cyrilzakka/clinical-trials huggingface dataset:
Flywheel Exercise for CKD

Among Veterans, the prevalence of chronic kidney disease (CKD) is reported to be as high as 47.3% and a third higher than the general population. Muscle wasting and dysfunction have been identified as primary consequences of CKD. Disease-induced reductions in lean tissue adversely affect muscle fatigability. Consequently, muscle fatigability may serve as a potential limiting factor that contributes to activity limitations. However, there is a lack of evidence informing our understanding of muscle fatigability in patients with CKD. Dialysis treatment is a major factor contributing to the high financial costs of CKD care. Thus, in addition to potential health and quality of life benefits, treatments capable of maintaining kidney function or delaying the onset of dialysis treatment would provide substantial socio-economic benefit. Both lean body mass and muscle fatigability may be improved through strength training. Eccentric-overload (i.e. muscle lengthening) progressive resistance exercise (PRE) has been shown to be safe and effective for a variety of chronic conditions. Eccentric PRE using portable flywheel technology may provide a clinically viable treatment option to combat muscle impairments in CKD given the cost effectiveness and minimal space requirements for this mode of exercise.

The purpose of this study is to assess feasibility of the eccentric-overload PRE regimen for Veterans with CKD stage 3 \& 4 predialysis using a prospective single-arm pre-test post-test intervention design. The primary aim of the project is to determine the effects of eccentric-overload PRE on muscle fatigability in Veterans with CKD Stages 3 \& 4 predialysis. Feasibility of the regimen will be determined by the time needed to complete the 4-exercise regimen and the perceived exertion levels reported by the study participants.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory patients (with or without a gait aid)
* CKD stage 3 or 4
* patients receiving care at the DC VAMC Renal Service
* the ability to speak and read English
* orientation to person, place, and time

Exclusion Criteria:

* unable to speak English
* acute renal failure
* pregnant
* unable to follow study instructions
* any uncontrolled cardiovascular or musculoskeletal problems that would make participation in this study unsafe
Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.


Eligibility Criteria:
Inclusion Criteria:

• Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows:

\*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma:

EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma

INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, transformed NHL histologies, etc.

\*Hodgkin's lymphoma

* Life expectancy of 12 weeks or longer.
* Subject must have received ≥ 1 prior treatment regimen.
* The subject must not be a candidate for potentially curative therapy, including stem cell transplant.

Exclusion Criteria:

* Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
* Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
* Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.
* Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3.
* Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
* Received autologous hematopoietic stem cell transplant within the last 3 months.
* Laboratory parameters not within the protocol-defined range.
* Current or recent history (\<30 days prior to screening and/or \<45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection.
* Current clinically active viral infection.
* Known history of infection with the human immunodeficiency virus (HIV).
* History of active hepatitis or positive serology for hepatitis.
Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma

A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Study Participants must be 18 years or older.
* Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery.
* Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.
Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques

Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20 years. However, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. A possible explanation for this fact is that most ACL reconstructions consider only one of the functional bundles of the ligament. Our hypothesis is that the ACL reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had ACL reconstruction with the single-bundle technique.

The aim of this study is to compare the ACL reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the ACL with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the ACL), both in terms of objective and subjective results.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. Body mass index (BMI), which corresponds to the ratio between weight in kilograms (pounds) and height in m2 (square meters) between 18.5 and 24.99.
3. Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation.
4. Magnetic resonance imaging (MRI) confirming the ACL injury.
5. Aged between 20 and 45 years.
6. Not having asymmetric varus alignment, greater than or equal to 5 degrees (to eliminate cases with indication for osteotomy of the tibia), using panoramic radiographic comparison of the lower limbs in standing position.
7. Absence of associated ligament instabilities (medial, lateral or posterior).
8. No previous surgery on the affected knee.

Exclusion Criteria:

1. New post-surgical trauma after 12 months.
2. Interruption of treatment / follow-up.
3. Postoperative infection.
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan

This is a multicenter study in Japan. Eleven sites which have already participated in the investigator-initiated clinical study (Early Access Program) will participate in this study.The objective of this study is to gain further information on the safety and efficacy of treatment with asfotase alfa.

The primary objective of this study was to collect data on the safety of repeated subcutaneous (SC) injections of asfotase alfa. There were no secondary objectives. Exploratory objectives related to the efficacy of asfotase alfa are not being reported.

Eligibility Criteria:
Inclusion Criteria:

1. Patient or parent (or legal guardian) must provide written informed consent prior to the performance of any study-related procedures and must be willing to comply with study procedures. Where appropriate and required by local regulations, patient assent for participation must also be obtained.
2. Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol for asfotase alfa

Exclusion Criteria:

1. Patient has a documented form of rickets caused by a condition other than HPP, including, but not limited to, rickets caused by 25(OH) vitamin D deficiency
2. Patient has serum calcium and/or phosphorus levels below the normal range
3. Patient is pregnant or lactating
4. Patient received treatment with bisphosphonates within 2 years prior to the Screening visit
5. Patient has a documented sensitivity to any of the components of asfotase alfa
6. Patient is currently enrolled in any other program or clinical study involving an investigational new drug, device, or treatment for HPP (eg, bone marrow transplantation)
7. Patient has clinically significant other disease in the opinion of the Investigator, defined as any other non HPP-related condition for which the patient is considered medically unstable.
Measuring Hand Edema in Burn Patients

The purpose of this study is to determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. Establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.

A prospective study involving 33 burn patients admitted to the US Army Burn Center. Two raters will perform three separate blinded measurements for hand edema using the figure-of-eight measurement technique. A third rater will then perform two blinded measurements using water volumetry. All measurements will be read and recorded by an independent recorder. The three measurements of rater 1 and 2 will be analyzed to determine intratester reliability. The average of the three figure-of-eight measurements will be compared to measure intertester reliability. The two volumetry measurements will be compared to determine intratester reliability. The average of the 2 volumetry measurements and the average fo the three figure-of-eight measurements will be used to determine concurrent validity.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-89 years old
* Admitted to the United States (U.S.) Army Burn Intensive Care Unit (ICU) or ward with burn injury and the presence of bilateral or unilateral hand edema

Exclusion Criteria:

* Subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician, that precludes the safe use of volumetry.
* Subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing.
* Subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement
Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease

Endoscopic full-thickness plication (EFTP) of cardia/fundus has been shown effective in treating GERD patients. However, EFTP requires proprietary equipment that are not available in many countries. Here, we designed a metal clip and endoloop mediated cardioplication (ECLC) procedure to achieve EFTP.

Endoscopic full thickness pancreatography (EFTP) is a minimally invasive surgical method that has emerged in recent years for the treatment of severe gastroesophageal reflux disease. This surgery requires the use of disposable patented instruments, which is expensive and has not entered the domestic market. To this end, we have innovatively developed an endoloop mediated cardioplication (ECLC) that only requires metal clips and nylon ropes. The most common and inexpensive endoscopic consumables can achieve the effect of tightening the lower esophageal sphincter, which is expected to be used for the treatment of gastroesophageal reflux disease. The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old
* hiatal hernia ≤ 3cm
* Sliding hernia ≤ 3cm
* Classic reflux symptoms (heartburn, reflux) lasting for more than 6 months
* Daily PPIs ≥ 6 months
* Esophagitis (Los Angeles grade) Grade A, B, and C
* Gastroesophageal valve I-III grade (Hill grade)
* Pathological esophageal acid exposure (percentage of time with 24-hour esophageal PH\<4 \<4.2%)
* Normal or near normal esophageal movement (through manometry or impedance)
* The lower esophageal sphincter pressure (LESP) is between 5-15mmHg
* DeMeester score ≥ 14.7 or total reflux episodes\>73
* Patients who sign an informed consent form and voluntarily accept surgical expenses.

Exclusion Criteria:

* BMI\>35kg/m2
* ASA \>II
* Barrett's esophagus
* Hill IV level
* Large esophageal hiatal hernia\>3cm
* Esophagitis (Los Angeles grade) Grade D
* Peptic ulcer
* Primary esophageal motility disorders such as achalasia
* Previous esophageal or gastric surgery
* Uncontrolled systemic diseases
* Pregnancy or planned pregnancy within 1 year
* Have a history of cervical fusion surgery, esophageal diverticulum, scleroderma or dermatomyositis, eosinophilic esophagitis, liver cirrhosis or coagulation dysfunction, immune system diseases
* Patients deemed unsuitable for inclusion by researchers.
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to adhere to protocol requirements and sign a informed consent form
2. Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criteria:

1. Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
2. Symptom of an acute illness within 4 weeks prior to drug administration
3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. History of clinically significant allergies including drug allergies
6. History of clinically significant allergies about atorvastatin or metformin
7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
8. History of myopathy
9. Clinical laboratory test values are outside the accepted normal range

   * AST or ALT \>1.25 times to normal range
   * Total bilirubin \>1.5 times to normal range
   * e-GFR \<90 mL/min
10. History of drug, caffein(caffein \> 5 cups/day), smoking (cigarette \> 10/day) or alcohol abuse(alcohol \> 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
11. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
12. Donated blood within 60 days prior to dosing
13. Participated in a previous clinical trial within 60 days prior to dosing
14. Use of any other medication, including herbal products, within 10 days before dosing
15. Subjects considered as unsuitable based on medical judgement by investigators
Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors

Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors

PURPOSE OF THE STUDY:

The purpose of this research study is to examine the aesthetics (the appearance of the implanted tooth and gums) as well as the soft tissue loss over a three-year period. This study involves replacing a missing small front tooth with a dental implant, abutment, and crown. A titanium dental implant acts as the replacement for a tooth root. An abutment is made of titanium which is either gold or silver in color and cannot be seen; but may affect the way the gum looks. An abutment is the component that attaches the crown to the implant post. A crown (which acts as the tooth replacement) is made of metal and/or porcelain and attaches over the abutment.

The dental implant and the abutments used in this study have been approved by Health Canada and the U.S. Food and Drug Administration (FDA) for the use of replacing the small teeth in the front of the mouth.

The abutment is made in two colors (either gold or silver) and you cannot choose. For each subject this is decided by chance. You will have an equal chance of getting a gold or silver-colored attachment. You will know which color the abutment will be once you have consented to be in the study and registered. You will know the color of the abutment before the implant is placed. The abutment is covered by the crown.

You will be in this study for about three years. There will be approximately 60 subjects who will participate in this study in different centres, in Canada and the USA.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide written informed consent to participate in the study.
* 18 years or older

Site requirements:

Missing one or both maxillary lateral incisors (if missing both, then both sites must be used in the study) or Single missing mandibular incisor or Two missing mandibular incisors, not adjacent to one another (both sites must be used in the study) Aside from the missing teeth specified above, all other teeth in the sextant must be present.

A minimum of premolar occlusion is required. A minimum mesio-distal and buccal-lingual distance of 5mm is required

Exclusion Criteria:

* Rampant caries or unstable periodontal disease of the remaining dentition.
* Any systemic or local disease or condition that may compromise post-operative healing.
* Long-term use of systemic corticosteroids or other medications that may compromise post-operative healing.
* Present alcohol and/or drug abuse.
* Unable or unwilling to return for follow-up exams over a 3 year period.
* Pregnancy or lactation at time of enrollment.
* Smokers will be excluded from the subject pool.
Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold

The purpose of the study will be to assess the efficacy and safety of XIGO administered orally, three times a day, compared with placebo in patients with the common cold.

The common cold is one of the most frequent human illnesses and has been shown to result in significant morbidity and economic loss. At the present time no truly effective therapy is available. Therapeutic interventions with compounds such as zinc have been found to be helpful however well reported side-effects have prevented its extensive use.

Based on several years of anecdotal clinical evidence which has shown that XIGO is effective in alleviating the symptoms of the common cold-the findings of which are supported by competent and reliable evidence from in vivo and in vitro and clinical trials studies on each of the individual active ingredients of the formulation, it has been proposed that XIGO, when administered orally, has a direct stimulatory effect on multiple components of the immune system. It is proposed that this stimulation increases both the immune cell population as well as its functionality and this will be observed in cells and molecules from both the innate and adaptive responses.

Eligibility Criteria:
Inclusion Criteria:

* Must be in good health in the clinical judgment of the investigator, other than cold symptoms
* Must have a cumulative score of 2 or higher, but not larger than 6, with symptom severity rated as 0=absent, 1=mild, 2= moderate, or 3=severe for each of the eight symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chillness. At least one of the first four "cold specific" symptoms must be present, and none of these symptoms can have been present for more than 12 hours.
* Must enter trial within 12 hours of symptoms onset.
* Aged 18-50 years, (inclusive), at visit 1.
* Subjects must understand and sign and date an informed consent form prior to any study related procedures being performed.
* Subjects must be capable of understanding and following directions.

Exclusion Criteria:

* Subjects taking medications, other than birth control, which, in the opinion of the investigator, could influence the purpose, integrity or outcome of the trial.
* Pre-menopausal women (last menstruation \<=1 year prior to ICF) who are nursing or pregnant or are of child-bearing potential and, in the opinion of the investigator, are not practicing an acceptable method of birth control, or do not plan to continue using method throughout the study.
* A history of adverse reactions to OTC drugs or other personal care products.
* Subjects who have used systemic steroids for at least 6 weeks prior to trial initiation or during the trial.
* A medical history of autoimmune disease, including Type 1 or Type 2 diabetes or HIV.
* Treatment with immunosuppressive drugs with the exception of cyclosporine for keratitis sicca.