cyrilzakka/clinical-trials huggingface dataset:
The Effect of Iron Deficiency Anemia During Pregnancy

Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations.

Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication.

Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy.
2. Gestational age 14-18 weeks.
3. Mild to moderate anemia
4. No associated medical or obstetric complications.
5. Women not already receiving iron therapy.
6. Women accepted to participate in the study.

Exclusion Criteria:

1. Multiple pregnancy
2. Severe anemia
3. Iron hypersensitivity.
4. Liver diseases.
5. Women refuse to participate in the study.
Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics

Two methods for detecting outcomes after knee prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (Oxford Knee Score) VS detection using digital questionnaires created on Google Forms and sent to the patient's smartphone on which the compilation takes place in the extra area outpatient.

PROMs (Patient Reported Outcomes Measures) are used globally for the evaluation of the results of a prosthetic surgery. One of the most used methods in the evaluation of PROMs in knee prosthetic surgery is the Oxford Knee Score, usually measured in an outpatient setting using paper questionnaires.

The aim of the study is to investigate the validity of an alternative method of evaluating PROMs in which the questionnaire will be administered to the patient digitally (Google Forms) in an out-of-patient setting.

The questionnaire aimed at the subjective evaluation of the discomfort induced by arthrosis of the knee (Oxford Knee Score), will be administered during the pre-hospitalization visits and again during the follow-up visits carried out at 1, 3 and 6 months after intervention. The digital evaluation will be sent to the patient during the outpatient visits and will be considered valid only if completed within 48 hours of the same.

On each patient the measurements will be carried out in both methods and differences in terms of compliance and satisfaction with the two methods under examination will be detected. Any differences in the final result of the Oxford Knee Score compared to the two methods and the differences in terms of outpatient assessment times will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with gonarthrosis with indication of hip arthroplasty
* males and females aged 18-78 and with a Barthel scale score ≥ 91
* patients in possession of private digital electronic support (smartphone, tablet or PC)

Exclusion criteria:

* patients with a Barthel scale score ≤ 90
* patients with psychiatric pathologies, a history of drug and alcohol abuse
* patients not in possession of private digital electronic support
Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors

CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.


Eligibility Criteria:
Inclusion Criteria

* Must be at least 18 years of age;
* Life expectancy: At least 3 months;
* Performance status: ECOG of 0 or 1;
* Histologic or cytologic proof of a solid tumor cancer that is not amenable to curative surgical resection;
* Evaluable or measurable disease documented within 4 weeks of the start of treatment;
* Prior chemotherapy or radiotherapy is allowed if 4 weeks or more have elapsed prior to starting treatment and patients have recovered from toxicities of prior treatment;
* Adequate organ function:

Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) \< 3 x upper limit of normal (\< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine \< 2.0 mg/dL;

* Patient has the initiative, geographic proximity, and means to be compliant with the protocol;
* Fertile patients (male or female) must agree to use effective contraception;
* Must be able to swallow and retain tablets.

Exclusion Criteria

* Major surgery within the four weeks preceding the start of treatment;
* Serious medical or psychiatric illness that would prevent self-determined informed consent;
* Intensive chemotherapy treatment;
* Infection or antibiotics at the time of screening;
* Uncontrolled cardiovascular, pulmonary, renal, neurologic, psychiatric, or hepatic dysfunction;
* Pregnant or nursing;
* Pre-existing diarrhea or uncontrolled clinically significant illness other than cancer (i.e. ulcerative colitis, malabsorption syndrome);
* Brain metastases that have not been stable for more than 3 months;
* Known Dihydropyrimidine Dehydrogenase (DPD) deficiency.
Recognize High Pressure Areas in Human Body to Prevent Decubitus Ulcers

Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer.

Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain.

Bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue.

Others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. Three primary contributing factors are sustained pressure, friction and shear.

Bedsores are easier to prevent than to treat.

* age
* weight
* high
* BMI
* pressure scanning map
* Alimentary status
* Diseases

Eligibility Criteria:
Inclusion Criteria:

* Any patient admitted for elective surgery,
* Patients above 18 y.o.,
* Patient admitted for surgery that required 3 or more days in hospital

Exclusion Criteria:

* Patients under 18
* Patients that require emergency surgery
* Patients that have bedsores before admission
Stimulus-Stimulus Pairing Study

The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.

The purpose of this study is to teach children with autism who do not produce sounds or words to vocalize sounds or words by using the stimulus-stimulus pairing (SSP) procedure. The investigators will use SSP, an intervention based in behavior analysis, to try to help the child vocalize sounds. A vocal recorder will also be sent home so that the caregiver can record the child's vocalization at home. The caregiver will then be asked to return this so that the investigators can listen to it. By doing this, the investigators hope to learn if the treatment helps increase the child's vocalizations at home. Some children in the study will receive treatment immediately. Some children may enroll in the study now but not receive intervention until a later date. All children in the study will receive treatment within one year of enrolling in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of autism
2. Currently do not emit vocalizations or minimally verbal
3. Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks.

Exclusion Criteria:

1. Children with significant problem behavior that interferes with structured intervention
Reliability of Myotonometry in Swimming Athletes

The clinical analysis of athletes has been performed in the sports field to obtain parameters for reliable evaluations. Among the tools used is the myotonometry, an analysis capable of quantitatively measuring tone, stiffness and elasticity. Its reliability has been tested in several populations, however, showing changes in results and presenting high variability in the confidence interval, also, the values of myotonometry differ according to sample specificity and the biomechanical properties of each muscle. Therefore, it seems pertinent to perform the reliability analysis in swimming athletes and verify their applicability and if the values of tone and muscular biomechanical properties vary according to the specificity of the modality. It will be a test and retest study composed of 50 young male and female swimming athletes, aged between 12 and 20 years. The evaluation of myotonometry will be performed randomly by two evaluators and the parameters measured will be: tone, stiffness, elasticity, relaxation time of mechanical stress and displacement. In the test stage, the first evaluator will perform the measurements bilaterally on the muscles and the second evaluator will perform the same measurements in the same order immediately after the first one. After 15 minutes, the retest will be performed following the same order of evaluators in the test. For characterization of sample will be used descriptive statistic through central tendency and variability for all variables collected. Relative reliability will be tested by the Intraclass Correlation Coefficient (ICC). Absolute reliability will be verified by means of standard error of measurement (SEM), values of least detectable change (MMD) and coefficient of variation (CV). The statistical package SPSS Statistics 22.0 will be used to conduct the reliability analyses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy swimming athletes

Exclusion Criteria:

* Being an alcoholic, consuming drugs, smoking or anti-inflammatory and / or analgesic drugs less than 24 hours before the test, presenting anemia, inflammatory process, diabetes, cardiovascular disease, episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months, in addition to swimming for less than two years.
Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)

The main objective of this study is to evaluate the efficacy of SRP-4045 (casimersen) and SRP-4053 (golodirsen) compared to placebo in participants with DMD with out-of-frame deletion mutations amenable to skipping exon 45 and exon 53, respectively.

This is a double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of SRP-4045 and SRP-4053. Eligible participants with out-of-frame deletion mutations amenable to exon 45 or 53 skipping will be randomized to receive once weekly intravenous (IV) infusions of 30 milligrams/kilograms (mg/kg) SRP-4045 or 30 mg/kg SRP-4053 respectively (combined-active group) or placebo for up to 96 weeks (the placebo-controlled period of the trial). This will be followed by an open-label extension period in which all participants will receive open-label active treatment for 48 weeks (up to Week 144 of study).

The study will enroll approximately 222 participants. Twice as many participants will be randomized to receive active treatment as will receive placebo (2:1 randomization).

Clinical efficacy will be assessed at regularly scheduled study visits, including functional tests, such as the 6-minute walk test (6MWT). All participants will undergo a muscle biopsy at baseline and a second muscle biopsy either at Week 48 or Week 96.

Safety will be assessed through the collection of adverse events (AEs), laboratory tests, electrocardiograms (ECGs), echocardiograms (ECHOs), vital signs, and physical examinations throughout the study.

Blood samples will be taken periodically throughout the study to assess the pharmacokinetics of both drugs.

Eligibility Criteria:
Inclusion Criteria:

* Genotypically confirmed DMD, with genetic deletion amenable to exon 45 or exon 53 skipping
* Stable dose of oral corticosteroids for at least 24 weeks prior to Week 1, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight).
* Intact right and left biceps brachii muscles or 2 alternative upper arm muscle groups
* Mean 6MWT ≥300 meters and ≤450 meters
* Stable pulmonary function: forced vital capacity (FVC) ≥50% predicted

Exclusion Criteria:

* Treatment with gene therapy at any time
* Previous treatment with SMT C1100 within 1 week prior to Week 1 and previous treatment with PRO045 (BMN 045), PRO053 (BMN 053), or PRO051 (BMN 051) within 24 weeks prior to Week 1
* Current or previous treatment with any other experimental treatment within 12 weeks prior to Week 1
* Major surgery within 3 months prior to Week 1
* Presence of other clinically significant illness
* Other inclusion/exclusion criteria may apply.
Efficacy of Treatment for Obsessive Compulsive Disorder

The purpose of these questionnaires is to give us an overview of how OCD has affected your life and perhaps also to give us some clues about things that may have set you up to experience OCD.

For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your obsessive-compulsive disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your OCD (e.g., depression, personal standards). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Obsessive Compulsive Disorder, and are accepted for treatment at the clinic.

Exclusion Criteria:

* Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Obsessive Compulsive Disorder.
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users

The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.


Eligibility Criteria:
INCLUSION CRITERIA

1. Healthy male or female subjects 18 to 55 years of age, inclusive.
2. Body mass index (BMI) within the range of 18 to 33 kg/m2, inclusive, and a minimum weight of at least 50 kg at Screening.
3. Free from any clinically significant medical or psychiatric abnormality
4. Recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months.
5. Female subjects must have a negative serum pregnancy test at Screening and urine pregnancy test at each admission.
6. Female subjects of childbearing potential must be practising abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month after the last study drug administration. Male subjects who have female partners of childbearing potential must ensure that their partner use an acceptable method of contraception.
7. Willingness to take a drug that might alter perception in a controlled setting.

EXCLUSION CRITERIA

A subject will not be considered eligible to participate in this study, if any one of the following exclusion criteria is satisfied:

1. A history or presence of drug or alcohol dependence (excluding nicotine and caffeine).
2. Use of non-prescription, prescription medication or natural health products (except acetaminophen, vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the qualification phase and throughout the study.
3. Use of SSRIs (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study.
4. History of allergy or hypersensitivity to the study drugs
5. Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration
6. Treatment with any investigational drug within 30 days prior to first drug administration during the qualification phase.
Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine

Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. When patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help.

Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used as a complementary therapy among patients with cancer. It can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment.

This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective Traditional Chinese Medicine assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 75 years, either gender.
* Visit emergency department
* Chief complaint is pain.
* Diagnosed by oncologist with International Classification of Diseases 9th revision (ICD-9) code between 140.0 to 239.9.

Exclusion Criteria:

* Serious comorbid conditions (for example, life-threatening condition).
* Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.
* Pregnancy status.
"VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density

The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.

The treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. Preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (LMMS) can preserve bone mineral density (BMD) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation.

To confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (60 years of age and older). A clinical center located in Boston, MA has recruited participants from multiple independent living facilities in close geographic proximity. Participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a three year period. All participants receive 1000 mg of elemental calcium and 800 IU of vitamin D per day.

This study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 60 years and over of all ethnic groups
* Weight less than 250 pounds
* Absence of terminal cancer or other illness necessitating hospice level services
* Capable of following the protocol and of understanding and providing informed consent
* Scoring less than 12 on the Short Blessed Test

Exclusion Criteria:

* Immobilization of the axial or lower appendicular skeleton within the last year
* Nonambulatory (ambulation with an assistive device will be permitted)
* Malignancy other than cured thyroid cancer or skin cancer
* Hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement
* Medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening TSH, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (SERMs), PTH, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time
* Paget's disease of bone, rheumatoid arthritis or other connective tissue disorders requiring systemic treatment with disease modifying drugs, or a history of Cushing's syndrome
* Fragility fracture within the past five years unless pharmacologic therapy not to be prescribed
Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

The purpose of this study is to compare two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome.

The investigators are planning to include 100 patients, undergoing LESI for radicular low back pain. This will be single-blinded randomized study. Every patient will receive the same medication we would use regardless of participating in the study. The patients will be randomly assigned to one of two groups, based on the approach:

* Group I (50 patients) - will get LESI using midline (MIL) approach.
* Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.


Eligibility Criteria:
Inclusion Criteria:

* 18- 80 years old
* History of low back pain and unilateral lumbosacral radiculopathy pain
* Lumbar disk disease including disk herniations, bulging discs, and degenerated discs, where at least 50% of the disk height is preserved respective to contiguous levels

Exclusion Criteria:

* Discogenic pain without radiculopathy pain
* History of previous spinal surgery
* LESI(s) in the past year
* Allergy to methylprednisolone, or lidocaine, or iodine-based contrast
* Concurrent use of systemic steroid medications
* Opioid habituation
* Pregnancy