cyrilzakka/clinical-trials huggingface dataset:
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.

The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants born at age between 29 and 37 weeks
* sham osteopathic treatment performed \< 14 days after birth
* preterm infants born in the same hospital

Exclusion Criteria:

* gestational age \< 29, \> 37 weeks;
* sham osteopathic treatment performed \> 14 days after birth;
* newborn transferred to/from other hospital;
* newborn from to HIV seropositive and/or drug addict mother;
* newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.
Sexual Dysfunction in Hypertensive Women

Several studies describe the existence of an association between sexual dysfunction and high blood pressure (hypertension), most often characterized by a decrease in the number of orgasms and the existence of dyspareunia.

Hypertension is a contributing factor, and nonadherence to medication could amplify it.

There are several ways to assess adherence to treatment: the use of declarative questionnaires, a method not without criticism because it is subject to the subjectivity of the declaration by the patient; and drug dosages, a standard technique, although insufficiently disseminated due to the high cost and greater weight of the survey protocols. Drug non-compliance is multifactorial. In addition, it has been shown that having undesirable drug effects and / or being afraid of developing them is one of the major causes of non-compliance with antihypertensive treatments.

The investigators hypothesize that DS is significantly more common among hypertensive women treated with non-observers compared to hypertensive women treated with observers.

The main objective is to compare the prevalence of sexual dysfunction between a group of hypertensive women treated as observers and a group of hypertensive women treated as non-observers.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18,
* Hospitalized or received in consultation for the management of hypertension treated in one of the hypertension and therapeutic, nephrology or cardiology departments participating in the study, with confirmed hypertension, treated with the following dosable antihypertensive agent(s): diltiazem, verapamil, acebutolol, atenolol, nébivolol, bisoprolol, metoprolol, propranolol, amiloride, furosemide, hydrochlorothiazide, indapamide, spironolactone, spironolactone, Lorsartan, Irbesartan, Ramipril, Perindopril, Amlodipine,
* Having signed the informed consent form.
* Beneficiary or affiliated to a French Social insurance

Exclusion Criteria:

* Patients with bariatric surgery,
* Patients under guardianship/trusteeship/protection of justice,
* Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.


Eligibility Criteria:
Inclusion Criteria:

* Claudication or critical limb ischemia (Rutherford Category 2-5)
* Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery
* Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm
* Minimum reference vessel diameter is 4 mm

Exclusion Criteria:

* Contraindication to an endovascular procedure
* Previous stent placement in the target vessel
* Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease
* Platelet count \<150,000 mm3 or \>600,000 mm3
* Renal insufficiency with a serum creatinine \>2.3 mg/dl
* History of major amputation (ankle level or above) in the same limb as the target lesion
* Current participation in another drug or device clinical study
JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines

A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines


Eligibility Criteria:
Inclusion Criteria:

* Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe)
* Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related

Exclusion Criteria:

* Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
* Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator
* Have a history of skin cancer
* Is an active smoker
* Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area
* Have had an active oral herpes or cold sore within 12 months
* Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
* Have undergone cosmetic facial or perioral area procedures \[e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers\] or be planning to undergo any of these procedures at any time during the study
* Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months
* Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures.
* Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. \[NOTE: Use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment\]
* Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months
* Have received treatment with botulinum toxin of any serotype for any indication in the lower face \[below the infraorbital rims (IORs)\] within 1 year of the baseline visit
Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique

Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.

Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.


Eligibility Criteria:
Inclusion Criteria:

* primary ACL reconstruction, closed growth plates

Exclusion Criteria:

* ligament injury to the opposite knee
AGARIC Case Control Study

The aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.


Eligibility Criteria:
Inclusion Criteria:

CASES

* Patients aged ≥ 45 years
* with a first recently-diagnosed colorectal cancer
* due to undergo elective surgical resection with curative intent (in practice, stage I, II, III or IV if there was only one hepatic nodule that was resected with curative intent) in one of the 5 following digestive surgery units: CHU de Dijon, CHU de Nancy, CHU de Strasbourg, CHU de Reims et CHU and Besançon.
* who have given their informed consent

CONTROLS

* Patients aged ≥ 45 years
* due to undergo surgery for a benign abdominal disease (sigmoid diverticulitis, appendectomy, hiatal hernia ...)
* matched for abdominal site with cases for age (± 3 years), sex and hospital
* Who have given their informed consent

Exclusion Criteria:

CASES

* pre-operative anticancer treatment (chemo or radiotherapy)
* existence of visceral metastases except a single hepatic nodule resected with curative intent
* familial adenomatous polyposis and HNPCC syndrome (when suspected: inclusion after complementary tumor phenotype study: screening for microsatellite instability and/or immunohistochemistry study of the expression of DNA mismatch repair proteins.
* known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
* personal history (recent or not) of colorectal cancer
* emergency treatment for the presenting complication (perforation, occlusion...)
* significant modification in dietary habits during the previous three months
* other evolving neoplastic disease
* psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
* pregnant or breast-feeding women

CONTROLS

* personal history of cancer or adenomatous colorectal polyps,
* emergency intervention
* known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
* personal history (recent or not) of colorectal cancer
* emergency treatment for the presenting complication (perforation, occlusion...)
* significant modification in dietary habits during the previous three months
* evolving neoplastic disease
* psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
* pregnant or breast-feeding women
Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Prospective Cohort Study

This study evaluate use of a translated Norwegian version of the Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen (ECAS-N) as an early predictor in car-driving, working and use of advanced life-prolonging therapy.

Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Screening of cognitive and behavioral impairment is a distinct recommendation in ALS-specific health care. However, knowledge in how cognitive impairment shall influence health-care professionals' information given to patients and in decision making is lacking.

One of the major challenges in ALS management is the decision-making on advanced therapy. There is a lack of knowledge in how cognitive impairment in ALS shall be interfere on complex medical treatment that will affect quality of life or life itself. This means significant implications not only to the ALS patient and the community, but also the family and especially the spouse. Thus, further investigation of the ECAS-N and its potential in clinical use is needed. The scale may contribute a more proactive treatment better tailored to individual needs. The objective is to evaluate if the ECAS-N can be applied as an early predictor in car-driving, working and use of advanced life-prolonging therapy

Eligibility Criteria:
Inclusion Criteria:

* Voluntary informed consent
* Native Norwegian speaker

Exclusion Criteria:

* Great difficulties in writing or reading
* Comorbid medical history
* Neurological disorders others than ALS
* Psychiatric history of importance to cognitive function
Application of Electronic Endoscope in Fetal Distress

Fetal distress is a common emergency in obstetrics, which refers to the combined symptoms of fetal health and life in utero due to acute or chronic hypoxia, with an incidence of 2.7% to 38.5%. Fetal distress is mainly related to abnormal amniotic fluid, umbilical cord entanglement and compression, which is an important reason for the increase of cesarean section rate during delivery. At present, the diagnosis of fetal distress mainly relies on electronic monitoring of fetal heart, and the false positive rate is high. Intrauterine pressure catheter has not been widely used because of the little effect of intrauterine treatment and the increase of infection. Endoscopy has been widely used in the diagnosis and treatment of various specialties at present, but the diagnosis and treatment during childbirth are still in a blind area. The characteristics of endoscopic visualization provide a new idea for the diagnosis and treatment of fetal distress during delivery, especially for the etiological diagnosis and treatment of umbilical cord factors. The use of intraauterine endoscope during delivery can make up for the defects of intrauterine pressure catheter, realize the visual diagnosis of the causes of fetal distress such as oligoamniotic fluid, meconium contamination of amniotic fluid, umbilical cord compression caused by entangling and true junction, etc. At the same time, it can also improve the intrauterine environment by perfusion of saline for the causes of fetal embarrassment, correct fetal distress, and extend the observation time during labor. It is beneficial to reduce caesarean section during labor.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 20-45 years with single pregnancy;
2. Intrauterine fetal distress occurs during labor (during the first stage of labor), and the fetal membrane was already broken;
3. Fetal heart monitoring category II, after stopping oxytocin, oxygen inhalation, change of position, intravenous fluid and other measures can not improve;
4. Understand the research procedures, be able to follow the procedures of the research protocol, and voluntarily sign a written consent.

Exclusion Criteria:

1. Type III fetal heart monitoring for pregnant women who require emergency c-section
2. Pregnant women with GBS positive
3. Pregnant women suspected of chorioamniotic infection
4. Pregnant women have signs of reproductive system infection (vaginal inflammation, cervicitis, uterine infection)
5. Pregnant women suspected of uterine rupture
6. Pregnant women with abnormal contractions: excessive strong contractions
7. Check the fetus for serious deformities during pregnancy
8. Check pregnant women with serious abnormal functions of cardiovascular system, urinary system, digestive system, reproductive system and other organs
SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among POR Subgroups

The goal of this prospective, observational study is to learn about the pathogenesis and biological target of the subtypes of poor ovarian response (POR) during In vitro fertilization and embryo transfer (IVF-ET). The main question it aims to answer is:

1. Can the relative expression level of SIRT3 differentiate between POR subtypes, and do these differences reflect distinct metabolic characteristics among the subtypes?
2. Investigate whether SIRT3 expression levels correlate with clinical outcomes. This study will enroll patients with various POR subtypes and collect discarded follicular fluid and granulosa cells on the day of egg retrieval. IVF outcome information routinely collected in electronic databases will also be recorded. Notably, this is a purely observational study with no additional interventions. Your participation will not alter your clinical treatment compared to other patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Women who are married and aged between 20 to 45 years, diagnosed with infertility;
* 2. Individuals undergoing their first or second cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), with a scheduled fresh embryo transfer;
* 3. Participants must fulfill the diagnostic criteria corresponding to one of the following prognostic categories as determined by the clinician: Normal prognosis, unexpected poor prognosis, poor prognosis of advanced maternal age, or expected poor prognosis.

Exclusion Criteria:

* 1. A body mass index (BMI) of ≥ 35 kg/m²;
* 2. Participation in cycles involving pre-implantation genetic testing or diagnosis of embryos;
* 3. Involvement in cycles utilizing frozen gametes;
* 4. Engagement in cycles that employ donor-derived oocytes;
* 5. Participation in in vitro maturation cycles;
* 6.The presence of uterine cavity or endometrial abnormalities, including but not limited to fibroids, endometrial polyps, malformations, adenomyomas, endometritis, endometrial thinning, hydrosalpinx, uterine infections;
* 7.The existence of contraindications to assisted reproductive technology or pregnancy, such as uncontrolled liver or kidney dysfunction, diabetes mellitus (with glycated hemoglobin ≤ 7% and fasting blood glucose \&amp;amp;amp;lt; 10 mmol/L), hypertension, thyroid disorders, asymptomatic cardiac conditions, moderate-to-severe anemia, malignancies, a history of thromboembolism or thrombosis, severe mental health disorders, acute infections of the urinary and reproductive systems, sexually transmitted infections, and detrimental lifestyle factors including substance abuse. Additionally, exposure to teratogenic levels of radiation, toxins, or medications (such as prednisone, other hormones, adrenaline, antibiotics, or medications for hypertension, cardiovascular issues, or antiviral treatment) during surgical procedures, as well as any physical conditions rendering pregnancy inadvisable, are also considered disqualifying factors.
Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment

Obesity is epidemic in Australia, and current preventative strategies have had limited success in alleviating this health crisis. While numerous options are available for treatment of obesity, most do not result in sustained weight reduction. Obesity results from an imbalance between energy intake and expenditure, therefore new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies show that brown adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore targeting BAT to increase its activity (energy burning rate) and quantity in humans is potentially a powerful tool for the treatment of obesity and related diseases. BAT has only recently been irrefutably identified in adult humans therefore little is known about how it functions in humans.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 19 - 35 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Unmedicated
* No major illness
* BMI \<27 kg/m2

Exclusion Criteria:

* Unable to give informed consent
* Smokers
* Participant in research projects involving ionising radiation within the past 5 years.
* Claustrophobia
* Fasting plasma glucose \> 6.0 mmol/L
Speech Therapy in the Management of Chronic Cough

Speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. This method has not been available for patients with cough in Poland so far.The aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group.

Patients with difficult-to treat chronic cough will be offered speech and language intervention as an added therapy. The effectiveness of speech therapy will be measured by changes in cough severity, its influence on quality of life and cough challenge test before and after speech therapy measured in every patient.

The efficacy of management of chronic cough in adults is limited. Speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. This method has not been available for patients with cough in Poland so far.

The aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group.

Patients, who are diagnosed and unsuccessfully managed because of difficult-to treat chronic cough, will be offered speech and language intervention as an added therapy. It is based on the technique described by Vertigan et al.The entire therapy will consist of eight sessions once a week.

Cough severity, its influence on quality of life and cough challenge test with capsaicin will be assessed by Visual Analogue Scale, Leicester Cough Questionnaire and cough challenge test with capsaicin will be performed before and after speech therapy in every patient to analyze its effectiveness

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 80 years,
2. chronic cough lasting more than six months
3. earlier thorough diagnosing of cough reason
4. unsuccessful cough management despite at least 3 months of earlier treatment
5. no symptoms of any airway infection during last 4 weeks.

Exclusion Criteria:

1. lack of opportunity to participate in speech therapy sessions
2. cough lasting less than 6 months
3. active cigarette smoking
4. taking ACE inhibitors
5. symptoms of airway infection (other than cough).
PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty

Regional anesthesia for postoperative analgesia in THA includes epidural anesthesia and peripheral nerve blocks. However epidural anesthesia has a great role in THA, it has become restricted as perioperative antithrombotic drugs are generally used for orthopedic patients.

the study aim to evaluate and compare efficacy and safety of pericapsular nerve group block (PENG) block and lateral femoral cutaneous nerve versus Lumbar plexus block on postoperative analgesia in hip surgery.


Eligibility Criteria:
Inclusion Criteria:

(ASA) physical status I to III scheduled for hip surgery aged (30-70) years

Exclusion Criteria:

* Drug allergy,
* Morbid obesity (BMI \>40 kg/m2),
* Coagulopathy,
* Psychiatric disorder,
* Opioid dependence,
* Patient refusal to give informed consent.