cyrilzakka/clinical-trials huggingface dataset:
Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy.

Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

Since the first gastrectomy by Theodore Billroth in 1881, this procedure remained a curative treatment for gastric cancer. Reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (QoL). There are several reconstruction methods for distal gastrectomy, including Billroth I (B-I), Billroth II (B-II), Roux-en-Y (R-Y). B-I and B-II were considered better than R-Y in terms of shorten operation time and lessen blood loss due to technical simplicity. In contrast, R-Y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen QoL. However, long term QoL was similar between B-I and R-Y in some randomized controlled trials. Although bile reflux was higher in B-I and B-II groups, remnant gastric cancer was similar between 3 groups in this study. In brief, which one is the ideal reconstruction after distal gastrectomy is still controversial.

At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.

Eligibility Criteria:
Inclusion Criteria:

* Patients confirmed with gastric cancer
* Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
* Age from 18- to 80-year-old
* Agreed to participate in study with written inform consent

Exclusion Criteria:

* Pregnant patients
* An American Society of Anesthesiology (ASA) score of higher than 4
* Concurrent cancer or history of previous other cancers
* Previous gastrectomy
* Complications including bleeding, perforation required emergency gastrectomy
Near-Infrared Spectroscopy for Blood Glucose Measurements

The purpose of this study is to evaluate the performance of a near-infrared transmission measurement in blood samples collected from healthy volunteers. We propose that NIR spectroscopic blood glucose measurements in healthy patients are as accurate as handheld glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood samples spiked with pharmacological interferents to test if the spectroscopic glucose measurement is affected by common medications.

Luminous Medical is developing an automated glucose measurement system that addresses the rapidly growing clinical demand for tight glycemic control in the intensive care unit (ICU), operating room (OR), and intermediate care units. The system automatically measures glucose and other analytes by spectroscopically analyzing blood as it passes through a disposable Sensor Set. Our unique optical measurement does not chemically interact with blood, is insensitive to sensor fouling, and, unlike a biosensor, does not require frequent recalibration.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 65
* Healthy
* Not currently pregnant
* Hematocrit \>38%

Exclusion Criteria:

* Pregnancy (Self Reported)
* Females that have given birth 6 weeks prior (self reported)
* Anemia (hematocrit \<38%) Hematocrit is checked via a capillary fingerstick and a blood hematocrit reader.
* Under the age of 18 or over the age of 65.
* Diagnosed with Type I or II Diabetes (Self-Reported).
* Donated blood (\>25 mls) in the last 8 weeks
* Heart rate \>100 beats per minute
* Weigh less than 110 lbs.
* Currently taking anticoagulants (ex: coumadin)
* Abnormal blood pressure (diastolic \>90)
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of \[14C\]-CTP-543 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 19 and 55 years, inclusive (healthy is determined by medical evaluation, including medical history, full physical examination, vital signs, electrocardiogram, and clinical laboratory tests)
* Body Mass Index of 18.0 to 32.0 kg/m2
* Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study

Exclusion Criteria:

* Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening
* Infection with hepatitis B or hepatitis C viruses
* History of irregular bowel movements
* History of herpes zoster
* A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
* History or presence of alcoholism or drug abuse within the past 2 years prior to dosing
* Participation in another clinical study within 30 days prior to dosing
Role of Pepsin Assay in Wheezy Infants

Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and exacerbations recurrence.

Wheezy infants were tested for gastro-esophageal reflux disease using combined MII-pH, EGD, LLMI and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux esophagitis were given domperidone and omeprazole for 12 weeks then re-evaluated for symptoms control and wheeze exacerbations recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Infants with physician documented 3 attacks of wheezing episodes over the last 6 months or persistent wheeze over the last one month

Exclusion Criteria:

* Wheezy infants with atopy (allergic rhino-conjunctivitis or eczema), prematurity (less than 34 weeks), abnormal neurological examination, congenital heart diseases, airspace opacity on chest radiography, tracheal-bronchial malformations, immune deficiency and anatomical esophageal or gastric malformations
IPT-G for Mums With Postpartum Depression

Postpartum depression is a very common and costly illness with numerous, long-term deleterious effects for women, their offspring and families; yet most women are not treated. Group IPT delivered virtually offers women a 1st-line, low-cost intervention that overcomes existing treatment barriers. To test its acceptability and effectiveness, a RCT will be conducted to compare virtually delivered group IPT immediately to usual care in women in Ontario Canada who have postpartum depression.

Depression during pregnancy and in the first year following delivery affects 15-20% of women. Left untreated, these disorders increase the risk of future depressive episodes, postpartum depression in their partners, as well as emotional, behavioural, and cognitive problems in offspring. Unfortunately, up to 85% of these women will not receive treatment, which is estimated to cost the province of Ontario upwards of $6 billion annually. There is significant stigma surrounding perinatal depression which can result in less help-seeking by women, as well as a lack of awareness about available non-medication treatment options among both physicians and patients, even though most women prefer psychotherapy over medication.

Despite the very strong evidence base for IPT, relatively few clinicians are trained to deliver IPT. Rather than travelling to tertiary care centres, the delivery of group psychotherapy virtually via telemedicine or Zoom allows women anywhere in the province to access this highly effective first-line treatment, thereby increasing access for women with perinatal depression and improving outcomes for mothers, babies, and families in Ontario.

Study Objective: To compare the effectiveness of virtual group IPT to usual care in women with postpartum depression symptoms for reducing depression symptoms and anxiety, improving mother-infant attachment, and increasing social support, functioning, and quality of life.

Study Design: RCT Population: postpartum women, aged 18 or older, with a baby under a year old Intervention: 12 weeks (15 sessions - 12 acute, 3 maintenance sessions) of group IPT delivered virtually via Zoom Comparison: 12 weeks of usual care followed by group IPT Outcomes: Pre-treatment versus post-treatment change in depression symptoms, anxiety, acceptability, mother-infant bonding, social support \& functioning, and quality of life.

All women in the study will be able to access care as usual from their physicians and other therapists throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* postpartum with baby under 1 year
* score greater than or equal to 10 on the Edinburgh Postnatal Depression Scale (EPDS)

Exclusion Criteria:

* active alcohol or substance use disorder
* bipolar disorder
* borderline personality
* antisocial personality
* PTSD
* psychosis
Tympanometric Analysis in Cleft Palate

Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.


Eligibility Criteria:
Inclusion Criteria:

* cleft incisive trans unilateral or bilateral
* post-foramen complete or incomplete

Exclusion Criteria:

* isolated cleft lip
* associated syndromes
* malformation of ear
Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from a peripheral destruction of platelets in the presence of the drug only. They usually involve immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory drugs or anticonvulsants but the list is not exhaustive.

in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM is suspected but the offending drug is difficult to identify in generally poly-medicated patients.

Several drugs may be suspected and the clinician uses biology for rapid assistance to the "de-prescription" and reduces unnecessary therapeutic substitutions in an always difficult clinical situation.

The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a biological test of thrombocytopenia induction in the presence of the drug and the patient's serum that is to say its antibodies and complement fractions with cytometry reading flow. This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in hospital laboratories. But this test must be validated on well-documented clinical cases.

The purpose of this pilot project is to validate the technical and assess the clinical specificity of the test TITIM for hard imputability drugs validated by a committee of experts combining a posteriori of clinical and biological criteria of routine.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients with suspicion of thrombocytopenia drug
* consent signed

Exclusion Criteria:

* Thrombocytopenia plants such as secondary to the following molecules: antineoplastic (except oxaliplatin which gives TIM), immunosuppressants.
* Induced thrombocytopenia heparin and IIb / IIIa glycoproteins (abciximab, tirofiban, epifibatide).
* Presence of anti platelet antibodies allogeneic or autoimmune which are part of the MAIPA test.
* Patient exposed to at least one suspect molecule does not exist in water-soluble form or drug to which the metabolite is suspected
* Patients transfused (plasma, platelets) for less than a month
* Patients with an other bloodline
Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.

Eligibility Criteria:
Inclusion Criteria:

* Seen at the dry eye service at the Singapore National Eye Centre
* Age between 21 and 75 years old
* Symptomatic for dry eye or VA worse than 6/12 in Snellen chart
* Presence of corneal punctate staining involving central zone
* Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician
* No contraindication for blood extraction/plasmapheresis

Exclusion Criteria:

* HIV/HCV/HBV/syphilis
A Phase II Study of BI-505 in Smoldering Multiple Myeloma

The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:

  * Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent.
  * Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder.
* Male or female, 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.

Exclusion Criteria:

* Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.
* Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator.
* Severe other conditions.
Zirconia Implants: Practice-based Evidence

This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners.

The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments.

To evaluate the effectiveness of one-piece ceramic implants placed into fresh extraction sockets and provide practical clinical evidence, the investigators will assess their performance in defined clinical settings, encompassing a variety of clinical situations, patients, and practitioners. This evaluation, conducted according to a precise surgical and treatment protocol, considers factors such as patient and clinician variability and long-term outcomes in routine clinical practice.

Study Question:

The cumulative survival rate (CSR), Marginal Bone Level (MBL) and Pink Esthetic Score (PES) of one-piece ceramic implants supporting crowns during a 12-month follow-up period will be determined.

Eligibility Criteria:
Inclusion Criteria:

* The need for implant placement in position of single or multiple teeth to be extracted and to replace up to 3 teeth
* Availability of patient for a minimum follow-up of one year following implantation
* Availability of complete follow-up data in medical records
* Availability of post-operative and follow-up periapical radiographs

Exclusion Criteria:

* History of head and neck irradiation
* History of bisphosphonate or medications that induce osteonecrosis of the jaw
* Untreated systemic diseases that are known to affect wound healing, such as uncontrolled diabetes mellitus
* Immunocompromised or immunoproliferative diseases
* Heavy Smoking of \&gt;10 cigarettes per day
Multimodal Imaging of Retinal Vessels

Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable.

The present study aims to reveal and quantify differences in vessel morphology between fundus photography, fundus angiography, and optical coherence tomography in health and disease.

This is considered a pilot study and will pe performed on patients scheduled for routine fluorescein angiography.

During the study day the following procedures will be performed:

* Medical history and concomitant medication
* Blood pressure and heart rate
* Assessment of visual acuity using Snellen vision charts
* Biomicroscopy
* Intraocular pressure
* Funduscopy
* IOL-Master axial length measurement
* Fundusphotography
* Optical coherence tomography
* Fluorescein Angiography Fundus photography analysis will be performed with an automated software and analysis of both angiography and optical coherence tomography will be performed via the devices inbuilt software.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent, clear media

Exclusion Criteria:

* any abnormality preventing reliable vessel measurement, pregnancy,
Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan

The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream

The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Chronic Keratinized hand eczema for at least 3 months
* The affected area is greater than 30%
* Overall assessment of the severity of the disease(IGA)≥3 OR HEES≥13
* No obvious incentive .Who have read the instructions of the subject, agreed to and signed written informed consent, and have been able to provide a personal medical history.

Exclusion Criteria:

* Pregnancy, breast feeding
* Severe liver and kidney disease, blood system disease, autoimmune disease, chronic severe infection, diabetes, mental illness, drug use, alcohol abuse, etc
* Malignant neoplasms or other serious maladies that may affect the correct assessment of efficacy
* Topical corticosteroid was suspended for less than 2 weeks;The system used corticosteroids and other immunosuppressive agents (thunder vine and other drugs) which were suspended for less than four weeks
* Eczema of the facial and skin creases
* Atopic dermatitis, contact dermatitis, blister hand eczema, contact urticaria, discoid eczema
* participated in other clinical trials within 3 months.
* Known sensitivity to Halometasone Triclosan
* failure to follow the prescribed medication or the incomplete record of the test process which will affect the curative effect judgment
* Other reasons why researchers think they should not be included
Study Consortium for Evaluation of RNPC Program in Obese and Overweight Patients (SCOOP-RNPC)

The investigators hypothesize that weight loss obtained with the French RNPC weight reduction program is beneficial for the general health of overweight/obese patients in the medium term.

The objective of this cohort study is to demonstrate the effectiveness of the RNPC program on the reduction of drug or instrumental treatments (for example, continuous positive pressure ventilation for the treatment of sleep apnea syndrome) and the improvement of overweight/obesity-associated comorbidities in the medium term.

This is a multicenter clinical study, as part of routine care, with standardized nutritional care (RNPC Program) in all RNPC centers in France. A cohort will be formed based on the clinical and biological data usually collected in the centers, enriched by data from additional clinical and biological examinations as well as by self-questionnaires completed by the participants. About 10,000 overweight or obese participants will be included for 2 years and followed 5 years.

The SCOOP-RNPC study will have benefits for individual participants, for the scientific community in terms of knowledge acquired and for society with a better definition of the impact of treatments.

Responding to the major public health issue represented by overweight, this prospective cohort of overweight or obese patients will make it possible to evaluate, in real-life conditions, the effects of weight loss obtained by the RNPC Program in the short, medium and long term on biological parameters predictive of cardiometabolic risk, drug consumption, quality of life, diet and eating behavior, sleep, physical activity, stress/anxiety, as well as depression.

This cohort will make it possible to identify clinical phenotypes and biomarkers to optimize the personalization of the management of overweight or obese patients, in particular those at risk of developing comorbidities associated with excess weight.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) greater than or equal to 25 kg/m² and/or waist circumference greater than or equal to 80 cm in women and 94 cm in men;
* Possessing a personal smartphone;
* Subjects subject to the French health system;
* Subjects able to sign the informed consent.

Exclusion Criteria:

* Persons refusing to sign the participation consent;
* Pregnant, parturient and breastfeeding women;
* Persons with missing limb(s);
* People with an electrical medical device such as a pacemaker, battery, insulin pump or cochlear implant;
* People carrying any metallic material present in the body, such as prostheses or screws;
* Persons under guardianship;
* Subject in period of exclusion from another study;
* Person deprived of liberty by judicial or administrative decision;
* Person subject to a legal protection measure, who cannot be included in clinical trials;
* People with an open wound or bleeding on the palms of the hands or soles of the feet (Neuropathy group only).
Why in Hospital - Factors Determining Time to Discharge Readiness After Arthroplasty Surgery

The purpose of this study is to evaluate patient related factors determining length of stay in hospital after arthroplasty surgery.

To evaluate why the patient is in hospital after surgery, when predefined discharge criteria are met, which patient related clinical problems hinder fulfilling of the discharge criteria, and to evaluate actual length of stay in hospital.

All consecutive patients scheduled for total hip or knee arthroplasty are included in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total hip or knee arthroplasty

Exclusion Criteria:

* Age under 18 years