cyrilzakka/clinical-trials huggingface dataset:
Pneumonia Vaccine in Bone Marrow Transplant Recipients: Usefulness of Donor Vaccination

Streptococcus pneumoniae, also known as Pneumococcus, is a common cause of pneumonia in transplant patients. There has been a vaccine available for this infection called Pneumovax. Recently, a new vaccine for this infection called Prevnar has been developed which may be more effective. Vaccinating the bone marrow donor before transplant may boost the recipient's immune response to the vaccine after transplant. This study is done to compare how vaccinating the donor with one of the vaccines will affect the recipient's immune system response to the vaccine.

This is a randomized controlled trial designed to assess the immunogenicity of the new pneumococcal conjugate vaccine in a cohort of allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients. This will be done by using an approach of pre-transplant donor immunization with post-transplant recipient immunization. Response will be compared with the standard 23-valent polysaccharide vaccine. It is hypothesized that the conjugate vaccine will provide an enhanced response in this group of immunosuppressed individuals who respond poorly to standard polysaccharide vaccines.

Specific objectives of this study are:

* To determine the antibody response to both vaccines via a measurement of total antibody response and by the opsonophagocytic assay. This assay has the advantage of assessing if patient antibody responses represent truly functional antibodies that display opsonic activity against pneumococcus and is likely better correlated with protective efficacy.
* To determine any acute adverse reactions of the conjugate vaccine in this population. Results of this trial will help lay the foundation for the development of a rationale and optimal pneumococcal vaccination strategy that would prevent significant morbidity in this patient population.

We hypothesize that pneumococcal conjugate vaccine, due to its T-cell dependent response will have greater immunogenicity and protective effect in an allo-HSCT population by using a donor immunization strategy.

Eligibility Criteria:
Inclusion Criteria:

Recipient - Adult male or female marrow recipients who fulfill the following criteria will be eligible for the study: a) Will undergo allogeneic-HSCT in 2-3 weeks.

b) No splenectomy c) Not currently receiving IVIG d) Able to provide written informed consent and comply with study protocol e) Age \> 16

Donor - Adult male or female marrow donors who fulfill the following criteria will be eligible for the study:

1. Recipient of donor marrow agrees to participate in study.
2. No prior pneumococcal vaccination within the last 5 years
3. Not on immunosuppressive medication (eg., corticosteroids)
4. No history of immunosuppressive condition that may potentially impair vaccine response eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis
5. No splenectomy
6. Able to provide written informed consent and comply with study protocol
7. Age \> 16
Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity

The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.

The secondary objectives of this study are:

A. To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.

B. To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.

C. To study the potential links between pain trajectories and the presence or absence of PSCP.

D. To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).

Eligibility Criteria:
Inclusion Criteria:

* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow-up
* The patient has undergone a planned surgical procedure in one of the participating departments
* The patient is willing and able to respond to the study questionnaires (HADS, PCS, EN, DN4)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* It is impossible to correctly inform the patient
* Patient admitted to the ICU and still intubated at day 1
Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)

Celiac disease is a disorder commonly diagnosed during childhood. The treatment is a lifelong gluten-free diet. Both the condition and the diet can influence the children's physical and emotional well-being.

The main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children.

The nutritional assessment includes information on diet, biochemical measurement, and body composition. Quality of life will also be assessed.

The study can contribute to ensure good health and well-being in children on a gluten-free diet.

* A 24-hour dietary recall will be done by a clinical dietician to assess intake of energy and micro- and macronutrients.
* Blood will be drawn for assessment of vitamin- and mineral status.
* Feces and urine samples will be collected to measure gluten immunogenic peptides (GIP) to assess exposure to gluten.
* A self-developed interview will be used for assessment of adherence to the gluten-free diet and compared with the results from a 11-item questionnaire.
* Weight and height will be measured.
* Bone mineral density and body composition will be measured by dual-energy x-ray absorptiometry (DXA).
* Health-related quality of life (QOL) will be measured by the PedsQL.

Eligibility Criteria:
Inclusion Criteria:

* eating a regular diet

Exclusion Criteria:

-
Improving Informed Consent Process for Trauma Patients in the Emergency Department

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* scheduled to receive the surgery

Exclusion Criteria:

* clinically unstable
* refuse to participate
* unable to understand the consent process for this study
Impact of Microfinance and Participatory Gender Training for Women in Reducing Intimate Partner Violence

Violence against women and girls is increasingly recognized as a major global public health and development concern. However, evidence on what forms of intervention should be prioritised is severely lacking. A cluster randomized controlled trial (The Intervention with Microfinance for AIDS \& Gender Equity - IMAGE Project) in rural South Africa combined a group-based microfinance intervention with a participatory gender and HIV training curriculum for loan participants and showed that, over a two-year period, levels of physical and/or sexual partner violence experienced by participants in the past year were reduced by 55%.

The overall goal of the current study is to design and implement a cluster randomized controlled trial to assess the impact on intimate partner violence of: 1) combining participatory gender training with microfinance for women in existing microfinance loan groups, and 2) a participatory gender training programme for women (not receiving microfinance) and their male partners.


Eligibility Criteria:
Inclusion Criteria:

Arms 1 and 2 - microfinance loan groups:

1. there are between 15 and 30 active members in the group
2. less than 25% of the women have been members for less than one year
3. there is a good attendance (repayment) record
4. a minimum of 70% of active members consent to take part in the study

Arms 3 and 4, women who:

1. are aged 20-50 years
2. are not formally employed, i.e. either self-employed or not currently working
3. have been resident in Mwanza for at least two years
4. have not been a member of a microfinance loan group in the past 12 months
5. are fluent in Swahili
6. have consented to take part in the study.

Exclusion Criteria:

None
The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis

In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.

Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. The method of one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin 100mg anal route will be administered for all patients without allergy history. All participants will receive the empiric antibiotics treatment for cholangitis.

Eligibility Criteria:
Inclusion Criteria:

* naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.

Exclusion Criteria:

* procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
* stenosis of the pyloric ring ;
* tumor-related obstruction;
* failure to locate the papilla ;
* active peptic ulcer bleeding ;
* intolerance due to inadequate sedation
* CBD sludge;
* non-naïve papilla in ERCP
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.


Eligibility Criteria:
Inclusion Criteria:

* Age : 1\~70 years
* More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
* Must provide signed informed consent prior to participation in any study-related procedures

Exclusion Criteria:

* Have a pyogenic infection
* Part of the facial cosmetic surgery cost
* Hypersensitivity reactions in patients with bovine proteins
* Hypersensitivity reactions in patients with Gentamycin
* Pregnancy or lactation
Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation

Recent studies show that EET and 20-HETE have important biological effects, particularly in the vascular system. The investigators studied the effect of eicosanoids on the gravid rat uterus. The results suggest that 20-HETE had an tocolytics effect on gravid uterus. In the previous study, we demonstrated that the enzymes of the pathway of EET were present in human uterine tissues. Moreover, the addition of an inhibitor of degradation of EET had an tocolytic effect on the human myometrium, as the exogenous addition of 8.9, 14,15-EET and 20-HETE.

Objectives:

Primary objective: To compare the balance of different metabolic pathways of arachidonic acid (AA) of the pregnant human myometrium in pathological situations (preterm labor, uterine atony, prolonged pregnancy).

Specific objectives: i) To study the effect of derived from the AA on in vitro contractile activity of normal and pathological uterine tissues, and ii) detect and quantify the different sub-products of metabolism of AA in the uterine tissues (myometrium, fetal membranes and placenta).

The management of uterine contraction is in the heart of modern obstetrics year, yet the progress made in other specialties, based on the study of smooth muscle have not yet been transposed in obstetrics. A better understanding of systems for regulating the contraction is important in terms of 1) new physiological knowledge, but it could also be the source of 2) modification of strategies to take care of premature delivery (new Tocolytic), or 3) improving the efficiency of uterine muscle during delivery or 4) for treatment of patients with prolonged pregnancy.

It is a clinical study with a slope fundamental aims to examine the metabolic pathways of AA of human myometrium and their functional roles according to their clinical profile divided into three contractile pathological situations - threat of premature delivery, dynamic dystocia, prolonged pregnancy - and two groups of patients at term: a group before work and group work.

The sampling method. After birth, a biopsy will be perform from the lower segment of the uterus. After caesarean sections of membrane and placenta are collected.

The substances studied during isometric tension tests are part of the three degradation pathways of the AA.

1. new eicosanoids in cumulative dose (8,9-EET, 11,12-EET, 14,15-EET, 20-HETE), and in combination
2. enzyme inhibitors of the eicosanoids pathway (AUDA, MS-PPOH, DDMS), and the COX and LOX pathways (indomethacin), alone or in combination.

Eligibility Criteria:
Inclusion Criteria:

* all women who will have a c-section

Exclusion Criteria:

* induction of labor,
* child with malformation,
* birth weight less than 2500 grams or greater than 4500g
Packing of Perianal Abscess Cavities Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity

The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute primary perianal abscess
* Have undergone surgical incision and drainage as an emergency

Exclusion Criteria:

* The abscess is the sequelae of concurrent disease or trauma
* Fourniers gangrene is suspected
* Unable to give informed consent
Competency-based Assessment in Musculoskeletal Ultrasound

Early diagnosis and rapid treatment initiation are of most importance to prevent joint damage in patients with arthritis. Musculoskeletal ultrasound (MSUS) is becoming an integrated part of rheumatology routine care and is more sensitive than clinical examination for detecting synovitis even in the early stage of disease.

However, MSUS is highly operator dependent and competences are needed to ensure correct image interpretation. Traditionally competences are evaluated on how many examinations the trainees have performed, but the gold standard has now shifted towards competency-based education where objective assessment tools are the key element. A previous study has developed a scale for assessment of ultrasound competence, The Objective Structured Assessment of Ultrasound skills (OSAUS). Although expert consensus supports evidence of content validity of the assessment instrument, it is not known if the OSAUS scale can discriminate differences in performance scores between different levels of MSUS experience in rheumatology in a reliable way.


Eligibility Criteria:
Inclusion Criteria:

* Physicians working at the rheumatology departments in Denmark:

  1. Novices: No or little experience with MSUS (less than 100 examinations).
  2. Intermediates: Participated and completed at least one formal ultrasound course and more than 100 examinations (less than 1000 MSUS examinations).
  3. Physicians with a long experience in MSUS doing the procedure almost daily and providing teaching and/or research within this field (more than 1000 examinations).

Exclusion Criteria:

* No informed consent
* Novices/Intermediates: extensive experience in MSUS
Fasting Effects on Metabolism and Immunity Study in Human

This study aims to investigate the effects of 1-week fasting but not prohibiting water drink on human immune function, metabolic indicators, and brain function in human, and to explore the underlying mechanisms of these changes from a multi-omics perspective and/or other ways.

As a historic practice, fasting has a place in religion, culture and modern medicine. In recent years, studies have found that moderate food interruption can positively affect metabolism, immunity, and brain function. It can promote cellular autophagy, improve insulin sensitivity, reduce inflammation, and may protect brain health. Intermittent fasting is thought to improve metabolic health, reduce the risk of obesity and type 2 diabetes, and promote cellular self-repair by regulating signaling pathways. Food fasting also improves insulin sensitivity, reduces blood glucose, reduces inflammatory markers, and improves fat oxidation rate, contributing in the prevention and treatment of metabolic diseases. Moreover, food fasting can regulate immune cell function, reduce chronic inflammation, and may regulate immune function by affecting gut microbiota diversity. In terms of brain function, fasting may improve cognitive function by promoting neuroplasticity and enhancing neuroprotective mechanisms. However, most of the existing studies focus on animal experiments, lack large-scale human clinical trials, and the mechanism of feeding is not completely clear. This study will explore the effects of complete fasting for 1 week (but can feel free to drink water) on human immune function, metabolic indicators and brain function in human, and analyze its change mechanism from a multi-omics perspective and/or other ways, so as to provide new data support for understanding the biological mechanism of fasting, and promote its application in disease prevention and treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old, gender is not limited;
2. BMI≥18.5;
3. Can tolerate a certain degree of hunger;
4. Can voluntarily sign written informed consent.

Exclusion Criteria:

1. Women planning pregnancy, pregnancy and breastfeeding;
2. Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;
3. Suffering from acute infectious diseases or chronic wasting diseases;
4. Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;
5. Participate in other clinical investigators within 3 months before enrollment in this study.
The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity

Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh.

Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy infant (as determined by medical officers)
2. Age 0-7 days at enrolment
3. Mother willing and able to provide signed informed consent
4. Mother willing to allow infant to be vaccinated according to study schedule
5. Mother willing to allow biological specimens, including blood, stool, and saliva, to be collected from infant according to study protocol
6. Mother willing and able to adhere to study schedule

Exclusion Criteria:

1. Obvious congenital malformation
2. Birth weight (if known) or enrolment weight (if birth weight unknown) \< 2000 gm
3. Known immunocompromising condition in infant
4. Enrolment in other vaccine research trials
5. Other household member enrolled in this study
PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

Intraoperative hypotension is closely related to the poor prognosis of surgery. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia.

Intraoperative hypotension is closely related to the poor prognosis of surgery. Hypotension decreased blood flow perfusion of organs, which lead to dysfunction of multiple organs, especially increasing serious complications such as cardio-cerebrovascular events and acute renal injury within 30 days after surgery. The aim of this study is to establish a set of strategies that can effectively prevent and treat intraoperative hypotension, so as to alleviate possible harm to patients from perioperative hypotension. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia. The lower target mean arterial pressure (MAP) was higher than 65 mmHg. MAP less than 65 mmHg was defined as intraoperative hypotension between induction and tracheal extubation.

Eligibility Criteria:
Inclusion Criteria:

65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin

Exclusion Criteria:

abnormal Allen's test higher target than 65 mmHg history of diabetes vascular diseases arrhythmia cardiac function class II and above physical disability, unable to conduct PPI monitoring participated in other clinical studies in the past month
Effects of Pioglitazone Combined With Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients.

To study the effects of pioglitazone combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI \< 24 in China. 60 cases of nonobese PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + ph. To evaluate the improvement of met or met + ph in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
2. BMI\<24 kg/m2
3. No pregnant plan in recent 6 months
4. Written consent for participation in the study

Exclusion Criteria:

1. type 1 or type 2 diabetes mellitus
2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Serious systemic disease or malignant tumor
5. History of pancreatitis (chronic, acute or recurrent)
6. Body weight change ≥10% at 3 months before treatment
7. Used oral contraceptives or sex hormone drugs in the past 1 month
8. Used oral glucocorticoids in the past 1 month
9. Substance (alcohol or drug) abuse or dependence within 3 months
10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR\<60ml/min/1.73m2)
12. Increase of transaminases up to \< 2.5 times of upper limit of normal value
13. Have a history of thromboembolic disease or thrombotic tendency
14. Subjects in pregnant or lactating or within 1 year after delivery
15. Subjects have an allergic history to the drugs used in the study
16. Subjects have participated in other clinical researches of medicine within

    1 month prior to randomization
17. Use of metformin, pioglitazone, or pioglitazone combined with metformin within 30 days before screening