cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment

The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations
* Body mass index (BMI) of 18.0 kg/m\^2 to 40.0 kg/m\^2, inclusive. BMI = weight (kg)/height (m\^2)

Exclusion Criteria:

* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status
* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease

Other protocol-defined inclusion/exclusion criteria apply
The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Obese Patients

The goal of this study is to determine the success rate of the retroclavicular approach for the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)

Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population.

Since the retroclavicular variant of the infraclavicular approach for the anesthesia of the brachial plexus offers a better needle visualisation, we believe that this technique can be used successfully in the obese patient population with a low complication rate.

Eligibility Criteria:
Inclusion Criteria:

* Elective or Urgent Surgery of the hand, wrist or forearm
* 18 years and older
* Ability to consent
* American Society of Anesthesiologists class 1 to 3
* BMI ≥ 30 kg/m2

Exclusion Criteria:

* Infection at the site of infection
* Abnormal anatomy at the site of infection
* Coagulopathy
* Severe Pulmonary Disease
* Preexisting neurological symptom(s) in the operated arm
* Pregnant patients
* Patients weighing less than 50 kg
* Allergy to amide type local anesthetics
Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered SILDENAFIL(Revatio).
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.


Eligibility Criteria:
Inclusion Criteria:

* Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
* Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
* Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type

Exclusion Criteria:

* Pregnant woman or breast-feeding mother
* Has an immunological high risk, defined as having a most recently measured PRA grade of \> 50% within the previous six months
* Known allergy to the study drug or any of its components
* Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
* Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Subject or donor is known to be HIV positive
* Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
* Previously received or is receiving an organ transplant other than kidney
* Receiving a graft from a non-heart-beating donor
* Cold ischemia time of the donor kidney \>30 hours
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
Cerebral Toxoplasmosis and AIDS

With a HIV incidence much higher in the DFA than in European French territory, this disease is a major public health problem in these areas, especially in French Guiana.

Cerebral toxoplasmosis is a priority among the opportunistic infections in AIDS patients from the DFA because of its frequency (French West Indies) and of its lethality (French Guiana).

The diagnosis of cerebral toxoplasmosis may be difficult because based only on presumptive clinical and radiological features. The response to specific antitoxoplasmic therapy confirms a posteriori the diagnosis.

In reference to the data collected by the Biological Resource Centre Toxoplasma, in particular in French Guiana, we think that T. gondii strains reactivating in AIDS patients from DFA are genetically different from those reactivating in AIDS patients from Europe, with an increased capacity for dissemination via peripheral blood in the first ones. This more frequent or more prolonged parasitemia could facilitate the diagnosis of cerebral toxoplasmosis by PCR test from peripheral blood samples in AIDS patients from the French departments of America.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years)
* Patient being informed and accepting to participate in the study with signature of informed consent
* HIV positive serology
* Clinical and radiological suspicion of cerebral toxoplasmosis justifying the start of specific antitoxoplasmic therapy

Exclusion Criteria:

* Protected patient
* Patient uncovered by social insurance
* Specific antitoxoplasmic therapy already initiated since 72h or more
Childhood Asthma Mentoring Program for Parents

There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the community) can be effective in reducing hospitalizations for asthmatic children.

This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to reduce asthma-related pediatric hospitalizations and emergency department visits.


Eligibility Criteria:
Inclusion Criteria:

* Parent of child with persistent asthma, prescription of controller medications, and at least one asthma exacerbation in the past year

Exclusion Criteria:

* Parent has no access to smartphone
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects

The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:

   * Wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and
   * An average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight.
2. Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa

Exclusion Criteria:

1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
2. Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
3. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
4. Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
Personalized Training for People With Rare Neuromuscular Disorders

The goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: Charcot-Marie-Tooth (CMT), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy Type 1 (DM1).

The key objectives are:

1. To investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group
2. To investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up
3. To investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life.

This is a national study and will involve 120 individuals with rare-neuromuscular disorders from Norway's four health regions.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of either FSHD, DM1 or CMT
* 18-70 years of age at the time of signing the informed consent.
* Any gender
* Ability to stand, rise from a chair and walk at least 10 meters with or without any need of assistive devices
* Indication for rehabilitation as confirmed by the treating neurologist or physiotherapist
* Ability to understand and follow instructions in Norwegian
* Capable of giving signed informed consent

Exclusion Criteria:

* Pregnancy or planning to become pregnant
* Any other neurological or non-neurological disorders affecting physical capacity, such as disabling arthritis, severe heart-failure/cardiomyopathy, on-going cancer treatment
* Alcohol or drug abuse as per their medical chart
* History of non-compliance to medical advice/follow-up
Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients

The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients.

A total of 270 Chinese mild to moderate Asthma patients will be enrolled and 230 will be completed in this multi-center, randomized, single blind, parallel efficacy and safety comparison study of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 70 years old and diagnosed as Asthma in clinics
* Diagnosed as Asthma according to the 2016 Asthma guidance of Chinese Thoracic Society, and without administer corticosteroids within three months, either new or old patients
* FEV1 predicted ≧ 60%
* Patients is willing to participate the study and signed the Informed Consent Form

Exclusion Criteria:

* Allergy to budesonide or salbutamol
* Infections of Respiratory tract, nasal-sinus and ear within 4 weeks before enrollment
* Severe nasal allergy and need the treatment of corticostreoids and histamines.
* Severe cardiovascular disease history
* Has used leukotriene receptor antagonist (Montelukast, Pranlukast, Zafirlukast etc.) within 2 weeks before enrollment
* Severe cognition or mental disorder and can not cooperation with the treatment
* Significant liver dysfunction, AST, ALT \> 3 X normal upper limits, CR \> 1.5 X normal upper limits
* Patients with uncontrolled diabetes or fasting blood glucose \> 10 mmol/L
* Patients currently receiving beta-antagonists or beta-agonists treatment (including eye drops)
* Patients who has contraindications to beta2-agonists
* Patients who has participated others drug's clinical study within three months
* Female patients who are pregnant or lactation or prepare to pregnant
* Any conditions which the investigators considered not suitable to enrolled
Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy

The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.

The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index score (BIS) was monitored during the operation and the first postoperative night.

Eligibility Criteria:
Inclusion Criteria:

* Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy

Exclusion Criteria:

* Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a Pittsburgh Sleep Quality Index global scores higher than 6, had an anesthesia time longer than 4 hours, had a history of cardiovascular, neurological, or psychiatric disease, had cervical lymph node metastasis, were treated with sedative and analgesics during the postoperative BIS-Vista monitoring period, were allergic to drugs used in the study, or had been diagnosed with Graves' disease or hyperthyroidism or hypothyroidism.
Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose

Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.

The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.

In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy male subjects aged 18-45 years old
* 2. Male subjects weight over 50 kg

Exclusion Criteria:

* 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
* 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
* 3. Blood donation or blood loss \> 400 mL in 3 months before screening
Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%.

The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%. Immunosuppression reduction is the management cornerstone for BKV and has been shown to be effective at clearing the virus while maintaining graft function in both kidney alone and simultaneous kidney-pancreas transplant recipients. However, there is a lack of published data on the prevalence and outcomes in simultaneous liver-kidney (SLK) transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* SLK recipients transplanted at MDMC between 2015-2020

Exclusion Criteria:

* Below 18 years of age
* Patients who did not undergo SLK transplant at MDMC
Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy

This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy.

This study retrospectively obtained non-contrast enhanced and contrast enhanced CT scans of patients with NSCLC who underwent surgery after receiving neoadjuvant immunochemotherapy. at multiple centers between August 2019 and February 2023. Deep learning features were extracted from both non-contract enhanced and contract enhanced CT scans to construct the predictive models (LUNAI-nCT model and LUNAI-eCT model), respectively. After feature fusion of these two types of features, a fused model (LUNAI-fCT model) was constructed. The performance of the model was evaluated using the area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). SHapley Additive exPlanations (SHAP) analysis was used to quantify the impact of CT imaging features on model prediction. To gain insights into how our model makes predictions, we employed Gradient-weighted Class Activation Mapping (Grad-CAM) to generate saliency heatmaps.

Eligibility Criteria:
Inclusion Criteria:

1. Patients' with non-small cell lung cancer, diagnosed through biopsy pathology and clinically classified as stage IB to III;
2. Patients who receive at least two cycles of neoadjuvant immunotherapy combined with chemotherapy induction therapy;
3. According to the IASLC guidelines, postoperative pathological evaluation was performed on the treatment response of the tumor primary lesion and lymph nodes.

Exclusion Criteria:

1. Missing or inadequate quality of CT;
2. Time interval between CT and start of treatment is greater than 1 month;
3. Incomplete clinicopathologic data.
Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients

To implement a quality improvement plan aimed at achieving a 5% increase in the Forced expiratory volume in 1st second (FEV1) (% predicted value) in cystic fibrosis (CF) patients with impaired pulmonary function parameters over 12 months. Additionally, the plan aims to measure serum human epididymis protein 4 (HE4) levels in the studied subjects before and after pulmonary function improvement.

This study will be conducted on 35 children diagnosed with cystic fibrosis, aged between 6 and 18 years. Patients will be selected during their follow-up visits to the Pediatric Chest Clinic at Ain Shams University Hospital.

Inclusion Criteria:

A. Pediatric cystic fibrosis patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two cystic fibrosis disease-causing gene mutations.

B. Age ≥6 years. C. Forced expiratory volume in 1st second (FEV₁) ≤80%.

Exclusion Criteria:

A. Patients unable to perform spirometry.

All subjects in the study will undergo an interventional quality improvement plan.

A specialized clinic for CF patients will be established based on the quality improvement (QI) plan, where patients will be followed up every three months by a specialized multidisciplinary team, including a pediatric pulmonologist, pediatric nutrition consultant, pediatric gastroenterologist, chest physiotherapist, and pediatric endocrinologist.

Each specialized clinic will develop and implement standardized cystic fibrosis care algorithms and individualized treatment plans for each patient. These algorithms and plans will be continuously adjusted based on challenges encountered during follow-up to address barriers and deficiencies that may contribute to poor outcomes.

Areas needing improvement will be identified, and appropriate resources and strategies will be proposed. This will include the development of fishbone diagrams, flowcharts, Plan-Do-Study-Act (PDSA) cycles, PDSA ramps, and other quality improvement tools to address specific deficiencies. Additionally, training and engaging the team in quality improvement methodologies will be conducted.

Patients will undergo pulmonary function tests at baseline, followed by assessments at six months and one year during the study.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric CF patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two CF disease-causing gene mutations.
* Age ≥6 years.
* Forced expiratory volume in 1 second (FEV₁) ≤80%.

Exclusion Criteria:

●Patients are unable to perform spirometry.