cyrilzakka/clinical-trials huggingface dataset:
Extension Study of Gelesis100 on Body Weight

This study is designed to assess the effect of Gelesis100 on body weight after an additional exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least 3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.


Eligibility Criteria:
Inclusion Criteria:

1. Completion of the GLOW study with at least 3% weight loss
2. Informed Consent Form signed by the subjects at the end of the GLOW study

Exclusion Criteria:

1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
2. Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
3. Subjects considering smoking cessation during the study
4. Subjects anticipating surgical intervention during the study
5. Significant intolerance to the study product during the GLOW study
6. Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if HbA1c is \> 8.5% (\> 69 mmol/mol)
7. Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides from the Baseline Visit of the GLOW study in subjects with elevated lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)
8. Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine SBP is \> 160 mm Hg and/or supine DBP is \> 95 mm Hg, based on the mean of two consecutive readings
9. Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
10. Anticipated requirement for use of prohibited concomitant medications
Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer

As early complications of transplantation (acute rejection and infections) were better controlled and that the survival of kidney transplants has increased, chronic complications of immunosuppression became increasing challenges. The incidence of cancer is greatly increased in transplant and cancer is now the first cause of death. The iatrogenic immunosuppression plays a major role in the increased incidence of cancer. If it is accepted that the incidence of cancer is generally increased after transplantation, the increased risk is very different from a specific cancer to another. Furthermore the specific treatment of the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the context of transplantation is related to the possibility of modulation of immunosuppression. However, there is no immunological marker for predicting the effectiveness of a modification of the immunosuppression.

Several studies point to the important role of CD4 T cells into Th1 anti-tumor immunosurveillance group cancers. Identified "helper" degenerate peptides, called Universal Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP peptides bind most HLA-DR alleles most frequent of the population and have the particularity of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it possible to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of human cancers.

The main objective of this study is to determine whether, in renal transplant patients, the occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 80 years included
* Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study
* Join a French social security or receiving such a plan
* Group 1A: renal transplant patients reporting a first cancer (all types of cancer except skin inclued in group 2A or 2B)
* Group 1B: renal transplant patients without cancer (matched to patients in group 1A)
* 1C Group: Non transplant patients reporting a first cancer (patients matched to Group 1A for the type and stage of cancer and the status CMV / EBV)
* Group 2A: kidney transplant patients reporting a single squamous cell carcinoma
* Group 2B: kidney transplant patients with multiple recurrences of squamous cell carcinomas.
* Group 2C: renal transplant patients without cancer (matched to patients in group 2A and 2B)

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Topic unlikely to cooperate in the study and / or low early cooperation by the investigator
* Without health insurance Topic
* Pregnant woman
* Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study
* Active infection or not by HIV
Running Study for Runners With Chronic Knee Pain

The purpose of this study is to determine whether changing foot strike pattern from a rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is believed that switching foot strike pattern from a rearfoot strike to a forefoot strike pattern will reduce associated running-related patellofemoral knee pain.

Runners will come to the Gait Analysis Lab on north campus of the University of New Mexico, HSSB 168, for the first running trial. During this time you will fill out a health questionnaire, receive an assessment by a physical therapist, and be given a new pair of running shoes to use for the duration of the study.

Runners will be equipped with several reflective markers, which will be placed on your lower body. Runners will then complete several passes across a runway while we record your running with a motion analysis system. Runners will be equipped with a mouthpiece and nose clip. You will run for 10 minutes while we collect the gases you breathe.Twenty-four hours after you complete this running trial, you will come to our Exercise Physiology lab in Johnson Center, B143 to perform the training sessions. During this time you will run for about 10-30 minutes in front of a mirror and receive feedback from the research team. You will perform these training sessions eight times over two weeks. Twenty-four hours after your last training session, you will perform another follow-up running trial, which will be the same as the first trial. After completing the second running trial, you will be allowed to return to your normal running routine for about one month. After one month, you will return to the Gait Analysis lab to perform a final running trial, which will be the same as the first and second running trials.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of patellofemoral pain
2. No history of any cardiovascular issues.
3. Currently running as part of training program

Exclusion Criteria:

1. No patellofemoral pain present.
2. Not currently running as part of training program
3. Other lower extremity pain and/or injury that interferes with ability to run.
4. Pregnant
5. Not in the selected age ranges
6. Presence of cardiovascular or cardiopulmonary diseases
Spironolactone Therapy in Chronic Stable Right HF Trial

The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart function and remodeling in patients with chronic right heart failure.

This study is a phase 4, single center, randomized, double blind, placebo-controlled trial evaluating the safety, tolerability and mechanistic effects of spironolactone, an aldosterone antagonist, on neurohormonal activity and remodeling in patients with chronic right heart failure (RHF).

RHF is one of the most important predictors of prognosis in many cardiac disease states including pulmonary hypertension (PH), and left heart failure. Sympathetic nervous system activation plays an important role in the development and progression of heart failure. It remains to be determined whether there is a role for neurohormonal therapy in chronic right HF, but evidence points to the role of sympathetic nervous system stimulation and activation of the renin-angiotensin and aldosterone system as a contributor to progressive right heart failure.

The study will determine if treatment with spironolactone is associated with reduction in right ventricular wall stress. In addition, the study aims to evaluate the effects of spironolactone on cardiac sympathetic activity assessed by HED(11 C-hydroxy-ephedrine) retention on PET(positron emission tomography) imaging, and global autonomic function assessed by heart rate variability.

Approximately 30 patients with RHF will be randomized to receive either spironolactone daily or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Provide a personally signed and dated inform consent form.
* Male or female ≥ 18 years.
* Able to comply with all study procedures.
* History of right heart failure (RHF) secondary to either:

  i) WHO, group 1 pulmonary arterial hypertension PAH OR ii) WHO group II PH with normal LV systolic function OR iii) WHO group III or IV PH OR iv) primary RV cardiomyopathy.
* Current NYHA II-IV
* RV dysfunction as measured by 2D echocardiogram:

  i)defined as a tricuspid annular plane systolic excursion (TAPSE) \<16 mm ii) and /or a two dimensional fractional area change \<35% on screening echo plus
* NT-proBNP\>400 pg/ml
* Chronic use of diuretics
* Clinical stability: defined as no need for increased diuretics, hospitalization or emergency room visit 3 months prior to enrollment

Exclusion Criteria:

* Patients on chronic MRA therapy or other potassium sparing diuretics.
* Baseline serum potassium\>5 ummol/l.
* Estimated glomerular filtration rate \<30 ml/min.
* LV ejection fraction \<45%,
* Moderate or severe LV diastolic function,
* Moderate or severe aortic or valvular disease.
* Patients requiring augmentation of diuretics or otherwise not meeting definition for clinical stability.
* Severe Liver Failure (Child-Pugh Class C)
* Claustrophobia or inability lie still in a supine position
* Patients with contraindications to either PET or CMR imaging
* Pregnancy or lactation.
* Unable to provide consent and comply with follow up visits.
Assessing the Quality of Life in Adults With Spinal Deformity

Spinal deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools for this condition have been developed to investigate the extent of this impact, such as the SRS-22 questionnaire and ISYQOL questionnaire.

The latter was initially used for underage patients, but given that some of them continue their therapy and the monitoring beyond the age of 18, we have continued its use in these subjects as well. Given the clinical usefulness and given the lack of questionnaires developed in the Rasch environment for adults, we have extended the application of the ISYQOL questionnaire to the adult population. However, a comparison between the ISYQOL and SRS-22 in adults has not yet been made.

The objective of this study is to verify the validity of ISYQOL and to compare the properties of ISYQOL with those of the SRS-22 questionnaire in adults with spinal deformity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve

Exclusion Criteria:

* Previous spinal surgery
* Previous and relevant illnesses, surgery or trauma
Chronic Rhinosinusitis: Biochemical Markers and Biofilm

The investigators will conduct a descriptive, prospective, three-armed study concerning the pathophysiology of chronic rhinosinusitis.

In one part of the study the investigators want to investigate the presence of biofilm in patients with chronic rhinosinusitis both with and without nasal polyps compared with a control group of subjects without chronic rhinosinusitis. The investigators will also compare quality of life in the three groups and correlate disease severity in biofilm patients versus patients where biofilm was not present.

The hypothesis here is that biofilm patients suffers a more severe disease.

In the other arm of the study the investigators will compare the presence of different biochemical compounds in the three study groups. The investigators specifically want to investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The investigators may also add other compounds to our test-battery if interesting candidates surface in the literature during the inclusion period.

The purpose of this part of the study is to investigate candidates for the development of nasal polyposis.

The investigators plan to include 100 patients suffering from chronic rhinosinusitis with nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30 control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis based on EPOS3
* Submitted to surgery
* Using nasal corticosteroids

Exclusion Criteria:

* Age below 18 years
* Using antibiotics at the time of surgery
* Using systemic corticosteroids
* Sempers triad
Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance

Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR).


Eligibility Criteria:
Inclusion Criteria:

* HIV-1-infected subjects with age ≥18 years old.
* Desire of the patient to simplify their ART-regimen.
* Having plasma HIV-1 RNA \< 50 copies/mL during at least the previous 24 weeks.
* Currently receiving an ETR-containing regimen (unchanged during the previous 24 weeks).
* Documented pooled/historical genotype or GRT in pro-viral DNA must show the presence of 103N and/or 181C and/or 190A and/or 100I and/or 138K/A.

Exclusion Criteria:

* Documented pooled/historical genotype or GRT in pro-viral DNA of any DOR-DRM (Mutations V106A, Y188L, and M230L, and combinations of V106A and L234I; V106A and F227L and L234I; and V106A and 190A and F227L).
* Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods, for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
* Active tuberculosis infection.
* Any clinical condition or therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements.
Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Severe and Moderate Traumatic Brain Injury

Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.

The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.

Design: Prospective, monocentric, pilot study. The study will be proposed to all patients admitted to the neurosurgical intensive care unit (ICU) at Pitié-Salpêtrière hospital, following a traumatic brain injury (TBI), over a period of 1 year. Around 100 patients will be included.

Day 1 : In the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. The known prognostic variables as the IMPACT score in the first 24 hours will be collected.

Day 7 : The same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit.

At 6 months : After 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the Glasgow Outcome Scale (GOS). This interview will be blinded to the clinician's prediction and the IMPACT score. For patients identified as GOS 3 or 4, a second GOS telephone interview will be carry out in the following days (\<7 days), by a committee of adjudication composed of 2 examiners.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older,
* Hospitalized in the neurosurgical ICU department of the Pitié-Salpêtrière hospital following a head trauma,
* Presenting a Glasgow Coma Scale (GCS) ≤ 12 in the first 24 hours following the head trauma,
* Relatives informed of the research and not having objected to the patient's participation in the study.

Exclusion Criteria:

* Opposition of the patient,
* Patient under the protection of justice,
* Pregnant woman,
* Modified scale of Rankin\> 1 before the traumatic brain injury.
* Patient unable to speak French.
Tranexamic Acid and Blood Clots in Knee Surgery

This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.

This study is anticipated to consist of 30 participants over 18 years of age scheduled for total knee arthroplasty at Sandoval Regional Medical Center with administered intraoperative tranexamic acid, who do not meet the exclusion criteria. The patients will be examined on postoperative day 1. Lower-extremity ultrasound will be used to screen for deep vein thrombosis (DVT). Incidence data for DVT will then be compared with the historical incidence rate at our institution for total knee arthroplasty without the use of tranexamic acid, which is approximately 12%. Patients found on screening to have deep vein thrombosis will be referred for appropriate care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for total knee arthroplasty at Sandoval Regional Medical Center with an intraoperative dose of tranexamic acid

Exclusion Criteria:

* Previous deep vein thrombosis or pulmonary embolism episode
* Known coronary artery disease or peripheral vascular disease
* Previously diagnosed hypercoagulable states (e.g. Leiden factor V, antiphospholipid antibody, protein C or S deficiency)
* Pregnancy
* Creatinine clearance less than 30 ml/min
* Non-fluency in English
Eosinophil and Anticoagulation in COVID-19 Patients

Despite prophylactic anticoagulant treatments, thrombotic complications may develop in patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years, who were diagnosed with COVID-19 and were administered LMWH,
* agreed to participate in the study were included

Exclusion Criteria:

* Patients with previous coagulopathy,
* continuous indication of anticoagulant therapy (atrial fibrillation (AF), valve disease),
* glomerular filtration rate (GFR) \<30 mL/min or undergoing dialysis, or with known liver dysfunction were excluded from the study.
Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS

This study is designed to look at the relationship between brain glucose utilization, neurotransmission (e.g., glutamate, also known as the main excitatory amino-acid neurotransmitter in the brain), and synaptic density. This relationship will be explored in the brain's prefrontal cortex, an area important in decision-making and impulsivity.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-55 years;
2. Voluntary, written, informed consent;
3. Physically healthy by medical history, physical, neurological, ECG and laboratory examinations;
4. DSM-IV criteria for Cocaine Dependence (304.20) (Note: subjects will also meet DSM-5 criteria for Cocaine Use Disorder);
5. Documented evidence (by urine toxicology) of abstinence from cocaine (2 weeks for scan 1, and 2 and 4 weeks for scans 2 and 3, respectively)
6. Full scale and verbal IQs \> 80;
7. For females, a negative serum pregnancy test (β-HCG) at screening and negative urine pregnancy test on PET scan day prior to imaging.

Exclusion Criteria:

1. A history of other substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine;
2. A primary DSM-IV Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-IV (SCID);
3. A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness;
4. Current use of psychotropic and/or potentially psychoactive prescription medications;
5. Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.);
6. For females, laboratory (β-HCG) evidence of pregnancy, physical evidence of pregnancy;
7. For subjects interested in pharmacotherapy component, history of allergies to NAC and current elevation on liver function tests above twice the normal limit;
8. Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year;
9. Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans;
10. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto);
11. Blood donation within eight weeks of the start of the study.