cyrilzakka/clinical-trials huggingface dataset:
Effects of Magnesium Oil Application on the Muscle Contractile Properties

This study will aim to investigate the effects of magnesium oil administration on skeletal muscle contractile properties.

Aim: This study will aim to investigate the effects of magnesium oil administration on skeletal muscle contractile properties (SMcp).

Design: Randomized controlled study

Participants: For this purpose, investigators will recruit 40 recreationally active and healthy adults of both sexes (18-35 years of age).

Methods: The experimental leg (EXP) will receive the 10 sprays of magnesium oil (20 mg per spray) that will be topically applied to the skin covering the knee extensor muscles, whereas the control leg (CON) will receive 10 sprays of natural mineral-free oil. The vastus lateralis SMcp will be measured by using a tensiomyography (TMG) device before application (PRE) and after 10 (POST10), 20 (POST20), 30 (POST30), 40 (POST40), and 50 (POST50) minutes of application onset, respectively.

Eligibility Criteria:
Inclusion Criteria:

* healthy, recreationally active adults, no history of neuromuscular and musculoskeletal diseases

Exclusion Criteria:

* if some of the criteria are not met
Balance Training With Stroboscopic Vision

Balance training with stroboscopic vision in patients with chronic ankle instability.

This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.

Eligibility Criteria:
Inclusion Criteria:

* a previous episode of ankle sprain in at least 6 months before the beginning of the study
* a score of 25 or less in the Cumberland Ankle Instability Tool
* no history of others musculoskeletal injuries in the lower limbs

Exclusion Criteria:

* an acute ankle sprain within the last six weeks
* Recent lower limb surgery
Stereotactic Radiation to Decrease Pancreatic Secretions

Patients that have undergone pre-operative radiation for pancreatic carcinoma, that upon pathologic examination of the normal portion of the pancreatic gland that was in the radiation field showed acute and chronic changes in the pancreatic cells. The hypothesis for utilizing stereotactic radiation on pancreatic fistulae is that the treatment will decrease pancreatic secretions, thus decreasing autodigestion.

Stereotactic radiation for cancer has been utilized to successfully treat the head of the pancreas, which is generally a well-tolerated procedure with minimal complications. Upon further investigation under the microscope, after resection during a complex Whipple operation, it is noted that particularly the exocrine glandular tissue atrophied substantially. Based on this information, the hypothesis for utilizing stereotactic radiation on the remaining pancreas is production of a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland. The use of stereotactic radiation will be performed on individuals that are non-surgical candidates.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic fistula
* Non-surgical candidate

Exclusion Criteria:

* Surgical candidate
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC

This study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.

Immune checkpoint inhibitors (ICIs) are commonly used for advanced stage of hepatocellular carcinoma (HCC) in recent years. The incident rate of Grade 4 immune checkpoint inhibitors-induced immune mediated hepatitis reaches 14.5%. Since these patients usually develop into liver failure, it is urgent to find out a more suitable therapy. Artificial liver support system (ALSS) treatment has been proved to effectively control both immune mediated hepatitis and liver failure, it may be a new therapy for immune checkpoint inhibitors-induced liver failure (ICIs-LF) in patients with HCC. Therefore, this study aims to investigate the efficacy and safety of ALSS treatment, including the classic mode of plasma exchange (PE) and new combination mode of double plasma molecular adsorption system (DPMAS) with sequential low-dose plasma exchange (LPE), for ICIs-LF in patients with HCC. Sixty patients with HCC and ICIs-LF will be enrolled in this study. The participants are randomly divided into trial group (DPMAS+LPE, and comprehensive internal medical treatment) and control group (PE and comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65 years old;
2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
3. Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors is less than three months from inclusion;
4. The level of hepatitis b virus DNA \< 2000 IU/mL；
5. Serum aspartate aminotransferase/alanine aminotransferase \> 20 times upper limit of normal；serum total bilirubin\>10 times upper limit of normal；
6. Prothrombin time international ratio \> 1.5;
7. Platelets \> 50\*10 E9/L;
8. Without intrahepatic bile duct dilation due to tumor progression.

Exclusion Criteria:

1. Other active liver diseases;
2. Other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
6. Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;
7. Patients received artificial liver support system treatment in one week before inclusion;
8. Patients can not follow-up;
9. Investigator considering inappropriate
A RCT of an AEBT Website for Adults With Skin Picking

The goal of this clinical trial is to test an online intervention for adults with excoriation disorder (skin picking). The main questions it aims to answer are:

1. Is the online intervention effective, compared to a waitlist control condition?
2. Is the online intervention acceptable to use?

Participants will be randomized into either the online intervention or waitlist control condition:

1. Participants in the intervention condition will be asked to complete an 8 module acceptance-enhanced behavioral training (AEBT) program for skin picking and 4 surveys over 3 months.
2. Participants in the waitlist condition will be asked to complete 4 surveys over 3 months, and will receive access to the intervention once the study is complete.

Excoriation disorder, also known as skin picking, is a chronic repetitive condition that impacts an individual's daily functioning and causes clinically significant distress. Excoriation is estimated to impact between 2-5% of the general population, although some studies have found up to 14% prevalence rates in undergraduate samples. Acceptance-enhanced behavioral training (AEBT), has shown promising results for targeting skin picking symptoms. However, a recent study demonstrated that mental health providers have limited knowledge of skin picking and how to treat it effectively, creating a dearth of available treatment opportunities .

This study aims to address the gap in accessible evidence-based excoriation treatment by examining the efficacy and feasibility of a self-guided, online program based in AEBT. Participants will be recruited from across the United States from August to November 2023, and will be randomized into either the online intervention group or a waitlist control condition. All participants will complete online self-report assessments at baseline, mid-, post-intervention, and 1 month follow-up, and waitlist participants will be provided access to the program once the study is complete. For the primary aim evaluating efficacy, the investigators predict that both primary (skin picking severity) and secondary outcomes (psychological flexibility, well-being, and distress) will be significantly improved in the active treatment condition compared to a waitlist control group. For the secondary aim evaluating feasibility, the investigators predict that participants will report acceptable feasibility as measured through treatment adherence, reports of usability, and program feedback.

Eligibility Criteria:
Inclusion Criteria:

* currently meet criteria for DSM-5 excoriation disorder
* at least 18 years old at intake
* fluent in English
* reside in the United States

Exclusion Criteria:

* currently receiving alternative psychotherapy for skin picking
* modifying or starting psychotropic medication 30 days prior to starting the study
* currently living outside of the United States
* under the age of 18
* did not meet DSM-5 criteria for excoriation at the time of intake session
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening in the assessment of patient's risk of preterm delivery.

The study will investigate whether the levels of individual maternal serum screening biomarkers, their combinations or temporal changes in the level can be associated with an increased risk of preterm delivery. Blood samples at three time points in pregnancy will be collected from the study participants. The first two blood draws will be timed to coincide with the first and second trimester maternal serum testing. The third blood draw will coincide with the screening for gestational diabetes. Pregnancy outcome information will be collected from the physicians and linked to the subject samples.

Subject samples from a case-control patient group will be analyzed by the serum screening biochemical assay. Statistical analyses will be performed to achieve the study objectives.

NOTE: This study is recruiting in Florida, USA. The laboratory data coordination is being performed in Massachusetts, USA and New Mexico, USA. New study locations will be identified on an ongoing basis.

Eligibility Criteria:
Inclusion Criteria:

* The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of the English language.
* The participant consents to and signs the approved consent form.
* The participant is 18 years of age or older.
* The participant has a singleton pregnancy.
* The participant is planning on continuing the pregnancy.
* The participant has intent to clinically test for Down syndrome risk.
* The participant consents to the study at the first trimester of her pregnancy.
* The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of either the English or Spanish language.

Exclusion Criteria:

* N/A
Mediterranean Diet Post-liver Transplantation

The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.

Study Hypotheses

* A modified Mediterranean diet after liver transplantation results in weight loss, improvement of insulin sensitivity, lipid profiles, blood pressure, BMI, and waist circumference in patients who adhere to the program.
* A modified Mediterranean diet after liver transplantation results in relative improvement in cardiovascular outcomes in patients who adhere to the program when compared to standard of care.
* A modified Mediterranean diet after liver transplantation results in relative improvement in 10-year ASCVD risk in patients who adhere to the program when compared to standard of care.
* A modified Mediterranean diet after liver transplantation decreases the risk of development of NAFLD/NASH/NASH fibrosis in patients who adhere to the program.

Study Design:

* Single-center, prospective, randomized interventional trial
* All eligible post-liver transplant patients during the enrollment period will be invited to participate in the trial.
* All enrolled patients will be randomized to the Dietary Intervention (DI) arm or the Standard of Care (SOC) arm.
* All patients will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria

* Adult patients ≥ 18 years of age undergoing primary liver transplant
* Ascites-adjusted BMI ≥ 25 kg/m2
* Acceptable graft function (total bilirubin level \< 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)

Exclusion Criteria

* Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
* Untreated post-transplant vascular complications or biliary strictures
* Multi-organ transplantation
* Urine protein excretion ≥2.0 g/day
* Uncontrolled diabetes mellitus (HbA1c \> 10%)
* Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders
* Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)
* History of bariatric surgery
* Pregnancy or planning on pregnancy in the next year
Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer

The primary objective for this trial is to determine the biological ability of apricoxib to decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects compared to those who have not in subjects with early stage Non-small Cell Lung Cancer (NSCLC). The secondary objectives are to determine the efficacy of apricoxib to inhibit CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 capable of giving informed consent. Radiographic findings suspicious for primary lung cancer or pathologically confirmed NSCLC which is surgically resectable and radiographically early stage (stage I and II).
* ECOG performance status of 0, 1, or 2 (see Appendix A).
* Ineligible for or refuse preoperative chemotherapy or chemoradiation therapy
* Normal renal function (defined as serum creatinine ≤ 2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73m2).
* Normal liver function (defined as total bilirubin ≤ 1.5 x ULN, SGOT \& SGPT ≤ 2.5 xULN).
* Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment.
* Preoperative pulmonary function test (PFT) with FEV1 and D LCO ≥ 60% or predicted postoperative FEV1 and DLCO ≥ 40% based on quantitative lung perfusion scan
* Must be able to come off anticoagulants and have normal coagulation studies (PTT \< 40 seconds and INR \< 1.4) prior to planned surgery.
* For subjects on COX-2 inhibitors or other NSAIDS prior to study initiation, cessation of the drug for 1 week prior to Apricoxib administration is required for study enrollment.

Exclusion Criteria:

* Radiation therapy, chemotherapy, non-cytotoxic investigational agents, or corticosteroids within 4 weeks of initiating treatment.
* Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol.
* Hypersensitivity to apricoxib, sulfonamides, aspirin, or other NSAIDS or to any reagents used in the study.
* Previous history of gastrointestinal ulceration, bleeding, or perforation.
* Required concurrent use of COX-2 inhibitors or other NSAIDS during Apricoxib administration.
* Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated).
* Pregnant or nursing women.
* Evidence of NYHA class III or greater cardiac disease.
* History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months of initiating treatment.
* History of heart surgery for coronary artery disease.
* Known HIV infection or AIDS.
Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer

The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
* Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
* At least 1 measurable lesion.
* Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
* Must be able to follow study guidelines and be able to show up for appointments.

Exclusion Criteria:

* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Previous treatment with enzastaurin or pemetrexed.
* Concurrent administration of any other antitumor therapy.
* Inability to swallow tablets.
* Pregnant or breastfeeding.
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer

The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response \[CR\] and partial response \[PR\]) at study closure.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18 and 70 years, inclusive
2. Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
3. Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
4. At least one uni-dimensionally measurable lesion according to the RECIST
5. World Health Organisation (WHO) performance status (PS) of 0 or 1
6. No previous chemotherapy for recurrent or metastatic disease
7. Before subject registration a quality of life questionnaire should be completed

Exclusion Criteria:

1. Previous chemotherapy for recurrent or metastatic disease
2. Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
3. Known severe hypersensitivity to ZD1839 or any of the excipients of this product
4. Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
6. Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
7. Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
8. Serum bilirubin greater than the upper limit of the reference range (ULRR)
9. Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
10. Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
14. Pregnancy or breast feeding (women of child-bearing potential)
15. Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
16. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
17. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa

The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

This was a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of SD-101 dermal cream (3% or 6%) on skin lesions in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.

SD-101 cream \[containing 3% or 6% or vehicle (0%)\] was applied topically, once a day to the entire body for a period of 90 days. Eligible participants had a target wound assessed at baseline. Selected target wound had to be at least a certain age and within a prespecified size range at study entry. Photographic confirmation of the target wound location was collected at baseline, and the picture saved from the first visit was used to confirm location of the target wound at subsequent visits. The participant returned to the study site at Week 2, Month 1, Month 4, and Month 5 (at 14, 30, 60, and 90 days, respectively) to have the target wound previously identified at baseline re-assessed for the level of healing. In addition, changes in itching, pain, body surface area coverage of blisters and lesions, and scaring of the healed target wound were also assessed at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent form signed by the participant or the participant's legal representative; if the participant is under the age of majority but capable of providing assent, signed assent from the participant.
* Participant (or caretaker) was willing to comply with all protocol requirements.
* Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
* Participants 6 months of age and older.
* Participants had 1 target wound within a prespecified size range at study entry.
* Target wound was at least 21 days or older.

Exclusion Criteria:

* Participants who did not meet all the entry criteria outlined in inclusion criteria.
* Selected target wound had clinical evidence of local infection.
* Use of any investigational drug within 30 days before enrollment.
* Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
* Use of systemic or topical steroidal therapy within 30 days before enrollment (inhaled steroids and ophthalmic drops containing steroids were allowed).
* Use of systemic antibiotics within 7 days before enrollment.
* Current or former malignancy.
* Arterial or venous disorder resulting in ulcerated wounds.
* Diabetes mellitus.
* Pregnancy or breastfeeding during the study (a urine pregnancy test was performed at screening for female participants of childbearing potential).
* Females of childbearing potential who were not abstinent and not practicing a medically acceptable method of contraception.
* Known history of cardiac, hepatic, or renal disease.