cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Phase II, randomised, controlled, non comparative study with 2 parallel groups:

* Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
* Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Non-Small-Cell Lung cancer cytologically or histologically proved
* Stage III AN2 inoperable or non resectable
* presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry)
* Possibility to include all targets in one irradiation field
* Age of 18 to 70
* Patients non previously treated
* Performance Status 0 or 1
* Loss of weight ≤10% in the 3 last months
* Neutrophil ≥ 1500/mm3 and platelets ≥ 100000/mm3
* Creatinine clearance ≥ 60 ml/min
* total bilirubin ≤ 1,5N and ASAT ALAT ≤ 2,5N
* Respiratory function normal: VEMS ≥ 40% theorical, DLCO/VA ≥ 50% theorical and PaO2 ≥ 60 mmHg
* Signed inform consent form
* Compliance to radiotherapy 66 Gy with dosimetry V20 ≤ 35% and pulmonary mean dose≤20 Gy

Exclusion Criteria:

* Pretreated bronchial carcinoma, excepted endoscopic deobstruction
* operable bronchial carcinoma
* small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer
* superior vena cava syndroms
* puncturable pleural effusion
* metastatic lung cancer
* Stage IIIb cancer with neoplastic pericarditis
* Previous thoracic irradiation
* severe cardiac disease in the 12 months before inclusion
* interstitial lung disease
* anti-EGFR and anti-VEGF treatments
* hypersensitivity to murine proteins and allergies to protocol drugs
* uncontrolled infectious state
* HIV patient
* corticoid definitive contraindication
* péripheric neuropathy grade≥2
* neurologic, psychiatric and organic disorder
* past or concomitant cancer excepted treated skin baso-cellular cancer or in situ cervical cancer, or any cancer only surgically treated for 5 years
* breastfeeding woman
Platelet Concentrate in Achilles Tendon Repair

People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Achilles tendon rupture, age 18-65.

Exclusion Criteria:

* Any counterindication for surgical treatment.
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
* Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

* Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
Infant Feeding Practice and Gut Comfort Study

Multi-country, cross-sectional, observational study in diverse geographic locations all over the world.

This is a cross-sectional single time point study. Infants and caregivers who come to a clinic for a routine health visit who wish to participate in the study by signing the consent form and meet all inclusion criteria/exclusion criteria will be enrolled.

At the visit, a research staff member will assist the parents to complete (i) Feeding Practice and Gut Comfort Questionnaire and (ii) Infant Gastrointestinal Symptom (IGSQ)-13 items. Additionally, infant's anthropometrics (weight, length, head circumference) will be recorded. These anthropometrics will be measured by the researcher as part of the routine visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy full term (37-42 weeks of gestation) singleton infant.
* Postnatal age ≥ 6 weeks and ≤ 4 months
* Parent as primary Caregiver and ≥ 18 years old
* Exclusively/predominantly breastfeeding or exclusively/predominantly formula feeding of the same type/brand, for at least the past 2 weeks.
* Evidence of personally signed and dated informed consent document by the infant's parent(s).

Exclusion Criteria:

* Chronic illness necessitating medical follow up
* Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up
* Any known case of food allergy (e.g milk)
* Caregivers who are not likely to comply with the study procedures
The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

This repository will establish for the first time a system to carefully assess and monitor over time the general health and the amount of cholesterol in the arteries of U.S. children and adults with homozygous familial hypercholesterolemia (hoFH). Patients with this very rare disorder have very high blood levels of cholesterol from birth due to the inheritance of an abnormal gene from each parent. As a result, if untreated, heart attacks and sudden death occur in childhood. Treatments such as LDL-apheresis and liver transplant will lower the cholesterol level, but the best treatment and the best way to monitor the effect of the treatment on the arteries are unknown. The collection of clinical data and blood for analysis of known and yet-to-be discovered markers and predictors of arterial disease will yield new information about the natural history of the disorder and response to treatment. The repository will greatly aid the development of specific protocols that seek to learn more about this disease and new therapies.

Detailed information of "standard of care" procedures will be compiled in a database. These include medical history and physical exam, lipid profiles and other standard blood tests, dietary evaluation and counseling, cardiology evaluation including EKG and echocardiogram,ultrasound of carotids and femoral arteries, CT angiogram and, if indicated, intracoronary angiography (ICA) with intravascular ultrasound (IVUS) and stress echo or nuclear stress testing.

The recommendation for treatment will be individualized. Current options are a) FDA approved cholesterol-lowering medications: statins, ezetimibe b) LDL-apheresis c) liver transplant d) portacaval shunt e) investigational drugs. Treatment of vascular and/or valvular disease may include aspirin, beta blockers, clopidogrel, angioplasty with metal stent, coronary artery bypass surgery, aortic valve repair/replacement.

Research procedures will include medical photos of skin xanthomas, blood assays (apolipoproteins A and B, LDL particle size, homocysteine, TNF, IL-6, insulin, glucose, ICAM, VCAM, P and E selectin, and endothelial progenitor cells), and DNA analysis of the genes for the LDL receptor and other lipid-related genes.

Eligibility Criteria:
Inclusion criteria:

1. Patients of any age and sex who meet clinical or genetic criteria for hoFH as follows:

* Documented, untreated fasting LDL cholesterol level of \> 500 mg/dL and triglycerides \< 200 mg/dL on a cholesterol-lowering diet for at least 8 weeks with secondary causes excluded, AND:

  * DNA confirmation of a double mutation of the LDL receptor or apoB gene OR
  * LDL \> 160 mg/dL in both biological parents not associated with a disorder know to elevate LDL OR
  * Coronary artery disease in one or both parents or grandparents \< 55 years for males, \< 65 for females OR
  * Tendinous/cutaneous xanthomas \< age 10 or coronary artery disease \< age 20

Exclusion criteria:

1. Inability of patient, or, if less than 18, a parent, to sign informed consent.
Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.

All consecutive newborn babies were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis.

This study was approved by institutional ethical review board of Linyi Maternal and Child Healthcare Hospital. Spoken informed consent was obtained from the participating babies' parents.

Physicians from departments of neonatal medicine and developmental medicine undertake auscultation screening. When abnormal murmur occurred, an echocardiography would be requested to confirm if the newborn has CHD or not.

Physicians from obstetrics department and nursing staff from neonatal department undertake POX measurement. If a positive POX occurred, an echocardiography would be requested to confirm if the newborn has CHD or not.

Physicians from department of ultrasonography undertake echocardiography confirmation for newborns deemed positive by auscultation or POX.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive newborn babies delivered in the study center were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis.

Exclusion Criteria:

* None.
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

Eligibility Criteria:
Inclusion Criteria

1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
2. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
3. primary diagnosis of ADHD based on a detailed psychiatric evaluation.
4. Subjects must have a baseline ADHD-RS-IV total score ≥28.
5. Subject is functioning at an age-appropriate level intellectually.
6. comply with all the testing and requirements.
7. Subject is able to swallow a capsule.
8. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Exclusion Criteria

1. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
2. Subject has Conduct Disorder.
3. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
5. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence.
6. Subject has a positive urine drug result.
7. Subject weighs less than 50 pounds (22.7kg).
8. Subject is significantly overweight.
9. Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
10. Subject has any reported history of abnormal thyroid function.
11. Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening.
12. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments.
13. The female subject is pregnant or lactating.
14. Subject is well-controlled on their current ADHD medication with acceptable tolerability.
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better arterial catheterization. Since an increase in body temperature can cause peripheral vasodilation, we aimed to determine if local warming of the radial artery (RA) catheterization site could improve the success rate of catheterization in pediatric patients.

This randomized, controlled study enrolls 126 pediatric patients aged ≤ 2 years who were scheduled for heart surgery. They are randomized into non-warming (C) and warming (W) groups. After induction, the baseline artery ultrasonography images are collected. In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. The primary outcome is the first-attempt success rate. The secondary outcomes included the ID and CSA of the artery and overall complications.

Eligibility Criteria:
Inclusion Criteria:

* aged ≤ 2 years
* cardiac surgery with peripheral artery catheterization

Exclusion Criteria:

* unstable vital signs
* pre-existing arterial catheter (exception of umbilical artery catheterization)
Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair

Two hundred consecutive unilateral inguinal hernia patients will be included in the study. Patients will be recorded by measuring the distance between the pubic tubercle and the deep inguinal ring, the distance between the inguinal ligament and the internal oblique aponeurosis, the distance between the deep and superficial inguinal ring diameters and their anterior superior iliac spine. The contribution of these measures to the determination of the ideal mesh size will be analyzed.

This prospective study includes 200 consecutive male patients who underwent unilateral open inguinal hernia repair since March 2020. Under-18 hernias, complicated hernias, recurrent hernias, and those with laparoscopic hernia repair will be excluded. Initially, the distance between the pubic tubercle and the medial edge of the deep inguinal ring will be measured. Next, the distance between the inner edge of the inguinal ligament and the upper level of the internal oblique aponeurosis will be measured at the Hesselbach triangle. Hesselbach triangle area will be calculated. The diameter of the superficial and deep inguinal ring and their spina iliaca anterior superior (SIAS) distance will be measured. The contribution of these measures to the determination of the ideal mesh size will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Male patients over 18 years of age who applied for inguinal hernia surgery

Exclusion Criteria:

* Patients under the age of 18
* Complicated hernias
* Recurrent hernias
* Those undergoing laparoscopic hernia repair
The Effect of Marketing Variable on Effect of Active Drugs

The efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. Placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches.

A Meta analysis checked 47 studies about placebo and showed great significance when a patient is treated with placebo pill, no active substance, just by activating conditioning and expectation mechanism in his body, thus providing to the healing process, and that is it's importance.

In recent years studies established a relationship between marketing variables (such as price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed a significant relationship between the marketing strategies and the efficacy of medication; more specifically, patients in this research experienced less (controlled) pain when treated with placebo medication introduced to them as more expensive than patients treated with placebo medication that was introduced to them as much cheaper. All patients were treated with the exact same medication.

In the investigator's experiment the investigators design a laboratory experiment to determine if marketing factors could invoke the placebo effects described earlier. For the initial laboratory experiment, we decided to examine the difference in price, on the efficacy of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's wrist.

The investigators study hypothesis is that marketing variables such as price and brand name will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater influence when the patient is aware of its price compared to one who is not.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer participants will be between the ages of 18 and 65

Exclusion Criteria:

* Candidates who have had a history of cardiac problems, epilepsy, diabetes, or are pregnant will be excluded.
* Taking no pain medication at the time of the experiment.
Ablation in Brugada Syndrome for the Prevention of VF

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria
* Diagnosed symptomatic BrS with an implanted ICD within the last 5 years
* Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years
* The patient is legally competent, willing and able to undergo the study and signed the informed consent
* The patient is willing and able to adhere to the follow-up visit protocol

Exclusion Criteria:

* A patient who does not meet inclusion criteria
* A patient who has had a previous epicardial ablation
* A patient who is pregnant (which would exclude an ablation procedure)
* A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation
* A patient who has a history of radiation therapy on the thorax
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

It is well known that implantation of the developing blastocyst occurs during the luteal phase of the menstrual cycle when the endometrium is under the direct influence of Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis demonstrated that it may be of benefit to patients undergoing ovulation induction with gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered only in an oil-base solution owing to the insoluble properties of the molecule, which made the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P formulation that could be a game changer. The aim of the present pilot trial will be to compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel P for luteal phase support (LPS) in COH and IUI cycles.

The present randomized study will be conducted to compare the safety, effectiveness and tolerability of SC P (Pleyris; IBSA Institut Biochimique SA) with vaginal P gel (Crinone; Merck Serono) for LPS in COH/IUI cycles. The study will be conducted, recorded and reported in compliance with the principles of Good Clinical Practice (GCP) guidelines at the Department of Obstetrics and Gynecology of Magna Graecia University of Catanzaro.

Eligibility Criteria:
Inclusion Criteria:

\<38 years of age with either primary or secondary infertility for at least 1 years; body mass index between 19 and 30 kg/m2; Day 2 serum FSH \<15 IU/ml; normal serum prolactin level; normal uterine cavity on hysterosalpingography or hysteroscopy.-

Exclusion Criteria:

female partners with previous ovarian surgery, one ovary, polycystic ovaries on ultrasound examination, other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders, hyperprolactinemia, hypogonadotropic hypogonadism), diminished ovarian reserve (basal FSH level \>15 IU/mL), or age of \>38 years
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome

This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 \[PD-L1\]) to evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI4736 as monotherapy or in combination with Tremelimumab with or without Azacitidine in adult patients with myelodysplastic syndrome.

Eligibility Criteria:
Inclusion Criteria:

Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function.

Exclusion Criteria:

Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior MAb against CTLA-4, PD-1, or PD-L1, alllogenic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.