cyrilzakka/clinical-trials huggingface dataset:
Serotonin Control of Impulsivity in Tourette Disorder

Tourette disorder (TD) is a neurodevelopmental disorder characterized by motor and vocal tics. It is often associated with multiple psychiatric comorbidities involving a high degree of impulsivity such as obsessive-compulsive disorders (OCD), attention-deficit hyperactivity disorders (ADHD), and intermittent explosive disorders (IED). Although a substantial body of clinical studies have emphasized the role of the dopamine system in motor symptoms, little is known about how the serotonergic (5-HT) system modulate both cognitive and affective abilities in TD. Several lines of evidence suggest that different 5-HT receptor subtypes may constitute a crucial factor in the development and maintenance of different symptoms. Because abnormal 5-HT2A receptor bindings have been reported in patients with TD and aripiprazole (drug of first choice) is a 5-HT2A antagonist, we hypothesize that 5-HT2A receptors may play an important role in regulating psychiatric symptoms in TD such as those characterized by impulsive behaviors. To investigate the involvement of 5-HT2A receptors in TD, we propose to perform a multimodal imaging study with 20 adult patients (ON and OFF treatment). Neuroimaging data will be collected with a hybrid system that simultaneously combines the positron emission tomography (PET) and the functional magnetic resonance imaging (fMRI). A highly selective PET radiotracer (\[18F\]-altanserin) will map 5-HT2A receptor bindings in the whole brain, while fMRI will provide detail information regarding the altered brain activities.


Eligibility Criteria:
* Inclusion Criteria \* :

  * Male or Female
  * Diagnosed with a Tourette Disorder following the DSM-5
  * Age between 18-65 years
  * Member of a social security scheme in France
  * Freely-given informed consent to participate to this study (written form)
  * With a current treatment by aripiprazole already scheduled
  * With Tics compatible with TEP/fMRI exams
  * Having (for women only) effective contraception throughout participation in the study.

Exclusion Criteria \* :

* Male or Female
* A serious not controlled psychiatric comorbidity
* A serious, evolving or debilitating pathology with a potential influence on the study
* Drug-taking with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)
* Contraindication for fMRI and PET (e.g., pacemaker, ferromagnetic implant, claustrophobia)
* Women breastfeeding
* Protected or restricted person (administratively or in judicial terms)
* Participants to another study with radiations or radiotracers since less of one year, participants to a concomitant study
* Do not speak french
Use of TpCO2 (Transcutaneous CO2 Measurement) as PaCO2 Predictor During NIV in Case of Acute Hypercapnic Respiratory Failure

In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments.


Eligibility Criteria:
Inclusion Criteria:

* ICU patient equipped with an arterial line
* NIV treatment prescribed by the clinician in charge
* Hypercapnia defined by PaCO2\> 42mmHg

Exclusion Criteria:

* Severe hemodynamic instability
* Severe psychiatric disorders
* Denied consent
* Age \< 18 years
Hexoskin Medical System - ECG Performance Testing

The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

The main questions it aims to answer are:

1. Whether the HMS ECG recordings can be used to accurately detect cardiac beats when compared with the Holter monitor
2. Whether there are good agreements between the HMS and Holter monitor in ECG characteristics
3. Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm disturbance when compared with the Holter monitor
4. What is the accuracy of using HMS ECG recordings to detect cardiac beats
5. What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm disturbance

Participants will wear the HMS and the Holter monitor at the same time to record ECG signals. Researchers will evaluate the ECG recordings acquired from both devices and assess the above questions.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 21 years or older.
* Participants must be suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Exclusion Criteria:

* Body circumference that is not covered by the HMS Shirt sizing chart
* Presence of pacemaker or Implantable Cardioverter-Defibrillator (ICD) devices
* Known allergic reactions to silver or polyamide/polyester/elastane
* Known allergic reactions to ECG gel electrodes
* Documented medical condition or illness requiring intensive medical treatment or care
A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System

retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System


Eligibility Criteria:
Inclusion Criteria:

* women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

Exclusion Criteria:

* none
Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy

The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.

Paclitaxel is an active antitumor agent that has demonstrated a broad range of activity in preclinical and clinical studies. The optimal dose and schedule has not yet been determined in either adults or children. The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy. In addition, the pharmacokinetics of paclitaxel given in this way will be studied and both model-dependent and model-independent parameters will be determined.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed cancer (including leukemia) that is: Refractory to standard therapy (objective disease progression required) OR For which no standard therapy exists and patient is ineligible for potentially curative surgery.

PRIOR/CONCURRENT THERAPY:

Recovery from the toxic effects of prior therapy required.

Biologic Therapy: Not specified.

Chemotherapy: No prior taxanes. At least 3 weeks since myelosuppressive therapy (6 weeks since nitrosourea).

Endocrine Therapy: Not specified.

Radiotherapy: Prior extensive craniospinal or pelvic irradiation allowed.

Surgery: Ineligible for potential curative surgery.

Other: Prior bone marrow transplant allowed.

PATIENT CHARACTERISTICS:

Age: Over 1 to 21;

Performance status: ECOG 0-2;

Life expectancy: At least 8 weeks.

Hematopoietic: (except with leukemia, bone marrow involvement, history of bone marrow transplantation, or extensive prior radiotherapy).

Absolute granulocyte count at least 1,500/mm(3);

Platelet count at least 100,000/mm(3);

Hemoglobin at least 8.0 g/dL.

Hepatic:

Bilirubin no greater than 1.5 mg/dL;

AST less than 2 times normal.

Renal:

Creatinine no greater than 1.5 mg/dL OR;

Creatinine clearance at least 60 mL/min per square meter.

OTHER:

No concurrent anticonvulsant therapy.

No grade 2 or worse neuropathy.

No significant systemic illness (e.g., infection) that could compromise drug excretion or confuse assessment of toxicity.

Not pregnant or nursing.
Effect of Smoking on Periapical Healing After NSRCT

Goal of this prospective observational study is determine effect of smoking on periapical healing after NSRCT. Population includes systemically healthy smokers with radiographic evidence of apical periodontitis will be recruited and compared with same type of population of non smokers after non surgical root canal treatment intervention in both the groups. Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period

The clinical and radiological success of primary non-surgical endodontic treatment in smoker \& nonsmoker patients will be compared between both groups and smoking cessation effect on periapical healing will be assessed.

The correlation between the self-reported smoking status \& smoking status by urine analysis

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy patients of age 18 years and above, known current smoker patient , a non-smoker or former smoker patient ,should have at least minimum 8 teeth in oral cavity, requiring periapical radiographs of teeth with periapical pathosis

Exclusion Criteria:

* Pregnant or patient having systemic disorders, those patients who are non-compliant and not maintaining oral hygiene, teeth requiring retreatment and having procedural errors. Teeth that are not suitable for rubber dam isolation, teeth that have advanced periodontal disease and having endo-perio lesions and, patients requiring endocarditis prophylaxis
CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI

The studys evaluates the effect of prehospital administration of crushed tablets of Prasugrel loading dose (in addition to ASA and standard care) versus uncrushed tablets of Prasugrel loading dose on efficacy and safety as well as pharmacodynamics as measured by platelet reactivity using VerifyNow.

The study is a two-centre, randomized, 1:1 trial comparing prehospital prasugrel initiation therapy between crushed vs. uncrushed prasugrel tablets on efficacy and safety as well as pharmacodynamics in STEMI patients.

Patients with STEMI planned for primary PCI will be screened and, if inclusion criteria are met, included at first medical contact (paramedics). After enrolment, patients will be randomly assigned (1:1) to receive 60mg prasugrel loading dose by ingesting integral or crushed tablets.

The follow-up duration is 12 months, i.e. clinical outcomes will be analysed in-hospital, at 30 days, and 12 months

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients with STEMI planned for primary PCI:

* Deferred written informed consent within 4 hours after prasugrel loading dose
* Adult men and women aged at least 18 years
* Symptoms of acute MI of more than 30 min but less than 6 hours
* New persistent ST-segment elevation ≥ 1 mm in two or more contiguous ECG leads

Exclusion Criteria:

* Contraindication to prasugrel (e.g., hypersensitivity, active bleeding, history of previous intracranial bleed, history of any CVA including TIA, moderate to severe hepatic impairment, GI bleed within the past 6 months, major surgery within past 4 weeks)
* Patient who has received loading dose of clopidogrel or ticagrelor for the index event or are on chronic treatment of ticagrelor, or prasugrel. However, patients on maintenance dose clopidogrel for at least 7 days are included in the study (see appendix A).
* Oral anticoagulation therapy that cannot be stopped (i.e. patients requiring chronic therapy)
* Planned fibrinolytic treatment
* Patient requiring dialysis
* Known, clinically important thrombocytopenia
* Known clinically important anaemia
* Known pregnancy or lactation
* Need for a concomitant systemic therapy with strong inhibitors or strong inducers of CYP3A
* Condition which may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock with severe hemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up)
* Patient unable to swallow oral medication (i.e. intubated patients)
* Patient who have not received prasugrel loading dose in the ambulance
* Patient who vomited after randomization / receiving the loading dose prasugrel
Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy

This study aimed to compare the efficacy of intravenous ibuprofen with peri-prostatic nerve block in pain control during prostate biopsy and to investigate factors influencing pain scores.

This study aimed to compare the efficacy of intravenous (IV) ibuprofen with periprostatic nerve block (PPNB) in controlling pain during prostate biopsy, a common procedure used to diagnose prostate cancer. The study also aimed to investigate factors influencing pain perception during the procedure, such as prostate-specific antigen (PSA) levels, prostate volume, and comorbidities.

Eligibility Criteria:
Inclusion Criteria:

Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels \> 4 ng/mL.

Exclusion Criteria:

Renal failure. Liver failure. Neurological disorders (e.g., dementia, Alzheimer's disease, epilepsy, paraplegia).

Rectal disorders. Previous negative prostate biopsy. Chronic anticoagulant therapy or bleeding diathesis. Severe comorbidities. Psychiatric conditions interfering with consent or compliance.
Effects of Watermelon Consumption on Satiety and Digestive Health

The objective of the proposed research is to determine the effects of watermelon (fruit and rind blenderized) on satiety, metabolic markers, bowel habits, microbiome and weight management in children and adults


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy subjects

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to watermelon
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.

Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).

In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been possible to discriminate more hypoxic tumours from less hypoxic tumours.

A hypoxia gene profile has shown to discriminate between responders and non-responders to nimorazole.

In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/- nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.

Hypoxic modification of radiotherapy with nimorazole has in the DAHANCA 5 trial been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).

Previously, it has not been possible to discriminate more hypoxic tumours from less hypoxic tumours. Thus, nimorazole has been added the radiotherapy of most HNSCC.

Recently, a hypoxia gene profile has been developed, that discriminate between more and less hypoxic tumours. The basis of the discrimination is the cumulated expression of 15 hypoxia responsive genes, quantified from the tumour biopsy.

The profile has been validated on the independent DAHANCA 5 cohort. There was a significant effect of adding nimorazole to the radiotherapy of more hypoxic tumours as estimated with the gene profile, whereas there was no effect of adding nimorazole to the less hypoxic tumours. In a test for interaction, there was a significantly different response to nimorazole in the more hypoxic tumours compared to the less hypoxic tumours.

In the Dahanca 30 trial it is aimed to verify, that there is no benefit of supplying the radiotherapy of less hypoxic HNSCC with nimorazole. Thus, to explore whether it is possible to avoid the sideeffects of nimorazole without risk for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck squamous cell carcinoma with indication for hypoxic modification with nimorazole in accordance to the Danish Head and Neck Cancer guidelines (DAHANCA guidelines).
* Informed consent

Exclusion Criteria:

* Previous or present malignant disease conflicting with the radiotherapy treatment or evaluation of the treatment.
* Participation in a conflicting protocol.
* Initiation of radiotherapy more than 3 weeks after inclusion
Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Dental membrane used in dental surgery and to identify emerging risks in comparison to clinical data related to other treatment modalities.

The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 50 patients followed for 24 months. The study will be conducted in France in 4 investigational centres.

The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Dental membrane used in dental surgery.

All evaluations will be performed and products used according to the usual practice and the device IFU. CELLIS Dental will be used in accordance with its approved labelling.

The study will be conducted in France in 4 investigational centres including 50 patients scheduled for dental regeneration of soft tissue defects and development of soft tissues around teeth or implants.

Each patient will participate in one assessment period including a preoperative visit followed by the surgical procedure.

Patients will return for ambulatory visits on day 15 (+/- 5 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.

CELLIS Dental will be implanted following standard techniques according to indications:

* Treatment of recession defects (gingival recession),
* Soft tissue augmentation around teeth and implants,
* Soft tissue grafting in combination with GBR/GTR,
* Covering/sealing of extraction sockets.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥18 years,
* Patient with an indication of keratinized soft tissue regeneration in the buccal cavity and/or keratinized soft tissue development around teeth or implants,
* Patient being informed of his participation to the study and of the follow-up visits, and having given his written informed consent,
* Patient being informed of the porcine origin of the device in advance of the procedure.

Exclusion Criteria:

* Patient with known hypersensitivity to porcine materials,
* Patient with acute or chronic infection or inflammation of the buccal cavity,
* Patient with a general illness contra-indicated for implantology, periodontology, stomatology, cranio-maxillo-facial surgery,
* Patient who is pregnant,
* Patient who is incapacitated including protected and deprived of liberty person,
* Patient having refused to participate in the study,
* Patient refusing to return for the follow-up visits.
A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension

The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures.
* At least 18 years of age.
* Willing and able to comply with all study-related procedures.
* History of documented essential hypertension (BP greater than or equal to 140 mm Hg systolic and/or 90 mm Hg diastolic measured on 2 separate occasions).
* Have poorly controlled hypertension despite use of at least two conventional antihypertensive agents with different mechanisms of action taken concurrently and consistently for at least 3 months before randomization. (Note: Antihypertensive agents may be individual or combined into a single medication.)
* During the two-week screening period, mean SBP and mean DBP fall within the following ranges:
* Mean SBP between 135 and 160 mm Hg
* Mean DBP between 85 and 110 mm Hg
* Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during this study.

Individuals in the diabetic cohort must meet this additional criterion:

* Documented history of type 2 diabetes that has been treated using the same therapy for at least 3 months.

Exclusion Criteria:

* Previous treatment with any formulation of BH4.
* Known allergy or hypersensitivity to any excipient of 6R-BH4.
* Known secondary cause for hypertension.
* Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, history of syncope or vertigo, severe gastrointestinal reflux disease (GERD), symptomatic coronary or peripheral vascular disease, arrhythmia, organ transplant, organ failure, or type 1 diabetes mellitus.
* Any sever co-morbid condition that would limit life expectancy to less than 6 months.
* Serum creatinine \>2.0mg/dL or hepatic enzyme levels more than 2 times the upper limit of normal.
* Requirement for concomitant treatment with any drug known to inhibit folate metabolism (e.g., methotrexate).
* Concomitant treatment with levodopa.
* Concomitant treatment with any phosphodiesterase (PDE) 5 inhibitor (e.g., Viagra(R), Cialis(R), or Levitra(R), or Revatio (TM) or any PDE 3 inhibitor (e.g., cilostazol, milrinone, or vesnarinone).)
* Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
* Pregnant or breastfeeding at screening or planning to become pregnant (subject or partner) at any time during study.