cyrilzakka/clinical-trials huggingface dataset:
The Effect of Kinesiotaping in Pregnant Women

The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.

Lumbar-sacral spinal pain is a medical and socioeconomic problem affecting approximately 80% of the population. Pregnancy predisposes women to this pain. The most well-known cause of low back pain during pregnancy is an increase in lumbar lordosis, a lordotic syndrome that develops rapidly due to the pregnant uterus and maternal weight gain. This lordotic posture and the related change in load distribution, along with lengthening abdominal muscles and shortening lumbar muscles, create a mechanical disadvantage. The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.

Eligibility Criteria:
Inclusion Criteria:

* 20-32-week pregnant women without neurologic deficits
* Females with mechanical low back pain
* VAS of at least 3

Exclusion Criteria:

* High-risk pregnant women with twin pregnancy
* Placenta previa
* Pre-eclampsia
* Threatened preterm delivery
* Orthopedic and rheumatologic diseases
* Radiculopathy
Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors

The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with pembrolizumab in adult patients with Locally Advanced/Metastatic Solid Tumors


Eligibility Criteria:
Inclusion Criteria:

* Phase 1a patients must have locally advanced or metastatic solid tumors,
* Phase 1b patients must have locally advanced or metastatic and/or non-resectable head and neck squamous cell carcinoma, cholangiocarcinoma, stomach cancer, melanoma, pancreatic cancer, NSCLC (as high expression of αVβ3, αVβ5, or αVβ6 have been reported for these tumors)

  * Measurable disease: For Phase 1a patients can have non-measurable or measurable disease. For all other parts: measurable disease defined by RECIST v1.1 is required
  * For Phase 1a Part 3 and Phase 1b patients (combination treatment) must be refractory or relapsed to anti-PD-1, anti-PD-L1 or anti-CTLA4 checkpoint inhibitors for all tumor types, For Part 1 and Part 2 of Phase 1a (BJ-001 single agent treatment) both checkpoint inhibitor naïve or refractory/relapsed patients will be considered.
* Patient who have diagnosis for which treatment with pembrolizumab to be enrolled. Patients previously treated with pembrolizumab and who have progressed are eligible. to be enrolled.

  * Adequate hematologic function,
  * Adequate hepatic function, defined by all of the following:
  * Adequate renal function defined by estimated creatinine clearance ≥ 45 mL/min (Cockcroft and Gault formula
  * ECOG Performance Status (PS) of 0-2.
  * No history of any hematopoietic malignancy.
  * No active or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy).

Exclusion Criteria:

* Pregnant or nursing females.
* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug. Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives (LHRH antagonists are allowed).
* Patients previously treated with an anti PD-1/PD-L1 targeting agent who have had any prior history of immune-mediated pneumonitis, any immune-mediated toxicity of ≥ Grade 3,
* Patients with a history of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity.
* Patients with a history of pneumonitis, myocarditis, history of Stevens-Johnson syndrome or toxic epidermal necrolysis.
* Patients who have undergone a bone marrow transplantation, solid organ transplantation, or stem cell transplant.
* Patients with unresolved AEs \> Grade 1 from prior anticancer therapy.
* Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment.
* Uncontrolled primary central nervous system (CNS) tumors or CNS metastases; based on screening.
* Patients with active autoimmune disease or a documented medical history of autoimmune disease managed by replacement therapy.
Ultrasound Imaging Measurements of the Thoracolumbar Fascia

In this prospective study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique.

The overall aim of the present research is to develop ultrasonographic parameters that characterize the geometrical, the mechanical and tissue characteristic properties of the thoracolumbar fascia, and to explore the effect of a massage therapy technique on these parameters.

In this prospective proof of concept study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound (US) exam of the thoracolumbar fascia (TLF) of the lower back. A musculoskeletal radiologist will perform the US exams consisting of a series of 5 dynamic scans of both the right and left paraspinal muscles, obtained during 15 degrees of passive flexion of the lower body using a motorized table.

Following the US exam, the group of patients and the group of volunteers will be respectively randomized to receive either a standardized massage technique intervention or a sham technique. The US exam will be repeated after the intervention.

Ultrasound image segmentation will be performed by two independent observers and inter-rater variability will be assessed. Post-processing of the US recordings will include assessment of geometrical (thickness), mechanical (percent shear strain between the TLF and the epimysium-muscle complex) and tissue ultrastructure features (the mean intensity μ, the scatterer clustering parameter α and the structure parameter κ of the echo envelope). These features will be compared between patients and volunteers and between the intervention groups.

Eligibility Criteria:
Inclusion Criteria:

Patient group:

* Presenting with chronic low back and/or referred pain (non specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 6 months;
* Pain is present at least 50% of the time during the day;

Asymptomatic group:

* No history of low back pain or any other chronic pain limiting activities of daily living or work.

Exclusion Criteria:

* History of back surgery;
* History of severe back or low extremity injury;
* Back pain attributable to a specific, recognizable, known pathology (i.e.: infection, tumor, fracture, spinal stenosis, sciatica etc.);
* Corticosteroid medication intake or corticosteroid injection in the lumbar spine in the previous 3 months;
* Pregnancy.
Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.

To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Acute-on-Chronic liver failure caused by hepatitis B virus
* Model for End-Stage Liver Disease (MELD) \<30

Exclusion Criteria:

* Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
* History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
* Severe problems in other vital organs(e.g. the heart, renal or lungs)
* Severe bacteria infection
* Tumor on ultrasonography, CT or MRI examination
* Pregnant or lactating women
Efficacy and Safety of a Cutaneous Formulation of Gonyautoxin 2/3 (GTX 2/3) for the Treatment of Facial Wrinkles

The main objective of the trial is to determine whether the current topical formulation of GTX 2/3 reduces the wrinkling of the skin (crow's feet) after a single application

Other evaluation criteria include: safety assessment and local tolerance, depth of facial wrinkles (video microscopy imaging).

This is a single volunteer group study. Each volunteer will be her own control. A volunteer will receive the active product containing cream on one side of her face and will receive the placebo cream on the other side.

Eligibility Criteria:
Inclusion Criteria:

* Women with no bearing-child potential or with adequate birth control method.
* Volunteers between 30 to 60 years of age.
* Subjects with bilateral crow's feet wrinkles.
* Regular user of cosmetic products, willing and able to comply with the study objectives.
* Signed informed consent.

Exclusion Criteria:

* Any medical condition or any use of a medication that could modify the study results (e.g.: NSAIDs, immunosuppressant drugs, insulin...).
* Any other significant medical condition (e.g.: diabetes mellitus, heart disease, liver disease...).
* Any other condition that in the investigator's opinion could not be appropriate with the participation in this trial.
* Any health condition that could affect the evaluation of study parameters.
* Acute or chronic skin disease.
* History of allergic reaction to cosmetic compounds.
* Pregnancy, planned pregnancy or breast-feeding.
* Allergy to shellfish, fish or sea product (seaweed).
* Known or suspected hypersensitivity to any of the study product compounds.
* Participation in another clinical trial within 30 days previous to enrolment.
* Known or suspected alcohol or drug abuse.
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.

This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 study participants (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.

This is a proof of concept study, to determine whether administration of patiromer has the potential to change the risk category for ESRD patients who are on conventional HD schedules. In addition, the study will develop and pilot study procedures that could be implemented in a large-scale clinical trial. By nature of the limited size of the study, the power of the trial will be limited. Reducing serum potassium with the use of low dialysate potassium is actually associated with an increased risk of sudden cardiac death. Furthermore, HD patients already carry a high pill burden, and it is unclear if prescription of an additional oral medication will reduce the frequency of episodic hyperkalemia.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females, age at least 18 years
* ESRD treated with thrice-weekly HD for ≥ 6 months.
* At least two measured pre-dialysis serum \[K\] ≥ 5.5 mEq/L or one \[K\] ≥ 6.0 mEq/L noted over the past three months
* Current use of dialysate with potassium concentration ≤ 2 mEq/L
* Typical consumption of at least two meals per day
* Have received customary dietary instruction over prior month
* Considered by the treating physician(s) to be in otherwise stable clinical condition.
* If patient is of childbearing potential, he/she will be willing to avoid pregnancy during the study using an acceptable birth control method.

Exclusion Criteria:

* Not considered by the treating physician(s) to be adherent with recommended dialysis schedule and prescribed medications
* Life expectancy \< 3 months
* Dialysis-dependent for less than 6 months
* Non-elective hospitalization in prior 3 months
* Currently prescription of oral potassium supplements
* In the prior 3 months, therapy with oral potassium-lowering medication
* Underlying severe gastrointestinal disorders, including history of ischemic bowel.
* Corrected serum calcium concentration \> 10.5 mg/dL in prior three months
* Anticipated kidney transplant within the next 3 months
* Prisoners or others who are involuntarily incarcerated or detained
* Pregnant, breastfeeding, or considering pregnancy.
* Participation in a clinical trial of an experimental treatment within the past 30 days
Simulating Laparoscopy With an Eye Patch

Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.

Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.

Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.

They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.

All participants will complete the tasks on both the computerized lap simulator and the box trainer.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic Novices
* 20-40 years
* All genders

Exclusion Criteria:

* Previous laparoscopic surgical experience
Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes

Muscle contractions induced by calf low-intensity neuromuscular electrical stimulation (C-LI-NMES) can increase venous return and may reduce venous thromboembolism. This study aimed to compare the effect of different C-LI-NMES frequencies and plateau times on hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse textile electrodes.

Fifteen healthy participants were stimulated via two 3x3cm transverse textile electrodes integrated in a sock, with ten different combinations of frequency (1Hz or 36Hz) and plateau times (0.5/1.5/3/5/7s), with gradually increasing NMES-intensity until plantar flexion-induction. At this point, popliteal peak venous velocity (PVV), time-averaged mean velocity (TAMV) and ejection volume (EV) were assessed by Doppler-ultrasound, discomfort by a numerical rating scale (NRS, 0-10) and values for current amplitude and energy were calculated based on the NMES-device´s intensity level. Values expressed with median (interquartile range), significance set to p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-99 years of age
* Voluntary participation

Exclusion Criteria:

* Pregnancy
* Pacemaker
* Ongoing thromboprophylaxis
* Skin wounds
* Vascular abnormalities
* Previous vascular system surgery in the lower limbs
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120).

Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120).

A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia.

.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female patients at least 18 years of age
* Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
* Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
* Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
* Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
* hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

Exclusion Criteria:

* Patients with total ankylosis of the spine
* Pregnant or nursing (lactating) women
* Evidence of ongoing infectious or malignant process
* Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
* Subjects taking high potency opioid analgesics
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents

Other protocol-defined inclusion/exclusion criteria may apply
Mannitol Dose Response Study in Cystic Fibrosis

Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis (sweat test/genotype)
* 7 years or older
* FEV1 between 40% and 90% of predicted for height, age and gender.
* Able to perform acceptable-quality spirometry
* Clinically stable in the week up to study entry
* No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)

Exclusion Criteria

* Currently active asthma
* Subjects colonized with Burkholderia cepacia or MRSA
* Considered "terminally ill" or listed for transplantation
* Requiring home oxygen or assisted ventilation
* Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)
* Significant episode of haemoptysis (\>60 mLs) in the previous 12 months
* Heart attack or stroke in last 3 months
* Known aortic or cerebral aneurysm
* Subjects who are breast feeding or pregnant.
* At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
* Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
* Known intolerance to mannitol or unable to take any form of bronchodilator medications.
* Uncontrolled hypertension, systolic BP \> 200 or diastolic BP\> than 100
* Concurrent use of beta blocker medication
* Concurrent use of hypertonic saline

Canada:

* Concurrent use of other pharmacological mucolytic agents other than Pulmozyme

Argentina:

* Concurrent use of other pharmacological mucolytic agents including Pulmozyme
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer

To assess the ability of a combination of updated and approved modalities in the treatment of first line pancreatic cancer patients to increase the time to Progression Free Survival

For resectable patient; surgery with Intraoperative Radiation Therapy (IORT). Radiation Therapy within 6-8 weeks after surgery followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery.

For marginally resectable patients; the patients will have 2-3 cycles of neoadjuvant chemotherapy of FOLFIRINOX and then restaged, undergo surgery with IORT within 2-4 weeks following chemotherapy. Then radiation therapy starting within 6-8 weeks. Followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Exocrine Adenocarcinoma of the pancreas
* Clinically resectable or marginally resectable disease
* No prior radiation or chemotherapy for carcinoma of the pancreas
* ECOG performance status of 0-1
* Patients must be medically able to undergo surgical resection
* Patients of child bearing potential must follow study specific precautions
* Women that are lactating will not be excluded on the condition that they dispose their breast milk.
* Adequate hematologic and biochemical parameters.

Exclusion Criteria:

* Prior treatment for pancreatic cancer.
* Concurrent investigational treatments.
* Unresectable pancreatic mass.
* Neuroendocrine Histological pancreatic cancer
* Distant Metastatic disease
* Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements