cyrilzakka/clinical-trials huggingface dataset:
Perception of Smell and Taste During Antibiotic Treatment

Antibiotic use may be associated with effects on the perception of smell and taste. These effects are poorly known. The mechanisms can be very diverse, and the effect can be very variable depending on the type of antibiotic used, the dose, and the duration.

The aim of this study is to analyze the perception of the taste and olfactory capacities of patients, during an antibiotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with bacterial infectious disease requiring antibiotic treatment.
* Having been informed about the study and not having opposed to participate

Exclusion Criteria:

* Patient under legal protection
* Patient refusing to participate
Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility Criteria:
Inclusion Criteria:

1. female patients aged 18 years or older
2. patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
3. patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
4. measurable tumour deposits by one or more radiological techniques (MRI, CT)
5. life expectancy of at least 6 months
6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
7. patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion Criteria:

1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
2. known secondary malignancy requiring therapy
3. active infectious disease
4. brain metastases requiring therapy
5. neuropathy common toxicity criteria (CTC) grade 2 or above
6. absolute neutrophil count less than 1,500/mm3
7. platelet count less than 100,000/mm3
8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/L, système internationale (SI) unit equivalent)
9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L, SI unit equivalent)
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
14. women who are sexually active and unwilling to use a medically acceptable method of contraception
15. pregnancy or lactation
16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
17. patients unable to comply with the protocol
Replication of the POET-COPD Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal than 40: days \[0,0\]
* Diagnosis of COPD: days \[-All Data, 0\]
* History of at least 1 COPD exacerbation within the past year requiring treatment with antibiotics and/or systemic steroids and/or requiring hospitalization: days \[-365, -28\]

Exclusion Criteria:

* Patients with 3 diagnosis of asthma: days \[-180, 0\]
* Patients with current severe cardiovascular disorders (Heart Transplantation, LVAD/Implantable heart, Pulmonary hypertension/other pulmonary disease) and use of systemic corticosteroid medication at unstable doses: days \[-365, 0\]
* Patients with any respiratory infection (Acute respiratory infections, pneumonia and influenza) or COPD exacerbation: days \[-28, 0\]
* Exclude use of salmeterol or tiotropium containing inhaler use \[-180, 0\]
Cognitive Behavioral Factors and Central Sensitization in Chronic Shoulder Pain

The objective of this study is to examine the relationship between symptoms of central sensitization (CS) and important cognitive behavioral and psychosocial factors in patients with chronic shoulder pain.

Participants, both male and female, with chronic shoulder pain for at least 3 months will be included in the study. They will complete several questionnaires and a functional test. Spearman's correlation will be used to analyze associations between symptoms of CS and pain behavior, functioning, pain, pain catastrophizing, kinesiophobia, and illness perceptions.

Additionally, a between-group analysis will be performed to compare patients with and without clinically relevant symptoms of CS.

Eligibility Criteria:
Inclusion Criteria:

(1)chronic unilateral shoulder pain (Chronic pain will be defined as pain lasting for 3 or more months. Also, pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months).

Exclusion Criteria:

1. recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, fibromyalgia and/or polymyalgia rheumatic
2. shoulder pain considered to be originated from the cervical region, and other traumas,
3. neurological dysfunction (ie, multiple sclerosis or stroke), osteoporosis, haemophilia and/or cancer
4. shoulder surgery
5. participants with shoulder pain after post fracture
6. Being pregnant or given birth in the preceding year
7. Overconsumption of alcohol or any other recreational drug2
8. Cognitive impairment
9. inability to provide informed consent and/or complete written questionnaires

If participants use medication with a known influence on the central nervous system (eg, anti-epileptic and antidepressant, analgesics, and/or NSAID's), it should be stable in medication intake for at least 1 month prior to his/her participation to be included in this study (Kuppers et al. 2017). Patients are required to continue usual care at least 6 weeks prior to study participation to obtain a steady state.
Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma

This phase II study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma


Eligibility Criteria:
Inclusion Criteria:

HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.

HCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of RT.

liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7). performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.

WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no ascites).

no serious comorbidities other than liver cirrhosis. written informed consent.

Exclusion Criteria:

HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.

HCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of RT.

Liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7). Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.

WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit.

Written informed consent.

Exlusion criteria:

Evidence of extrahepatic metastasis. Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7). Previous history of other forms of RT adjacent to target tumors. Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score.

Pregnant or breast feeding status. Previous history uncontrolled other malignancies within 2 years.
STL Registration Measures Mandibular Bone Loss After Denture Adjustment. 3D Analysis Quantifies Resorption Post-equilibration.

STL registration-based superimposition is an advanced technique for assessing mandibular bone resorption in removable complete denture (RCD) patients. This 3D method involves aligning and comparing digital models of the mandible before and after RCD use, offering high accuracy and comprehensive analysis. The process includes 3D scanning, STL conversion, registration, superimposition, and quantification. Occlusal equilibration of RCDs plays a crucial role in distributing masticatory forces and influencing bone resorption patterns. Studies using this technique have revealed non-uniform resorption, with variations in different regions of the mandible. While offering numerous advantages over traditional methods, challenges include potential registration errors and the need for specialized equipment and expertise. Future developments may incorporate machine learning, biomechanical modeling, and long-term studies to enhance understanding and clinical application of this technology in prosthodontics and oral surgery.

STL registration-based superimposition is an innovative technique for evaluating mandibular bone resorption in patients using removable complete dentures (RCDs). This 3D method aligns and compares digital mandible models from different time points, providing precise volumetric and surface change measurements. The process involves 3D scanning, STL file conversion, model registration, superimposition, and quantification.

Occlusal equilibration of RCDs is crucial for distributing masticatory forces evenly, influencing bone resorption patterns. Research using this technique has shown that mandibular bone resorption is non-uniform, with variations across different mandibular regions.

While offering superior accuracy and comprehensive analysis compared to traditional methods, this approach faces challenges such as potential registration errors and the need for specialized equipment and expertise. Future developments may incorporate machine learning, biomechanical modeling, and longitudinal studies to enhance understanding and clinical application in prosthodontics and oral surgery.

Eligibility Criteria:
Inclusion Criteria

* Completely edentulous patients ranging from age 45 to 75 years
* Angle's Class I skeletal relationship
* Normal facial symmetry
* Cooperative patients
* Adequate inter-arch space not less than 12mm

Exclusion Criteria

* Temporomandibular disorders
* Uncontrolled diabetes
* Bleeding disorders or anticoagulant therapy
* Flabby tissues or sharp mandibular residual ridge.
* Heavy smokers.
* Patient's with neuromuscular disorders
* Patients on chemotherapy or radiotherapy
* Severe psychiatric disorders
* Angle's class II and III skeletal relationship
Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.

This study will evaluate the safety and effectiveness of adding daily infant NVP to standard prevention measures to decrease vertical transmission of HIV.

According to current statistics from the study site, approximately 70% of the pregnant HIV infected women in this study will have begun antenatal ZDV prior to the initiation of NVP at labor. The remaining 30% of the HIV infected women enrolled in this trial will have been previously undiagnosed. These women will be diagnosed with HIV infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for HIV screening prior to delivery.

All infants will receive the standard does of NVP at 72 hours postpartum. Infants will then be randomized to receive either daily NVP and a daily multivitamin (MVI) or a daily MVI alone. Infants will take NVP/MVI or MVI alone during Weeks 2 to 6 postpartum. The primary outcome measure is infant HIV infection rates at 6 months.

Two additional related cohorts of women will be followed for comparison: 1) an equal number of HIV uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality; and 2) consenting HIV infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort.

Eligibility Criteria:
Inclusion Criteria for Pregnant or Postpartum Mothers

* HIV infected
* Planning to breastfeed
* Able to tolerate oral drugs and available for 12 months of postpartum follow-up

Exclusion Criteria

* Significant physical or emotional distress
* Infant with serious or life threatening disease or severe fetal abnormality
* Obstetrical complications affecting maternal health
* Prior antiretroviral drugs (except antenatal ZDV or intrapartum (NVP)
Culturally Adapting CBT for East Asian Youth in Ontario

This mixed methods study proposes a culturally adapted cognitive behavioural therapy (CA-CBT) model for an East Asian demographic in Canada. The client population of East Asian youth who have been diagnosed with anxiety and/or depression are the focus of the study. CBT has been proven as a very effective form of therapy, and when adapted can promote positive mental health outcomes for a growing and increasingly vulnerable population. Developing a culturally adapted version of CBT (CA-CBT) for this population adds a practical treatment that improves access to culturally relevant care.

There is a major lack of culturally relevant mental health services for East Asian youth in Ontario and Canada. Beginning with a participatory/qualitative research approach, common themes amongst clients, caregivers, healthcare professionals, and community leaders, will divulge basic elements needed to develop a culturally adapted model of cognitive behavioural therapy. The information from the adapted model will be taught to participating psychologists who will deliver the therapy in a randomized control trial design, with feasibility testing of the intervention using a quantitative approach ensuing. Immediate guidelines will then be developed for use by therapists working with East Asian youth.

Eligibility Criteria:
Inclusion Criteria:

* Self identification as East Asian origin
* Between the ages of 12 to 21
* Diagnosed as having depression and/or anxiety

Exclusion Criteria:

* Have been affected by psychosis
* Have been affected by serious addiction
* Have been affected by cognitive impairment
Effect of FAn-7 in UC Activity

Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional treatment is not effective; therefore, alternative therapies may be effective specially in UC patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The increasing incidence and prevalence of UC and ineffective treatments in some patients, allows search coadjuvant therapies. Objective: Quantification of differences between patients with and without FA. Methods: In two groups of patients with UC is administered FA and placebo. We will measure the changes clinical, endoscopic and histological in both groups, before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histopathologically confirmed diagnosis of UC.
* With mild and moderate disease.
* Patients treated with only doses of 5-aminosalicylates (5-ASA)
* BMI, 18 to 34.9 kg/m2
* Born in Mexico the last two generations
* Each patient will be asked to sign and date the consent form, to indicate that you agree to participate.

Exclusion Criteria:

* Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
* With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
* If the patient use drugs that inhibit fat absorption.
* Patients after partial or total resection of stomach or small intestine.
* Steroid users.
* Patients in remission histology, clinical and endoscopic.
* Patients treated with FAn-3,6 or 9.
Growth and Development of Children With Inborn Errors of Metabolism in Assiut Governorate

Assessment of growth and development of children with inborn errors of metabolism in Assiut Governorate

Inborn errors of metabolism (IEM) are diseases resulting in deficient activity of an individual enzyme, structural protein in an intermediate metabolic pathway, present clinically in a wide variety of ways a ranging from non-specific chronic issues such as childhood delay in attaining development milestones, to acute decompensation.

The prevalence of all of inborn errors of metabolism globally is 50.9/100000 live birth, In Egypt the prevalence among clinically suspected children is 7.8%.

A study conducted in Minia Governorate (Egypt) on children less than 18 years included 67 children showed that 65.7% of children were under height. Also a study conducted in upper Egypt on 113 PKU patients showed that global developmental delay 54.9% was the most frequent presentations of PKU children. Parents of children with IEM face many challenges; as the financial burden and perceived restrictions in all aspects of life, discrimination by society in general, and the main challenge is dietary restrictions.

Rationale:

Despite being rare in Egypt, IEM are regarded as a national priority because of the substantial health burden they place on the growth and development of the affected children, which can range from delayed achievement of developmental milestones to acute decompensation and death.

However, there is lack of longitudinal studies in Egypt that focus on how IEM affect physical development and growth, as well as the difficulties parents encounter while caring for their children and following up with them. To our knowledge, no local studies have been conducted in this field before.

Eligibility Criteria:
Inclusion Criteria:

* Under five years old children with confirmed diagnosis of IEM.
* Attending the study settings.

Exclusion Criteria:

* Patients diagnosed since birth with dysmorphic features.
* Patients diagnosed since birth with congenital anomalies.
* Patients with other neurological deficits (e.g. cerebral palsy, convulsions, birth anoxia.....)
Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)

The objective of the study is to determine the relative roles for various testing modalities in the diagnosis and prognosis of mild traumatic brain injury.

Subjects will undergo functional brain testing (magnetoencephalography, electroencephalography), anatomical brain imaging (diffusion tensor imaging, susceptibility-weighted imaging), neuropsychological testing (memory, language, processing speed), sleep patterns using actigraphy, and blood testing of candidate biomarkers. Testing will be done at 3 time points post-injury: 1 day, 14 days, and 30 days post-injury. Analysis of these tests collectively will be used to develop diagnostic tools for acute mTBI.

Eligibility Criteria:
Inclusion Criteria:

1. Civilian (non-military) presenting to HMH ED.

Exclusion Criteria:

1. Prior history of diagnosed TBI.
2. Other significant non-head injury/trauma or open wound.
3. Other significant medical co-morbidities, such as heart disease or cancer.
4. Self-reported current use or substances contributing to ED visit (e.g. illicit drugs, medications, alcohol abuse).
5. Currently diagnosed psychological condition (e.g. depression, PTSD).
6. Medications for psychological or neurological disorder.
7. Any implanted metal, such as medical device or braces on teeth.
8. Injury to the back or other injury that will make it difficult for the participant to tolerate tests.
9. Injury to dominant arm that would cause difficulty using computer or responding to stimuli during functional imaging.
10. Pregnancy.