cyrilzakka/clinical-trials huggingface dataset:
A Pilot RCT on the Management of Term Prelabour Rupture of Membranes

This is a pilot study that will eventually result in a main randomised controlled trial that will look at what management is associated with a higher rate of normal birth and a lower rate of chorioamnionitis (maternal infection) when women break their waters but labour does not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks gestation) is a physiological event that happens during labour. However, according to Gunn et al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time between the rupture and the onset of labour is called latent phase and time wise is variable.

Studies have showed no statistically significant differences in terms of neonatal infection or chorioamnionitis when the investigators induce labour with prostaglandins compared to when labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number of confounding factors that might relate to the incidence of chorioamnionitis (maternal infection), the strongest predictor was having more than 8 vaginal examinations since the rupture of membranes and before delivery which was a stronger predictor than the duration of the latent phase. It is thought that by reducing the number of internal examinations, chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main RCT will compare clinical outcomes and maternal satisfaction when women consent to be randomized to four groups: (1) Active management and routine internal examinations during labour, (2) Active management and reduced internal examinations, (3) Expectant management and routine internal examinations, (4) Expectant management and reduced internal examinations.

This application seeks ethics approval for the pilot phase to ensure that a definitive study can be undertaken appropriately. It is important to test that all the components work well individually and as a whole, to estimate sample size and ultimately to test the integrity of the research protocol before embarking on the main trial.


Eligibility Criteria:
Inclusion Criteria:

* Prelabour rupture of membranes (confirmed)
* Term pregnancy - from 37+0 till 41+2 weeks gestation (both inclusive)
* Normal/Low risk pregnancy
* Singleton, cephalic pregnancy
* No known current infectious diseases
* Aged 18-45 years old
* Understands English and is able to read and write in English
* Agree for their placentas to be sent to histology if clinical signs of infection
* Not taking part in other clinical research at present
* Consent to take part

Exclusion criteria:

* Pregnancy of 36+6 or less or 41+3 or more weeks gestation
* Breech or oblique presentation
* Twin or multiple pregnancy
* Previous caesarean section
* Meconium stained liquor
* Pre-eclampsia
* Diabetes
* Known to be colonised by Group B streptococcus
* Current infections: HIV, Hepatitis B, Herpes
* Doesn't give consent for the placenta to be sent to histology if clinical signs of infection
* Not able to understand, read or write in English
* Currently taking part in other clinical research
Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation

About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
2. Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
3. The acetabular component must have a minimum outer diameter of 50 mm.
4. The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
5. Patients must be able to reply to questionnaires in either French or English.

Exclusion Criteria:

1. Patients who are undergoing revision for recurrent dislocation.
2. Revision of the acetabulum requiring structural allograft or reconstruction ring.
3. Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
4. Revision of the acetabulum using a liner cemented into an existing metal shell.
5. Intra-operative decision to use a constrained liner.
Effect of Increased Positive End-expiratory Pressure on Intracranial Pressure in Different Respiratory Mechanic in Acute Respiratory Distress Syndrome

There are concerns that the use of positive end-expiratory pressure (PEEP) for the treatment of pulmonary complications in patients with brain injury may potentially elevate intracranial pressure (ICP), and deteriorate neurological status. It is suggested that both respiratory system compliance and ventricular compliance would contribute to the elevation of ICP when PEEP increases. In theory, PEEP may cause elevation of ICP by increasing intrathoracic pressure and diminish venous return. However, the transmission of PEEP into thoracic cavity depends on the properties of the lung and chest wall. Experimental study showed that when chest wall compliance is low, PEEP can significantly increases intrathoracic pressure; whereas low lung compliance can minimize airway pressure transmission. It is generally recognized that the lung compliance decreases in acute respiratory distress syndrome (ARDS) patients due to extensive alveolar collapse. However, it has been report that the elastance ratio (the ratio between elastance of the chest wall and the respiratory system, where elastance is the reciprocal of compliance) may vary from 0.2 to 0.8. Therefore, it is important to distinguish the compliance of the chest wall and the lung when investigating the effect of PEEP on ICP.

Because intrathoracic pressure (pleural pressure) is difficult to measure in clinical situations, esophageal pressure (Pes) is considered as a surrogate of intrathoracic pressure. In the present study, the investigators determine the effect of PEEP on intrathoracic pressure and ICP by Pes measurement.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and above;
2. Glasgow Coma Score ≤ 8;
3. Ventricular ICP monitor was placed for ICP monitoring and cerebrospinal fluid (CSF) drainage;
4. Need for mechanical ventilation with PEEP;
5. ARDS was diagnosed according to Berlin Definition.

Exclusion Criteria:

1. Hemodynamic instability requiring more than 10 μg/kg/min dopamine or more than 0.5 μg/kg/min norepinephrine;
2. ICP \> 25 mmHg;
3. Esophageal varices;
4. History of esophageal or gastric surgery;
5. Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;
6. History of chronic obstructive pulmonary disease.
Beta Blocker Therapy in Mild to Moderate Asthmatics

Current asthma medicines include inhalers. A common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the airway causing it to widen. Although these drugs are useful short term, long term use can make asthma worse in some people.

'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks.

The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. These work by dampening down the inflammation in the lungs that occurs in asthma.

New research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. At the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids.

In this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.


Eligibility Criteria:
Inclusion Criteria:

* Stable mild to moderate asthma
* Histamine PC20 \</= 8mg/ml
* Receiving inhaled corticosteroid 0-1000ug daily (BDP equivalent dose)
* FEV1 \> 60% predicted
* Diurnal variability \< 30%
* Reliever use \</= 8puffs/day
* ECG demonstrating sinus rhythm

Exclusion Criteria:

* Uncontrolled symptoms of asthma
* Systolic BP\<110mmHg
* Heart rate\<60bpm
* Pregnancy or lactation
* Heart block
* Heart rate limiting medications currently prescribed
* Asthma exacerbation within 6 months of study commencement
Predicting Difficult Airway in Children

Background: Obtaining airway security holds the utmost importance in anesthesia. Specific predictive tests or findings for difficult airway are not defined for various pediatric age groups. Anthropometric measurements are defined parallel to percentile curves in different age groups.

Aim: The aim of this study is to find out the value of body mass index and anthropometric measurements in prediction of difficult laryngoscopy in children by comparing to direct laryngoscopic evaluation of Cormack-Lehane test.

Methods: Following institutional ethics committee approval and informed consent of parents of 108 patients (ages 0-3years), undergoing elective surgery were included in this study. Weight, height, body mass index and head circumference of the patients were measured and percentiles were recorded, prior to induction.

Following standard anesthesia induction with thiopental all patients received 0,6 mg.kg-1 rocuronium intravenously. After sufficient time for neuromuscular relaxation laryngoscopy performed and Cormack-Lehane scores recorded. All recorded parameters were compared with Cormack-Lehane scores.


Eligibility Criteria:
Inclusion Criteria:

* 0-3 years old (1-36 mounts) pediatric patients
* Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study

Exclusion Criteria:

* Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study
Physical Activity, Life Satisfaction and Medication Adherence in Older Adults

This study will examine the relationships between physical activity, life satisfaction, and medication adherence in elderly individuals with chronic diseases. The research will involve participants aged 65 and above, using the The Physical Activity Scale for the Elderly scale to assess physical activity, the Turkish version of the Satisfaction with Life Scale for life satisfaction, and the Modified Morisky Scale for medication adherence.

The Physical Activity Scale for the Elderly will be used to assess the physical activity levels of geriatric patients. Life satisfaction will be measured using the Turkish version of the Satisfaction with Life Scale, and medication adherence will be evaluated with the Modified Morisky Scale. The data collection will involve forms, including a Sociodemographic Information Form, the Physical Activity Scale for the Elderly, Turkish version of the Satisfaction with Life Scale, and the Modified Morisky Scale, all of which will be digitized using Google Forms. The Google Forms link will then be shared via email by the researchers with individuals who have elderly family members. Before starting to complete the scales with older patients who meet the inclusion and exclusion criteria, they will be informed about the study's purpose, the forms involved, and the time required for completion.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Voluntarily participating
* Having at least one chronic disease such as hypertension, diabetes mellitus, or hyperlipidemia
* With prescribed medication for the medical treatment of their diagnosed chronic disease

Exclusion Criteria:

* Presence of chronic neurological diseases such as Multiple Sclerosis (MS), Parkinson's Disease, or Amyotrophic Lateral Sclerosis (ALS)
* Any oncological disease
Splenic Surgery for Hydatid Spleen in Single Institutional Experience

Splenic-preserving surgery in hydatid spleen: Single intuitional experience

Background:

Although hydatid disease affects many organs in the human body, splenic hydatid represents about 0.8-4% of all human echinococcosis cases. Until recently, splenectomy was the recommended surgical procedure for splenic hydatid. Since 1980 there has been an increasing tendency to use conservative option to deal with such pathology.

Aim of the study:

To evaluate our experience in open splenic-preserving surgery for splenic hydatid in a single institutional study.

Patient and methods:

A retrospective study. Ten patients with splenic hydatid were operated upon from August 2013 to January 2018 in our medical centre. Spleen has affected alone in 7 cases, liver and spleen were affected in 3 cases, and one of them had intraperitoneal cyst affection in addition. The diagnosis confirmed mainly by ultrasonography. In some cases, it computed tomography CT scan, and magnetic resonance imaging MRI were needed. Chest X-ray had taken for all patients to exclude pulmonary hydatid. The open surgical procedure used. Isolation of the field, aspiration of cystic fluid and injection of 1% cetrimide solution, re-aspiration, endocystectomy, suturing of cystic edges over intracystic tube drain. All surgery did under cover of albendazole pre and postoperative 15mg/kg/day.

Results:

No significant intraoperative and postoperative complications. No reoperation was needed. Hospital stays 3-5 days. No recurrence after (1-3) year follow-up. However, three patients missed follow-up after two years.

Conclusion:

Our experience in splenic hydatid encourages us to use splenic-preserving surgery whenever possible instead of splenectomy.

Eligibility Criteria:
Inclusion Criteria:

Single hydatid spleen Primary spleen hydatid

-

Exclusion Criteria:

* Multiple splenic hydatid Rupture hydatid spleen
Protopic Ointment in Children Atopic Eczema

Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.

Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.

Eligibility Criteria:
Inclusion Criteria:

* Children with moderate to severe atopic dermatitis (Rajka \& Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
* Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
* Informed consent
* Therapeutic washout for atopic dermatitis treatments

Exclusion Criteria:

* Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
* Any female patients who were pregnant or breast-feeding
* Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
* Superinfected eczema
* Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment
* Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
* Ulcerated lesions, of whatever type
* Moderate to severe acne or rosacea
* Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
* substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
* Known serologically proven HIV positivity
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.

Eligibility Criteria:
Key Inclusion Criteria:

* Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
* Signed a valid, IRB approved informed consent form

Key Exclusion Criteria:

* Meets any contraindication in BSC Indirect Decompression Systems local IFU
Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

OBJECTIVES:

Primary

* Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
* Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a non-myeloid malignancy
* Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
* Hemoglobin no greater than 11.0 g/dL
* 18 and over
* ECOG 0-2
* Bilirubin less than 2 times upper limit of normal (ULN)
* Creatinine less than 2 times ULN
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* More than 30 days since prior darbepoetin alfa or epoetin alfa
* More than 30 days since prior participation in investigational device or drug trials

Exclusion Criteria:

* The following diagnoses are excluded:

  * Acute myeloid leukemia
  * Chronic myeloid leukemia
  * Acute lymphoblastic leukemia
  * Hairy cell leukemia
  * Burkitt's lymphoma
  * Lymphoblastic lymphoma
* other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
* angina
* congestive heart failure
* New York Heart Association class III or IV heart disease
* hypertension
* cardiac arrhythmia
* other unstable or uncontrolled disease or condition that would affect cardiac function
* pregnant or nursing
* known seizure disorder
* known sensitivity to study agents
* clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
* confirmed neutralizing antibodies to epoetin alfa
* other disorder that would preclude study compliance or giving informed consent
* other concurrent epoetin alfas
* prior randomization to this study
* other concurrent investigational agents or procedures
Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants

NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.

Additional for healthy Japanese participants:

* First generation Japanese (Japanese born participants).

Exclusion Criteria:

* HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening.
* Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:

  1. Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) +10%
  2. Aspartate aminotransferase (AST) \> UNL+20%
  3. Total bilirubin \> UNL+20%
  4. Creatinine \> UNL+10%
  5. International normalised ratio (INR) \> UNL
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears

* The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma(PRP) and conventional rotator cuff repair in treatment of large to massive rotator cuff tears.
* PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.


Eligibility Criteria:
Inclusion Criteria:

large to massive rotator cuff tear as a determined by clinical examination and MR prior to surgery.

Exclusion Criteria:

* previous history of shoulder surgery
* acute trauma
* chronic dislocation
* pyogenic infection
* rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
* showed abnormal serological test results
* thrombocytopenia (platelets less than 15000 per microliter)
* had been received anti-platelet medication
* psychiatric problems that precludes informed consent or inability to read or write
* other serious problems that preclude participation of the study