cyrilzakka/clinical-trials huggingface dataset:
Fat Distribution and Glucose Metabolism in Williams Syndrome

Williams Syndrome (WS) is a genetic syndrome with features that may include vascular stenoses, neuro-developmental changes, and a variety of endocrine and metabolic abnormalities, including impaired glucose metabolism and abnormal body composition. Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data suggest increased overall body fat in these individuals, as well as a relative increase in fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain incompletely characterized. The purpose of the current study is to carefully describe glucose metabolism and lipid parameters in people with WS.


Eligibility Criteria:
Inclusion Criteria

1. M or F age 14-70yo
2. Diagnosis of WS confirmed by FISH or chromosomal microarray (WS only)
3. Availability of a parent or guardian to participate in the consent process (all WS, and controls \<18yo)

Exclusion Criteria

1. History of weight loss surgery or liposuction
2. Use of weight-lowering drugs
3. Positive urine pregnancy test (females only)
4. Obesity or abnormal fat distribution due to a known secondary cause (except WS) such as Cushing syndrome, HIV-infection, etc.
5. Known diabetes will preclude administration of the OGTT but not participation in other aspects of the study.
Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.

Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests

Study period 1 Clinical examination Measurement of the basal pain thresholds Administration of product (T0) T0+100min : Thermal stimulation according to the established paradigm and fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm and fMRI data acquisition

Study period 2: same of period 1.

Eligibility Criteria:
Inclusion Criteria:

* - Healthy volunteers
* Aged at last 18 years and over 60 years
* Male
* Non-smoking subject
* Fasting coffe, tea, coca-cola or other stimulant products since the last evening
* Subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments

Exclusion Criteria:

* Contraindications to the administration of paracetamol
* Contraindications to the completion of MRI
* Medical history and/or surgical judged by the investigator as being incompatible with the test
* Progressive disease at the inclusion
Safety Trial of Patient Specific Guides for Lumbar Fusion

This is a single centre, non-blinded safety trial. Patients undergoing lumbar fusion will be treated using patient specific guides (PSG) or navigation. Patients requiring lumbar fusion will be treated using conventional surgical methods except when inserting pedicle screws, where half of the patients will be having screws inserted using PSGs. The conventional method of navigation and intraoperative imaging will be used in conjunction with PSGs, to confirm the safety of the guide trajectory. The primary outcome will be screw accuracy measured in degrees from planned trajectory and mm from the planned entry point.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
* Recently has or requires a CT-scan of the spine
* No previous spine surgery on the level being used for patient specific guides
* Sufficient understanding of the English language or interpretation assistance available.

Exclusion Criteria:

* History of alcohol or drug abuse
* History of psychiatric disorders
* Previous spine surgery adjacent or at the level of the surgery
* Unable to read or comprehend the consent form/letter of information
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer

Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer

OBJECTIVES:

I. Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.

OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.

Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months until disease progression.

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

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ovarian epithelial carcinoma
* Previously treated with an adequate course of platinum based chemotherapy
* Evidence of intraabdominal disease
* No significant adhesions
* Performance status - Zubrod 0-2
* Lymphocyte count at least 500/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* SGOT less than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* No major disorder of the cardiovascular system
* No major disorder of the pulmonary system
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Successful placement of peritoneal catheter
* No overt autoimmune disease
* No concurrent chronic steroid therapy
* No prior radiotherapy
* Prior surgery allowed
* Recovered from prior therapy
A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)

This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Type 1 or type 2 Diabetes Mellitus
* Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
* Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Macular edema due to causes other than DME
* Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
* Previous confounding treatments / procedures, or their planned / expected use during the study period
* Presence of neovascularization at the disc (NVD) in the study eye
* Uncontrolled glaucoma in the study eye
* Any active ocular / intra-ocular infection or inflammation in either eye
* Poorly controlled Diabetes Mellitus
* Uncontrolled hypertension
NIPD of CFTC by WGA Coupled to Mini-exome Sequencing

The purprose of this study is to develop a single test based on circulating fetal trophoblastic cells (CFTC) analysis from maternal blood, searching for the familial mutation for a wide range of monogenic diseases.

Context:

Non Invasive Prenatal Diagnosis (NIPD), based on the analysis of circulating cell-free fetal DNA (cff-DNA) is very promising for early diagnosis of monogenic diseases. Such an approach is a safer alternative to invasive methods of prenatal testing (amniocentesis or choriocentesis) which entails a significant risk of miscarriage (0.5%-1%). However, technical issues related to the characteristics of cff-DNA remain, and NIPD techniques require long process development which are specific for a gene and/or a particular mutation.

Objectives:

The objective of this study is to complete our offer of NIPD by developing an approach on isolated Circulating Trophoblastic Fetal Cells (CFTC) adapted to the analysis of the genes and mutations involved in current prenatal testing requests.

Methodology :

The blood of pregnant women from 9 weeks of gestation for which a prenatal testing is requested will be collected.

CFTC isolation using Circulating Tumor Cells (CTCs) enrichment systems will be followed by whole genome amplification coupled to mini-exome sequencing and bioinformatic filtering that will be specific to the prenatal testing indication.

The study will be carried out in 2 stages:

* analytical validation of the method by studying the data quality of the sequencing of targeted genes that are frequently subject to prenatal testing (see prenatal testing diseases list from "ABM DPN 2014" in Appendix 2).
* clinical evaluation of the method by checking the concordance between the results obtained by our new approach versus those obtained by standard procedure (amniocentesis or choriocentesis) for 15 pregnant women.

Expected results and perspectives:

The purpose of this study is to establish the proof of concept of a semi-universal NIPD method based on a simple maternal blood test that could be applied on most rare diseases requiring prenatal testing.

This NIPD approach would reduce the number of invasive procedures and thus eliminate the risk of miscarriage due to amniocentesis or choriocentesis. It would also enable national access to this NIPD test for a wide range of rare diseases.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* pregnant woman between 9 and 34 weeks of gestation
* Couple undergoing prenatal diagnosis for a monogenic disease caused by point mutation(s)
* Written informed consent was obtained for the study
* Prenatal diagnosis has been programmed for the current pregnancy during which maternal blood is collected
* Couple molecular diagnosis results for a monogenic disease caused by point mutation(s) MUST BE AVAILABLE.

Exclusion criteria:

* Couple Genomic DNA are unavailable
* Subjects at risk of transmitting the family disease, but not wishing to know their molecular status
* Individuals under guardianship by court order
Safety of ENC-201-CED ENCRT

The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Candidates must satisfy site's eligibility for standard of care islet infusion.

Exclusion Criteria:

* Candidates are excluded based on the site's criteria for standard of care islet infusion.
Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)

To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less

Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (NCPAP) wean utilizing the method of sudden wean as compared to gradual wean. . Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age (GA) \<32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared.

Eligibility Criteria:
Inclusion Criteria:

All babies born with GA \<32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-

Exclusion Criteria:

Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort
Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).

* Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation
* Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion

The study may subsequently continue via a protocol amendment with dose escalation of AMX-500 combinations (Part 3) followed by combination therapy dose expansion (Part 4).

Duration of the study up to approximately 48 months.

Eligibility Criteria:
Inclusion Criteria:

* Has histological, pathological, and/or cytological confirmation of prostate adenocarcinoma OR metastatic disease typical of prostate cancer (ie, involving bone or pelvic lymph nodes or para-aortic lymph nodes)
* Has metastatic disease, defined by ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging - Has documented progressive mCRPC
* Have been treated with ≥ 1 prior taxane regimens (eg, docetaxel, cabazitaxel)
* Participants deemed unsuitable for standard of care
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Has a life expectancy more than 6 months

Exclusion Criteria:

* Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components
* Has acute or chronic infections
* Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to AMX 500, per the Investigator
* Has lesions in proximity of vital organs
* Has known active CNS metastases and/or carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Job Adaptation in Patients With Rheumatoid Arthritis

The specific aim of this study is to compare the rate of negative work role events in individuals with rheumatoid arthritis compared to healthy controls.

Rheumatoid arthritis can cause multiple socio-medical disabilities, with work disability among the most marked. While a major focus has been documenting the rates of job loss and returning patients to the workforce, there is little information about how to foster job retention in those still employed. The goals of this study are to document negative workplace events over 1 year in 122 employed patients with rheumatoid arthritis, and to compare these to 122 healthy controls, who are included to account for the effects of socioeconomic status on employment. Events will be recorded with the work domain of the Psychiatric Epidemiology Research Life Events Scale. Additional goals are to compared fatigue, physical activity, functional status and sleep disturbances as covariates.

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible if they are:

  * over age 18;
  * meet American Rheumatism Association criteria for rheumatoid arthritis; and
  * are employed for salary or monetary reimbursement.
* Controls are eligible if they are:

  * over age 18;
  * have no major comorbidity; and
  * are employed for salary or monetary reimbursement.

Exclusion Criteria:

* Patients and controls are excluded if they:

  * have cognitive deficits and cannot provide informed consent;
  * do not speak English or Spanish; or
  * their physicians do not grant permission to enroll them.
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk

Four retrospective studies were recently published on efficacy of aspirin in patients with surgically resected colon cancer. Two of these studies strongly suggested that aspirin used in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. The other two studies did not confirm the benefit of aspirin in this situation. These four retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as recommended in the conclusion of these studies and meta-analyses to perform a randomised prospective study to validate these data.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Colonic adenocarcinoma stage III
* Colonic adenocarcinoma stage II high risk MSS:

  * T4bN0 or T4aN0 tumour penetrating the surface of the visceral peritoneum
  * or less than 12 nodes evaluated;
  * or with at least two of the following criteria:lymphatic involvement, perineural invasion, venous invasion
  * or diagnosis of bowel obstruction or perforation; or poor differentiated tumour.
* PI3K mutation, exon 9 or 20 (tumour)
* Resection R0
* WHO performance status 0-2
* Chest and abdominal CT scan ≤ 8 weeks
* Life expectancy ≥ 3 years
* Written consent signed

Exclusion Criteria:

* Anticoagulant and/or Antiaggregating treatment including clopidogrel
* Regular aspirin use (\> 3 doses per week during more than 3 months the last year)
* Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer
* Severe renal or hepatic insufficiency
* Pregnancy or nursing ongoing
* Rectal cancer
* Hereditary forms (i.e. lynch syndrome patients)
* Follow-up of the patient not feasible
Impact of Glaucoma and Visual Field Loss on Life Space

Mobility refers to a person's purposeful movement through the environment from one place to another and can be conceptualized as a continuum from bed bound (immobility) on one extreme to making excursions to distant locations on the other extreme. Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy that can lead to gradual loss of vision in the peripheral field and central vision. Older adults with POAG have an increased risk for motor vehicle collisions and falls. Moreover, existing studies suggest that patients with POAG exhibit more postural sway while standing as measured by a balance platform and also tend to walk more slowly than those who are normally sighted and free of ocular disease. While these disturbances likely influence mobility, there has been little research directly assessing the impact of POAG on mobility. This study will assess the impact of POAG on life space (one aspect of mobility) and will determine whether difficulties with life space are associated with difficulties experienced under conditions of dim lighting.

Aim 1: To examine the extent of life space in older adults with POAG using the Life Space Questionnaire and to examine whether life space in persons with POAG is associated with the magnitude of visual field impairment.

Aim 2: To examine difficulties seeing under dim illumination and at night in older adults with POAG using the Low Luminance Questionnaire and to examine whether greater difficulty in seeing under dim illumination and at night is related to the magnitude of visual field loss.

Aim 3: To examine the relationship in older adults with POAG between visual problems seeing under dim illumination and at night (Low Luminance Questionnaire) and their life space (Life Space Questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary open-angle glaucoma
* Best-corrected visual acuity of 20/40 or better
* Spherical refraction within ± 5 Diopters
* Cylinder refraction within ± 3 Diopters

Exclusion Criteria:

* History of intra-ocular surgery other than uncomplicated cataract or glaucoma surgery
* Significant cognitive impairment
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan

The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria.
* Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL).
* Patients willing to provide written authorization to provide data for the study.

Exclusion Criteria:

* Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male Volunteers (Age: 19\~45years)
* 55\<Body Weight\<90, 18\<BMI\<27
* FPG: 70-125 mg/dL

Exclusion Criteria:

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Clinically significant Medical History
* Allergy or Drug Hypersensitivity
* AST(SGOT), ALT(SGPT) \> Upper Normal Range\*1.5, eGFR\<80 mL/min
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception
Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.

However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.

The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* inoperable hilar malignancy

Exclusion Criteria:

* age under 18 years
* uncontrolled coagulopathy
* inability to provide informed consent