cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305

The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures.
* Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Strength Training Adaptations, Age and Genes

The study investigates the effect of maximal strength training on muscular strength and power in different age groups from 20 to 80 year old. It also relates the training adaptations to different known genes such as angiotensin I-converting enzyme (ACE) and Alpha-actinin-3 (ACTN3). Participants will complete an eight weeks, three times per week training intervention of maximal strength training with a pre-post design. In addition, blood samples will be collected for the analyses of genetic variances.

Aim: The study aims to investigate the effect of age and genes on training adaptations to a maximal strength training intervention.

Methods: Participants will be recruited through invitations at work places and other community arenas. The investigators aim to recruit 10-15 subjects in each of the following age groups: 20-29, 30-39, 40-49, 50-59, 60-69 and 70-80 years of age. Both genders will be included. All age groups will be matched for age-related baseline maximal strength and distribution between the two genders. All participants will be checked via a health registration scheme, and excluded if contra indications for hard physical training or testing should appear. When in doubt, the projects physician will decide on inclusion or exclusion due to a thorough examination. Subjects will give a blood sample to be analyzed for known genes such as ACE and ACTN3. The intervention has a pre- post design. Tests of maximal strength and power will be conducted in a leg-press machine, using the protocol assessing one repetition maximum (1RM) previously described. Force and Power will be measured by the Muscle Lab system from Ergotest Tech. (Langesund, Norway). The intervention is an eight week, three times per week protocol, each training session consisting of a standardized warm-up, and 4 repetitions x 4 sets with an intensity of 4 repetition maximum (4RM) performed in the leg press machine.There will be a three minutes pause between sets. Participants will be given instructions and supervision.

Hypothesis: Maximal strength training adaptations will be affected by age and baseline maximal strength but not by gender or genetic variations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 20 to 90 years old

Exclusion Criteria:

* Contraindications to maximum strength training and testing
A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).

The goal of this clinical trial is to evaluate the safety and efficacy of PLB1001 Enteric Capsules in the treatment of PTPRZ1-MET fusion gene positive recurrent secondary glioblastoma. The main questions it aims to answer are:

1. To evaluate overall survival (OS) in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules.
2. To evaluate if it is safety and tolerant in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules.

Participants will

1. Be given PLB1001 300mg BID,oral who were randomly assigned in test group.
2. Be given Temozolomide capsules ,oral, who were randomly assigned in control group.
3. Be given EP, ivgtt, who were randomly assigned in control group.

84 sGBM or IDH mutant glioblastoma patients with the ZM fusion gene will be randomly divided into group A (receive vebreltinib) or group B ( receive investigator choose), and the randomize ratio will be 1:1, patients in group A will receive PLB1001 300mg Bid, 28days/cycle. Patients in group B will receive temozolomide (100-150mg/m2/d, 7 days 1 to7 and days 15 to 22 of each 28-day cycle ) or cisplatin+etoposide(cisplatin:80-100mg/m2/3 days, 28days/cycle; etoposide:100mg/m2/d, 3days, 28 days/cycle).

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed secondary glioblastoma,or glioblastoma with IDH mutantation
2. Must have evidence of PRPRZ1-MET fusion gene positivity from the result of molecular pre-screening evaluations
3. Prior treatment with temozolomide and radiotherapy
4. Stable or decreasing dose of corticosteroids within 5 days prior to the first dose
5. Platelet count≥75×109/L,Neutrophilic granulocyte count≥1.5×109/L, Hemoglobin\>90g/L,AST or ALT \< 3 times the lab's upper normal limit,Serum creatinine \< 1.5 times the lab's upper normal limit,INR≤2.0
6. Karnofsky performance score ≥ 60%
7. Pregnant or nursing women
8. Written consent

Exclusion Criteria:

1. Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
2. Received antibody anti-tumor drug within 30 days before enrollment
3. Previous treatment with Camustine sustained release implant
4. The subject is unable to undergo MRI scan
5. Patients with active bleeding were found by brain CT or MRI scan before enrollment
6. Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥100 mm Hg
7. Major surgery within 4 weeks prior to first dose of PLB1001
8. Pregnant or nursing women
9. Involved in other clinical trials \<30 days prior to first dose
Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

The purpose of this quasi-experimental study is to explore the impact of a therapeutic horticulture program as an occupation-based intervention to address chronic pain symptoms for cancer survivors. The main objectives are to assess participants' perceptions of pain, physical and psychosocial wellness, stress management, and quality of life at pre-, post-, and 3-month follow-up. Quantitative and qualitative data will be synthesized and analyzed to explore this phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 64 years of age
* History of cancer diagnosis
* Chronic pain longer than 3 months
* Have interest in therapeutic horticulture and exercise
* Able to participate in a moderate physical activity in sitting and/or standing for at least one hour twice a week
* Able to provide own transportation to the horticulture site or the supervised exercise program
* Able to comprehend, speak and write in English

Exclusion Criteria:

* Uncontrolled seizure disorder
* Pregnancy
Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) is characterized by acute diffuse alveolar injury caused by a variety of pulmonary and extrapulmonary factors, leading to refractory hypoxemia. It has high incidence and mortality rates. Neuromuscular blocking agents (NMBAs) play a crucial role as adjunctive therapy for ARDS, aiding in lung-protective ventilation by inhibiting excessive spontaneous breathing, improving patient-ventilator synchrony, and reducing barotrauma.

Determining the appropriate depth of muscle relaxation in moderate to severe ARDS patients receiving NMBAs remains a clinical challenge. Research has shown that partial neuromuscular blockade is feasible in certain ARDS patients. However, large randomized controlled trials (RCTs) and clinical practices often use higher doses of NMBAs to ensure complete cessation of spontaneous breathing. This indicates an ongoing debate regarding the optimal depth of neuromuscular blockade necessary for lung-protective ventilation in ARDS patients. It also raises the question of whether the optimal depth of neuromuscular blockade varies among patients with different severities of ARDS.

This study aims to investigate changes in respiratory mechanics and other physiological parameters in moderate to severe ARDS patients under different depths of neuromuscular blockade. The investigators will evaluate the impact of targeted neuromuscular blockade depth on lung protection in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with moderate to severe ARDS requiring the use of NMBAs, as assessed by clinicians (Berlin definition 2012: PaO2/FiO2 \< 150 mmHg, PEEP ≥ 5).
2. Age: 18-85 years.
3. Signed informed consent.

Exclusion Criteria:

1. History of allergy to NMBAs.
2. Open chest or abdominal injuries.
3. Patients with pulmonary masses, lung transplantation, or lung resection.
4. Contraindications to esophageal catheter placement.
5. Pregnant patients.
6. Contraindications to TOF measurement (e.g., history of neuromuscular disease, presence of a cardiac pacemaker).
7. Severe dysfunction of other organs with an expected short-term mortality (within 7 days) or palliative care.
8. Previous inclusion in this study.
Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）

To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung cancer
2. NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC;
3. NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy);
4. Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment;
5. Age 18 -70 years old, ECOG performance status of 0-1; Life expectancy of 3 months or more;
6. Patients must have measurable disease, defined as at least one target lesion that can be accurately measured by imaging techniques in at least one dimension as ≥20 mm with conventional computed tomography (CT), ≥10 mm with spiral CT scan (≥15mm for lymph node) within 3 weeks before enrolment;
7. Patients with no brain metastases or with brain metastases but are stable for more than 4 weeks after treatment;
8. Peripheral neuropathy (PN) \<grade 2 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment;
9. Patients must have normal haematology as defined below: HGB ≥9 g/L, absolute neutrophil count ≥1.5×109/L, platelets ≥80×109/L, bilirubin ≤1.5× the upper limit of normal (ULN) (patients with liver metastasis ≤3xULN), aspartate transaminase (AST)/ alanine transaminase (ALT) ≤2.5 ×ULN (patients with liver metastasis ≤5xULN), and creatinine clearance ≥45 mL/min;
10. Patients with no major organ dysfunctions and heart disease;
11. Patients who give written informed consent with good compliance.

Exclusion Criteria:

1. Patients who are pregnant or breast feeding;
2. Patients with active tuberculosis
3. Patients with high possibility of interstitial lung disease ;
4. Patients with comorbidities, such as carcinomatous meningitis, central nervous system (CNS) metastasis, other active malignancies requiring simultaneous treatment, but not including cervical cancer in situ or basal cell carcinoma of the skin, severe disorders of the heart, lung, liver, or kidneys, severe hypertension, uncontrolled diabetes, severe gastrointestinal ulceration, active infections in need of antibiotics, or with incontrollable psychiatric history;
5. patients with HIV, untreated active hepatitis；
6. Patients with poor compliance;
7. Patients not fitted for this study determined by the investigators.
Mechanisms of Impaired HIV-associated B Cell and Pneumococcal Vaccine Responses

Human Immunodeficiency Virus (HIV) infection is complicated by high rates of infections and cancers which are often the cause of death rather than the HIV/acquired immune deficiency syndrome (AIDS) virus itself. Treatment of HIV with antiretroviral medications has decreased the frequency of many complications by over 90%, but bacterial pneumonia remains extremely high. Current vaccines are not very effective in preventing these infections in patients with HIV infection. The investigators are studying the cells (B cells) that make antibodies to fight infection by binding to and killing bacteria. The goal is to understand how HIV impairs the ability of B cells to make antibodies in sufficient quantity and of sufficient quality to protect patients with HIV to learn how to enhance protection against these infections. The investigators also seek to understand the role of the bacteria (specifically Streptococcus pneumoniae) that normally live in the nose and throat in the development of pneumonia and other infections.


Eligibility Criteria:
Inclusion Criteria:

For HIV-infected subjects:

* adults aged 18-55 years
* \>200 CD4+ T-cells/microliter
* no antiretroviral therapy (at the time of nasal swab/week 0)
* receiving antiretroviral therapy for \>6 weeks (at the time of vaccination/week 12)

For HIV-seronegative controls:

* adults aged 18-55 years

Exclusion Criteria:

For all subjects:

* age \<18 or \>55 years
* history of prior pneumococcal vaccination
* immunosuppressive therapy, defined as: prednisone \>15mg/day currently or \>14 days in the past 3 months, cytotoxic agents, anti-metabolites, cyclosporine, anti-tumor necrosis factor, B cell monoclonal antibodies
* current or chronic pulmonary infection (bacterial, fungal, mycobacterial), pneumonia, or rhinosinusitis within 2 months
* chronic lung disease
* renal insufficiency, defined as serum creatinine \>1.6
* active liver disease, including hepatitis C virus infection
* history of splenectomy
* history of antibacterial therapy within 3 months of nasal swab (week 0)
* current alcohol abuse
* chronic heart disease
* diabetes
* current cigarette smoking
Intravenous Dexamethasone on Postoperative Pain and Complications in Jaw Surgery

This study aims to evaluate the effect of single-dose intravenous dexamethasone on postoperative pain and other complications in compacted tooth and cyst enucleation procedures performed under general anesthesia.

During surgery, patients were carefully monitored with standard equipment to track oxygen levels (SpO2), heart activity (ECG), blood pressure, and carbon dioxide levels. General anesthesia was started with medications like thiopental, rocuronium, and fentanyl, and maintained with a mix of oxygen, air, sevoflurane, and remifentanil. Patients were intubated with appropriate tubes, and the surgical team applied a local anesthetic (Articaine with Epinephrine) to the area before starting the procedure. After the surgery, patients were given dexamethasone (DXM) and pantoprazole intravenously, then safely extubated and sent to recovery. All patients were discharged on the same day.

Postoperative recovery was assessed using pain scores (VAS) and physical evaluations. Pain levels were categorized as mild, moderate, or severe, and an analgesic was provided if the score exceeded 3. Facial swelling was measured by comparing pre- and post-surgery facial landmarks, with swelling classified into grades based on the percentage of change. Mouth opening was evaluated with a caliper to check for trismus (jaw stiffness), with results grouped into normal, mild, moderate, or severe grades depending on the degree of restriction. Follow-ups were conducted by an independent clinician on postoperative days 1, 2, and 7.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* underwent split-mouth surgery

Exclusion Criteria:

* Patients undergoing corticosteroid therapy
Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain

This study will be a randomized control trial and will be conducted in Riphah International Hospital, National orthopedic and specialist hospital, Riphah international hospital and Chambeli institute of physiotherapy. A sample of 34 participants will be taken. Participants will be randomized into Group A and Group B through lottery method. Group A will receive High Dose Neural Mobilization Technique, Hot pack for 15 minutes, strengthening exercises with 10rep/8sets , strengthening exercises for quadriceps and static stretching exercise for hamstring with 10 rep/8sets, While Group B will receive Low Dose Neural Mobilization Technique with minimal intensity, hot pack: 15 minutes, strengthening exercises with 10rep/4sets. Both groups will be given session of 40 min/day, 2 days/week for 4 weeks, assessment will be done at baseline, at the end of 1st week, 2nd week, 3rd week \& at the end of 4th week. The outcome measure will be Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), Active Knee Extension test (AKE) and Lumbar flexion by Schober method. Data will be analyzed be SPSS 22.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain \> 3 months
* No exercises for last 6 months
* Non-specific LBP in its sub-acute \& chronic phase

Exclusion Criteria:

* Specific causes of LBP (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis),
* Central or peripheral neurologic signs
* Systemic illness (tumor and rheumatologic diseases),
* Psychiatric and mental deficits.
* Patients who had undergone operations within 6 months
Is Sheep Ghee Cardioprotective?

Normal volunteers were randomly received Sheep ghee or sunflower oil, and before and after the study lipid profile and HS-CRP were measured.

During outpatient clinic visits, potentially eligible individuals were screened for enrollment according to the inclusion and exclusion criteria.

Patients were randomly allocated into the treatment and control groups via the blocked randomization method.

The control group received a normal diet for eight weeks with 10 g of sunflower oil. In the treatment group, sunflower oil was replaced with 10 g of sheep ghee.

50 patients in each group were enrollment. Patients' information, including demographic data and the serum levels of fasting blood sugar (FBS), LDL, HDL, triglyceride (TG), and hs-CRP, were recorded in datasheets twice: once before treatment with sheep ghee and once eight weeks later.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults, seeking outpatient visit at professor kojuri cardiology clinic

Exclusion Criteria:

* any history of ischemic heart disease (IHD),
* coronary artery bypass grafting (CABG)
* percutaneous intervention (PCI)
* stroke
* peripheral vascular diseases
* use of anti-hyperlipidemic agents
* unwillingness to participate.
* Need of tight hyperlipidemia control.
Establishment of Voice Analysis Cohort for Development of Monitoring Technology for Dysphagia

Collection of basic data to develop a technique for monitoring the state of dysphagia using voice analysis.

* Design: Prospective study
* Inclusion criteria of the patient group

  * Patients scheduled for VFSS examination and normal person (without dysphagia) capable of recording voice (selected as a control group for comparison of voice indicators with patients with dysphagia)
  * Patients who can record voices such as "Ah for 5 seconds", "Ah. Ah. Ah.", "umm\~\~\~"
* Inclusion criteria of the control group: Patients unable to speak, Patients who cannot follow along, If the VFSS test is a retest
* Setting: Hospital rehabilitation department
* Intervention: After obtaining the consent form for the patient scheduled for the VFSS test, "Ah for 5 seconds", after clearing the throat, "Ah for 5 seconds", briefly cut with a high-pitched sound, "Ah. Ah. Ah", close your lips lightly and make a "ummm\~\~\~\~" sound, and record 2 times each.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dysphagia and scheduled for VFSS testing
* Patients who can record voice such as "Ah for 5 seconds", "Ah. ah. ah", or "Um\~\~"
* Normal people (without dysphagia symptoms) who can record voice (additionally recruited for comparison of voice indicators with patients with dysphagia)

Exclusion Criteria:

* Patients who cannot speak.
* Patients who cannot speak according to the researcher's instructions.
* Patients whose VFSS test was reexamined
Investigation of A-ECM for the Correction of Soft Tissue Defects

Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects. Current autologous fat transfer techniques, however, have a number of limitations including significant donor site morbidity, unpredictable resorption, and the potential for requiring revision. Thus, an "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction.

Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our collaborators have recently generated a novel tissue-derived material to improve soft tissue reconstruction. The final, processed adipose tissue does not contain cellular components, yet retains the native architecture and bioactivity of the original adipose tissue. The tissue is then further processed into particles to create an injectable implant. In preclinical models, we have demonstrated that human adipose tissue can be decellularized by mechanical processing with preservation of matrix ultrastructure. Histologic analysis two-weeks after implantation into rats showed minimal inflammatory reaction and good tissue integration of the decellularized, dilipidized, adipose derived-ECM.

The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after 6 weeks. Specifically, the volume of the soft tissue defect will be determined before implantation and at multiple time points over the following 6 weeks. We hypothesize that the decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks. If our results are promising, decellularized adipose derived-ECM may be a viable alternative to autologous tissue transplantation for correction of soft tissue deformity.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 20-50, with previous congenital or acquired soft tissue deformities of the body or face that are willing to have photographs taken may join this study

Exclusion Criteria:

* pregnant women, patients with known immunocompromise or wound healing disorders
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil

The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.
* The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.
* Patient and caregiver should understand, speak, and read local language.

Exclusion Criteria:

* Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.
* Females of child bearing potential
* Impaired vision or hearing