cyrilzakka/clinical-trials huggingface dataset:
Frailty Syndrome of Post-cancer Treatment Eldery Patients

Decrease the prevalence of frailty syndrome in individuals with complete response of cancer.


Eligibility Criteria:
Inclusion Criteria:

* in complete remission from cancer (all type of cancer)
* have a frailty syndrome (positive GFST score)
* ability to provide signed informed consent
* be affiliated with social security or beneficiary of such a scheme

Exclusion Criteria:

* patient with active cancer or any other pathology affecting the prognosis at 5 years
* currently participating or having participated in the month preceding inclusion in another interventional clinical research that may impact the study. This impact is left to the investigator discretion
* subjects referred to articles L1121-5 to L1121-8 of CSP (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to legal protection measure)
Struvite Stones Antibiotic Study

The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).

Struvite stones or infection stones are a subset of kidney stones that are related to bacterial infection. They only make up 15% of all kidney stones, but account for a much higher percentage of mortality (up to 67%) compared to other stones-due to the infectious component. Treatment is to ensure 100% eradication of the stone with surgery followed by antibiotics to eliminate the infection. Failure to eliminate the bacteria results in the stone growing back quickly. It is unknown how long antibiotics should be administered immediately after surgery-some urologists give 2-4 weeks while others give 2-3 months. We seek to randomize patients to receive 2 weeks of antibiotics or 3 months of antibiotics after surgery to remove all the kidney stones. We will see patients at 3, 6, and 12 months with x-rays and to test their urine for bacterial infections. This is a multi-centre study with participating 12 sites across North America.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female.
2. No age restriction.
3. Diagnosed with an infection related stone.
4. Medically fit for definitive surgical management of stone.
5. Life expectancy greater than one year.
6. Stone free after definitive surgical therapy defined as fragments less than 3mm.

Exclusion Criteria:

1. Patients with medical comorbidities preventing them from definitive surgical therapy.
2. Patients with persistent stone burden following definitive surgical therapy.
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity

Most research to date on bariatric surgery outcomes has been about metabolic syndrome, a disorder very effectively treated by bariatric surgery. However, obesity is also associated with many other problems that have received much less attention. Amongst the most troubling of these for patients is dyspnea. Dyspnea results in substantial patient distress that can greatly reduce health-related quality of life. Little is known about the relationship between dyspnea, weight loss, and bariatric surgery. Dyspnea is a complex symptom that may lead to adaptive responses, such as the need to rest as a consequence of even minimal activity or seeking medical attention. The main outcome of the study will be measured using a new state-of-the-science validated HRQOL measure, the Patient Reported Outcome Measuring Information System for Heart Failure (PROMIS+HF 27).

The main purpose of this prospective matched cohort study is to determine the feasibility for a future, novel large-scale study, clinical trial that will aim to determine how common dyspnea is in obese patients, how much dyspnea affects their quality-of-life, and how these parameters are affected by medically or surgically induced weight loss. Our basic assumption is that dyspnea is more common than is commonly believed in obese patients and that it profoundly affects quality of life. Our main hypothesis is that weight loss improves dyspnea and HRQOL and that bariatric surgery induced weight loss is more effective than medical weight loss at improving dyspnea-related quality-of-life.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. All patients undergoing gastric sleeve resection for serious obesity at the Ronald Reagan medical center will be considered for enrollment in the experimental group.
3. English/Spanish speakers.
4. The patients included will be with preserved cognition and a capacity to understand questionnaires.
5. Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Serious cardiovascular disease, previous gastrointestinal surgery, psychological concerns (mental disorders and dementia), recently hospitalized, pulmonary diseases, renal failure, or history of malignancy.
2. Undergoing procedures other than gastric sleeve resection or are having these operations after they have had other bariatric procedures.
3. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

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Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg

Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry.

Improving quality of life observed in the visual analogue scale (VAS).


Eligibility Criteria:
Inclusion Criteria:

* subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
* 9-18 years
* signed Infromed Conset

Exclusion Criteria:

* subjects who have previously used a food suplemts Joalis
* subjects with known intolerance or hypersensitivity to the components of food supplements
* subjects with alcohol abuse or drugs at the time of recruitment into the study
* subjects enrolled in another clinical trial in the last 1 month before enrollment in this study
* subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects
* pregnant girls, lactating girls and girls of childbearing age without adequate contraception
Practicing Self-Control Lowers the Risk of Smoking Lapse

The proposed study will investigate the role of self-control in smoking cessation and whether interventions that improve self-control can help reduce the risk of lapsing among smokers who wish to quit. Our model predicts that the regular practice of self-control should lead to a building of strength and a general improvement in self-control performance. Hence, smokers who practice self-control prior to quitting should be more likely to succeed in their cessation attempt than smokers who do not practice self-control


Eligibility Criteria:
Inclusion Criteria:

* smoked at least 10 cigarettes per day for at least two years
* currently smoking

Exclusion Criteria:

* have at least an 8th grade education level
* have a working touch-tone phone
* report low motivation and efficacy to quit
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia

A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:

Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia

OBJECTIVE :

To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.

Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.

Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.

OBJECTIVE :

To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.

the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.

the investigators included in the study all parturients:

* Aged between 18-45 years
* ASA 2
* Between 37 and 41 weeks of gestation
* scheduled for elective caesarean delivery under spinal anaesthesia
* To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification.

The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.

were assigned to one of the two parallel groups to receive either :

* Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron)
* Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-45 years
* ASA 2
* Between 37 and 41 weeks of gestation
* scheduled for elective caesarean delivery under spinal anaesthesia
* To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification

Exclusion Criteria:

* All patients who required :
* more than two attempts for spinal anaesthesia
* conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level \<T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).

As well as patients who have subsequently withdrawn their consent for participating to our study.
Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

This is a single center project assessing the requirements for three essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 3 amino acids. The investigators will first determine the requirement for Phenylalanine, then Methionine and finally Histidine. The investigators will recruit 18 - 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (phenylalanine, methionine, and histidine) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid.

It is hypothesized that the requirement for phenylalanine, methionine and histidine will be at least 50% lower than what is currently available in commercial amino acids solutions used for TPN feeding of neonates.

The study is based on the carbon oxidation protocol. Each baby will receive one or two levels of either phenylalanine or methionine or histidine. Each level will be assessed over a two-day period.

On day 1: each baby will receive a standard pediatric amino acid solution, Primene used in the NICU and L-\[1-13C\]Na Bicarbonate will be given to measure carbon dioxide production. On day 2: he/she will receive the appropriate TPN Test Solution made up of the appropriate Bulk Amino Acid solution (for Phenylalanine/ Methionine/ Histidine Studies) with a different amount of the amino acid being investigated. To see how these amino acids are used in the body the investigators will add a small amount (calculated based on the body weight of the baby) of the amino acid L-\[1-13C\]phenylalanine to the amino acid solution. Breath and urine will be collected from the baby to study the oxidation of the L -\[1-13C\]phenylalanine. The investigators will take 2 x 0.75 ml blood to measure plasma amino acid concentration. The investigators will aim to coordinate blood taking with regular blood work done for clinical monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein).
2. TPN providing adequate calories and protein as determined by attending physician and dietitian.
3. Babies born ≥ 28 weeks gestation,
4. ≤ 28 days chronological age at the time of the study,
5. Birth weight and length appropriate for gestational age,
6. Medically stable as determined by normal blood results and lack of a fever or infection,
7. At least 3 days after surgery, if the baby had a surgery.

Exclusion Criteria:

1. Babies on mechanical ventilation, on low flow oxygen and CPAP.
2. Small for gestational age,
3. On medications known to affect protein and amino acid metabolism,
4. Documented infection, fever
5. Unstable medical condition
6. Receiving enteral feeding providing \> 10% of protein intake.
Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale

This study evaluated the inter- and intra-rater reliability of the GEBA Scale with photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment (intervention) associated with this study.


Eligibility Criteria:
Inclusion Criteria:

* Willing to remove makeup and jewelry at each visit
* Willing to have photographs taken of the facial area

Exclusion Criteria:

* Permanent eyebrow makeup (i.e., tattooing) or eyebrow implants of any kind
* Eyebrow extension application within 3 months of study entry
* Eyebrow tint or dye application within 2 months of study entry
* Eyebrow grooming (i.e., tweezing, waxing, or threading) between visits that is not part of the current routine
An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease

The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.

Type 1 Gaucher disease, the most common form,accounts for more than 90% of all cases and does not involve the CNS. Typical manifestations of type 1 Gaucher disease include hepatomegaly, splenomegaly, thrombocytopenia, bleeding tendencies, anemia, hypermetabolism, skeletal pathology, growth retardation, pulmonary disease, and decreased quality of life. Gene-Activated® human glucocerebrosidase (GA-GCB,velaglucerase alfa) is produced in a continuous human cell line using proprietary gene-activation technology and has an identical amino acid sequence to the naturally occurring human enzyme. GA-GCB contains terminal mannose residues that target the enzyme to the macrophages-the primary target cells in Gaucher disease. This study was designed to determine the long-term safety of GA-GCB in men, women, and children with Type 1 Gaucher disease.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has completed study TKT032 or TKT034, or study HGT-GCB-039.
2. Female patients of child-bearing potential must agree to use a medically acceptable method of contraception at all times during the study and must have negative results to a pregnancy test performed at the time of enrollment and as required throughout their participation in the study.
3. Male patients must agree to use a medically acceptable method of contraception at all times during the study and report a partner's pregnancy to the investigator.
4. The patient, the patient's parent(s) or legal guardian(s) has provided written informed consent that has been approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
5. The patient must be sufficiently cooperative to participate in this clinical study as judged by the Investigator

Exclusion Criteria:

1. The patient has received treatment with any non-Gaucher disease-related investigational drug or device within the 30 days prior to study entry; such use during the study is not permitted.
2. The patient is pregnant or lactating.
3. The patient, patient's parent(s), or patient's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study.
4. The patient has a significant comorbidity(ies) that might affect study data or confound the study results (e.g., malignancies, primary biliary cirrhosis, autoimmune liver disease, etc.).
5. The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult, has an uncooperative attitude, is unable to return for safety evaluations, or is otherwise unlikely to complete the study, as determined by the Investigator
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.


Eligibility Criteria:
Main Inclusion Criteria:

1. Signed written informed consent before any trial-related processes;
2. Age ≥ 18 years and \<75 years male or females;
3. Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
5. EGFR-TKI resistance, confirmed by RECIST 1.1
6. The investigator confirms at least one measurable lesion according to RECIST 1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed; The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

Exclusion criteria:

1. Squamous cell \> 10%. If small cell types are present, the subject is not eligible for inclusion.;
2. Has previously received systemic anti-tumor treatment other than EGFR-TKI for or advanced non-squamous NSCLC (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors);
3. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4, OX-40, CD137);
4. Has received EGFR-TKI treatment within 2 weeks;
5. Diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.
6. History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
7. Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.

   Hemoptysis within 3 months,
8. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;
Tissue-specific Effects of Insufficient Sleep

This study plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.

Participants will stay in the hospital for 6 days and will not be able to leave. Sleep habits will be measured for 7 days before the study. A research diet that is designed to maintain weight will be provided for 3 days before the study and during the study. Multiple tests will be performed, including metabolic testing and muscle and fat biopsies, both when participants first arrive and have had normal sleep and again after 4 nights of only 5 hours time in bed. The visit takes place at the Clinical Translational Research Center (CTRC) at the University of Colorado Denver, Anschutz Medical campus. It will take approximately 2 weeks to complete this study.

Eligibility Criteria:
Inclusion criteria:

1. Healthy, lean participants.
2. No regular physical activity (\<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
3. Habitual sleep duration between 7-9.25h. Subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission.
4. Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.

Exclusion Criteria:

1. Current or history of any clinically significant medical, psychiatric, or sleep disorder.
2. Use or history of any drugs, medications, supplements, caffeine, and alcohol.
3. Current or history of shiftwork in six months prior to laboratory study.
4. Travel more than one time zone in three weeks prior to laboratory study.
5. Blood donation in the 30 days prior to inpatient study.
Pregnancy, Mindfulness, and Massage

This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.

Massage therapy may be a viable approach to decrease stress during pregnancy that may in turn reduce tobacco consumption. Massage therapy may not be sufficient as a stand-alone approach, and may be better suited partnered with a cessation approach that targets another mechanism of addiction, craving. Therefore, participants (N=60) will be enrolled in the Craving to Quit® tobacco cessation program, designed by researchers at Yale, which employs a mindfulness-based approach to train participants to recognize and bring cravings into their conscious awareness. Each mother will be randomly assigned to a bi-weekly massage intervention (n=30) or control (n=30) group. Participants in the intervention group will receive two prenatal massages a week for a three-week period.

Eligibility Criteria:
Inclusion Criteria:

* currently pregnant in third trimester
* singleton pregnancy
* aged 18 years or older
* women smoked before their pregnancy
* women who currently smoke at least 5 cigarettes per day at enrollment
* women need access to a smartphone
* women expressing an interest in learning skills to help decrease tobacco-smoking

Exclusion Criteria:

* incapable of giving informed consent
* insufficient English fluency
* participating in other smoking cessation programs
* evidencing severe psychiatric symptoms
Clonal Architecture of ASXL1-mutated Myelofibrosis

Prospective study to decipher the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis and its impact on prognosis

The clonal architecture of myelofibrosis patients is still little described. Inconsistent results in terms of the prognostic value of some mutations are observed in the literature, in particular concerning ASXL1 mutations. We assume that a better understanding of the clonal architecture of ASXL1-mutated myelofibrosis could help refining the prognostic impact of ASXL1 mutations.

This study aims to evaluate a multicenter cohort of 50 patients. Blood of patients will be collected within 18 months of diagnosis. After 4 years of follow-up of the patient as part of his usual care, data on survival and leukemic transformation will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years),
* Affiliated to the national social security system,
* ASXL1 mutated primary or secondary myelofibrosis,
* Signed the consent to participate in the study,
* Included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).

Exclusion Criteria:

* Patient with another active hematological disease or cancer at the time of diagnosis,
* Person subject to legal protection scheme or incapable of giving consent.