cyrilzakka/clinical-trials huggingface dataset:
Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract

Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Ribose has been shown to be very helpful in CFS and fibromyalgia. Many studies have also shown benefit for the symptoms of these conditions from Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract. The study is undertaken as an early open label study to check for the efficacy of a proprietary combination of these

Eligibility Criteria:
Inclusion Criteria:

1. be diagnosed with CFS and/or fibromyalgia
2. live in the United States 3 - be over 18 years of age

Exclusion Criteria:

1. pregnancy
2. Diabetes
3. Hypertension
Plasma Profile of Exclusively Breastfed Infants

To characterize nutrient levels in breastfeeding infants and their mothers.

The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Eligibility Criteria:
Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth.
* Infant's birth weight was \> 2490 g.
* Infant is between 6 weeks and 16 weeks (42 to 112 days).
* Infant must have been exclusively breastfed at enrollment.
* Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
* Mother is a non-smoker.
* Mother is in good health.
* Mother confirms her intention to continue breastfeeding.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
* Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
* Infants who have consumed any solid or liquid foods or juices prior to enrollment.
* Infants who have received any supplements containing carotenoids prior to enrollment.
* Mother who is consuming dietary supplements containing carotenoids.
* Participation in another study that has not been approved as a concomitant study.
Developing School Health Champions to Increase Health Literacy Both in School Adolescents and Community People Through Providing Health Education by the School Nurses in Bangladesh: Community-based Pre- and Post-experimental Design

Health literacy is a person's decision-making ability to improve their quality of life and prevent diseases by accessing, understanding and applying health information. Health literacy in the adolescent's period can aid them to gain and understand health information which can bring positive health outcomes.

The aim of this pilot study is to examine the efficacy of health education and school health activities provided by school nurses on improving health literacy among secondary school adolescents. The study will also examine whether health education by health champions (the adolescents) is effective in improving the health literacy of the community people, and examine whether these interventions develop awareness, improve health knowledge, empower, and change behaviors of secondary school adolescents.

This intervention study aims to improve health literacy in the adolescents in Bangladesh and the school-located community. The Begum Ayesha Pilot Girl's High School in Dohar, Dhaka district will be selected as a field. First, we will place school nurses at the school, provide health checkups for both the adolescents (about n=316) and community people (about n=200), and school nurses will provide weekly health education for 3 months to the adolescents. After certifying them as "Health Champions", the health champions visit the community and provide health education activities to the community people. For both participant groups, health literacy will be measured as efficacy checking of this pilot study.

Assent and informed consent will be obtained from the participants. Autonomy, beneficence, non-maleficence, fidelity, veracity, confidentiality, and justice of the participants will be ensured. Also, anonymity will be maintained across all stages of the study.


Eligibility Criteria:
Inclusion Criteria:

For school adolescents:

* Students who are willing to participate.
* Students who study in class 8 (Grade 8) at the time of enrollment.
* Students who are female.
* Students whose parents or legal guardians agree to give consent and are willing to participate in the study
* Students who agree to receive health checkup, and are willing to respond to the questionnaire.
* Students who will stay in the same school till study completion.

For community people:

* Persons who are aged at least 18 years old.
* Persons who are willing to participate.
* Persons who agree to receive health checkup, and willing to respond to the questionnaire.
* Persons who will attend the health education activities.

Exclusion Criteria:

For school adolescents:

• Students who are absent from school during the health checkup periods due to severe illness or without any reason or information

For community people:

* Persons who will not attend the education sessions physically.
* Persons who will not live in the community until the post-test.
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* metastatic colorectal cancer;
* \>=1 target lesion;
* failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

* previous treatment with oxaliplatin;
* progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
* \>=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.
The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

The optimisation of drug absorption through skin is of great value in modern therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug absorption. However,few studies have compared pulsed and continuous modes of therapeutic ultrasound.This study compared these two modes by investigating the effect of lidocaine phonophoresis on sensory blockade.

Ninety-three healthy volunteers, assigned at random to one of three ultrasound groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham ultrasound+lidocaine).

Lidocaine was administered transdermally using a transducer.Two point discrimination, touch and maximum pain thresholds were assessed before and after the intervention in each group.

Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared with continuous ultrasound with topical lidocaine gel and lidocaine application alone. The mechanical properties of pulsed ultrasound appear to be responsible for greater drug penetration.

Lidocaine is a common local anaesthetic drug that is used topically to relieve pain,itching and burning, and also for minor surgery.However,its application via this conductive method,has been confined to surface anaesthesia because it seems that it is not possible to have a deep transmission with local drug massage, without injection or systematic administration.On the other hand,the injection of lidocaine can lead to tissue injury and pain,and its use is not advised in children. Phonophoresis is one of the common procedures for reducing these problems. Therefore, the main aim of this study was to compare the two modes of therapeutic ultrasound by assessing the effect of lidocaine gel phonophoresis on percutaneous absorption and sensory blockade.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 25 years

Exclusion Criteria:

* individuals who had a disease that could affect the experiment, such as systemic disease,impairment of the sensory system(e.g.neuropathy,diabetes),cardiovascular disorders(e.g. increased blood pressure),pain due to an injury to the upper extremity,tumours,malignant and precancerous tissue,acute infection and broken skin in the area; and individuals taking medication to relieve disease symptoms were excluded
Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.

The goal of this pilot study is to evaluate the usefulness of FMS as a noninvasive method to stimulate the GI motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. FMS has demonstrated the ability to generate significant rectal pressure and enhance GI transit in normal and spinal cord injury subjects. With proper abdominal muscle conditioning, FMS may improve colonic motility partly due to improved abdominal muscle tone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* constipation defined by the Rome II criteria

Exclusion Criteria:

* Past history of abdominal surgery
* past history of diabetes mellitus
* past history of hypothyroidism
* past history of inflammatory bowel disease
* past history of significant psychiatric disturbances
* past history of drug abuse
* past history of cardiac pacemakers
* past history of metal implants
* patients who cannot travel to keep the follow up
* patients who are prisoners
* patients who are mentally handicapped
* patients who are pregnant
Pain in Patients With Cystic Fibrosis in Rouen University Hospital

Objectif Principal

- To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.

Objectifs secondaires

* To assess the relationship between pain and disease severity.
* To assess the relationship between pain and the age of the patient.
* To describe the pain locations.
* To describe the use of pharmacological or nonpharmacological treatment.
* To evaluate the procedural pain.

Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit.

Primary evaluation criteria :

Intensity and frequency of pain are evaluated with the prospective diary.

* The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10).

  0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported
* The pain frequency is completed twice a day (morning and evening) on the prospective pain diary.

Secondary evaluation criteria

* The disease severity, estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator, collected in the patient's medical record)
* Pain locations, pharmacological or nonpharmacological treatment and procedural pain are evaluated using the diary and the questionnaire.
* Demographic data and characteristics of cystic fibrosis are collected using the medical file.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
* Seen for routine planned visits.
* Having expressed their non-opposition or whose non-opposition was expressed by the parents or legal representatives for minors

Exclusion Criteria:

* Patients seen for an acute episode or exacerbation outside of routine planned visits or patient hospitalized.
* Major patient under legal protection.
* Major patient having problems understanding the oral and written French language or child whose parents or legal representatives have problems understanding the oral and written French language.
Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi

The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).

The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).

This is a mixed method study in which subjects will participate in focused group discussions and complete a questionnaire. Discussions will be 1-2 hours in length aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Data collected from the focus groups will be analyzed for common themes to generate questionnaires to assess reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health among persons living with HIV.

Eligibility Criteria:
Focus Group Arm

Inclusion Criteria:

* Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
* On antiretroviral treatment (ART) for the past 6 months
* Sexually active within the past 6 months
* HIV positive

Exclusion Criteria:

No exclusion criteria specified

Questionnaire Arm

Inclusion Criteria:

* Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
* Sexually active within the past 6 month
* HIV positive

Exclusion Criteria:

No exclusion criteria specified
A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine Clinical Trial).

Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety.

Subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.Bone in combination with autologous bone in a 1:1 ratio. Subjects will be followed up at discharge, week 6, Month 3, Month 6, and Month 12.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ≥ 18 years old.
2. Patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels.
3. Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
4. Patients who have provided written informed consent to participate in the study and the processing of personal data before any study procedure is performed.

Exclusion Criteria:

1. Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s).
2. Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
3. Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture.
4. Bone infection.
5. Bone malignant tumor(s).
6. Concomitant infectious systemic diseases,
7. Inflammatory systemic diseases,
8. Concomitant myeloproliferative disorders,
9. Active autoimmune disease,
10. Known or suspected allergy or hypersensitivity to the b.Bone device components,
11. Calcium metabolism disorder (i.e. hypercalcemia),
12. Known hyperthyroidism or autonomous thyroid adenoma.
13. Patients currently treated with systemic immunosuppressive agents.
14. Patients who are currently enrolled in another clinical study that would directly interfere with the current study, except when the patient is participating in a purely observational registry with no associated treatments.
15. Body mass index (BMI) larger than 36 (morbidly obese).
16. Known severe osteoporosis.
17. Patients requiring instrumented fusion in the cervical spine.
18. Woman who is pregnant or breast-feeding.
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor

The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on prevention and treatment of infection in children with malignant tumor.

G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant tumor including acute myeloid leukemia (AML) after complete remission, acute lymphocytic leukemia (ALL) after complete remission, stage III or IV lymphoma after partial remission or complete remission, stage III or IV neuroblastoma (NB) or retinoblastoma (RB).
* Eastern Cooperative Oncology Group performance status ≤ 2.
* Did not receive treatment of CSFs in two weeks.
* Without symptomatic infection and with normal values of C-reactive protein or procalcitonin.
* The first time of ANC \< 1.5\*10\^9/L after chemotherapy.
* More than 24 h after the last chemotherapy.
* The function of liver was normal.

Exclusion Criteria:

* Allergic to GM-CSF or drugs which expressed in Escherichia coli.
* Patients with infection, diabetes or primary immunodeficiency.
* Patients infected with hepatitis B, hepatitis C or HIV.
* Patients confirmed autoimmune thrombocytopenic purpura.
Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?

Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and peripheral vascular disease. Patients undergoing major vascular surgery are at particularly high risk of delirium and other, more subtle, changes in cognitive function following surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both delirium and postoperative cognitive dysfunction (POCD).


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or greater
* Open repair of the abdominal aorta

Exclusion Criteria:

* refusal;
* planned endovascular repair;
* emergency surgery;
* previous diagnosis of dementia, Parkinson's disease, or psychiatric illness;
* active alcohol or substance abuse; and
* physical inability to complete neuropsychometric testing.
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients

Ankle osteoarthritis (OA) is a painful, progressive condition that can severely limit physical activity and reduce quality of life. Rocker bottom (RB) shoes and ankle-foot orthoses (AFOs) are commonly used as non-surgical treatments for ankle OA. RB shoes have a curved sole in the toe to heel direction that may alleviate joint pain by reducing ankle range of motion (ROM). Similarly, AFOs may reduce joint motion by securing the foot and ankle within the ankle-foot orthosis (AFO) frame. This study aims to determine the ability of RB shoes and AFOs to improve mobility, by relieving pain and reducing joint ROM.

The investigators' objective is to compare two non-surgical treatments (RB shoes and Toeoff brand AFOs) in OA subjects by measuring their mobility and pain during and after a multi-week trial period. The investigators will use a biplane fluoroscopy system to measure foot joint motion for each condition (RB shoe, AFO, control shoe). This will yield clinical and biomechanical measures of the effect of each orthotic on mobility, pain, and joint ROM in an ankle OA population. The investigators will also compare the clinical and biomechanics outcomes of OA subjects to those of control subjects. This information will provide evidence to support clinical decision making.

Aim 1: Compare the daily sep count, self-selected walking speed, clinical outcome measures (PROMIS surveys) of a control shoe, RB shoe, and AFO worn over a multi-week trial period.

Aim 2: Evaluate the effect of a control shoe, RB shoe, and AFO on the foot and ankle joints range of motion.

Aim 3: Compare the ankle OA clinical and biomechanical outcome measures for the control shoe, RB shoe, and AFO to a healthy control group wearing control shoes.

The efficacy of conservative treatments such as RB shoes and AFOs for managing OA pain and discomfort is not well supported by clinical evidence. By using biplane fluoroscopy along with validated clinical measures of pain and mobility, this study will elucidate the mechanism by which RB shoes and AFOs biomechanically alter foot and ankle function. Identifying beneficial treatment strategies for people with ankle OA will help them regain their mobility and improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

For osteoarthritis patients:

* radiographic evidence of tibiotalar osteoarthritis
* ambulatory

For healthy controls:

* ambulatory
* aged 18 or older

Exclusion Criteria:

For osteoarthritis patients and healthy controls:

* subtalar joint arthritis
* plans for surgical treatment of ankle osteoarthritis within the next 4 months
* surgical, neurological, metabolic, or lower limb musculoskeletal problem that would impair study measures
* inability to walk unassisted during short, repeated walking trials
* rheumatoid arthritis
* inadequate cognitive or language function to consent or to participate
* no phone number or stable mailing address
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers

The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-G1.1-NN at a low dose, a high dose or placebo.

Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-G1.1-NN prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.

Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo

Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers aged 18 - 49 years, inclusive
2. Able to give written informed consent
3. Healthy (no clinically significant health concerns)
4. Safety laboratory values within the following range criteria normal range
5. Body mass index between 17 and 35 at screening

Exclusion Criteria:

1. Receipt of any investigational norovirus vaccine within two years prior to study
2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
3. Administration of any licensed vaccine within 30 days prior to study
4. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination
6. Presence of a fever ≥ 38oC measured orally at baseline
7. Stool sample with occult blood at screening -