cyrilzakka/clinical-trials huggingface dataset:
Assessing Interventions of Diet in IBD

In this study, we are trying to learn how certain diets affect people with inflammatory bowel disease (IBD). We want to understand what makes it hard or easy for them to stick to different eating plans, like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet. By finding out how these diets help with symptoms and which ones are easier to follow, we hope to improve the quality of life for people with IBD.

This study aims to explore the impact of specific dietary interventions on individuals living with inflammatory bowel disease (IBD). By examining dietary patterns such as intermittent fasting, the Mediterranean diet, and the Low FODMAP diet, we seek to identify barriers to adherence and facilitators that make these eating plans sustainable. Additionally, we aim to evaluate the perceived benefits of these diets in managing IBD symptoms and their influence on overall quality of life. The findings will provide valuable insights to develop patient-centered nutritional strategies that enhance adherence and therapeutic outcomes in IBD care.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years) diagnosed with ulcerative colitis or Crohn's disease.
* Having willingness to use their personal smartphone to access the app
* Able to understand the indication by the registered dietitian.
* Able to provide informed consent.
* Willingness to attempt intervention diet and commit to study procedures.

Exclusion Criteria:

* Pregnant women.
* Currently being treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders.
* Currently being treated for chemotherapy.
* Diabetes
* Advance chronic kidney disease
* Short bowl syndrome
Cognitive Behavioral Social Skills Training in Early Onset Psychosis

Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. In addition, CBT may reduce hyperactivation of the brain structures responsible for the stress response. In patients with early onset psychotic disorder (EOP) there are not any previous controlled study that has analyzed the efficacy of this type of intervention.

The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional improvement after the treatment in patients with EOP. The study will also examine the potential effect of the intervention on neurobiological stress markers.

Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a worse clinical and psychosocial evolution than in the adult form of the illness. In the case of patients with EOP, international and national clinical guidelines recommend the combination of pharmacological treatment with CBT. However there are not any previous controlled study that has analyzed the efficacy of this type of psychological intervention.

A controlled randomized study will be carry out of CBT + SST intervention compared to a control intervention of the same duration, format and contact with a therapist. The sample will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to be in the early phase of the disease (first 5 years after the onset) and in non-acute treatment. All participants will be evaluated before and after the intervention with clinical scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age, puberal stage and sex will be also recruited and evaluated only at baseline point. The evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 20.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of 9 and 18 (Schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified according to DSM-V criteria).
* Critical period after the first psychotic episode (which covers the first 5 years) and in non-acute treatment

Exclusion Criteria:

* IQ \<70
* Toxic dependence comorbid disorder
* Presence of Neurological disorder.
Study Comparing the MiStent SES Versus the XIENCE EES Stent

The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.


Eligibility Criteria:
Inclusion Criteria:

All comers" patients:

* Male or female patients 18 years or older;
* Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
* The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
* The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Known pregnancy or breastfeeding at time of randomization;
* Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
* Concurrent medical condition with a life expectancy of less than 12 months.
* The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up.
* Currently participating in another trial and not yet at its primary endpoint.
Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger

Study purpose is to evaluate the effectiveness of Platelet-rich Plasma (PRP) injection in the treatment of trigger finger. We compare PRP to a corticosteroid (methylprednisolone) injection in a prospective randomized triple-blind placebo-controlled study.

Patients with clinically confirmed trigger finger are randomized (1:1:1 computer generated sequence with random block size) to three parallel groups and will receive an injection of either PRP, corticosteroid or placebo (0.9% saline) around the affected tendon sheath in a double-blind setting.

Baseline data is collected and is followed by a phone call at 1 month, and follow-up visits at 3, 6, 12 and 24 months after the intervention. Unveiling of the allocation is at 6 months post-intervention.

The primary outcome measures are:

* Symptom resolution
* Patient-Rated Wrist Evaluation

Secondary outcomes:

* Quick-Disabilities of the Arm, Shoulder and Hand
* Pain Visual Analogue Score
* Global improvement (7-step Likert-scale)
* Grip strength
* Finger range of motion


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75
* Symptom duration \> 3 months

Exclusion Criteria:

* Diabetes
* Rheumatoid arthritis or other condition requiring continuous oral corticosteroids
* Previous history of surgery or injection to the affected ray
* Alcohol or drug abuse
* Mental instability
Zinc Supplementation for Young Infants with Clinical Severe Infection in Tanzania

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection.

The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.


Eligibility Criteria:
Inclusion Criteria:

* Young infants aged 0-59 days
* Diagnosis of clinical severe infection (CSI)
* Ability to feed enterally
* Intend to stay in the study area for 90 days
* Provided informed consent

Exclusion Criteria:

* Prior use of zinc supplements during the current illness
* Receipt of antibiotics for \>24 hours before enrollment
* Diarrhea at enrollment
* Signs suggestive of serious illness/condition that is not clinical severe infection
* Previously enrolled in the trial
* Enrolled in other research study
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Characteristics in Parkinson's Disease

In this randomised placebo-controlled trial, the investigators will include 30 PD (Parkinson's disease) patients with HY (Hoehn Yahr stage) \>2 and L-dopa unresponsive gait characteristics. Each participant will receive taVNS at 25Hz, taVNS at 100Hz and sham VNS (sVNS). During each stimulation, different gait characteristics will be measured with wearable insertion motion sensors.

Participants and study overview:

In this randomised placebo-controlled trial, the investigators will include 30 PD patients with HY\>2 and L-dopa unresponsive gait characteristics. Each participant will complete 1 visit, during which the instrumented stand and walk test will be repeated 16 times. The baseline measurement will be followed by three different stimulation conditions sham VNS (sVNS), taVNS at 25Hz (taVNS25) and taVNS a 100Hz (taVNS100). sVNS, taVNS25 and taVNS100 in a randomized order. To enhance gait disturbances, the participants will perform iSAW during each condition twice in silence and twice while simultaneously performing calculations around.

Instrumented stand and walk test (iSAW):

To perform iSAW, participants will first stand still for 30s, after which they will start walking in a straight line for 7m, turn and walk back to the start. The participants will be equipped with 6 inertion Opal ® motion sensors (on both feet, both wrists, on the lumbar back and on their sternum). For the laud counting iSAW condition (iSAW-C), the participants will perform iSAW as described above while also counting backwards by 3 from numbers above 100.

TaVNS:

Noninvasive electrostimulation will be applied to the left ear. taVNS will be applied to the cyma conchae and sVNS will be applied to the earlobe. Both taVNS and sVNS were applied through the Nemos® electrode with the following parameters: square-shaped pseudobiphasic pulse, interpulse duration 80μs, pulse width 300μs, pulse intensity 0,1mA above the perceptual threshold (figure 1). taVNS25 and sVNS will be applied at 25Hz and taVNS100 will be applied at 100Hz. The intensity for each separate stimulation will be adjusted for each participant at the beginning of the experiment. For each condition, the electrode will be placed in the ear by a third person and the ear will be covered by cotton pads and an EEG cap to hide the electrode position from the experimenter. The order of stimulation will not be revealed until the automated data and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* HYstage \>2
* L-dopa unresponsive gait characteristics present, preferably with history of freezings

Exclusion Criteria:

* unable to walk for 50m
* unable to follow simple commands due to hearing loss/cognitive impairment
Time Interval for Changing Closed System Suction Catheters, Effect on Ventilator Associated Pneumonia

The purpose of this study was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Comparison(s): the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Eligibility Criteria:
Inclusion Criteria:

* Aged greater than 18 years
* Mechanically ventilated for more than 24 hours

Exclusion Criteria:

* Admitted from other hospital already mechanically ventilated
* Massive haemoptysis
* Previously received mechanical ventilation
Exploring Clinical Study Experiences of People With Anorexia Nervosa

The study seeks to delve into the firsthand experiences of patients diagnosed with anorexia nervosa who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future anorexia nervosa patients and play an active role in advancing medical research.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with anorexia nervosa
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
Investigating Utility of ctDNA and Tumour Evolution in Advanced Thyroid Cancer

Although most thyroid cancers are treated and cured successfully there are still 30% who recur after many years. This will eventually progress and at this point may become incurable with treatment options including complex and high risk surgery. The overall efficacy of systemic treatment in advanced thyroid cancer has a good initial response in most patients but not all. The study will collect tissues and blood samples for various protein analysis, nucleic acid extraction and live cell analysis in order to try and detect the presence of plasma ctDNA at baseline of eligible patients.

The treatment decisions are based on relying on radiological parameters such as using the RECIST criteria and measuring the rise in certain serum tumour biomarkers. However, the disadvantage of this is that this method can take many months to detect a change in disease volume. An improved understanding of genetics and cancer and potential gene sequencing can help achieve personalised treatment for patients. However, there are many questions and issues that still need to be answered and require urgent attention before being able to achieve optimate patient stratification. We need to identify better tumour biomarkers to detect disease progression, show real time response to treatment and understand why tumours evolve to becoming more aggressive. This study hopes to address these issues by proposing a multicentre prospective study to investigate the presence and role of ctDNA in advanced thyroid cancer including differentiated thyroid cancer , medullary thyroid cancer and Anaplastic Thyroid Cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older. (all cohorts)
* Patients diagnosed with radioiodine refractory differentiated thyroid carcinoma (RR-DTC) under surveillance. (cohort 1)
* Patients with newly diagnosed resectable locally advanced medullary thyroid cancer Or Patients with newly diagnosed metastatic medullary thyroid cancer for surveillance Or Patients with locally advanced or metastatic medullary thyroid cancer on surveillance (cohort 2)
* Patients with RR-DTC starting systemic therapy Or Patients with RR-DTC on systemic therapy Or Patients with MTC starting systemic therapy Or Patients with MTC on systemic therapy (cohort 3)
* Patients with newly diagnosed anaplastic thyroid cancer (cohort 4)
* Availability of tissue from one archival diagnostic tumour tissue block or be willing to have biopsy of accessible disease (all cohorts)
* Patients must be willing to undergo standard monitoring and treatment as recommended by their clinical team (all cohorts)
* Ability to give informed consent for biological sample collection. (all cohorts)

Exclusion Criteria:

* Previous or concurrent illness, which in the investigator's opinion would interfere with collection of the complete sample collection
* Any invasive malignancy within previous 5 years (other than non-melanomatous skin carcinoma or carcinoma in situ)
* Pregnancy
Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of oxaliplatin combined with capecitabine in treating patients who have metastatic or recurrent solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with oxaliplatin in patients with metastatic or recurrent solid tumors. II. Determine the toxicities of this treatment regimen in this patient population.

OUTLINE: This is a dose escalation study of capecitabine. Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for disease progression and survival.

PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2.5 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No evidence of neuropathy No history of allergies to platinum compounds or antiemetics that would preclude study No other uncontrolled illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Prior fluorouracil or cisplatin allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since prior investigational drugs No concurrent antiretroviral therapy (HAART)
Urinary Catheterization and Second Stage of Labor

* Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta
* The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes
* Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural.
* Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage
* Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization.
* Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage.
* This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Gestational age 24-42 weeks
* epidural anaesthesia
* Vertex presentation
* Singleton

Exclusion Criteria:
Diagnostic Performance of Hybrid PET/MRI in the Staging of Endometrial Carcinoma

Endometrial carcinoma (EC) is one of the most common gynecologic malignancy in China. EC is staged surgically according to the International Federation of Gynecology and Obstetrics (FIGO) system, including depth of myometrial invasion, cervical invasion, and the presence of lymph node metastases. The benefit of lymph node resection on the prognosis of low-risk EC patients is not definite. An accurate staging method preoperative is needed.The purpose of this study is to evaluate the effect of simultaneous hybrid PET/MRI in EC preoperative staging.

The treatment of EC is mainly surgery, mostly comprehensive staging surgery (complete hysterectomy, bilateral adnexectomy, pelvic and para-aortic lymph node resection). Lymph node metastasis rate in the early low-risk EC patients (histologically graded G1 and G2, myometrium invasion depth \<50%, primary tumor diameter \<2 cm) is low (\<4%). Lymph node resection has no clear benefit on the prognosis of low-risk EC patients, but will bring greater trauma to the patients.

Accurate preoperative assessment of EC staging plays a decisive role in the individualized surgical range for EC patients. Preoperative imaging can assist in optimal treatment planning. Through ultrasound, MRI, PET we always cannot accurately measure the depth of muscle infiltration, lymph node metastasis and extra-uterine lesions. The simultaneous hybrid PET/MRI technology combines the characteristics of MRI in high-resolution imaging of soft tissue and the advantages of PET in strong ability to identify tumor metastases, so it may be capable for more accurate staging.

Eligibility Criteria:
Inclusion Criteria:

* EC suspicious patients consent to diagnostic curettage
* Patients who pass standard clinical PET/MRI screening procedures
* Undergoing surgical staging and/or debulking at Xuanwu Hospital, Beijing

Exclusion Criteria:

* Allergy to (18)F-fluoro-D-glucose
* Contraindication to MRI scanning
* Pregnant or breast feeding patients
* Participation in any other clinical trial which may interfere with this study