cyrilzakka/clinical-trials huggingface dataset:
Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain

To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).

Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study. Gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. Weight (kg) and height (m) were measured using a mechanical column scale (SECA).

The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18 (TFEQ-18).

The Medical Nutrition Therapy (MNT) was offered every 2-4 weeks. This therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational BMI for an ideal weight .

We evaluated the effect of MNT on GWG using a multiple linear regression model

Eligibility Criteria:
Inclusion Criteria:

* Women in puerperium with known T2DM or GDM diagnosed at the hospital.

Exclusion Criteria:

* Women with a twin or other multiple pregnancy, type 1 diabetes mellitus (T1DM), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).
Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty

Total knee arthroplasty (TKA) is recognized as a successful procedure for treating osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the degree of knee flexion. Providing more range of motion after TKA impact on the convenience of daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures which require a lot of ground activities. Data are limited on the added benefits of perioperative photograph as motivation for increasing range of motion after TKA.

Half of participants received perioperative photograph as motivation, while the other half did not after total knee arthroplasty.

All participants received spinal anesthesia, multimodal local anesthetic infiltration and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical techniques, postoperative medications and rehabilitation protocols were identical in both groups. Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken and were given to experimental group in the day after surgery. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. The outcome assessors were blinded to treatment groups during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.

Exclusion Criteria:

* Knee range of motion less than 90 degrees
* Psychotic disorders
* History of stroke
* Inability to undergo a spinal block
Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access

The purpose of this study is to determine if the use of aromatherapy impacts patient anxiety and pain scores surrounding port access in pediatric oncology patients between the ages of 4 years and 18 years.

Specific aims include the following:

Aim 1: To compare pre and post port access anxiety scores for both control and intervention groups.

Aim 2: To assess pre and post port pain scores surrounding port access for both control and intervention groups.

Aim 3: To compare pain and anxiety scores between age groups. The overall goal of this pilot study is to identify if aromatherapy, using non-topical, STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents, is effective as a valid non-pharmacologic supplementation in reducing anxiety and pain scores during port access in pediatric oncology patients.

Eligibility Criteria:
Inclusion Criteria:

1. Children between 4 years and 18 years
2. Scheduled for port access with or without lab draw
3. Oncology, neuro-oncology, and stem cell transplant patients

Exclusion Criteria:

1. has asthma, reactive airway disease, or allergies to any of the ingredients we are using in the aromatherapy study (lavender, bergamot, sweet orange, and ylang ylang)
2. currently uses aromatherapy for port accesses or other painful procedures (does not apply to patients using aromatherapy, such as peppermint oil, for nausea)
3. has a cognitive impairment that prevents them from being able to provide anxiety or pain scores
4. does not wish to participate in the study
Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism

The aim of this study is to investigate how a short versus a long transit time impacts the gut microbiome's response to a high-fiber and a low-fiber diet, respectively. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.

The study consists of two parallel arms of whole-meal diets, a low-fiber diet, and a high-fiber diet, respectively. Each arm is designed as a cross-over where participants, in random order, are administered a laxative (Movicol) along with the provided diet to shorten their intestinal transit time or simply consume the provided whole-meal diet (control).

The two intervention periods both involve the following:

* One week of run-in where participants consume the provided whole-meal diet.
* One week where participants either consume Movicol with the provided whole-meal diet or simply continue consuming the provided whole-meal diet (control).

Both arms begin with a screening visit and one week where participants consume and record their habitual diets. Subsequently, the first intervention period follows with one visit before and after each of the two weeks (visit 1-3) followed by the second intervention period with one visit before and after each of the two weeks (visit 4-6). The two cross-over periods are split by a washout of at least two weeks.

The study thus runs for approximately 7-8 weeks depending on the length of the washout and consists of seven visits (one screening visit and six regular visits) in total.

Eligibility Criteria:
Inclusion Criteria:

* 18.5-30.0 kg/m2 BMI
* Self-reported ≤3.5 spontaneous bowel movements per week
* Willing to collect urine and stool samples at home and able to temporarily store them in their own freezer in a provided container.
* Willing to eat the foods provided.
* Owns a smartphone (iOS 11.0 and later or Android 5.0 and up) with access to the internet.

Exclusion Criteria:

* Pregnant or lactating women.
* Diagnosis of irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO), inflammatory bowel diseases (IBD), Gastrointestinal obstruction, or Ischemic colitis
* Diagnosed constipation according to the ROME IV criteria
* Intake of antibiotics ˂ 1month, or any medication that can affect the outcomes of the study
* Regular use of diarrhea inhibitors or laxatives
* Dysphagia
* Any chronic disease that can affect the outcomes of the study or pose a risk when consuming Movicol
* Intake of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
* Intake of medications potentially altering the gastrointestinal motility (prokinetics, antiemetic agents, anti-cholinergic agents, narcotic analgetics, nonsteroidal anti-inflammatory drugs, and peroral glucocorticoids)
* Concurrent participation in another trial
* Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation
A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy

The purpose of this study is to see if it is safe and effective to give HE2000, an experimental anti-HIV drug, to HIV-infected patients on salvage therapy (emergency treatment used when a patient has not responded to standard therapy).

HE2000 is a hormone that is suspected to make it more difficult for HIV to live in cells.

HE2000 is a synthetic steroid hormone that, when tested in the laboratory, had anti-viral activity against wild-type and drug-resistant variants of HIV. HE2000 works through a natural biochemical mechanism in cells to make them less able to support viral infection.

There are 4 treatment groups of increasing doses of HE2000; each group consists of 2 parts (Part A and B). Part A is a single administration of HE2000 injected intramuscularly, and Part B is 5 consecutive daily intramuscular injections of HE2000. Patients receive the same dosage throughout Parts A and B of the study. Patients are asked to return to the clinic periodically for blood sample collection. Patients may remain at the hospital overnight for pharmacokinetic evaluation. Drug safety, tolerance, efficacy, and pharmacokinetics are measured. Samples from treatment Group 4 are analyzed for specific cell function.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are HIV-positive.
* Have been on their current anti-HIV drug combination for at least 30 days prior to the screening visit.
* Are currently failing at least their second anti-HIV drug treatment.
* Are not responding to their current anti-HIV treatment, have failed at least 1 anti-HIV combination, and do not have many options for treatment (Groups 3 and 4 only).
* Are willing to not make any changes in their anti-HIV treatment until at least Day 50 during the study.
* Have a CD4 count of at least 100 cells/mm3 at study entry.
* Have a viral load (level of HIV in the body) between 5,000 and 250,000 copies/ml at study entry.
* Agree to use barrier methods of birth control (e.g., condoms) during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have hepatitis B or C.
* Have been treated for cancer within 4 weeks prior to study entry, or will need to be treated during the study. (Patients with Kaposi's sarcoma are eligible but must not have received any treatment within 4 weeks before study entry or require treatment during the study.)
* Have received certain medications including those affecting the immune system.
* Are pregnant or breast-feeding.
* Have an active, serious infection, including opportunistic (AIDS-defining) infection that requires treatment during the study or during the 2 weeks prior to study entry.
* Have a condition or are receiving therapy that would prevent them from completing the study.
Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction

Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)


Eligibility Criteria:
Inclusion Criteria:

* Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation

Exclusion Criteria:

* Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder
Antiviral Drugs on the Treatment of SARS-CoV-2

Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases

Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs

Eligibility Criteria:
Inclusion Criteria:

main group

* Patients with COVID19 with medium and easy condition disease
* take favipiravir/remdisivir control group
* Patients with COVID19 with medium and easy condition disease
* not take favipiravir/remdisivir

Exclusion Criteria:

* patients younger 18
* severe conditionis
Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.

The aim of the current study is to compare the cumulative stent patency of multiple PS and single plastic stent and the clinical success rate as a primary objective, investigate the technical success rate, procedure time incident of overall adverse events including stent dysfunction and overall procedure related mortality as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

In-operable distal malignant bile duct obstruction Age\>18

Exclusion Criteria:

Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients

The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gout

Exclusion Criteria:

* Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)
Prediction Model fo Screening and Diagnosis of Prostate Cancer in PSA Gray Zone Based on Serum PHI Combined With TPV

Prostate cancer (PCa) is a high incidence tumor of elderly men. In recent years, its incidence has rapidly increased in China. Serological examination of prostate-specific antigen (PSA) is particularly important in the early diagnosis of PCa, but its specificity is lower in gray areas with PSA between 4-10 ng / ml. Proposition of prostate health index (PHI) strengthens the specificity of PSA gray area prostate cancer diagnosis, but the composition of the index only relies on serological examination, neglects imaging indicators, and cannot be comprehensively evaluated. Based on the preliminary basis of PHI research in the undergraduate department, combined with ultrasound imaging indicators of total prostate volume (TPV), this research group prospectively analyzed the efficacy of PHI combined with TPV to predict prostate cancer in patients with PSA gray areas, and established an improved version of PHI-TPV combination. The prediction model mPHI assesses the sensitivity of the new model to predict the risk of prostate cancer in the Chinese population, provides data support for puncture decisions of middle-aged and elderly male patients in the gray area of PSA in China, and provides reference and guidance for the individualized prevention and treatment of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patient\> 45 years of age
2. Abnormal serum PSA
3. Prostate nodules found by DRE
4. Abnormal MRI or TRUS finding

Exclusion Criteria:

1. Incomplete medical history
2. Poor quality of serum samples
3. Bacterial acute prostatitis diagnosed within 3 months before biopsy 4.5α reductase inhibitors, anabolic steroids, or antiandrogen drugs taken within 12 months before biopsy

5.Previous prostate biopsy history.
Effects of High-concentration Topical Capsaicin on Histaminergic and Non-histaminergic Itch

The purpose of this project is to investigate the effect of capsaicin-induced neurogenic inflammation with three different intensities on itch subsequently induced by histamine and cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation significantly increases susceptibility to itch provocations with cowhage and histamine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Caucasian descent
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Moles or tattoos in the area to be irradiated
* Exposure of the irradiated area to UV radiation (e.g., sun) 48 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
World Bleeding Disorders Registry Pilot Study

The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international, observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the feasibility of conducting an expanded WBDR to more centres with a more comprehensive case report form, around the world.

The pilot phase of the WBDR is an observational disease registry of patients with hemophilia. Forty hemophilia treatment centres (HTCs), of varying levels of economic development (emerging, mid-level and established), that have data entry capabilities and the ability to obtain the required data on patients in English, were invited to participate in the pilot phase. Participating HTCs will complete a Minimal Data Set (MDS) of data on approximately 10 patients each.

A series of performance indicators have been identified by the Steering committee and will be used to assess the feasibility of expanding the pilot phase to the WBDR. The performance indicators include: proportion of HTCs invited that are willing to participate; proportion of participating HTCs who successfully obtain necessary regulatory approvals; proportion of patients approached who consent to participate; proportion of enrolled patients on which data collection and database entry is successful.

Eligibility Criteria:
Inclusion Criteria:

* Patients of participating Hemophilia Treatment Centres with Hemophilia A or B.
* Ability to provide data in English

Exclusion Criteria:

* none
Patients Understanding of PROM Graphs

This study evaluates patients' ability to understand PROM scores when presented in graphs. One half will receive one version of the survey, while the other half will receive a second version of the survey.


Eligibility Criteria:
Inclusion Criteria:

* patient at Stanford Clinics
* orthopaedic condition

Exclusion Criteria:

-
Physical Activity and Health of Children With Cancer in Remission

Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.


Eligibility Criteria:
Inclusion Criteria:

* children aged 6-16
* remission from cancer
* \>6 months after completion of all therapy

Exclusion Criteria:

* informed consent not given in writing
* refusal of tests: blood, fitness, questionnaires or DEXA
* locomotive handicaps
* extreme fatigue, nausea, dyspnea
* concurrent acute illness
* recent (less than 3 months) hospitalization
* documented (echocardiographic or nuclear medicine) decrease in cardiac function
* abnormal blood tests: Hb \< 10 gr/dl, neutropenia \< 500/mm3, thrombocytopenia \< 50,000/mm3
* additional chronic health conditions unrelated to cancer (e.g. celiac disease, cerebral palsy, Down's syndrome)
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children

The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).

In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.

this study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).

Eligibility Criteria:
Inclusion Criteria:

* Comparator group :
* have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.

  • Study groups:
* have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.

Exclusion Criteria:

* Have received other doses of hepatitis B vaccine;

  * Be considered immunosuppressed;
  * Have an autoimmune disease;
  * Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;
  * Have a bleeding disorder;
  * Be significantly delayed in development;
  * Have or plan to participate in other clinical studies with vaccines or products not approved in Canada;
  * Have presented a serious clinical condition to the vaccines administered as part of the study.
Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study

This study is designed for volume assessment in pediatrics during major surgery using non-invasive tools as ultrasonography without the need of invasive techniques avoiding its complications and as a guide for fluid therapy needed for maintaining adequate hemodynamics

Intravascular volume assessment during surgery is important for maintaining adequate hemodynamics. Methods approved for volume assessment include the use of echocardiography to measure left ventricular end diastolic area (LVEDA), central venous pressure (CVP) and pulmonary artery diastolic pressure (PAD). LVEDA is considered the good predictor for volume status assessment. CVP and PAD are invasive can potentially subject the patient to complications. Recently study performed an ultrasound assessment of the internal jugular vein (IJV) as a useful means of volume status assessment intraoperative under general anesthesia. In the pediatric population, only few studies are carried out to assess the use of ultrasound for intravascular volume assessment. This study will evaluate use of Ultrasonography of IJV in volume assessment in pediatrics will undergo renal transplant surgery and correlate IJV diameter, cross sectional area to CVP and LVEDA.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with end stage renal disease
* Weight between: 12 to 30 kg

Exclusion Criteria:

* Infection at the site of CVP or generalized infection.
* IJV thrombosis