cyrilzakka/clinical-trials huggingface dataset:
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients

The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.

Our three hypotheses are:

1. Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients.
2. Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion.
3. PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.

The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.

Eligibility Criteria:
Inclusion Criteria:

* migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention

Exclusion Criteria:

* other types of primary headache than migraine
* headache on trial day or later than 48 hours before trial day
* migraine up to three days before trial day
* any type of cardiovascular disease
* clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section

C-section is one of the commonly performed surgical procedures. During this surgical procedure the surgeon cuts into uterine cavity through abdominal wall and takes out the baby. This is done by by making the lower half body of the patient numb by injecting local anesthesia drugs into the space surrounding the spinal cord. This allows the mother to remain awake and immediately bond with the baby once it gets delivered. Also this technique provides effective pain relief both during and after the surgery. However like any other technique or drug it is associated with a number of side effects. The most important being fall in blood pressure. There are numerous ways to treat it. However if one is able to predict fall in blood pressure before administration of anesthetic technique one can easily prevent it. One of the recently discovered novel way to predict fall in blood pressure is Perfusion index which is calculated by Pulse oximeter. It is a device use to check amount of oxygen in blood and heart rate. Perfusion index refers to the total amount of blood present in the limbs of the person. Once we administer drug in the space surrounding the spinal cord the amount of blood in the limbs increases while the amount returning to heart decreases which ultimately results in less amount of blood being pumped out by heart resulting in fall in blood pressure. Therefore theoretically those individuals who have a high baseline Perfusion index will more likely to develop low blood pressure. This study aims to identify the cut off value of perfusion index to predict fall in blood pressure.

Spinal anesthesia is employed to provide excellent surgical conditions in case of C-Section. It is the anesthetic technique of choice among obstetric patients. However it is associated with sympathectomy which reduces the venous return and ultimately causes hypotension. This hypotension is mainly due to redistribution of blood volume to the peripheral compartment. Perfusion index which is measured by Pulse Oximetery is a ratio of pulsatile to non-pulsatile blood in the peripheral compartment of the body. As spinal anesthesia causes sympathectomy, peripheral blood volume increases. As a result perfusion index value should rise. This will then co-relate with hypotension. In simple terms those individuals who have a high baseline Perfusion index value will more likely to develop hypotension. This study aims to identify the baseline perfusion index value which co-relates with development of hypotension following sub-arachnoid block for C-section.

Eligibility Criteria:
Inclusion Criteria:

* ASA class II and III
* Elective LSCS under sub-arachnoid block
* Age 18-35 years

Exclusion Criteria:

* Hypertensive disorders of pregnancy
* Autonomic neuropathy
* Fetal distress
* NPO \>8h
* Lack of maintenance fluid or oral clear fluid intake during NPO period.
* BMI \> 35 kg/m2
* Patients requiring Vasopressor and Ionotropic support.
Impact of Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart

Background: Knowledge, attitudes, and behaviors regarding the prevention and care of incontinence-associated dermatitis (IAD) need to be enhanced through educational training. There is a lack of innovative courses and convenient tools to assist nursing staff in learning and teaching in clinical settings.

Purpose: This study aims to investigate the learning outcomes of nursing staff in adult wards regarding the prevention and care of IAD, comparing the effectiveness of a course combined with an Directive Wheel Chart versus a course alone. Additionally, the study examines the effectiveness of nursing staff applying the course and Directive Wheel Chart in peer teaching.

Design: This study was a two-phase randomized controlled trial conducted at a regional teaching hospital in Taiwan.

Materials and Methods: The study involved eight wards, comprising a total of 106 nurses, who were initially randomly assigned to either an experimental group (EG) or a control group (CG). Subsequently, the nurses within each ward were randomly allocated to two phases. The researcher delivered a 50-minute lecture to both groups, providing the IAD directive wheel chart only to the nurses in the EG. After a two-weeks period, one or two nurses from each ward in the first phase utilized the same course and directive wheel chart to peer-teach the nurses in the second phase within the same wards. The Chinese version of the Knowledge, Attitudes and Practices of Incontinence-associated Dermatitis Questionnaire (KAP-IAD-Q-C) and the Chinese version of the attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD-C) were employed to evaluate effectiveness. The Generalized Estimating Equation (GEE) was utilized to analyze the effectiveness of the educational intervention for each phase.

Eligibility Criteria:
Inclusion Criteria:

(1)Nurses in the eight adult wards.

Exclusion criteria:

1. New nurses had not completed the three-month probation period;
2. Nurses are holding administrative management positions
3. Nurse practitioners;
4. Nurses who expected to be employed within six months due to job transitions.
Phenotype and Prognosis of Patients With Breast Cancer and Pathogenic Variants of TP53

A prospective and retrospective cohort study of patients with a documented pathogenic or likely pathogenic variants of TP53 were identified using blood DNA colection and breast cancer diagnosis by histological confirmation, between 1999 and 2022. All patients were followed by the Hereditary Group of a single cancer center (Instituto do Cancer do Estado de Sao Paulo). Patients were included if they had a histopathological diagnosis of localized invasive carcinoma or in situ carcinoma of the breast and with localized disease. Patients met Revised Chompret criteria, Li Fraumeni like syndrome,family member of carrier TP53 or hereditary breast and ovarian syndrome for germline test.

The primary outcome was progression free survival from specific breast cancer from patients with BC and TP53 mutation versus BC and no pathogenic variants documented in genetic test. We proposed 45 cases TP53 pathogenic carriers and localized breast cancer diagnosed for each case included we will be selected 2 controls resulting in 90 control patients, for control with no documented pathogenic variants in genetic test. With a sample of 135 patients with distribution 2:1, considering a two-tailed alpha of 5%, the study will have 80% power to identify a hazard hatio of 0.62 in the comparison of progression-free survival between the groups.

Descriptive statistics will be used to summarize clinical characteristics and treatments performed. Continuous variables may be compared between groups using T Student test or Mann-Whitney test, in the case of normal and non-normal data distribution, respectively. Categorical variables may be compared between groups using the Fisher exact test.

Progression-free survival will be estimated from the date of breast cancer diagnosis until the date of progression or date of recurrence (in cases of localized disease treated) of breast cancer. Death will not be considered as an event for progression-free survival, since patients with PV TP53 may have an increased risk of deaths from other neoplasms. The breast cancer specific survival will be estimated from the date of diagnosis of breast cancer until the date of death from the breast cancer. Patients without the specific events will be censored on the date of last follow-up.

The Kaplan-Meyer method will be used for survival estimates, comparing survival curves with log-rank testing. The Cox regression model will be used for hazard-ratio calculation and 95% confidence-interval. P value less than 0.05 will be considered statistically significant. Statistical analyses will be performed through Stata program, version 15.1 (StataCorp, Texas, USA).

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer (histopathological diagnosis of localized invasive carcinoma or in situ carcinoma of the breast) and documented germline pathogenic variants of TP53.

Exclusion Criteria:

* Patients with only other types of breast cancer such as sarcoma and phyllodes tumor were excluded from the analysis.

  * Metastatic Breast Cancer at diagnosis ("denovo")
Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method

Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.

Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.

In practice, in France, use of the IUD is still "reserved" for older women or those who have already had children, despite medical recommendations.

In this study the investigator will investigate whether clear information about the mode of action and insertion/withdrawal of IUDs would dispel these misconceptions of patients.

Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.

Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.

In practice in France, the use of IUDs is still "reserved" for older women or those who have already had children, despite medical recommendations. Indeed, there is a certain feeling of mistrust towards the IUD as a contraceptive method. Sometimes the patient's reasons for refusal were unclear or misconceptions and prejudices prevailed.

Various research studies and theses have identified the various obstacles to the use of the IUD as a contraceptive. Today it would be interesting to evaluate whether a short presentation of the IUD during a consultation would lead to a better acceptance of women to use it as a possible contraceptive method.

In this study the investigators will investigate whether clear information about the mode of action and insertion/removal of IUDs would dispel these misconceptions of patients.

Eligibility Criteria:
Inclusion Criteria:

* Any woman aged 18 years and over who comes to a family planning centre
* Having expressed her free and informed written consent
* Affiliated to a social security scheme

Exclusion Criteria:

* Women under 18 years of age
* Woman with an IUD
* Woman who has had an IUD before
* Woman whose reason for consultation of the day is the insertion of an IUD
* Menopausal woman
* Woman who is infertile for any reason
* Illiterate woman or woman who does not read French
* Refusal to participate in the protocol
* Incapable of age.
* Pregnant or breastfeeding women
* Vulnerable persons and protected persons as provided for in the Public Health Code Public Health Code (articles L. 1121-5 to L.1121-8 and L.1122-1-2).
Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy

Contrast-induced nephropathy (CIN) has remained significant and severe complication of angiographic procedures despite the increasing use of preventative methods. It has been associated with prolonged hospital stay, high morality and the need for dialysis. Since classically used creatinine for diagnosing of CIN does not reflect the degree of tubular injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and preventative methods are needed. Remote ischemic preconditioning is a non-invasive and safe method which in some studies has been reported to protect against contrast-induced nephropathy. The purpose of this study is to evaluate the effect of remote ischemic preconditioning (RIPC) (1) as an additional method to standard treatment to prevent subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on functional properties of arterial wall, organ damage biomarkers and low molecular weight metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years, no upper age limit
* Patients with stable coronary artery disease (II - III class according to the Canadian Cardiovascular Society) hospitalized for coronarography or with lower extremity arterial disease hospitalized for angiography
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Age less than 18 years
* eGFR \< 30 ml/min/1,73 m2
* Simultaneous participation in an other clinical trial
* Coexisting pathology of the upper-limbs limiting the use of the cuff (bilateral amputee, recent trauma, chronic ulcers, significant upper limb peripheral atherosclerosis (radial pulse not palpable on either side))
* Malignant tumor (in remission less than 5 years or ongoing treatment)
* Documented allergic reaction to iodinated contrast agent
* Acute infection (body temperature 38 degrees Celsius or higher, c reactive protein 50mg/L or higher)
* Cardiac rhythm abnormalities (atrial fibrillation, frequent supraventricular premature complexes)
* Documented myocardial infarction within 30 days
* Inability to understand the instructions of the study
* Vascular surgery in axillary region
* Unable to lie supine for 40 minutes
* Home oxygen treatment
* Documented upper limb deep vein thrombosis
Treatment of Pectus Excavatum Deformity Using Macrolane Filler

This is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum deformity.

Each subject participating in the study will be treated with approximately 50-150 ml of Macrolane VRF20. The amount of study product used will be individually determined in order to achieve an optimal correction of the deformity in each subject.


Eligibility Criteria:
Inclusion Criteria:

1. Give verbal and written informed consent to participate in the study.
2. Be a healthy male of 18 years or more.
3. Have a pectus excavatum deformity without functional problems; score 4 in items 10, 11 and 12 of the PEEQ, indicating there is no functional impairment due to the pectus excavatum deformation.
4. Present normal cardiac function as assessed by ECG and echocardiogram.
5. Present normal pulmonary function as assessed by pulmonary function test.
6. Present a chest X-ray taken within 12 months prior to the baseline visit, without clinically significant defects to heart, lungs, skeleton, ribs, sternum or spinal cord except for the pectus excavatum defect, in the opinion of the Investigator.
7. Have the ability to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Score 1, 2 or 3 in either of items 10, 11 and 12 of the PEEQ, indicative of functional problems due to the pectus excavatum deformity.
2. Previous treatment for the same indication.
3. Known or suspected hypersensitivity to hyaluronic acid based products.
4. BMI \< 20.
5. A history of severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies (as judged by the Investigator).
6. Known allergy to any anesthesia planned during the study.
7. Presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the study.
8. Subjects with bleeding disorders or subjects who are taking thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, including non-steroidal anti-inflammatory agents and acetylsalicylic acid, two weeks before treatment.
9. Subjects on immunomodulatory therapy (suppressive or stimulatory).
10. Subjects with contraindications for MRI, such as presence of pacemaker, clips or splinter, or tendency for claustrophobia.
11. Any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g., subjects not likely to participate for the duration of the study).
12. Use of any investigational drugs or devices within 30 days prior to baseline.
13. Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.
Efficacy and Safety of Tetrabenazine in Chorea

The primary objective of this study was to establish the absolute reduction of chorea in participants with Huntington's disease(HD) treated with tetrabenazine or placebo


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* suffer from manifest HD as confirmed by genetic testing
* Meet chorea and total functional capacity scores on Unified Huntington's Disease Rating Scale
* Meet criteria on Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating Scale dysphagia and dysarthria scale
* Independently ambulatory

Exclusion Criteria

* previous treatment with tetrabenazine
* unstable or serious medical or psychiatric illness
* concomitant use identified drugs
* untreated depression
* lack of caregiver
A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

The investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.


Eligibility Criteria:
Inclusion Criteria:

* valuntary 18-65-yers-old, patient have hallux valgus or hallux rigidus deformity which need surgery treatment

Exclusion Criteria:

* Over 65 yers-old or less than 18-years-old, diabetes, rheumatism, smoker or lack of co-operation
Real World Study of Linperlisib for Lymphoma Treatment

This is a multicenter, non-interventional and observational real-world study to evaluate the efficacy and safety of linperlisib in patients with lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Clinical diagnosis of lymphoma patients
3. Patients signed informed consent, volunteered to join the study, and had the willingness and ability to cooperate with the data collection in this study;
4. The researchers' assessment can use Linperlisib treatment

Exclusion Criteria:

1. The nature of the study could not be understood or informed consent was not obtained
2. Other ineligible conditions were assessed by the investigator
Study of Postoperative Chest Tube Management

A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection

This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to read, understand, and provide written consent
* Age 18-90
* Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable

Exclusion Criteria:

* Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded
* Patients undergoing non-anatomic lung resection only (i.e. wedge resection)
* Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis.
* Patients undergoing pneumonectomy or completion pneumonectomy