cyrilzakka/clinical-trials huggingface dataset:
Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles (LUTEAL Trial)

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response.

Two arms is established, the study group that will start ovarian stimulation in the luteal phase and the control group that will start ovarian stimulation in the follicular phase.

The randomization will be made in the 2-3 day of the menstrual cycle, according to a list of random allocation of treatments. After check that there is no contraindication to start the stimulation, the patients will be assigned to the treatment group.

The patients in the control group (follicular phase group) will start stimulation with two vials of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75). The patients in the study group (luteal phase group) will perform daily urine LH test from day 7th of the cycle and will start the administration of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75) at two vials daily from the 4th day of the LH positive test.

Antagonist cetrorelix acetate (Cetrotide® ) administration will start when the largest follicle shall be equal or greater than 14 mm. From this moment controls every 24-72 hours with foliculometría by ultrasound and blood hormone analysis with determination of estradiol and progesterone. For the final oocyte maturation 2 vials daily of 0.2 mg triptorelin acetate (Decapeptyl®) is administered. Oocyte collection will be made by transvaginal ultrasound-guided puncture according to IB protocol

The dosages and protocols used will be the usual for patients with diagnostic of poor ovarian response.

Eligibility Criteria:
Inclusion Criteria:

* Patient Bologna meets the criteria to be diagnosed as low responder
* Age under 41 years
* Regular menstrual cycles between 21 and 35 days
* Indication of in vitro fertilization
* Indication of start stimulation with 300 IU of FSH
* Presence of both ovaries
* Ability to participate and comply with the study protocol
* Having signed the written consent form

Exclusion Criteria:

* Presence of follicles larger than 10 mm in the randomization visit
* Endometriosis III / IV
* Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome...
* Concurrent participation in another study
Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture

This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.

Venepuncture is a painful procedure commonly performed in premature infants. Nonpharmacological intervention (oral sucrose solution) can reduce neonatal pain. EMLA cream is an oil in water emulsion of an eutectic mixture of prilocaine and lignocaine; it is an local anesthetic cream. Very few reports have looked at the efficacy of EMLA in preterm infants.

This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants (gestational age between 26 and 37 weeks)
* programmed venepuncture
* APGAR score (M5)≥ 7
* enteral feeding
* written parental consent

Exclusion Criteria:

* infant requiring oxygen
* analgesia or sedation or drugs causing methaemoglobinaemia
* congenital porphyria
* G6PD deficit
* multi organ failure
* convulsion
* dermatosis
Study of Blood Platelets in Sickle Cell Disease

We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease.

Research volunteers are seen in the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. The research volunteer's previous medical records will be requested. Upto 5 additional blood samples may be obtained in a subgroup of patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults and children \> 7 years of age with sickle cell disease (Hb SS) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy.

Exclusion Criteria:

* Current hydroxyurea therapy or,
* Hydroxyurea use within the past 3 months
* Blood transfusion or exchange transfusion within the past 3 months
* Current treatment with aspirin or clopidogrel
In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.

Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.


Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment in a body donation program
* Age ≥ 82 years
* Absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the IADL (4 items) (Lawton and Brody, 1969)
* Distance to one of the participating laboratories ≤ 120km
* Able to remain supine in the MR scanner for acquisition duration (60 min),
* Affiliation to Social Security
* Informed and written consent

Non Inclusion Criteria:

* Past or present Neurological or Neurosurgical diseases (excluding trauma or degenerative spinal lesions)
* Uncontrolled: High blood pressure, diabetes (types I or II), or dyslipemia
* Contraindications to MRI
* Contraindication to body donation

Exclusion criteria

* Diagnosis on MRI of brain lesions, excepted common age-related changes
Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

This study will use a data base of archived therapy sessions of family therapy for adolescent anorexia nervosa to determine the role of fidelity to treatment and outcome. In addition, it will develop a novel, more efficient way to train therapists in family therapy for adolescent anorexia nervosa and examine if it is feasible to conduct a trial comparing this novel training to standard, more intensive training.


Eligibility Criteria:
Inclusion Criteria:

* masters or doctoral training in their field (psychology, psychiatry, family therapy).
* must be licensed
* have no reports of malpractice or loss of privileges at clinical institution
* minimum caseload 5 adolescents with AN each year over past 3 years
* no previous training in FBT
* computer/web access

Exclusion Criteria:

* Previous FBT training for AN
Ketamine- Propofol Versus Pethidine- Propofol in ERCP

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to \<90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* both gender
* age between 18-70

Exclusion Criteria:

* pregnant patients.
* morbid obesity.
* chronic obstructive pulmonary disease.
* complicated airway.
* American society of anesthesia (ASA) physical classification IV-V.
* history of allergy or contraindications to the drugs used in the study
* emergency need for ERCP.
* those whose informed consent could not be signed.
* those with possible complex ERCP.
Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.

Pain is a common reason for emergency department (ED) visits. However, studies suggest that emergency physicians may not always provide optimal analgesic treatment due to various factors, such as time constraints, demographic factors like gender and age, and concerns about opioid use. As a result, patients with moderate to severe pain often experience long delays before receiving analgesia and may even be discharged with unresolved pain or suboptimal treatment. Additionally, diagnostic procedures for patients with isolated trauma (e.g., clinical examinations, radiographs) can lead to variations in pain levels, making it difficult to assess the effectiveness of analgesia.

A commonly used treatment for moderate to severe pain is intravenous opioid administration. However, this approach requires longer wait times, complex titration, and significant resources (beds, nurses, equipment), which may be limited during peak hours. While oral opioids require fewer resources, their delayed onset and limited titratability restrict their use for severe pain.

The sublingual sufentanil tablet (30 mcg), delivered via a single-dose applicator, was developed for patients with moderate to severe pain in emergency or outpatient surgical settings. Its unique pharmacokinetic and pharmacodynamic properties could offer advantages in non-invasive acute pain management.

Sublingual sufentanil received market authorization in June 2018 for the treatment of moderate to severe acute pain in adults and is already used in many hospitals. However, further studies are needed to confirm its effectiveness and potential superiority in pain management.

The objective of this study is to evaluate the effectiveness of 30 mcg sublingual sufentanil in patients admitted for moderate to severe pain due to isolated trauma. This will be compared to the standard pain management protocol used in the Clermont-Ferrand emergency department, focusing on pain score variations using a numerical rating scale (0-10)


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient with a pain rating on the Numerical Rating Scale (NRS) ≥ 4
* Pain of monotraumatic origin in the upper or lower limb
* Glasgow Coma Scale = 15
* SaO2 \> 95% in ambient air

Exclusion Criteria:

* Polytrauma
* Analgesic treatment within the 4 hours preceding admission (except paracetamol)
* Woman of childbearing age without effective contraception, declaring pregnancy or at risk of pregnancy, breastfeeding woman, or positive pregnancy test at inclusion
* Patient requiring intravenous access upon admission (e.g., displaced open fracture)
* Contraindication or allergy to any of the molecules in the analgesia protocol
* Refusal to participate
* Known substance abuse or psychiatric disorders
* Known oxygen dependence or COPD
* Not affiliated with social security
* Patient under guardianship, curatorship, deprived of liberty, or under legal protection
* Patient who does not speak or read French
Training on Unstable Surfaces and Effects on the Balance of Healthy Young People

The objective of this study is to determine the effects on balance and postural control produced by the implementation of a training program that includes work with unstable surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those achieved with a training of similar characteristics, but implemented on a stable surface. An intensive program is proposed, whose target population is young adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults aged between 18 and 30

Exclusion Criteria:

* Professional athlete
* Musculoskeletal injury in the last 12 months (i.e. sprain, bone fracture)
* Known balance disorders including vertigo, central or vestibular limitations
Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM

This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.

The study comprised a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants were administered MBL949 or placebo at 8 biweekly intervals starting on Day 1 and a 10-week follow-up period.

Participants were to be enrolled to:

* MBL949 Arm 1, MBL949 Arm 2 and placebo in a 1:1:1 ratio
* MBL949 Arm 3, MBL949 Arm 4 and placebo in a 1:1:1 ratio
* If MBL949 Arm 1 was tolerated, MBL949 Arm 5 was enrolled with a 2:1 ratio (MBL:placebo) within each stratum.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index: ≥ 32 kg/m2, weight ≥ 77 kg, stable body weight i.e., less than 1.5 kg self-reported change within 90 days
* Diagnosed T2DM as documented by medical history and confirmed by Investigator and with diagnosed duration \< 10 yrs, HbA1c ≤ 9%, and fasting C-peptide ≥ 0.2 ng/ml
* If treated for T2DM, treatment must be limited to diet and exercise and treatment with one of the following anti-diabetic agents (stable for 90 days prior to randomization):

  * Metformin
  * SGLT2i inhibitors (if prescribed as the first line, ie. single agent)
  * DDP4 inhibitors
  * Acarbose

Exclusion Criteria:

* Vitals at screening:

  * systolic blood pressure less than 95 mm Hg or greater than 155 mm Hg
  * diastolic blood pressure less than 60 mg Hg or greater than 95 mm Hg
  * pulse rate less than 56 or greater than 110 bpm
* History of bariatric surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening
* History of myocardial infarction with 2 years of screening
* Diet attempts within 90 days before screening
* Participation in organized weight reduction program within 6 months of screening
The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis

To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.

In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters \[Pocket depth (PD) and sulcus bleeding index (SBI)\] and the loads of four main periodontal pathogens \[Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)\]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth

Exclusion Criteria:

* pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension
A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
* Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test .
* Further exclusions criteria applied.
Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer

Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* metastases
* recurrent disease
* chronic diseases
The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility

No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on neurodynamic mobility, as compared to a sham intervention. This study aims to determine the immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.

A convenience sample will be utilized to obtain subjects. Subjects will be given a brief questionnaire to identify possible contraindications for spinal treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of two groups (spinal manual therapy or spinal range of motion which will serve as the name for the placebo group) and participate in neurodynamic testing procedures of the upper extremity (Upper Limb Provocation Testing) as well as lower extremity (Seated Slump Test). Subjects who are determined to be positive for one or more limbs will receive either a thoracic spine manipulation technique (spinal manual therapy) or a thoracic spine sham manipulation technique (spinal range of motion/placebo). After application of the technique, previously positive limbs will be retested. In attempt to determine validity and believability of the sham procedure and perception of its effect, subjects will be asked if they believe their upper/lower quarter mobility will change based on the group name and after the technique is applied. Subjects will also be asked if they believed they were in the treatment or placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Upper Limb Provocation Test results with limitation of greater than 60 deg of elbow extension at the time of measurement
* Seated Slump Test results with limitation of greater than 22 deg of knee extension at the time of measurement

Exclusion Criteria:

* History of cervical or lumbar pain requiring medical intervention within the last two years, history of upper or lower extremity paresthesia/numbness, self reported bone density disorders, previous spinal cord injury, diagnosed intervertebral disc herniation, previous diagnosis of spinal stenosis or disc pathology, current pregnancy, history of circulatory or neurological disorders, history of spine and extremity fractures or dislocations in the last two years
Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland

SETANTA study will investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected patients after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.

Approximately 100 participants from primary care will be enrolled via General Practitioner (GP) or Primary Care Centers in Dublin. A patient information sheet (PIS) will be made accessible to participants recovering from COVID-19 via their GP practice inviting the participants to contact Cardiovascular Research Institute Dublin. The participants, subject to suitability, will be invited for a site visit over two days, where upon explicit consent being granted, the Investigators will proceed with data collection. The study population includes participants who are recovering from COVID-19 in the community.

Primary Objective

To investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected participants after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.

Secondary Objectives

* To investigate the incidence of SARS-CoV-2 immunity and
* To investigate the extent of coagulopathy persistent after acute SARS-CoV-2 infection.

Follow-up data collection points will be at 1, 6- and 12-months including assessment of major adverse cardiovascular events (MACE) such as myocardial infarction (MI), revascularization, pulmonary embolism (PE), deep venous thromboembolism (DVT), incident heart failure and stroke. 'Patient reported outcome measures' via two quality of life (QOL) questionnaires will be administered at baseline and at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older
2. Written informed consent
3. Recent COVID-19 infection ≥ 6 weeks and ≤ 12 months before enrolment, as evidenced by positive reverse-transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 swab

Exclusion Criteria:

1. Prior history of myocarditis or ischemic heart disease
2. General contraindications for Magnetic Resonance Imaging e.g. Magnetic Resonance unsafe pacemaker, devices, implants etc.
3. Contraindication to gadolinium (estimated glomerular filtration rate \<30 ml/min)
4. Contraindication to Regadenoson, including cardiac conduction disease, asthma, seizures, pregnancy or breast-feeding
5. Inability to provide written informed consent, to fill out the safety questionnaire, or to fully cooperate with the scan and breath holds
6. Insufficient Cardiac Magnetic Resonance image quality
Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

Study in patients with knee osteoarthritis treated by embolization using NBGM200


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis proven by MR-imaging

Exclusion Criteria:

* Current local infection
* Life expectancy less than 6 months