primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). Secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. Protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.Post-anesthesia care unit recovery data were also recorded: Ramsay sedation scale; vital signs, post-operative pain; morphine consumption.

Eligibility Criteria:
Inclusion Criteria:

* Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.

Exclusion Criteria:

* History of: illegal drug and alcohol abuse
* Pregnancy on course or suspicion of
* Neuromuscular disorders
* Cerebral vascular disease
* Dysphagia
* Dysphonia
* Gastroesophageal reflux disease
* Previous larynx and/or upper gastrointestinal tract surgery
* Allergy to any drug to be used and malignant hyperthermia.
* Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.
* Patients unable to swallow 20 ml of water in an upright position were also excluded.
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma

The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of any race at least 18 years of age
* Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
* Planned enucleation or brachytherapy of the study eye due to uveal melanoma

Exclusion Criteria:

* Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
* Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
* Woman who is pregnant or lactating
Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia

To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with non-familial hypercholesterolemia and mixed hyperlipidemia after lipid-lowering therapy


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
2. The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
3. Fasting triglycerides less than equal to 5.6 mmol/L；
4. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria:

1. Have the following diseases or treatment history : (1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization or latest detected LVEF\<30%;(4) CVD events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other PCSK9 inhibitors; (7) inadequate organ functions.
2. Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
3. General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening; Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
4. The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease

Acute respiratory distress syndrome (ARDS) occurs in Clinically Amyopathic Dermatomyisitis(CADM) combined with Rapidly Progressive Interstitial Lung Disease(RPILD) within 1-3 months, which leads to death of patients and is difficult to treat. Even if high doses of glucocorticoids are ineffective, there is no recommended treatment for such patients, which is a huge medical challenge.Lymphopenia is an independent risk factor for death in CADM-RPILD, but the cause of lymphopenia is unclear.In this study, the level of lymphocyte subsets in peripheral blood was detected by flow cytometer, in order to further clarify the pathogenesis of the disease, to facilitate clinical guidance of treatment, and to improve the survival rate of patients.In addition, studies have shown that INF-α levels are significantly increased in CADM patients combined with RPILD and are a poor prognostic factor for CADM-RPILD, suggesting that the interferon system plays a role in the pathogenesis of CADM and can be used as an evaluation index of the severity of CADM-RPILD.In this study, the levels of relevant cytokines including INF and IL-2, IL-17, IL-18, IL-6 were detected simultaneously, and the relationship between disease activity and lymphocyte subsets was analyzed, and the changes of lymphocyte subsets after Tofacitinib treatment were determined in order to facilitate clinical guidance of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old,≤80years old,no gender limit;
2. CADM of diagnosis according to Sontheimer diagnostic criteria;
3. combined with Rapidly Progressive Interstitial Lung Disease

Exclusion Criteria:

1. Age\<18years old，\>80years old;
2. potential malignant tumor
Impact of Maternal COVID-19 Vaccines on Breast Milk

prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.


Eligibility Criteria:
Inclusion Criteria:

* Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.

Exclusion Criteria:

* cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.
Misoprostol for Second Trimester Pregnancy Termination

The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy 13-24 weeks.
* Women with indication for termination of the pregnancy due to intra uterine fetal death

Exclusion Criteria:-Pregnancy before 13 weeks.

* Pregnancy beyond 24 weeks.
* Women with scared uterus.
* Known hypersensitivity for misoprostol.
* Refusal of the woman to participate.
Resident Well-being and Performance

This project aims to investigate the effectiveness of a meditation intervention utilizing a smart phone-based meditation app on resident burnout, well-being, and performance self-efficacy in a randomized clinical trial. 500 participants will be enrolled for a 4 week intervention.

Burnout is an increasingly prevalent challenge in the medical field and especially prominent in residency. Burnout negatively affects learning and decision-making, physician performance, and patient outcomes. Studies have shown that mindfulness-based interventions are effective at reducing burnout and strengthening well-being in physicians. Furthermore, mobile health mindfulness-based interventions have similar benefits to in-person interventions while offering the advantages of increased scalability, lack of physical constraint, and lower costs. This project will use a novel mobile health MBI and measure resident burnout, well-being, and self-efficacy in performance.

Eligibility Criteria:
Inclusion Criteria:

* Resident in a high burnout rate specialty: family medicine, internal medicine, obstetrics and gynecology, emergency medicine, general surgery, or surgical sub-specialty (plastic surgery, urology, neurosurgery, orthopedic surgery, vascular surgery, cardiothoracic surgery, otolaryngology, ophthalmology)

Exclusion Criteria:

* Participants who have previously used the HMP (a version of HMP has been freely available to the public since 2020)
* Participants who have been practicing meditation daily or almost daily for the prior six months
Chronic Pain and Opioid Dependence Assessment and Treatment

This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).

To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT
* opioid dependence
* experience moderate to severe chronic pain

Exclusion Criteria:

* current suicide or homicide risk
* are unable to complete the informed consent or surveys because of psychiatric impairment
* have cognitive impairment
* are unable to read or understand English