cyrilzakka/clinical-trials huggingface dataset:
The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery

This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years;
* American Society of Anesthesiology (ASA) physical status classification I-III;
* Scheduled for elective lung resection surgery under thoracoscopy;
* Voluntarily opting for patient-controlled intravenous analgesia;
* Willing to participate in this trial after consultation with the patient or their family and signing the informed consent form.

Exclusion Criteria:

* History of previous thoracotomy or thoracoscopic surgery;
* Patients converted to open thoracotomy intraoperatively;
* Severe hepatic or renal dysfunction;
* History of substance abuse;
* Pregnancy or breastfeeding;
* History of chronic pain;
* Use of coenzyme Q10 for more than one month;
* Allergy to coenzyme Q10;
* Patients unable to communicate or cooperate.
Hemofiltration in Burns: RESCUE (Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure)

The purpose of this study is determine if High-Volume Hemofiltration in addition to 'contemporary' care will result in an improvement of select clinical outcomes when compared to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary to septic shock.

Acute renal failure (ARF) is a common and devastating complication in critically ill burn patients with mortality reported to be between 80 and 100%.(3-7) Despite recent advances in burn care, the unacceptably high mortality rate in this subgroup has not changed over time. The pathogenesis of ARF in burns, similar to other critically ill populations, is often multi-factorial with one major component being sepsis induced ischemic tubular necrosis. Thus, ARF secondary to septic shock is a common and devastating condition in the burn ICU.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the burn intensive care unit (ICU) with burns of any size
* Acute renal failure as previously defined by the Veterans Affairs/ National Institutes of Health (VA/NIH) Acute Renal Failure Trial Network study investigators(2)
* Patient is \> 48 hours post-burn and in Septic Shock
* Patients 18 or older
* Patient/legally authorized representative willing to provide consent

Exclusion Criteria:

* Age \<18
* Non-thermal injury (exfoliating skin disorders or necrotizing fasciitis)
* Pre-admission diagnosis of end stage renal failure
* Patients already on renal replacement therapy for more than 24 hours
* Patient not expected to survive more than 24 hours after randomization.
* Pregnancy
* Prisoners
Increasing Mitochondrial Function on Skeletal Muscle Performance in Older Men

As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail, by measuring how the muscles work and respond to exercise before and after taking the supplement. This will give us the basic information investigators would need to see if this is a useful idea.

A defining feature of ageing is loss of muscle mass ('sarcopenia') and associated functional weakness ('dynapenia'). A common characteristic of dynapenia is lowered mitochondrial content and metabolic function, causing reduced aerobic capacity, increased sensations of effort and impaired lipid oxidation (with resultant glucose intolerance). Exercise training improves mitochondrial and muscle function in ageing populations, however such adaptations remain below that of young counterparts, suggesting alternative approaches are required. Pre-clinical studies show that dietary supplementation with precursors of nicotinamide adenine dinucleotide (NAD+) restore mitochondrial biogenesis and oxidative capacity in ageing rodents and diabetic humans. However, whether NAD+ precursors rejuvenate mitochondrial capacity and, ultimately, muscle function in older humans is unknown. This pilot project will therefore investigate the efficacy of NAD+ precursor supplementation for increasing muscle performance in normally active older men, combined with examination of the molecular and metabolic mechanisms regulating physiological responses.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 65-75 years
* Body mass index between 19-29
* No active cardiovascular or metabolic disease
* No active respiratory disease
* No current musculoskeletal injuries
* A sedentary lifestyle (i.e. does not engage in strenuous, planned physical activity)
* The ability to give informed consent

Exclusion Criteria:

* Currently taking a statin drug or NSAIDs
* Have a current peptic ulcer
* Have any renal impairment
* Have a known hypersensitivity to Acipimox
Mechanical Ventilation With and Without Postural Drainage in Burn Patients With ARDS

Inhalation injury become a more common cause of death in burn patients but alone the smoke injury has low mortality rate. It is reported that a combination of smoke injury with cutaneous burn increases the mortality rate and predispose to Acute Respiratory Distress Syndrome. This experimental study aims to report the benefits of postural drainage on the respiratory system in burn patients. This study will determine the effects of postural drainage on oxygen saturation, airway clearance in burn patients with Acute Respiratory Distress Syndrome by comparing mechanical ventilation with and without the application of postural drainage. A randomized clinical trial will be conducted in the data and will be collected from the ICU of Jinnah Burn \& Reconstructive Surgery Centre and Shafique Aziz Free Burn Centre through consecutive sampling through technique on 50 patients which will be allocated through sealed opaque enveloped into Group A and Group B. Pre and post treatment value of oxygenation and other variables for both group will be recorded by using APACHE II. Group A will be treated by postural drainage and mechanical ventilation for two consecutive days. Similarly, Group B will be treated by mechanical ventilation only. Data will be analyzed using SPSS software 25. After assessing the normality of data by the Shapiro-Wilk test, it will be decided either parametric or non-parametric tests will be used within a group or between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both gender male and female are included.
* Patient age should be between 10-40 years
* Patients that are on mechanical ventilation
* Patients with inhalation injury
* Patients undergo mechanical ventilation for \>48 hours

Exclusion Criteria:

* Patient with no past medical history of Lung disease
* Subject with more than 80% of burn according to Rule of Nine
* Patients with cardiac instability such as recent Myocardial infarction, Unstable angina and severe hypotension and hypertension
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.

This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.

Eligibility Criteria:
Inclusion Criteria:

* HBV patients who have positive HBeAg or HBeAb
* Must be healthy males or females between 18 to 60 years old
* Must have a body mass index (BMI) of 18 to 30 kg/m2
* HBV DNA≥2000 IU/mL
* ALT≥1.3 ULN and ≤10 ULN

Exclusion Criteria:

* Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time.
* Participated in other clinical trials within a month.
* Allergic to interferon.
* T-Bil ≥2 ULN. ALB\<35g/L. PT≥4s.
* Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab.
* Organ transplant patients, except cornea or hair transplantation.
* Other hepatopathy exclude NAFLD .
* Drug addiction or alcohol dependence.
* Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history.
* Serious retinal disease.
* Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder.
* Autoimmune disease.
* Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure.
* WBC\<3×109/L or ANC\<1.5 ×109/L or PLT\<90 ×109/L or HGB\<ULN.
* HCC or AFP\>100ng/mL.
* Chronic kidney disease or sCr\>ULN.
* Lactating women or pregnancy.
* Cardiovascular and cerebrovascular events within 6 months.
* Neurological or psychiatric disease or family history.
Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System

This observational study evaluates peri-procedural results of the Niobe™ Remote Magnetic Navigation (RMN) ES system using the contact detection system (CDS) in patients undergoing standard of care radiofrequency ablation of cardiac arrhythmias.

The objective of this observational study is to confirm system performance of the CDS and that it does not alter pacing, electrocardiograms, or mapping during RF ablation procedures.


Eligibility Criteria:
Inclusion Criteria:

* patients with a clinical indication for RF ablation of cardiac arrhythmias with the Niobe Remote Magnetic Navigation system
* patients referred to one of the participating ablation centers
* written informed consent

Exclusion Criteria:

* presence of a atrial thrombus or left atrial appendage (LAA) thrombus seen on (contrast) echocardiography or MRI
* contra-indication for general anesthesia
* age below 18 years
Bone Metastasis on the Survival of Gefitinib Effective Patients

Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. histological and (or) cytological diagnosed NSCLC patients.
2. patient was effective in Gefitinib treatment more than 6 months.
3. whether patient received chemotherapy and other treatment is not restricted.
4. whether patient was detected for EGFR gene mutation was not restricted.

Exclusion Criteria:

1. patient with small cell lung cancer.
2. patient without cytology or histopathology diagnosis results.
3. patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
4. patient with poor treatment compliance.
5. patient with incomplete data.
Physical Therapy Students: Well-being

This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students.

Understanding the psychosocial state of academic students has become a primary concern in contemporary educational research and practice. As students go through the challenges of higher education, factors such as motivation, life satisfaction, and happiness play crucial roles in shaping their academic experiences and outcomes. Therefore, researchers have increasingly turned their attention to studying these elements in order to gain insight into the overall state of students and inform strategies designed to create positive educational outcomes.

The implications of studying motivation, life satisfaction, and happiness among academic students are far-reaching. By gaining a deeper understanding of these psychosocial elements, educators and policymakers can develop interventions and programs designed to cultivate positive learning environments that support students' psychological well-being and academic success. For example, strategies that enhance intrinsic motivation, such as promoting autonomy and providing meaningful learning opportunities, can lead to improved engagement and academic achievement. Similarly, initiatives that promote a sense of belonging and social support can improve students' overall life satisfaction and happiness.

Thus, this study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students.

Eligibility Criteria:
Inclusion Criteria:

Students: enrolled in the physical therapy study program (year I, II and III) Age: \> 18 years Ability to understand and follow instructions Availability to provide informed consent.

Exclusion Criteria:

Pre-existing medical conditions: uncontrolled medical conditions (cardiovascular disease, severe respiratory problems) Use of psychotropic drugs: drugs that could significantly affect mood, anxiety level, or sleep quality.

Pregnancy: due to potential physiological changes that could influence the results of the study.

Inability to comply with study requirements: these could include completing questionnaires and participating in the respiratory techniques program (if part of the intervention group).
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain

In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily. Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications affects on pain following treatment will also be recorded.

This is a dose-ranging study to evaluate the safety, pharmacokinetics, and tolerability of multiple doses of an oral, sustained release formulation of sodium nitrite (TV1001sr) in subjects with DNP. The primary objective is to assess the safety and tolerability of multiple doses of twice daily 40 mg and 80 mg TV1001sr compared with placebo over a 12 week treatment period and the pharmacokinetics of the sustained release formulation of sodium nitrite. Secondary objectives are to evaluate the pharmacokinetics and markers of functional improvement including pain questionnaires, quantitative sensory testing and changes in markers of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be post-menopausal, sterilized or using suitable birth control
* Diagnosis of diabetes (HbA1c \> 6.0)
* Diagnosis of diabetic peripheral neuropathy pain in feet
* Presence of ongoing diabetic neuropathic for at least 3 months
* A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening
* Ability to provide written informed consent

Exclusion Criteria:

* Patients with fibromyalgia or regional pain caused by lumbar or cervical compression
* History or diagnosis of significant neurological disease
* History and diagnosis of clinically significant psychiatric diseases
* Serious liver disease
* Poorly controlled diabetes
* Hypersensitivity to sodium nitrite or related compounds
* Life expectancy \< 6 months
* A chronic illness that may increase the risks associated with this study
* Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation
* Pregnant or nursing women
* Current diagnosis of alcohol or other substance abuse
* Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors
* History of methemoglobinemia, (met-Hb ≥ 15%)
* Subject is involved in litigation or receives worker's compensation
* Inability to speak English
A Phase I Study of LEE011 in Asian Patients

This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.

This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a histologically confirmed diagnosis of a solid tumor
* ECOG PS \<2
* Good organ function at screening visit
* A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy

Exclusion Criteria:

* Impairment of GI function
* Patients with concurrent severe and/or uncontrolled concurrent medical conditions
* Known diagnosis of HIV or active viral hepatitis
* Pregnant or nursing (lactating) women
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:
* RLS symptoms occur predominantly in the evening
* RLS history at least 6 months
* International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
* Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening

Exclusion Criteria:

* Any secondary RLS
* Current augmentation due to RLS treatment
* Placebo responders identified during the placebo run-in
Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)

The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.


Eligibility Criteria:
Inclusion Criteria:

* femoral head necrosis patients
* stage I/II/III (Ficat)
* age from 18 to 55 years
* stop steroid treatment for minimal 6 months

Exclusion Criteria:

* age younger than 18 or older than 55
* any hemopathy
* tumor
* femoral head/neck fracture
Open-Label Extension Study to ZPE-202

This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles, each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and vaginal bleeding intensity will be recorded using an electronic diary and Visual Analog Scale (VAS) pain assessment will be utilized. All subjects will have completed an Off-Drug Interval (ODI) prior to starting treatment. Visit 1 will be scheduled within a week before the next expected menses (+/- 2 days), following the off-drug interval. Subjects will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned. During the follow-up period subjects will continue to record study information in the electronic diary. The final follow-up visit will be scheduled after blood flow has stopped.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of protocol ZPE-202, or subject who withdrew from ZPE-202 for lack of efficacy after completion of at least 28 days of double-blind treatment (after Visit 3)
* Agreement not to attempt to become pregnant during the trial
* Women of child-bearing potential must be willing to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide
* Has a negative pregnancy test at Visit 1
* Is available for all treatment and follow-up visits

Exclusion Criteria:

* Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6-7 month study period
* Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit 1.
* Presence of intramural fibroids that impact the endometrial stripe, submucosal fibroids (any size), or endometrial polyps. Subserosal and intramural fibroids with no impact on the endometrial stripe are acceptable.
* Presence of endometrioma(s)
* Present history or condition that causes non-endometriosis related dyspareunia (e.g. vulvar vestibulitis).
* Past or present history of thrombophlebitis or thromboembolic disorders.
* Known or suspected carcinoma of the breast or reproductive organs.
* Cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV) or Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL).
* Known active infection with HIV, Hepatitis A, B or C.
* Endometrial stripe ≥18 mm in thickness at Visit 1.
* Subject is currently taking cimetidine or spironolactone.
* Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.