cyrilzakka/clinical-trials huggingface dataset:
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor

This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.

This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.

After diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. Patients were approached about study and if consented then were then randomized to placebo or nifedipine 30XL daily until delivery occurred.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by The American College of Obstetricians and Gynecologists (ACOG) criteria.
* Diagnosis of preeclampsia with severe features with decision made to induce labor. The patient may or may not have already received acute treatment for severe blood pressures.

Exclusion Criteria:

* Known allergy or adverse reaction to Nifedipine or any medical condition where Nifedipine is contraindicated, such as galactose intolerance, severe gastrointestinal (GI) structure, and GI hypomotility disorder.
* Currently receiving Nifedipine XL as part of hypertension management prior to induction of labor
* Participation in another trial that affects the primary outcome without prior approval
* Physician/provider or patient refusal
* Participation in this trial in a prior pregnancy
* Triplet or higher order pregnancy
Effects of the Physical Activity and Cognitive Training Program

Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities.

The purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.

1. to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
2. to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 year and older
* Able to communicate verbally
* Able to discern 5\*5 cm2 picture from a viewing distance of 20 cm
* Able to hear a sound of normal speech from a distance of 20 cm
* Able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort
* Has cognitive decline status assessing by CASI 2.0
* Lived in long-term care facilities during the study

Exclusion Criteria:

* Complete aphasia, blindness, deafness or completely dependent
* Unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression
* Thrombophlebitis, or malignancy of the limbs.
* Refusal by patient or family member.
* Others. Reason to be well documented.
Improving Newborn Survival In Southern Tanzania

This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design \& methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women living in the study area

Exclusion Criteria:

* Unwilling to participate
Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.

This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.

Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 yo and \<75yo
* Non progressive spinal cord injury
* Incomplete lesion (AIS C or D)
* Neurological level between C4 and L1
* Chronic stage (\>1 year since injury)
* Preserved walking ability for at least 5 m (aid allowed)
* Capability to provide informed consent
* For fertile women, possibility to use anti conceptive methods

Exclusion Criteria:

* Age \<18 yo or \>75
* AIS A, B or E
* Neurological level above C4 or below L1
* Subacute stage (\<1 year since injury)
* Preserved walking ability for less than 5 m (aid allowed)
* Pregnancy or breast feeding
* For fertile women, impossibility to use anti conceptive methods
* anticoagulant treatment
* Hypothyroidism
* Severe bone, kidney or liver disfunction
* Impossibility to reach the hospital
* Impossibility to rovide informed consent
Skin Autofluorescence (AF) Decision Tree in Detecting Impaired Glucose Tolerance (IGT) or Diabetes Mellitus (DM)

Early detection of (pre)diabetes, including impaired glucose tolerance is currently deficient because the best accepted standard, an oral glucose tolerance test (oGTT), is not feasible in a setting of screening or broad case-finding and other current methods lack in sensitivity. A previously reported study, and analysis of retrospective skin autofluorescence (AF) data, suggests that noninvasive skin AF may offer an alternative for detection of (pre)diabetes. The objective is to test the validity of a decision tree based on skin autofluorescence, and some simple clinical characteristics, as a detection tool for diabetes and impaired glucose tolerance. Sensitivity and specificity, positive and negative predictive value of this skin AF based decision model will be compared to those of fasting plasma glucose (FPG), glycated haemoglobin (HbA1c), and to two short questionnaires (Finnish Findrisk, and Cambridge score).

Study design: Skin AF, HbA1c and an oGTT (including an FPG) will be simultaneously performed in at least 120 persons with the characteristics described in the following paragraph. A Findrisk and Cambridge questionnaire will also be collected.


Eligibility Criteria:
Inclusion Criteria: -age \>20 years

* additionally a priori intermediate risk for IGT/diabetes: by having at least one criterion from the metabolic syndrome, or by at least once having had an increased glucose or glycated hemoglobin value in the preceding two years, but these outside the range of diabetes/IGT

Exclusion Criteria:-known diabetes mellitus

* use of oral antidiabetics for other purposes than diabetes such as hepatic steatosis
* local skin disease of the lower arm obviating skin autofluorescence measurement
* known serious renal insufficiency (s-creatinine \> 180 umol/l).
* inability to fill in questionnaires
A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults

The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status score: 0-1;
2. Histopathologically documented local advanced or metastatic breast cancer ;
3. Female of not childbearing potential must the related requirement;
4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
5. Adequate organ functions as defined;
6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
3. History of clinically significant cardiovascular or cerebrovascular diseases;
4. The subject has one of many factors affecting oral drugs;
5. Active infection or fever with unknown cause \> 38.5 °C;
6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
7. Known history of allergy to study drug ingredients.
Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation

The aim of this study was to investigate the consistency of NICU nurses' assessment of pain and sedation using NPASS in preterm infants in the NICU

The experience of pain is a common occurrence for infants in NICUs, with many undergoing painful procedures for diagnostic or therapeutic purposes. Effective pain management is a critical issue, as repeated painful experiences and stress in the early stages of life have the potential to have adverse short- and long-term effects on infant health. Although the importance of assessment and management of pain in neonates is well known, these practices still need to be improved in the NICU. Firstly, pain and sedation assessment with reliable tools is needed to provide adequate pain management practices. Because the evaluation of the pain and sedation level directs the treatment, thus avoiding inadequate or unnecessary treatment applied to the infants. However, the assessment of pain in newborns is a challenging endeavor, due to the inability of this age group to communicate, the existence of variations in pain responses based on age, the lack of training in the recognition of pain in premature infants, and the practical limitations of current assessment tools. Therefore, this study aimed to assess the inter-rater reliability of the N-PASS in a clinical actual setting. In this context, there needs to be consistency between assessors in pain assessment. As a result, the aim of this study was to investigate the consistency of NICU nurses' assessment of pain and sedation using NPASS in preterm infants in the NICU.

Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse in the NICU for at least six months and agreeing to participate in the study
* Preterm infant

Exclusion Criteria:

* Less than six months of NICU experience
* Term infant
Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement

This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 years and 85 years
* primary total knee replacement

Exclusion Criteria:

* obvious bone defect
* infection
* BMI\>\>35kg/m2
* severe osteoporosis
* mental disease
Managing Cyanosis Following Bidirectional Glenn Operation

The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005 who were significantly cyanotic.

Infants following bidirectional Glenn operation are at times significantly cyanotic. The medical management of significant postoperative cyanosis has changed with the advent of nitric oxide, sildenafil and bosentan. The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from Jan 1, 2003 to Dec 31, 2005 who were significantly cyanotic.

Summary of Procedures This is a retrospective study, therefore, the only procedure will be a chart review. I estimate the number of patients to be around 150, however, request permission to review the patient population in order to provide exact numbers. We request permission to review hospital charts from the time of bidirectional Glenn operation and the last clinic note within the dates Jan 1, 2003 to Dec 31, 2005.

We will assign each chart a unique study number and collect data of:

date of follow-up oxygen saturation during stay time since discharge 02 saturation at home home medications when discontinue medications

Eligibility Criteria:
Inclusion Criteria:

* Infants
* Bidirectional Glenn operation between 1/1/03-12/31/05
* Significant Cyanosis

Exclusion Criteria:

* Those who do not meet inclusion criteria.
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease.

In this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy.

The trial is double-blind, randomised and controlled.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known ulcerative colitis
* At least one prior flare of the disease
* Clinically and endoscopically active disease
* Age: 18 and above

Exclusion Criteria:

* Changes in azathioprine dosage within the last three months
* Patients with toxic megacolon, peritoneal reaction or severe colonic bleeding
* Known immunodeficiencies
* On-going infectious disease
* On-going treatment with NSAID or cholestyramine
* Pregnant og lactating women
Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation

This randomised study evaluates the efficacy of an oral dietary supplement of Hydrolyzed Collagen in reducing pain and improving physical function in subjects with osteoarthritis.

In recent years, research efforts have focused on interventions such as collagen supplementation as an alternative treatment for pain and physical function in patients with osteoarthritis. Hydrolyzed collagen (HC) is a mixture of collagen peptides with a molecular weight of less than 5,000 Da. It is obtained from the gelatinization and subsequent enzymatic hydrolysis of native collagen from animal tissues rich in this protein. In this line, several studies show that HC is more easily absorbed enzymatically, has a higher bioavailability, is distributed to joint tissues, and has analgesic and anti-inflammatory properties, consistently showing symptom-relieving effects, thus improving joint function and reducing joint pain, as well as optimizing the patient's quality of life. In this randomized pilot study, the investigators aimed to evaluate the effect on pain and other parameters related to physical function of an oral dietary HC supplement composed of lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin C), sucralose (sweetener) and stevia (sweetener). A 10.728 g dose provides 10 g of HC and 80 mg of vitamin C. Each placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation. Both the active and the placebo were manufactured by NutraResearch© SL (Barcelona, Spain) under Good Manufacturing Practices (GMPs).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis according to the clinical and radiographic criteria of the American College of Rheumatology.
* Pain score of at a minimum of 50 mm on a VAS scale of 0-100 mm

Exclusion Criteria:

* Presence of a previous cardiovascular event in the last 6 months.
* History of liver or kidney disease.
* Presence of medical condition requiring chronic treatment with drugs or other substances.
* Excessive alcohol consumption (\> 20 g/day) or substance abuse.
* Presence of intolerance or hypersensitivity to the food supplement or to any of its components in isolation.
* Use of any intra-articular injection in the anatomical area under study in the last 6 months.
* Treatment with symptomatic slow-acting osteoarthritis drugs (SYSADOA) in the last 3 months.
* Criteria listed in the Clinical Investigation Guideline for medicinal products used in the treatment of osteoarthritis published by the European Medicines Agency of the European Union in 2010 and radiographic osteoarthritis grade 4 according to the Kellgren-Lawrence classification system.
* Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism

This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in non-carious servical lesions in patients with bruxism. The lesions were restored with glass hybrid restorative (Equia Forte) or nano ceramic composite resin (Ceram-x One). Restorations were evaluated after 24 months according to USPHS criteria and the data were evaluated.

The aim of this study was to evaluate the clinical performance of a glass-hybrid-restorative compared with a nano ceramic composite resin in non-carious cervical lesions (NCCLs) of patients with bruxism.

For this purpose, twenty-five patients having NCCLs and bruxism enrolled to the present study. Before treatment, the dimensions of the NCCLs were measured in depth, gingival-incisal height and mesio-distal width using a CPI probe. Degree of tooth wear (TWI) and gingival conditions (GI) are also recorded. A total of 148 NCCLs were randomly restored with a a glass-hybrid-restorative system (Equia Forte Fil, GC, Tokyo, Japan) or a nano ceramic composite resin (Ceram.X One Universal, Dentsply, DeTrey, Konstanz, Germany) and restorations were evaluated at baseline and after 6,12 and 24 months according to the modified-USPHS criteria. Data were analyzed with Chi- Square, Fisher's Exact Test, Mann Whitney-U and Cochran's Q tests (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* non-hospitalized, healthy patients that were seeking dental treatmen
* occlusally contacted teeth

Exclusion Criteria:

* Patients having intensive medical history
* Chronic periodontitis,
* high caries activity,
* extremely poor oral hygiene,
* teeth with restorations,
* mobility due to periodontal disease
* in contacted with removable prosthetic construction were excluded from the study
Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19 Refractory to Other Treatments

Provide pre-approval single-patient Expanded Access (Compassionate Use) of VYD222 for patients with symptomatic COVID-19 refractory to other treatments.


Eligibility Criteria:
Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality Disorder

Mentalisation based treatment (MBT) for young people with co-morbid depression and emerging personality disorder will be more effective in a day/inpatient setting than treatment as usual.

Systematic literature review on outcomes with young people with depression and emerging personality disorder showed clear evidence that this group of young people are severely hampered and adult outcomes are strongly linked to both adult PD as well as adult psychiatric disturbance and lower levels of adult functioning. (Crawford et al, 2008; Kasen et al, 1999; Kasen et al, 2007; Lewinsohn et al, 1999) This argues very clearly for the need to diagnose young people presenting with co-morbid depression and emerging personality disorder in order to intervene and help these young people's struggles as it will prevent poor prognostic adult outcomes. There were no treatment programs that specifically focussed on the treatment of this co-morbid group in the literature. Several studies focussed on the treatment of depression alone and only one RCT focussed on the treatment of adolescent personality disorder (Chanen et al, 2007). In adult studies mentalization-based treatment programs were found to be effective ( as well as cost effective) in a day hospital setting for adults with personality disorder and depression (Bateman, et al, 2007) This study aims to conduct a control trial to test whether MBT will be more effective than TAU in this group. All cases will be tested on admission, at discharge and followed up at 2 years post discharge.

Eligibility Criteria:
Inclusion Criteria:

* all young people who are admitted to Brookside adolescent unit between the ages 12 - 17 presenting with depression and emerging personality disorder will be eligible

Exclusion Criteria:

* Young people with autistic spectrum disorders or severe learning disabilities.