cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment

Preterm infants are at risk for feeding problems which can persist through early childhood. These feeding problems may include oral motor, sensory, digestive, nutritional, respiratory, and/or behavioral components. In North Carolina's early intervention program, speech pathologists or occupational therapists are responsible for completing feeding evaluations, and may not know when to refer infants out to medical specialists to address these other domains. This study will test a decision support tool in hypothetical feeding evaluation scenarios. The hypothetical scenarios will consist of real feeding videos of preterm infants who recently participated in a multidisciplinary feeding evaluation. Parent-reported outcomes of the infant's real evaluation will be compared to those of the speech pathologists and occupational therapists in our study who do, and do not, use the decision support tool. The investigators hypothesize that therapists with the tool will make recommendations that are closer to those of the multidisciplinary team, and that they will find the tool useful and easy to use.

Due to recruitment limitations with families, the study was adapted in October, 2021 prior to enrollment of subjects to use case studies, rather than infant videos, as the hypothetical situation from which to test the tool. Therapists will then answer clinical questions without using the tool when viewing the first case study, and will use the tool to answer questions when viewing the second case study. Order of case study presentation will be randomized among participants.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age,
* speech language pathologist or occupational therapist,
* at least 2 years of experience evaluating and treating pediatric feeding,
* have worked in early intervention in last 5 years,
* English proficiency,
* currently reside in North Carolina

Exclusion Criteria:

* \<2 years of experience in pediatric feeding,
* have not worked in Early Intervention in last 5 years,
* younger than 18 years old
Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study

The ENDALGOFIV study of pain assessment during the IVF pathway at Lille University Hospital, conducted from November 2018 to July 2020, showed that endometriosis patients have intense pain, particularly of a neuropathic nature, even before starting their IVF pathway compared to patients without endometriosis, but without an increase in pain scores during the IVF pathway. As a result of this study, a new pain management protocol for all patients undergoing IVF have been implemented in our MPA center. The study will be evaluated the impact of this new management.

Main objective To evaluate the effect of the change in pain management protocol in all patients (endometriotic or not) undergoing IVF treatment during the study period by comparing them to the data of the ENDALGOFIV 1 study.


Eligibility Criteria:
Inclusion Criteria:

* All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)

Exclusion Criteria:

* Previously enrolled patient (ENDALGOFIV or ENDALGOFIV 2)
* Refusal to participate in the study
* Minor patient
* Patient over 43 years old
* BMI patient \> 35
* Pregnant woman
* Unable to provide clear information to the patient
* Patient under guardianship or lack of health cover
* Patient in IVF with donation of oocyte
* IVF patients for oocyte preservation
* Patient who had already participated in the study
Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment

Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission.

Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They both has proven efficacy for acute face treatment, with different security profiles. There are not enough adequate studies comparing both drugs made in a large number of subjects. Investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.


Eligibility Criteria:
Inclusion Criteria:

- Patients between 0 and 18 years of age with confirmed Chagas disease (defined as patients under 8 months with positive parasitemia or older with 2 positive different techniques for serology) that received treatment with Nifurtimox or Benznidazole.

Exclusion Criteria:

- Patients that abandoned follow-up
Study of Apatinib in Patients With Differentiated Thyroid Cancer

The purpose of this study is to assess the efficacy and safety of apatinib in locally advanced/metastatic radioactive iodine-refractory/resistant differentiated thyroid cancer


Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1);
2. Disease progression within 14 months before inclusion;
3. Subjects must be 131I-refractory / resistant as defined by at least one of the following;

   * Lesions that do not demonstrate iodine uptake on any radioiodine scan
   * Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Becquerel (GBq) \[≥ 100 millicurie (mCi) \]) and target lesion disease progression
   * Every two radioactive iodine treatment interval \<12 months, doses ≥ 3.7 GBq \[≥100 mCi\], disease progress more than 12 months after at least once iodine therapy;
   * Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi)
4. main organs function is normal;
5. Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2;
6. An expected survival of ≥ 3 months;
7. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug;
8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

Exclusion Criteria:

1. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma);
2. Received VEGFR inhibitor treatment within 1 month;
3. Subjects with poor-controlled arterial hypertension (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; II-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac dysfunction;
4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 3 months;
6. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed;
7. Received anti-thyroid cancer chemotherapy treatment (allows the use of low-dose chemotherapy with radiation sensitizer) or thalidomide(or derivative) therapy;
8. Pregnant or lactating women;
9. Other conditions regimented at investigators' discretion.
Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study

The goal of this retrospective study is to compare the long-term follow-up outcomes of pulses field ablation (PFA) Vs. radiofrequency ablation (RFA) for the patients with paroxysmal supraventricular tachycardia (PSVT). The main question to answer is:

Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.

1. Recieved PFA or RFA 1 year ago
2. Finish the visit to the clinic at 1, 3, 6, 12 months for examinations and blood testings
3. Patients recieved PFA and PFA under propensity matched comparison according to differen variety of PSVT

The goal of this retrospective study is to compare the long-term follow-up outcomes of PFA Vs. RFA for the patients with PSVT. The main question to answer is:

Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptomatic PSVT including: atrioventricular nodal re-entrant tachycardia (AVNRT), atrioventricular re-entrant tachycardia (AVRT);
2. Age range: 18 years old ≤ age ≤ 80 years old, with no gender restriction;
3. Willing to receive the examinations and testings during one year follow-up required by the protocol;
4. Voluntary signed informed consent.

Exclusion Criteria:

1. Organic heart disease;
2. History of cardiac surgery;
3. Previous failed ablation of PSVT;
4. Presence of any implants, such as a permanent pacemaker;
5. Patients with invasive systemic infections or advanced malignant tumors;
6. Contraindications for septal puncture or retrograde transaortic access surgery;
7. Any condition that makes the use of heparin or aspirin inappropriate;
8. Pregnant or lactating women;
9. Inability to fully comply with the study procedures and follow-ups or to provide their own informed consent;
10. Coexistence with other arrhythmias, such as atrial fibrillation.
Hypnosis and Closed-Loop Anesthesia System

Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.

A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.


Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for a surgical procedure under general anesthesia

Exclusion Criteria:

* pregnancy, breast feeding woman
* allergy to propofol, soy or peanuts
* history of central nervous system disease
* patient receiving a psychotropic treatment
* patient treated by a psychiatrist or a psychologist
* hypovolemia, high cardiovascular risk
* patients with a pace-maker
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)

Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or eliminated by separating and removing the plasma and replacing it with other fluids, a process called plasma exchange.


Eligibility Criteria:
Inclusion Criteria:

* considered by the Investigator to be free of signs and symptoms suggestive of any serious opportunistic infection
* willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon beta and glatiramer acetate) for the duration of the study
* willing and able to comply with the site's plasma exchange protocol which may require hospitalization or daily visits

Exclusion Criteria:

* considered by the Investigator to be immunocompromised
* history of, or available abnormal laboratory results indicative of any major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for the duration of the study.
* condition(s) considered to be contraindication(s) for plasma exchange, including but not limited to bleeding diathesis, hypotension, or vascular access limitations
Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease

Lower extremity artery disease (LEAD) is characterized by low awareness rate and high missed diagnosis rate, leading to low treatment rate and high disabling mortality rate. However, none of the current examination methods can comprehensively and thoroughly evaluate the vascular structure and blood oxygen status of the lower extremity at the same time. This study aims to evaluate the reliability and accuracy of photoacoustic tomography (PACT) in the diagnosis of lower limb arterial disease through a case-control study. It is planned to recruit 30 patients with clinically confirmed LEAD (15 patients with stenosis ≥50% and \< 50% respectively) and 5 patients without LEAD in preliminary clinical screening. The reliability of PACT was assessed by repeated measurements within the observer and different inter-observer measurements of the same subject. Compared with computed tomographic angiography (CTA), the sensitivity and specificity of PACT in diagnosing vascular stenosis were calculated. The ability of PACT to determine tissue blood oxygen was assessed by comparing PACT functional imaging with ischemic grading as determined by ankle-brachial index (ABI) and transcutaneous oxygen pressure (TcpO2) between subgroups.


Eligibility Criteria:
Inclusion Criteria:

1. LEAD patients with involvement of calf arteries;
2. the glomerular filtration rate (GFR) \&gt; 60 ml/min.
3. Patients voluntarily take part in the study and write informed consent. 2. Inclusion of the control group

1) Patients without LEAD by ultrasound and clinical diagnosis; 2) the glomerular filtration rate (GFR) \&gt; 60 ml/min. 3) Patients voluntarily take part in the study and write informed consent.

Exclusion Criteria:

1. age \&lt; 18 years;
2. pregnant women, nursing mothers and pregnant women in preparation;
3. allergic to CTA contrast agents;
4. with laser operation contraindication (for example, received a photodynamic therapy in the last month);
5. with metal implants in lower legs or feet;
6. with a history of mental illnesses or abuse of drug and alcohol;
7. with blood phobia or pathological hypotension;
8. with cerebral hemorrhage or peripheral vascular bleeding risk, or history of stroke;
9. with wounds in lower legs or feet;
10. unable or uncooperative with the experimenter.
Exercise Training and Plasma Lipoproteins in Man

To determine the effects in moderately obese subjects of weight loss by combined dieting and exercise training on risk factors for coronary artery disease including lipoprotein lipids, apoproteins and blood pressure.

BACKGROUND:

Evidence appears to be fairly conclusive that obesity has adverse effects on health and longevity when the relative body weight is 40 percent above desirable weight based on insurance industry tables of weights. The close association between obesity, hypertension, hypercholesterolemia, non-insulin dependent diabetes mellitus, an excess of certain cancers and other medical problems makes it imperative that interventions be directed to change the lifestyles and behaviors of individuals who are overweight. The Stanford Weight Control Project (SWCP) trial examined the effects of weight loss on cardiovascular disease risk factors.

The Stanford Weight Control Project (SWCP) randomized 155 overweight, sedentary, non-smoking men, aged 30-59 years, to one of three groups. Fifty-one were assigned to weight loss through dieting, 52 to weight loss through exercise, and 52 to a control, non-intervention group. Follow-up continued through July 1989.

DESIGN NARRATIVE:

Subjects were randomized to a control group, a hypocaloric National Cholesterol Education Program (NCEP) diet, or to a hypocaloric NCEP diet with exercise. One hundred nineteen of the men and 112 of the women returned for testing after one year.

Eligibility Criteria:
Men and women, ages 25-49. Subjects were overweight with blood pressure less than 160/95 mm Hg and total cholesterol less than 260 mm/dl.
Vildagliptin Versus Dapagliflozin on Glucagon

The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis.

The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis. Subjects will therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks followed by a meal test in which glucagon levels will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Written consent has been given.
2. Patients with type 2 diabetes treated with a stable dose of metformin during the last three months
3. Age 20-70 years.
4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
5. Ability to complete the study

Exclusion Criteria:

1. Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
2. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
3. Type 1 diabetes, positive GAD antibodies
4. Estimated glomerular filtration rate \<60 ml/min
5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
6. Any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes.
7. Any history of acute pancreatitis
8. Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
9. Liver disease such as cirrhosis or chronic active hepatitis
10. History of coronary heart disease or heart failure class III or IV
11. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
12. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
14. Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients

Otomycosis is a superficial fungal infection of the external ear canal. Patients should be treated with cleaning fungal debris combined with topical antifungal agent. There is wide range of topical antifungal agents. However, there is still no consensus of the most effective topical antifungal agents in treatment otomycosis is still lacking.

According to Thai National List of essential medicines for topical antifugal agents are:

* acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)
* boric acid (3% in isopropyl alcohol)
* gentian violet
* clotrimazole ear drop. But from literature review, there is no comparative study between boric acid and clotrimazole solution before.

Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.

The hypothesis has been formulated by H0 and Ha. H0 = 1% clotrimazole solution has clinical effectiveness not different from 3% boric acid in 70% alcohol for the treatment of otomycosis.

Ha = 1% clotrimazole solution has more clinical effectiveness than 3% boric acid in 70% alcohol for the treatment of otomycosis.

Inclusion criteria:

* Symptomatic otomycosis, age more than 7 year.
* Microscopic finding revealed fungus
* KOH smear positive for fungus

Exclusion criteria:

* Pregnancy
* Tympanic membrane perforation and post mastoid surgery
* Co-infection of ear e.g. severe otitis externa,severe myringitis which are needed other medication.
* Previous using topical antibiotic / steroid within 2weeks.
* During usage of systemic antifungal drug
* Allergic to 3% boric acid in 70% alcohol or 1% clotrimazole solution. PICO model: P= otomycosis patient I= 1%clotrimazole ear drop C= 3% boric acid O= result of treatment as cure

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic otomycosis, age more than 7 year.
* Microscopic finding revealed fungus
* KOH smear positive for fungus

Exclusion Criteria:

* Pregnancy
* Tympanic membrane perforation and post mastoid surgery
* Co-infection of ear e.g. severe otitis externa, severe myringitis which are needed other medications
* Previous using topical antibiotic / steroid within 2weeks.
* During usage of systemic antifungal drug
* Allergic to 3% boric acid in70% alcohol or 1% clotrimazole solution.
* Those who can not come to follow up after one week of the treatment
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System

Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance.

According to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer \>1:40) and/or anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and/or anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis).

The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. However, up to 31% of patients with PBC are lost without follow-up. The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression. To date, two studies (one Spanish and one Portuguese) showed that 27% and 45.5% of the patients lost with PBC presented advanced fibrosis, respectively.

The objective of this study is to identify, through computerized data, patients with PBC who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with positive AMA and/or with positive ANA anti-gp210 or anti-sp100 identified in the computer databases of each of the participating centers.
* Adults (≥18 years)

Exclusion Criteria:

* Patients with Overlap Syndrome (PBC overlap with Autoimmune Hepatitis (AIH))