cyrilzakka/clinical-trials huggingface dataset:
Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)

In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
* Affiliation to a social security scheme.

Exclusion Criteria:

* Minor or major women under guardianship or curatorship
* BMI \<18.5 (thinness)
* Ambulatory
* Several abortions on the duration of the study
* Take Mifepristone\> 48 hours before taking Misoprostol
* Contraindications to Misoprostol: Prostaglandin Allergy
EMA and mHealth in Preventing Postpartum Depression

This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA), mHealth-based psychological support, and CBT-guided telephone counselling to prevent postpartum depression (PPD).

The target participants are pregnant women between 20 and 28 weeks of gestation with a total EPDS-10 score of ≥7. Sixty participants will be actively recruited from the Department of Obstetrics and Gynaecology at Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. Recruitment will extend to other public hospitals if needed.

This study will be a three-arm (allocation ratio:1:1:1; permutated block size of 3, 6, and 9), single-blinded, parallel, pilot randomised controlled trial (RCT) with follow-ups at 2, 4, 6, and 8 weeks post-enrollment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. The EMA+IM group (group A) will receive an evidence-based intervention composed of brief psychological counselling and health education, 2-week EMA, mHealth-based psychological support, and CBT-guided telephone counselling, guided by comprehensive assessment. The EMA group (Group B) will only receive a 2-week EMA, and the control group (group C) will receive only brief psychological counselling and health education. Surveys will be collected via telephone after childbirth. Semi-structured individual interviews will be conducted with the participants in the intervention group to understand the experience and the perceptions towards the EMA data collection and mHealth-based intervention on mental health.

The primary clinical outcome of this study will be the difference in the EPDS scores between the two groups at 2 weeks postpartum. Secondary clinical outcomes will include differences in anxiety levels, stress levels, and insomnia symptoms at 2, 4, 6 and 8 weeks postpartum. Differences in participants' self-rated health, family functioning, family well-being and perceived happiness will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women who are in their 20 to 28 weeks of gestation,
2. Receiving regular antenatal care service in Hong Kong,
3. Had a total score ≥7 in EPDS-10 (suggesting potential distress symptoms),
4. Able to read and understand Chinese and use an instant messaging app weekly

Exclusion Criteria:

1) Pregnant women who are undergoing psychiatric/psychological treatment.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CP

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Cerebral Palsy

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cerebral Palsy

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety
* Previous organ transplant
* Seizure disorder
* Hypersensitivity to sulfur
An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications

The purpose of this study was to investigate the mortality and macrovascular morbidity as well as the incidence of malignancies over time, in high-risk diabetic participants who previously received long-term treatment with either pioglitazone or placebo in combination with their usual medication for glycaemic management.

This was a European,multicenter,observational study of participants who were previously treated with pioglitazone or placebo in addition to their existing anti diabetic medication. This 10-year observational study was conducted as a follow-up of PROactive study (NCT00174993) to investigate the CV and macrovascular effects observed with pioglitazone over time during PROactive.In this study,high risk T2DM patients previously enrolled in PROactive were analyzed for long-term incidence,nature, and pattern of all malignancies in pioglitazone and placebo-treated groups.This study enrolled 3599 participants.No treatment was prescribed by this protocol and participants will be managed in accordance with normal medical practice.The planned total duration of the study was 10 years,with data being analyzed and reported every 2 years.Participants were assessed at nominal visits every 6 months and every effort was made to obtain as much of the required information as possible.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the final visit of the PROactive Study (NCT00174993).
* Willingness and ability to give written informed consent for the observational study.

Exclusion Criteria:

* There were no exclusion criteria.
Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin

Large scale clinical trials have reported fluid retention and increase in plasma volume (6% to 7%) with glitazone therapy, with an increased incidence of peripheral edema occuring in 2% to 5% patients. Some evidence suggests that this effect may be related to increased endothelial cell permeability induced by glitazones therapy. Others report that glitazones may interfere with renal hemodynamics. In controlled clinical trials, the frequency of new onset congestive heart failure was very low in glitazones treated patients. The incidence of congestive heart failure is higher in patients receiving combination therapy with insulin and glitazones. Only few studies compared rosiglitazone and metformin on cardiac safety. Recently a study reported a reversible increase in endothelial cell permeability to albumin in cultured pulmonary arterial cells treated with rosiglitazone. To our knowledge, there is not any clinical study published for showing the reversibility of the cardiac adverse effects if the rosiglitazone treatment is continued.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus treated with oral hypoglycemic agents or diet only
* Without any symptom or finding of heart failure
* Normal liver enzymes and renal functions

Exclusion Criteria:

* Any known coronary artery disease, congestive hearth failure, renal disease or liver disease
* Any treatment for heart failure or diuretics for any reasons.
A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.


Eligibility Criteria:
Inclusion Criteria:

* Male patients of all ages with the diagnosis of severe congenital haemophilia A (coagulation Factor VIII \[FVIII\] activity less than 1%) based on medical records
* On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of transfer

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
* Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product
Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers

This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* No previous exposure to recombinant human GH (growth hormone)or IGF-I (insulin-like growth factor-I)
* Body mass index (BMI) 18.0-27.0 kg/m\^2 (both inclusive)
* Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator

Exclusion Criteria:

* The receipt of any investigational medicinal product within 1 month prior to this trial
* Current or previous treatment with recombinant human growth hormone or IGF-I
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law) for the duration of the trial
* Known presence or history of malignancy
* Diabetes mellitus
* Use of pharmacologic doses of glucocorticoids
* Use of anabolic steroids
* History of drug or alcohol abuse
Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.

Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parents of the patients who accept to participate and sign the informed consent
* Patients who have two first and/or second primary molars with caries affecting at least two surfaces
* Patients who are cooperative for the dental procedure

Exclusion Criteria:

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients with a systemic disease,
* Patients who have orthodontic treatment
* Teeth which have a short period of time for succedaneous teeth to erupt
* Teeth which need vital or non-vital endodontic treatment
* Patients and/or parents who does not accept the esthetic appearance of SSC
Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With CRSWD

The goal of this clinical trial is to learn the effectiveness of an intervention based on the Model of Occupational Harmony (MOHar) in treating patients with circadian rhythm sleep-wake disorders (CRSWD). The main questions it aims to answer are:

* Does intervention based on the MOHar can improve sleep quality in patients with CRSWD?
* Does intervention based on the MOHar can improve the quality of life in patients with CRSWD?

Researchers will compare intervention based on the MOHar to conventional treatment to see if the intervention works to treat CRSWD.

Participants will:

* Participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks)
* Complete questionnaires at 1, 3, and 6 months after the program for follow-up


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* meet the diagnostic criteria for CRSWD
* able to participate in research independently or with the assistance of a caregiver
* participate voluntarily in the study and sign an informed consent form

Exclusion Criteria:

* unable to cooperate with the study process due to cognitive, sensory, and motor dysfunction
* unable to skillfully use wearable monitoring devices or smartphones
* diagnosed with mental disorders such as anxiety and depression
* diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases
* have cardiac pacemakers
* being pregnant
* participating in other clinical trials
Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia

Studies have suggested that voluntary muscle exercise in the hand and face after botulinum toxin injection may enhance the clinical effects of the toxin. Exercise may speed up the absorption of the toxin by the nerves and enhance the clinical response. This study will explore the effect of exercise on botulinum toxin injections for spasmodic dysphonia (SD).

SD is a rare voice disorder that usually starts when individuals are in early adulthood and occurs in two common forms: adductor and abductor (Aronson, 1968, Brin et al., 1992, Schweinfurth et al., 2002). Adductor is the more common form (Aronson, 1985, Blitzer et al. 1998). With adductor SD, patients have been described as "trying to talk whilst being choked" (Critchley, 1939). The spasmodic hyperadduction of the vocal folds is associated with strained-strangled, rough voice quality and sudden intermittent voice arrests (Aminoff, Dedo, \& Izdebski, 1978, Blitzer \& Brin, 1992, Hillel, 2001, Izdebski 1992, Ludlow, Nauton, \& Bassich, 1984, Woodson, Zwirner, Murry, \& Swenson, 1991). On the other hand, the intermittent or continuous abduction of the vocal folds linked with abductor SD results in breathy or whispered voice quality with sudden intermittent voice arrests (Aronson, 1985, Hillel, 2001, and Zwitman, 1979).

Local injection of botulinum toxin is an effective treatment for spasmodic dysphonia and The National Academies of Otolaryngology and Neurology has endorsed the toxin as the treatment of choice for adductor spasmodic dysphonia. Consequently, this treatment is widely used. The clinical benefit of the botulinum toxin is related to muscle weakness in the vocal folds and the benefit lasts from 6 weeks to 6 months.

Studies have suggested that voluntary muscle exercise in the hand and face after botulinum toxin injection may enhance the clinical effects of the toxin (Chen, Scott, \& Smith, 2002; Chen et al., 1999; Kim et. al 2003;. Exercise may speed up the absorption of the toxin by the nerves and enhance the clinical response. You are invited to take part in a research study to learn more about the effect of exercise on botulinum toxin injections for spasmodic dysphonic. This project will examine whether or not exercise performed immediately following botulinum toxin injection affects the clinical benefit received from the injection.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of adductor spasmodic dysphonia
2. receiving ongoing botulinum toxin injections for a minimum of 1 year
3. improvement in voice to at least 70% following each of the last three injections

Exclusion Criteria:

1. other neurological disorder
2. other dystonia
3. upper respiratory infection in the last two weeks
4. analgesia at time of injection
5. illiterate
6. under 18 years of age
Bergen Psychosis Project 2 - The Best Intro Study

In the Bergen Psychosis Project 2 the antipsychotic drugs aripiprazole, amisulpride, and olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses and followed for 12 months. The study is independent of the pharmaceutical industry, and in accordance with a pragmatic design a clinically relevant sample will be included with as few exclusion criteria as possible. The patients will be assessed repeatedly with regards to symptoms, side effects, and cognitive functioning, as well as laboratory parameters. The study hypothesis is that clinically meaningful differences among the drugs will be disclosed in a pragmatic design.


Eligibility Criteria:
Inclusion Criteria:

A:The observational cohort

* Patients 16 years old or older
* Active psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).
* Or ICD-10 diagnosis corresponding to psychotic disorders or other mental disorders with psychotic features (F10-F19: .5 (psychotic disorder); F20-F29, F30.2, F31.2, F31.5, F32.3, F33.3). From which eligible patients are recruited to the B:The pragmatic, randomized, controlled trial (The Best Intro Study)
* Patients 18 years and older
* Schizophrenia spectrum and delusional disorder
* Symptoms of psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).

Exclusion Criteria:

* Inability to understand spoken Norwegian.
* Patients with organic psychosis due to limbic encephalitis detected by antibodies in serum obtains at inclusion (such as NMDAR, VGKC and paraneoplastic antibodies performed at the Neuroimmunology Laboratory, Department of Neurology, Haukeland University Hospital) Pregnant or breast feeding women.
* Aripiprazole: Hypersensitivity to the active substance or to any of the excipients
* Amisulpride: Hypersensitivity to the active ingredient or to other ingredients of the medicinal product; concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaeochromocytoma; lactation, combination with the following medications which could induce torsade de pointes: Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide. Class III antiarrhythmic agents such as amiodarone, sotalol. Other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin. Combinations with levodopa.
* Olanzapine: Hypersensitivity to the active substance or to any of the excipients. Patients with known risk of narrow-angle glaucoma.
Team, Competence and Safety Climate in the Operating Room

The main objective is to explore and evaluate the effect of a change in the WHO checklist on the safety climate in the operating room at a University Hospital in Gothenburg.

This study will assess the underlying safety climate in one operating ward at Sahlgrenska University Hospital, Göteborg. The Safety Attitude Questionnaire (SAQ) Operating Room version will be used to assess baseline safety climate. The use of the WHO check list will be investigated and documented according to a pre-defined CRF (case record form).

After this evaluation, changes in the WHO checklist will be performed. The changes will include educational efforts and involving focus groups to receive suggestions on improvements of the WHO checklist. The revised version of the WHO checklist will be implemented. To evaluate effects of the changes the SAQ will once again be distributed to the involved personnel.

The main objective is to explore, describe, educate and thereby improve the safety climate in the operating room. The setting is one of the operating room departments in Sahlgrenska University Hospital Gothenburg. The project includes to following parts:

* To assess baseline regarding the safety climate at a surgical ward at the Sahlgrenska University Hospital.
* Educational efforts on safety climate, team work, communication, and WHO check list by lectures and focus group discussions involving the OR team members to get input and suggestions on improvements of the WHO checklist.
* To explore differences in safety attitudes between different professions working in the OR.
* To identify areas for improvement in team work, communication and other non-technical skills.
* To re-implement the WHO check list with the aim to obtain more focus on the importance of teamwork and knowledge about the patient and procedure.
* To compare results from SAQ after implementation of safety related objectives with SAQ baseline data.

Eligibility Criteria:
Inclusion Criteria:

* Health care personnel working in the OR at Sahlgrenska University Hospital Östra, general surgery

Exclusion Criteria:

* All other health care personnel