cyrilzakka/clinical-trials huggingface dataset:
Improving Infant Nutrition in Southern Ethiopia

This cluster randomized controlled trial will test the effect of the promotion of vitamin A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.

Child stunting and vitamin A deficiency are persistent public health problems in Ethiopia.

Quality Diets for Better Health (QDBH) is a European Union-funded project led by the International Potato Center (CIP), in partnership with People in Need (PIN), Emory University and with support of governmental organizations and local universities. The 54 month-project strives to improve diet quality, primarily of women and young children, through the promotion of vitamin A-rich orange flesh sweetpotato (OFSP) production and nutrition education in 41 kebeles (communities) in SNNPR, reaching an estimated 15000 households. In addition, households in a subset of communities will receive a Healthy Baby Toolkit, consisting of a marked bowl, slotted spoon, and illustrated counseling card. The Healthy Baby Toolkit is designed to promote optimal complementary feeding practices of infants and young children 6 to 23 months, namely meal volume, meal frequency, and meal thickness.

As part of this project, Emory University will conduct a longitudinal, cluster randomized controlled trial in 20 kebeles to test the effect of the project on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in a Healthy Living Club (only a criteria for those in partial or full intervention arms)
2. Infant aged birth to 5 months
3. Primary caregiver and head of household (if different from primary caregiver) available and provides consent for survey

Exclusion Criteria:

1. Serious health problem (for example, HIV/AIDS or congenital defect)
Post-prandial Glycaemic Controlling Effects of BSG in Singapore Adults With Metabolic Syndrome

The purpose of this study is to assess the glycaemic controlling effects of BSG and bio-transformed BSG-containing biscuits in Singapore adults with MetS. The investigators hypothesized that consumption of BSG and bio-transformed BSG containing biscuit will improve glycaemic control.

This is a double-blind, randomised, crossover experiment. During the 3-week, 19 subjects will participate in a 3 meal tolerance test (MTT). During each MTT session, all subjects are required to consume 90 g biscuits (either control, autoclaved BSG or bio-transformed BSG biscuits) and monitored over a period of 240 minutes. All three types of biscuits will be consumed at a randomised sequence during this 3-week period. Post-prandial blood glucose, insulin, lipid and amino acid responses, breath analysis, body composition, blood pressure, appetite assessment, and any other glycaemic biomarkers will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants, aged 35-85 years old
* English-literate and able to give informed consent in English
* Willing to follow the study procedures
* Meet any 3 of the 5 following NCEP-ATP III MetS criteria: waist circumference \> 102 cm (male), \> 88 cm (female) (For Asian population: Waist circumference \> 90 cm (male), \> 80 cm (female)); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) \< 40 mg/dL (male), \< 50 mg/dL (female); systolic or diastolic blood pressure \> 130/85 mmHg or on medication);

Exclusion Criteria:

* Significant change in weight (≥ 3 kg body weight) during the past 3 months
* Allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits.
* Acute illness at the study baseline
* Exercising vigorously\* over the past 3 months. \*Defined as having \> 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day
* Following any restricted diet (e.g. vegetarian)
* Smoking
* Have a daily intake of more than 2 alcoholic drinks per day
* Taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.)
* Consumption of antibiotics over past 3 months.
* Pregnant, lactating, or planning pregnancy in the next 6 months
* Insufficient venous access to allow the blood collection
* Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation
* High current intake of fibre\* from brown rice or wholemeal products. \*High, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on My Healthy Plate guidelines
* High current intake of fibre\* from vegetables. \* High, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on My Healthy Plate guidelines
Low Grade Lymphoma

The purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis B virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of treatment criteria.

Rituximab is a human-mouse chimeric monoclonal antibody that targets the B-cell CD20. It is an indispensible drug for the treatment of B-cell lymphoproliferative syndrome which induced immunosuppression. So, the infectious complications increase. Reactivation of hepatitis B virus is one such complication that can lead in asymptomatic hepatitis to death. Prevention of hepatitis B reactivation is recommended like using nucleoside analog for patients with chronic hepatitis B or occult hepatitis and vaccination against virus for seronegative patients. The published data about efficacy of hepatitis b vaccination in onco-haematology are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis B vaccination in patients with lymphoproliferative disorder.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low tumor burden
* No indication of chemotherapy during the seven months of the vaccination protocol.

HBV serology negative for HBsAg / Ab HBs / HBc Ab.

* No history of vaccination against hepatitis B.

Exclusion Criteria:

* Indication of immediate chemotherapy.
* At least one HBV positive serologic marker .
* History of vaccination against HBV.
* Known neurodegenerative disease.
* Pregnancy.
* Febrile infection untreated.
* Known allergy to any vaccine component.
Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.

The trial aims to investigate the effect of supplementation with hyaluronic acid, alpha-lipoic acid, magnesium, vitamin D and vitamin B6 in progesterone-treated pregnant women with risk factors for abortion.


Eligibility Criteria:
Inclusion Criteria:

* Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)

Exclusion Criteria:

* Other pregnancy-related conditions
* Diabetes or hypertension
* Concomitant pharmacological therapies (anticoagulant or antihypertensive)
* Use of tocolytic drugs two months prior to enrollment
* Association with hypoglycemic drugs
Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Patients With COPD

Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients aged ≥40 years with stable moderate-to-severe COPD according to the GOLD Guidelines classification (grades II and III): forced expiratory volume in 1 second (measured between 10 to 15 minutes post-inhalation of 400 μg of salbutamol) is 30%≤FEV1\<80% of the predicted normal value
* Patients naïve to both study inhaler devices, Genuair® and Breezhaler®, for at least 2 years
* Agreement to participate and voluntarily sign the informed consent form

Exclusion Criteria:

* Patients with other clinically significant uncontrolled chronic diseases, particularly body malformations or diseases affecting coordination and/or motor system
* Patients unable to read product package instructions and answer patient reported questionnaires (PASAPQ)
* Patients with any other serious or uncontrolled mental health problems
* Patients currently participating in other randomised clinical studies
* Patients with COPD exacerbation within 6 weeks before Visit 1 and patient hospitalised for COPD exacerbation within 3 months prior to Visit 1
* Patients with any other conditions that, in the investigator's opinion, might indicate the patient to be inappropriate for the study
* Patient likely to be uncooperative
Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common procedure in management of ICP to avoid fetal complications. Surprisingly, this empirical approach has not been evaluated as to delivery complications and fetal outcome as yet. The investigators now examine weather ICP affects (i) delivery procedures chosen, in particular the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and (iii)possible impact of bile acids and UDCA treatment in a retrospective cohort study based on approximately 5000 induced deliveries at Danderyd Hospital, Karolinska Institutet, Stockholm. The investigators analyze data on on previous deliveries, BMI, medical history and medical book data. Primary endpoint is the risk of caesarian section.


Eligibility Criteria:
Inclusion Criteria:

* ICP during pregnancy and induction of labor ICP and spontaneous delivery No ICP but induction of labor

Exclusion Criteria:

* No ICP spontaneous delivery
* Elective caesarian section
Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress

The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce subjective sense of stress will be investigated in a randomised controlled trial with two condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the treatment (week 10) and 6-month follow-up will be assessed. The wail-list condition will be offered ACT-based self-help after the post-assessment.

The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce subjective sense of stress will be investigated in a randomised controlled trial with two condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the treatment and 6-month follow-up will be assessed. The wail-list condition will be offered ACT-based self-help after 10 weeks (i.e. when the post-assessment is completed). Inclusion criteria are: Adults with a score above 14 on the stress sub scale of the Depression, Anxiety, Stress Scale (DASS) at screening, a score below 10 on the Patient Health Questionnaire (PHQ-9), no indication of suicidality on the PHQ-9, and no ongoing psychotherapeutic interventions, and no previous work with the self-help manual that has been published as a self-help book.

A total of 140 participants will be recruited and randomised, using services on www.random.org. Informed consent will be obtained from all the participants ahead of screening. Participants will be asked to respond to the following questionnaires at pre-, post and follow-up assessments: Perceived Stress Scale-14 (PSS-14), General Anxiety Disorder-7 (GAD-7), Shirom Melamed Burnout Measure (SMBM), and Brunnsviken Brief Quality of Life Inventory (BBQ). Initially, they will also be asked to respond to the credibility/Expectancy Questionnaire (CEQ).

At the end of the intervention (week 10), participants will also be asked to respond to the Client Satisfaction Questionnaire (CSQ), and the Negative Effects Questionnaire (NEQ).

The following two scales will be used to study mediators: Acceptance and Action Questionnaire-2 (AAQ-2), and Attention Awareness Scale (MAAS), assess at pre-treatment, as well as at third and fifth week of treatment, at post-assessment (10 weeks later), and at the 6 months follow-up. A number of moderators, including demographics, will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* DASS score above 14
* PHQ-9 below 9

Exclusion Criteria:

* Any indications of suicidality
* Any indication of other psychiatric disorder in need of immediate attention/treatment
* Concurrent psychotherapy or other treatments for stress
* Previous work with the self-help book
Extracellular Vesicles in Fibrin Gel for Cartilage Repair

This project aims to produce and study in vitro/ex vivo a platelet rich plasma (PRP)-derived fibrin gel loaded with mesenchymal stromal cells (MSC)-extracellular vesicles (EVs), to combine the positive results on cartilage growth of PRP growth factors and the hyaline cartilage stimulating activity of MSC-EVs. Therefore, the project goal is to provide an advanced option for orthopedic patients with an innovative evolution of a gold standard procedure, making it easy to translate into daily clinical practice for physicians, healthcare professionals and patients.


Eligibility Criteria:
Inclusion Criteria:

* males and females ≥ 18
* patients undergoing plastic surgery procedures;
* patients undergoing elective joint surgery with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade);
* patients undergoing regenerative medicine treatments with PRP with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade;
* signed Informed Consent for the study

Exclusion Criteria:

* Positive virological test (HIV, HCV, HBV, TPHA)
* Pregnancy or breastfeeding by self-declaration
* Other conditions that, at the discretion of the investigator or the physician
Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation

The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and gut microbiome in order to understand the role of this pollutant on the risk of developing inflammatory bowel disease (IBD) as well as other diseases. With this information, the researchers hope to characterize better the role of environmental pollutants on IBD and develop novel strategies towards prevention.

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, progressive inflammatory disease of the intestinal tract. The etiology of IBD is not well understood, but believed to result from a complex relationship between genetics, environment, and gut microbiome alterations, resulting in a self-perpetuating, abnormal mucosal immune response. The incidence of IBD is rising in developing and recently developed countries, highlighting the importance of environmental exposures in determining disease risk. Microplastics, defined as plastic particles \<5 mm in size, are ubiquitous pollutants with unclear implications towards human health. Emerging studies indicate substantial disruption of intestinal immune function and a proinflammatory milieu due to microplastics. Therefore, identifying, and characterizing microplastics in stool samples of individuals with CD alongside alterations in microbiome and calprotectin, which are events that occur prior to CD onset, is the initial step in exploring the impact of microplastics on IBD. Moreover, CD affects women during their reproductive years and 25% become pregnant after diagnosis. Given that maternal IBD diagnosis is one of the major risks of future IBD in offspring, it is critical to better understand if babies born to mothers with IBD have higher content of microplastics or other toxins in the stools and whether these levels correlate with those of their mothers during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* The ability to sign and date an informed consent form
* Be pregnant, or wishing to become pregnant in the near future and enroll the infant that the individual is pregnant with
* Aged 18 or older
* English-speaking (this observational study uses non-validated questionnaires that are only available in English)
* Of any ethnicity
* Be a spouse, related household member (sibling, parent, etc.) or a child of an enrolled pregnant person

Exclusion Criteria:

* Individuals who are unable to give informed consent
* Be diagnosed with a pregnancy complication, such as intrauterine fetal demise/stillbirth, preeclampsia, hyperemesis gravidarum, or have an active infection, including chorioamnionitis or sepsis.
Efficacy of Pea Hull Fibre Supplementation

The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity.

A 10-week randomized, cross-over study will be carried out to assess the efficacy of pea hull fiber. Participants will complete a 2-week baseline period during which appetite, gastrointestinal symptoms, stool frequency, and stool consistency (transit time) will be collected by paper questionnaire, and participants will collect a single stool. Dietary data (24-hour dietary recalls) will be obtained via phone interviews 3 times during the baseline period. On or about day 15, participants will attend a study visit and complete the Simplified Nutritional Appetite Questionnaire (SNAQ) and Gastrointestinal Symptom Response Scale (GSRS). Participants will be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week treatment period separated by a 2-week washout period. In both intervention periods, participants will complete daily questionnaires to assess appetite, gastrointestinal symptoms, and stool frequency and consistency (transit time). Furthermore, they will complete SNAQ and GSRS after the end of each intervention period. The 24-hour dietary recalls will also be collected 3 times during each of the intervention periods. Participants will undergo an additional 2-week washout period after the second intervention period. During washout periods, the same data will be collected as was done during the baseline and intervention periods.Participants will be asked to collect one stool during pre-baseline and weeks 4, 6, 8 and 10 for a total of 5 stools. Stool samples will be analyzed for changes in the microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
* Willing to consume pea hull fiber and control snacks daily each for a 2-week period
* Willing to complete a daily questionnaire regarding general and gastrointestinal wellness throughout the entire 10-weeks study.
* Willing to complete the GSRS (Gastrointestinal Symptom Rating Scale) and SNAQ questionnaires bi-weekly at study appointments.
* Willing to be interviewed for a 24-hr food recall, 3 times per 2-weeks period throughout the study.
* Willing to provide 5 stool samples, one in each 2-weeks period throughout the study.
* Willing and be able to provide a valid social security for study payment purposes.

Exclusion Criteria:

* Have any known food allergies.
* Are currently taking medications for diarrhea.
* Have taken antibiotics within the past four weeks prior to randomization.
* Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study.
* Have previously or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care

The aim of this study was to compare the functional capacity of exercise by six-minute walk test before and after thoracic surgical procedure in subjects who have undergone the Fast-track protocol with those who were under conventional care. Researchers want to find out if Fast-track is a strategy to enhance functional capacity after thoracic surgery.

Fast track programs represents a new approach to the management of patients undergoing surgery. It is perioperative care pathway designed to achieve early recovery and helps to minimize postoperative morbidity and mortality.

These multimodal approaches focuses on enhancing recovery and reducing of surgical stress by minimal invasive surgery, optimized pain relief, early nutrition and ambulation.

In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity.

However, information on the results of Fast-track protocols in functional capacity of exercise during hospital stay is sparse.

The six-minute walk test is use to measure of functional capacity of exercise in different populations and to detect changes after interventions. The distances traveled in two six-minute walk test (preoperative and postoperative) will be compared between the two groups (Fast-track and Conventional).

In this trial the investigators will consider Fast-track protocol to be feasible to enhance functional capacity of exercise after thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo a thoracic surgical procedure
* sign the informed consent form
* independent ambulation
* ability to understand and follow instructions

Exclusion Criteria:

* contraindications for epidural catheter placement
* refusal to do physical exercises on postoperative
Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae

This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).

Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals.

Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth.

Poly-L lactic acid also promotes collagen growth in the areas injected.

The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.

Eligibility Criteria:
Inclusion Criteria:

* Subject has bilateral striae alba
* Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4

Exclusion Criteria:

* Subject has striae rubra
* Pregnant
* History of adverse effects to phototherapy
* Subject has single sided lesions
* Subject has immunosuppression
* Subject has radiation therapy to the study area
* Subject has topical or oral steroid use or chemotherapy within the last 6 months
* History of keloids or hypertrophic scar