cyrilzakka/clinical-trials huggingface dataset:
Understanding Fish Consumption Habits During Pregnancy

Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial for the developing fetus, yet potentially toxic because of mercury contamination, have created uncertainty about the appropriate fish consumption advice to provide pregnant women. The investigators objective was to determine knowledge, behaviors, and received advice regarding fish consumption among pregnant women who are infrequent consumers of fish.

Fish is a healthful food that is the primary dietary source of elongated n-3 polyunsaturated fatty acids (PUFA), nutrients essential for optimal neurodevelopment. Most pregnant women in the US do not consume adequate n-3 PUFA. However, fish also may be contaminated with methylmercury, and approximately 10% of women of childbearing age in the US have mercury levels higher than recommended. Because the same food contains both essential nutrients and harmful contaminants, substantial confusion reigns about the best course of action for pregnant women. Additionally, it is not clear what fish consumption advice would be most effective in changing women's fish consumption habits. The goal of this pilot study is to perform formative work to allow us to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. This project, together with a pilot RCT already funded, will serve as preliminary data to support a larger RCT to evaluate the effects of the intervention on pregnancy outcomes and postpartum maternal and infant health.

Specific Aims Aim 1. Among pregnant women, identify: 1) knowledge of the potential risks and benefits associated with fish consumption during pregnancy; 2) awareness of current recommendations for fish consumption by pregnant women; 3) the sources of information from which they are learning about the health effects associated with fish intake; and 4) facilitators and barriers to fish consumption, such as cost, availability, taste, and habits. To achieve this aim, we will conduct focus groups with pregnant women in the Boston area who are infrequent consumers of fish (defined as \<= 2 monthly fish servings).

Aim 2. Develop materials for a planned intervention to increase consumption of fish high in n-3 polyunsaturated fatty acids and low in methylmercury among pregnant women who are infrequent consumers of fish at baseline. We will use results from Aim 1 to inform the development of these materials.

Eligibility Criteria:
Inclusion Criteria:

* currently pregnant
* age at least 18 years

Exclusion Criteria:

* unable to speak or understand English
* consuming 2 or more weekly fish servings
* unable to eat fish (e.g. allergy, dietary restriction)
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment


Eligibility Criteria:
Inclusion Criteria:

* Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
* Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
* Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (\>10 ng/dL)
* Patient receives adjuvant standard chemoendocrine or endocrine therapy
* Bone density at study entry \> -2.5 T-Score

Exclusion Criteria:

* History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D
* Abnormal renal function
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
* Pregnancy or lactation
* Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa

Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .

This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy .

Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Diagnosis of retinitis pigmentosa
* willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
* To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
* willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

* Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
* Women who are pregnant or lactating
* Complications of diabetic retinopathy.
Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.

The ¹³C-Urea Breath Test (UBT) is a non-invasive test for detecting the presence of Helicobacter pylori (H. pylori) infection by the organism's urease activity. In the presence of H. pylori, the ingestion of urea, labeled with the non-radioactive isotope 13C, results in production of labeled 13CO2, which can be quantified in expired breath. Each test is performed using a test kit consisting of a 13C-urea tablet and citrica powder to be dissolved in tap water ("13C-urea solution"). Before and after ingestion of the 13C-urea solution, samples of exhaled breath can be collected using a nasal cannula for real-time analysis and comparison to baseline concentrations. The patient's exhaled breath is analyzed and the ratio between 13CO2 and 12CO2 is computed. The patient is considered H. pylori positive when the difference between the ratios exceeds a predefined threshold (5 delta over baseline (DOB)). The current device marketed by Exalenz is large and costly. Exalenz has built a smaller, cheaper and more reliable new generation device for this application. Equivalence is being demonstrated in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age
2. Present with clinical indication of H. pylori
3. Have the ability and willingness to sign the Informed Consent Form-

Exclusion Criteria:

1. Current serious disease
2. Participation in other trials
3. Antibiotics and/or Bismuth preparations for four (4) weeks prior to test
4. PPI or H2 blockers for two (2) weeks prior to test
5. Childbearing or breastfeeding women
6. Based on opinion of investigator, subject should not be enrolled in this trial
7. Allergy to citrus juice
8. Post -eradication therapy for H. pylori
A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants

This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18 participants (including at least 3 adolescents between 12 and 17 years of age, inclusive) with β-thalassemia major. The study will evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product \[autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human βA-T87Q-globin gene\].

Subject participation for this study will be 2 years. Subjects who enroll in this study will be asked to participate in a subsequent long-term follow up study that will monitor the safety and efficacy of the treatment they receive for up to 13 years post-transplant.

Eligibility Criteria:
Inclusion criteria:

* Participants between 12 and 35 years of age, inclusive, at the time of consent/assent, and able to provide written consent/assent, if applicable.
* Diagnosis of β-thalassemia major and a history of at least 100 mL/kg/year of pRBCs or ≥8 transfusions of pRBCs per year for the prior 2 years.
* Eligible for allogeneic bone marrow transplant.
* Treated and followed for at least the past 2 years in a specialized center that maintained detailed medical records, including transfusion history.

Exclusion criteria:

* Positive for presence of human immunodeficiency virus type 1 or 2 (HIV 1 and HIV 2).
* A white blood cell (WBC) count \<3 × 10\^9/L, and / or platelet count \<100 × 10\^9/L if not due to hypersplenism.
* Uncorrected bleeding disorder.
* Any prior or current malignancy or myeloproliferative or immunodeficiency disorder.
* Immediate family member with a known or suspected Familial Cancer Syndrome (including but not limited to hereditary breast and ovarian cancer syndrome, hereditary non-polyposis colorectal cancer syndrome and familial adenomatous polyposis).
* Receipt of an allogeneic transplant.
* Advanced liver disease, including persistent aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin value \>3 × the upper limit of normal, liver biopsy demonstrating cirrhosis, extensive bridging fibrosis, or active hepatitis.
* Kidney disease with a calculated creatinine clearance \<30% normal value.
* Uncontrolled seizure disorder.
* Diffusion capacity of carbon monoxide (DLco) \<50% of predicted (corrected for hemoglobin).
* A cardiac T2\* \<10 ms by magnetic resonance imaging (MRI).
* Any other evidence of severe iron overload that, in the Investigator's opinion, warrants exclusion.
* Clinically significant pulmonary hypertension, as defined by the requirement for ongoing pharmacologic treatment or the consistent or intermittent use of supplemental home oxygen.
* Participation in another clinical study with an investigational drug within 30 days of Screening.
* Any prior or current malignancy or myeloproliferative disorder.
* Prior receipt of gene therapy.
Understanding Quality of Life Among Patients with Cancer Receiving Palliative Care

This randomized controlled trial will assess the effects on quality of life of two approaches to symptom management among new patients referred to a palliative care oncology clinic.


Eligibility Criteria:
Inclusion Criteria:

* Be a new patient at an outpatient palliative care clinic
* Resident of Pennsylvania
* Over 18 years of age

Exclusion Criteria:

* Prior use of certain symptom focused therapies
* Currently pregnant
Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages

Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.


Eligibility Criteria:
Inclusion Criteria:

Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.

Exclusion Criteria:

Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.
Engaging Fathers for Improving Dietary Diversity in Kaduna State

The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children.

This was pre-post study designed to measure changes in complementary feeding practices and document the feasibility and acceptability of an intervention to engage fathers in supporting dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive \& Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and implementation of the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local government area in Kaduna State. We collected survey data cross-sectionally from 495 cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants were randomly sampled within 99 clusters selected proportional to population size. The purpose of the surveys was to obtain data on children's complementary feeding, changes in fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers' support for complementary feeding, and to measure participants' exposure to the intervention components. To measure feasibility and acceptability of the intervention, we conducted 24 in-depth interviews at the end of the intervention with community and religious leaders and Community Health Extension Workers who were involved in implementing the intervention. In addition, we conducted separate focus group discussions with mothers and fathers (8 groups each) at the end of the intervention to learn about changes in social norms related to fathers' engagement in complementary feeding and their experiences with participating in the intervention.

Eligibility Criteria:
Inclusion Criteria: For the surveys, men were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father. For the qualitative component, mothers, fathers, community and religious leaders, and community health extension workers who participated in the intervention were eligible.

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Exclusion Criteria: Refusal to participate or provide consent.

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Novel Non-opioid Post-surgical Pain Treatment in Females

This study aims to determine if treatment with Carbidopa/Levodopa and Naproxen in females (biological sex) with acute pain after a bunionectomy or toe fusion (24hrs, 48hrs and 5 days) will reduce pain when compared with females receiving Placebo and Naproxen.

Acute post-surgical pain remains commonly treated with opioids. Although such treatments are efficacious, they can lead to opioid dependency. Disturbingly, opioid abuse often began as a direct consequence of prescription medications, primarily for pain management, and post-surgical pain management. Recent studies in from Apkarian lab suggest that the combination of dopamine and non-steroidal anti-inflammatory may be a safe, tolerable and efficacious novel post-surgical pain treatment option.

Therefore, the main hypothesis is: patients treated with Carbidopa/Levodopa and Naproxen will show a statistically significant decrease in post-surgical pain when compared with control intervention (Placebo plus Naproxen (250mg)). This will be done through a double-blind, randomized, placebo-controlled, parallel-group trial of the pharmacological treatment Carbidopa/Levodopa for females (N = 60) undergoing a bunionectomy or toe fusion surgery.

Eligibility Criteria:
Inclusion Criteria:

* female with no racial or ethnic restrictions;
* 18 to 75 years old;
* Have a bunionectomy or toe fusion surgery scheduled;
* must be able to read, understand, and sign consent form;
* generally healthy.

Exclusion Criteria:

* Chronic neurologic conditions, e.g., Parkinson's
* pregnancy;
* opioids use 60 mg/day oral morphine milligram equivalent.;
* use of anticoagulants (low dose ASA allowed);
* history of gastric ulcer; renal insufficiency or congestive heart failure,
* contraindication to study medication as determined by surgeon
* Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
* In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
* Diagnosis of psychological diseases, such as major depression; bipolar disorder.
Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy:

This investigation aims to investigate the effect of high intensity laser therapy on radicular symptoms, neuropathic pain, cervical range of motion and quality of life in patients with cervical radiculopathy compared to cervical therapeutic exercises.

Most cases of cervical radiculopathy are due to cervical spondylosis or disc herniation. As the age progresses, disintegration of the disc causes a decrease in disc height and foraminal narrowing. The decreased disc height then results in hypertrophy due to vertebral loading in the intervertebral joints of Luschka. This leads to foraminal stenosis and cervical radiculopathy.If cervical radiculopathy is due to disc herniation, its mechanism is explained by the impact of the nerve root with the disc material and causing nerve damage by both mechanical and chemical effects.Non-operative treatment of cervical radiculopathy consists of a number of different modalities including immobilization, physical therapy, traction, manipulation,drug therapy, cervical steroid injection and laser therapy.The physiological effects of high intensity laser therapy(HILT) reduce the release of histamine and bradykinin from inflammatory tissue and increase the pain threshold. In addition, laser light reduces the secretion of substance P from peripheral nociceptors, thereby reducing the perception of pain and preventing the development of hyperalgesia. The laser analgesic effect is due to the increased secretion of endogenous opioids such as β-endorphins, where pain is centrally inhibited.

This investigation was designed double-blind prospective sham controlled randomized study. Participants were randomized into 3 groups: HILT + therapeutic exercise, sham HILT + therapeutic exercise, and only therapeutic exercise.

As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Arm, SF (Short form) -36 Quality of Life Scale, Pain Detect Pain questionnaire, Cervical Radiculopathy Impact Scale ) will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 3rd month controls.

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Eligibility Criteria:
Inclusion Criteria: Eligible patients aged 20-65 years old with pain in the cervical spine and arm pain with or without neck pain lasting for at least one month. Patients were included in the study

1. radicular clinical symptoms
2. cervical disc herniation and degenerative changes diagnosed with cervical MR
3. radiculopathy findings on Electromyography (EMG) and Nerve Conduction Studies

Exclusion Criteria:

1. Pregnancy
2. Inflammatory rheumatologic diseases
3. Malignity
4. Structural deformity
5. Previous surgery related to the cervical spine
6. Cervical spinal stenosis
7. Lokal corticosteroid injections
8. Medications for neuropathic pain such as pregabalin or gabapentin
9. Carpal tunnel syndrome, cubital tunnel syndrome
10. Shoulder pathology
Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes

Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.

A cardiovascular disease Toolkit was developed by the Canadian Diabetes Association and mailed to family physician with the Spring/Summer 2009 edition of the newsletter, Canadian Diabetes. The Toolkit was packaged in a brightly-coloured box with Canadian Diabetes Association branding, and contained: 1) an introductory letter from the Chair of the practice guidelines' Dissemination and Implementation Committee; 2) an eight page summary of selected sections of the practice guidelines targeted towards primary care physicians; 3) a four page synopsis of the key guideline elements pertaining to cardiovascular disease risk; 4) a small double-sided laminated card with a simplified algorithm for cardiovascular risk assessment, vascular protection strategies and screening for cardiovascular disease; and 5) a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool and a list of recommended risk reduction strategies.

Eligibility Criteria:
Inclusion Criteria:

* Alive on 1 July 2009 with prevalent diabetes

Exclusion Criteria:

* Age \<= 39
* Residing in long-term care

Secondary Analysis:

* Analysis will be repeated using all people alive on 1 July 2009 without prevalent diabetes using the same exclusion criteria, to determine the spill-over effect of the Intervention on physicians' other patients.