cyrilzakka/clinical-trials huggingface dataset:
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity.

Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2) between 88-95%.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
2. Inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks
3. Clinical course consistent with RDS
4. Requirement of endotracheal surfactant administration within 24 hours from birth
5. Fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%

Exclusion Criteria:

1. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
2. Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
3. Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
4. Mothers with prolonged rupture of the membranes (\>21 days duration)
5. Strong suspicion of congenital pneumonia/infection, sepsis
6. Presence of air leaks prior to study entry
7. Evidence of severe birth asphyxia
8. Neonatal seizures prior to study entry
9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
10. Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.
Evaluation of the Effectiveness of a Protocol for the Management of Female Functional Urinary Signs

Every year, between 4 and 6 million French people are affected by a urinary infection; the vast majority of these are women. Although the diagnosis of an uncomplicated urinary tract infection is simple to make, it requires prompt medical management to relieve the symptoms. The lack of immediate of a physician can slow down the management of patients affected by this condition, and lead to an inappropriate referral of patients to the emergency services.

Because of their wide availability, accessibility, and geographical distribution throughout the country, pharmacists are primary health care professionals who are regularly called upon to respond to patients with this type of infection.

A national protocol exists in France, but it is very difficult to apply. The PharmaCyst' study aims to evaluate its application in community pharmacies.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 18 and \<65 years
* Patient with less than 3 days of simple urinary tract infection symptoms:

  * Burning, pain on urination
  * Dysuria
  * Pollakiuria
  * Urinary urgency
* Patient affiliated or beneficiary of a social insurance
* Patient having signed an informed consent.

Exclusion Criteria:

* More than 3 cystitis in the last 12 months;
* Last cystitis less than 15 days old;
* Presence of fever;
* Presence of back pain;
* Presence of a functional or organic anomaly of the urinary tract (bladder residue, vesico-ureteral reflux, lithiasis, tumor);
* Pruritus or vaginal discharge;
* Vomiting, diarrhea, diffuse abdominal pain;
* Risk factors for C3G-resistant enterobacteria infection (grade B):
* Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G, fluoroquinolones) within the previous 3 months;
* A nosocomial or healthcare-associated infection;
* A history of colonization or infection with C3G-resistant enterobacteria within the last 3 months;
* A trip to a foreign country within the last 3 months in known geographical areas at risk (in particular the Indian subcontinent, South-East Asia, the Middle East and North Africa, the Mediterranean basin);
* Hospitalization within 3 months;
* Hospitalization within 6 months for UTI;
* Known severe renal insufficiency (creatinine clearance \< 30 mL/min);
* Severe immunosuppression or immunosuppressive treatments;
* Contraindications to drugs planned for experimental management (pivmecillinam and fosfomycin) or combination of drugs not recommended;
* Pregnant women (confirmed or suspected pregnancy), breastfeeding women or women in labour;
* Person deprived of liberty by judicial or administrative decision;
* Person under forced psychiatric care;
* Person admitted to a health or social institution for purposes other than research;
* Person subject to a legal protection measure;
* A person who is unable to give consent.
Fascial Anthropometry in Archery Athletes

In archery, the body morphological and anthropometric characteristics of the prominent athletes change. It is important to examine facial anthropometry, especially since the athlete's equipment touches the facial area, and there are no studies on this subject. The aim of this study is to determine the relationship between facial anthropometric measurements and anthropometry-related parameters and sports performance in archery athletes.

Within the scope of the study, a total of at least 60 athletes, between the ages of 9-18, who have been training archery at least twice a week for at least 2 years, who have not changed their bow category since it started, who do not have a temporomandibular joint problem, and who volunteer to participate in the study, will be recruited in equal numbers from each age category. Within the scope of evaluation; Demographic information and features regarding archery equipment will be recorded. Within the scope of anthropometric measurements; adipose tissue measurements with skinfold; circumference measurements and length measurements with tape measure; diameter measurements with caliper; Facial anthropometric measurements will be measured with a caliper/tape measure. Formulary named "Heath-Carter Anthropometric Somatotype Technique" to determine the body somatotypes of athletes; Lateral photography for biomechanical evaluation of the craniocervical region; Hand Grip Strength Test for performance evaluation; Corbin Postural Assessment Scale will be used for posture evaluation. In order to determine the shooting performance, the athletes' actual competition scores in the last year will be recorded. Medicine ball throwing test, upper extremity y balance test and closed kinetic chain upper extremity stability test will be used to evaluate upper extremity performance. For statistical analysis, normal distribution of parameters will be examined. To determine the relationship between shooting performance and stabilization and related parameters, Pearson test will be used for normally distributed parameters and Spearman correlation test will be used for non-normally distributed parameters.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 9-18 years.
* Having been practicing archery at least twice a week for at least 2 years.
* Not having changed the bow category since it started.
* Fonseca Anamnestic Questionnaire result is between 0-15 points
* volunteering to participate in the study

Exclusion Criteria:

* Having had surgery involving the spine and upper extremities in the last year
* Scoliosis being diagnosed
* Having an orthopedic, neurological or musculoskeletal disease that involves the upper extremity and prevents shooting
* Having received orthodontic treatment
* orthodontic surgery to have had
* Being actively involved in another sports branch for at least 1 year
D-Cycloserine as an Adjunct to Internet-CBT for OCD

The purpose of this study is to examine if D-Cycloserine is an effective adjunct to internet-based cognitive behaviour therapy for patients with obsessive-compulsive disorder.

Trial Objectives:

Primary aim is to investigate whether D-Cycloserine gives incremental effects to ICBT in terms of reduced OCD symptoms. Secondary aims are to a) replicate previous findings in that DCS fastens the effects of CBT, b) correlate the fastened effect to overall treatment adherence and c) investigate gene variation and therapeutic factors as predictors of symptom severity, symptom type and treatment response.

Trial Design: Double blinded randomized controlled trial

Dose/Duration: 5 capsules of 50 mg D-Cycloserine or placebo. 1 pcs per week for 5 weeks. All participants also receive Internet-based cognitive behavior therapy for 12 weeks.

Primary Endpoint: Change from W0-W13 and 3-months follow-up.

Efficacy Parameters: Y-BOCS clinician rated.

Safety Parameters: Adverse Events assessed weekly via the internet and also at post-treatment and at 3-months follow-up using face-to-face clinician assessments.

Description of Trial Subjects: Fulfilling diagnostic criteria of OCD not associated with hoarding.

Number of Subjects: 128

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Male or female
* ≥ 18 years
* Currently living in Stockholm, Uppland, Örebro, Södermanland, Gästrikland, Västmanland and Östergötland county in Sweden.
* Primary diagnosis of OCD according to the DSM-IV-TR.
* Signed informed consent
* Have regular access to a computer with internet access and skills to use the web
* Have received information about the need of using contraception

Exclusion Criteria:

* Pregnancy or breast feeding
* Patients unlikely to cooperate fully in the study
* Patients not able to read or understand the basics of the ICBT self-help material
* Psychotropic medication changes within two months prior to treatment
* Completed CBT for OCD within last 12 months
* Y-BOCS \[21\] \< 16 at Psychiatrist visit (6.2.3)pi
* OCD symptoms primarily associated with hoarding.
* Other primary axis I diagnosis according to the Mini-International Neuropsychiatric Interview (MINI) \[34\]
* Ongoing substance dependence
* Lifetime bipolar disorder or psychosis
* Suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation
* Serious physical illness that will be an obstacle in ICBT and DCS
* Other ongoing psychological treatments that could affect OCD symptoms
* Epilepsia
* Renal impairment
* Hypersensitivity to D-Cycloserine
* Porphyria
* Chronic Alcoholism
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.


Eligibility Criteria:
Key Inclusion Criteria:

* Patient must be ≥ 18 at the time of screening
* Patient must have a single ruptured or unruptured IA requiring treatment
* Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures

Key Exclusion Criteria:

* Patient has an IA with characteristics unsuitable for endovascular treatment
* Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
* Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
* Patient index IA was previously treated
* Patient is pregnant
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD based on the Japanese Dermatological Association's criteria
* Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
* IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

* Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
ANI Parasympathetic Monitoring in Neurosurgery

Surgery of large cerebellopontine angle (CPA) tumors (\>2 x 2 cm diameter), with compression of the pons exposes the patient to inadvertent parasympathetic nerve stimulation (IPNS) leading to bradycardia and asystole.

The analgesia nociception index (ANI) monitor assesses the balance between analgesia and nociception through the detection of parasympathetic tone. ANI \>80 generally denotes excessive analgesia (EA). The main objective of this study was to determine whether ANI values for IPNS are different or the same as ANI values for EA. This study also aims at calculating the number of patients with IPNS and EA during surgery of large CPA tumours.

Bradycardia and asystole are potential life threatning complications during surgery of large cerebellopontine angle (CPA) tumors (\>2 x 2 cm diameter), with compression of the pons.The incidence of such complications are unknown. One of the plausible mechanisms is inadvertent parasympathetic nerve stimulation (IPNS) due to the proximity of this cranial nerve to the CPA tumor. Monitoring parasympathetic nerve activity may provide further insight to the implication of this cranial nerve in the cardiac complications observed during surgery of large CPA tumors. The analgesia nociception index (ANI) monitor assesses the balance between analgesia and nociception through the detection of parasympathetic tone. Despite the abundant clinical reports about this index, to the knowledge of the investigators, only a few studies have been published in the neurological setting. Moreover, there are no data reporting the parasympathetic profile (measured by the ANI monitor) in situations of IPNS and EA. Are these profiles the same or different? Such is the main question this study thrives to answer. Understanding the behavior of parasympathetic nerve activity in this context could help provide the appropriate management strategy.

In order to answer this question, participants undergoing elective large CPA tumor surgery were included in this prospective observational study. Standard cardiorespiratory monitoring including heart rate (HR) was done. Target-controlled anesthesia with Propofol and Remifentanil was guided by a bispectral index of 30-40 and an ANI of 50-70 respectively. Data was continuously recorded with event markers at the onset of bradycardia (HR \< 45 bpm), asystole and the coincidence of ANI \> 80 with Remifentanil site effect \> 6 ng.ml-1 (defined as excessive analgesia).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective surgery of large cerebellopontine angle tumors

Exclusion Criteria:

* age below 18yr
* arrhythmia
* preoperative use of vagolytics, β-blockers and clonidine.
Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT

The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.

The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support
* Age 18-60 years
* ECOG-performance status 0-1
* Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1)

Exclusion Criteria:

* Serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy
* Severe cardiac failure (ejection fraction \< 40%)
* Severe impairment of renal function (Creatinine clearance \< 50ml/min)
* Severe impairment of liver function (bilirubine \> 2 fold of upper limits of normal)
* Pregnant or lactating women
* Other major organ or system dysfunctions(GI, neurological, psychiatric dysfunctions that would impair tolerance of chemotherapy or prolonged haematological recovery)
* Positivity for HIV
Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients

Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients.

The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients with leg ulcers. The study tests the program on effects regarding:

* compliance with compression therapy and exercise levels
* time to leg ulcer recurrence
* cost effectiveness from a social perspective.

The project is a multi centre study, using a randomized controlled design. Patients in the study (n=380) are equally randomized to either the experimental or the control group. Patients in the intervention group receive counseling during a period of six months, in line with the Lively Legs program. Patients in the control group receive regular care. Recruitment takes place within a period of nine months. Data are collected at baseline, directly after the intervention period at 6 months, and at follow-ups at 12 and 18 months. Quality of life is additionally assessed at 3, 9 and 15 months.

The population for this study consists of leg ulcer patients, suffering from peripheral circulation disorders of venous or mixed (venous and arterial) origin. The population is restricted to patients treated at outpatient clinics for dermatology.

Individual counseling is performed by nurses, based on the Lively Legs lifestyle-program for leg ulcer patients. This evidence-based program was systematically developed using the Intervention Mapping framework, thus integrating scientific evidence, relevant theories and patient and care provider expertise. The program aims at improved compliance with compression therapy and prescribed exercise level in all patients.

Social Cognitive Theory provides the theoretical framework and the core methods for the Lively Legs program. Nurses will perform the central role as health counselor. In a maximum of six consultations, they will offer tailored counseling, including compliance and physical activity assessment, identification of relevant determinants of behavior, goal setting, and the application of methods and strategies from the Lively Legs program

Eligibility Criteria:
Inclusion Criteria:

* Venous insufficiency
* Venous and arterial insufficiency
* Receiving treatment on outpatient clinics for dermatology at the moment of inclusion or in the past three months before inclusion

Exclusion Criteria:

* Total immobility
* Insufficient mental capacity
* Insufficient comprehension of the dutch language
Application Evaluation of Newborn Home Skin Care Management System Under the Service of "WeChat Platform+Health Care"

Through the establishment of the newborn home skin care management system under the service of "WeChat platform+health care", the investigators focus on the common skin problems of newborns at home, push health education materials through the system, teach parents the methods and details of home skin care, and evaluate the effect of the system on reducing the incidence of newborn home skin problems and the prognosis of home skin problems through cluster randomized controlled research.

In this study, the cluster randomization method is used, and eight centers are assigned to the experimental group or the control group according to the ratio of 1:1. Randomization plan is made by independent statistical team in statistical software: by creating random seed numbers and sorting them, the intervention plan distribution of each center is determined. The outcome evaluator and the statistical analysis team will not know the grouping situation of each center.

In this study, there are 4 centers in the experimental group and 4 centers in the control group. Sample size calculation is based on the main outcome index: the incidence of diaper dermatitis in newborns at home.

Eligibility Criteria:
Inclusion Criteria:

* Newborns born in normal delivery (gestational age ≧35w)
* Newborns' parents can cooperate, have certain learning, reading and understanding abilities, and have the ability to care for newborns
* Voluntary participation in this study.

Exclusion Criteria:

* Newborns requiring hospitalization.
* Newborns diagnosed with congenital skin diseases.
* The newborn mother has mental illness.
* The newborn mother has a serious illness and needs hospitalization.
A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers

The purpose of this study is to determine whether the intravenous administration of single- and multiple-ascending doses of Thymosin Beta 4 is safe and tolerable in healthy volunteers.

The cardio-protective effect of Tβ4 treatment was shown in a permanently ligated mouse model.The authors demonstrated that systemic Tβ4 treatment (intraperitoneal, intracardiac, or i.p. plus intracardiac) every third day enhanced early myocyte survival and significantly improved cardiac function. Several weeks after the heart attack, it was evident that mice treated with Tβ4 had less muscle damage and stronger hearts compared with mice treated with placebo. Specifically, Tβ4 treatment significantly improved fractional shortening by about 60% and ejection fraction by about 100% and myocardial salvage by about 53% when compared with controls.

Eligibility Criteria:
Inclusion Criteria:

* In good health with no underlying medical condition that, according to the Investigator, would place a subject at risk
* Having given written informed consent

Exclusion Criteria:

* Evidence of any malignancy
* Use of any tobacco product within 7 years of study entry
* Pregnant or lactating women
* History of drug abuse
* Clinically significant abnormal screening ECG
* Abnormal vital signs
* Use of systemic steroidal therapy), immunotherapy, cytotoxic, chemotherapy or any investigational drug or device within 30 days of study entry. Topical steroids are allowed
* Women, 40 years of age and above, who have not had a mammography within one year of study entry
* Men and women, 50 years of age and above, who have not had a sigmoidoscopy within 5 years and colonoscopy within 10 years of study entry