cyrilzakka/clinical-trials huggingface dataset:
The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing

Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of nonreactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important.

Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of non-reactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important. Stress ball is one of the nonpharmacological methods in the management of pain, stress and anxiety based on the logic of drawing the attention of the person to a different side and is an application for the sense of touch. In the obstetric field, there have been studies evaluating the effects of stress ball application on labor and vascular pain of pregnant women, but there is no study evaluating anxiety, comfort and NST parameters during NST.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-35,
* Turkish as the mother tongue,
* Being literate, having a singleton pregnancy,
* She has had NST at least once before,
* 32 weeks or more gestation,
* Being multiparous,
* Having eaten at least two hours before the NST procedure,
* Volunteering to participate in the research.

Exclusion Criteria:

* Having a high-risk pregnancy,
* Having a psychiatric disorder,
* Being pregnant with an urgent NST result,
* Smoking or drinking alcohol at least two hours before the NST procedure,
* Having any problem that prevents communication (such as hearing, speaking, ability to understand), having a visual, hearing, speech, physical or mental disability.
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome

The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.


Eligibility Criteria:
Inclusion Criteria:

1. Elective surgical intervention
2. Patients must be 18 years or older
3. Ambulation
4. ASA-Score I-IV
5. bioelectrical impedance analysis to determine the phase angle

Exclusion Criteria:

1. Emergency surgery
2. Pregnancy
3. ASA Score V-VI
4. Amputated limbs
5. Pacemaker and defibrillators
6. Cerebrovascular events
7. Tattoos on the electrode locations
Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors

The aim of this study was to evaluate the clinical success of modified celluloid strip crown restorations applied using interim therapeutic restoration and high-viscosity glass ionomer cement to the maxillary anterior teeth of children with early childhood caries and cooperation problems.

Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds. Clinical evaluations will be done at the 3rd, 6th and 12th months.

Eligibility Criteria:
Inclusion Criteria:

* Read the informed consent form and agree to participate in the study
* Healthy children, aged 2-6 years
* Presenting at least one primary anterior tooth with a class I, II, IV or V caries lesion

Exclusion Criteria:

* Uncooperative children
* The need for vital or non-vital endodontic treatment in the primary tooth to be treated
* Previously restorated tooth
* Presence of bruxism, Class III occlusion or deep bite
Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea

Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects women in low income countries. Despite the strengthening of research on fistula, there is little data on the follow-up after fistula repair.

The objective of this study is to analyse the factors associated with the recurrence of fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé Regional Hospital and Jean Paul II Hospital of Conakry).

The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest will include patient characteristics, fistula characteristics, the context of repair and the context of reintegration.

Participants giving an informed consent after a home visit by the Fistula Counsellors who managed women during surgery will be interview at enrolment and every six month from inclusion. The study duration is estimated at 48 months (January 2012 to March 2016) including the retrospective part.

A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2% margin of error (width of confidence interval is 4%) and 95% confidence interval and is sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10% precision.

The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier methods and the risk factor analysis will be performed using adjusted cox regression.

For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions of pregnancy outcomes between potential predictors and logistic regression models will be used and associations will be reported as risk ratios with 95% confidence intervals.

Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA) with a level of significance set at P\<0.05.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible, study participants must meet the following criteria:

* Had a fistula closed at discharge, as measured by a dye test (this include women dry and those with residual incontinence);
* Willing and able to provide written informed consent (assent for minors);
* Had a urinary or recto-vaginal fistula;
* Agree to participate in follow-up visits (every six months) from consent date and for the duration of the study;
* Agree to stay in Guinea for the duration of the study.

Exclusion Criteria:

Potential participants meeting any of the following criteria will not be enrolled in the study:

* Refusal to give free and informed consent;
* Surgery done outside the study sites;
* Incomplete medical records;
* Incontinence unrelated to urinary or recto-vaginal fistula.
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:

Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.

Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

Prospective study mono-centric, controlled, randomized cross over. Randomization of the equipment (without and with SmartDrive).

22 SCI manual wheelchair users. 22 caregivers (healthy subjects)

Eligibility Criteria:
Inclusion Criteria:

* men and women aged between 18 and 70 years
* spinal cord injury
* having given free and informed consent

Exclusion Criteria:

* No affiliation to a social security scheme
* Refusal to participate in the clinical trial
* Patient under guardianship
* Major cognitive disorder
* Bedsores
* Acute complication or systemic organ
Air Tamponade and Non-supine Positioning in Macular Hole Surgery.

This is a prospective, multicenter, randomized non-inferiority trial, where the macular hole closure rate with intraocular air tamponade is compared to the closure rate with gas tamponade.The patients are randomized to receive either air or gas (26% SF6) as intraocular tamponade, just prior to the intraocular flushing of the tamponade during the vitrectomy procedure. Postoperatively, the patients adhere to the nonsupine regimen for three days, and the tennis ball technique is used during sleep to enhance patients' positioning compliance.


Eligibility Criteria:
Inclusion Criteria:

* Primary macular hole ≤ 400 μm
* Duration no more than 24 months
* Able to sign informed content
* Signed informed content

Exclusion Criteria:

* Earlier vitreoretinal surgery in present eye
* Secondary macular holes caused by other conditions than vitreomacular traction
* Myopic macular hole, i.e. excessive myopia (more than -6 dioptres)
* Posttraumatic macular hole
* Macular holes secondary to retinal detachment or other retinal diseases
* Surgery under general anesthesia
* Visual acuity below 20/40 in fellow-eye
Study on the Therapeutic Effect of TCM Treatment for MDR MN

To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.

Based on previous research, the investigators hoping to identity the standard treatment program for MDR IMN patients with high treatment difficulty, TCM syndrome of s Pixushuifan. Subsequently, to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. With twenty national-grade III hospital of to formed TCM Comprehensive treatment plan and to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. Furthermore, search for potential diagnostic predictor in IMN by Proteomics and Metabolomics. The investigators purpose is improve the clinical remission rate of MN, further establish the treatment of TCM in the treatment of MN.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years;
2. Gender, nationality;
3. Pixushuifan syndrome, IMN confirmed by renal biopsy and clinical examination;
4. Treatment invalided by two or more than two kinds of Hormone or immunosuppressive agents ;
5. CKD phase 1-3（eGFR（EPI Formula）≥30ml/min/1.73m2）

Exclusion Criteria:

1. Progressive MN (progressive renal impairment, renal biopsy confirmed Necrotic Vasculitis and Large crescent formation\>50%), combined with IgA nephropathy, diabetic nephropathy and other renal diseases;
2. Anti-nuclear antibodies, double stranded DNA, ANCA or other indicators of immune disorders;
3. Active hepatitis B and liver function test sustained abnormal;
4. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases;
5. Merger with other serious disease and dysfunction of the organ;
6. Gravid or lactation woman;
7. Other clinical trials are being studied.
Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers

The objectives of PROVIDE are to:

1. Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive
2. To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms
3. To determine the safety of taking weekly prophylactic hydroxychloroquine


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older to participate.
* Healthcare workers with primary practice in intensive care unit, general internal medicine,
* COVID-19 testing centres, emergency rooms, and nursing homes.
* COVID_19 symptom free at the time of randomization and have a negative diagnostic swab.

Exclusion Criteria:

* Known COVID-19 positivity defined as: a laboratory confirmed case as defined by the local public health institutes
* Suspected COVID-19 positivity defined as possessing symptoms consistent with COVID-19 infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough
* Healthcare workers with pre-existing retinopathy or serious visual problems
* Healthcare workers with known malignancies receiving active chemotherapy or immune modifying medications
* Healthcare workers with known autoimmune disorders
* Healthcare workers with known QT prolongation
* History of ventricular arrhythmias
* Participants at risk of malignant arrythmias ○ At risk defined as: A sudden loss of consciousness with injury; anyone in their immediate family, under the age of 45year, with sudden cardiac death; anyone family history of long QT syndrome

  * Known sensitivity/allergy to hydroxychloroquine
  * Healthcare workers that are currently pregnant
  * Healthcare workers that are already taking chloroquine or hydroxychloroquine
  * Healthcare workers on colchicine or any other anti-viral medication
  * Healthcare workers taking a medication that may interact with hydroxychloroquine (see table below
  * Inability to take oral medications
  * Inability to provide written consent
  * Known G6PD deficiency
Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain

The aim of the study is to evaluate the efficacy and safety of matrifen in patients with severe and chronic pain who can only be sufficiently treated with opioid analgesics (WHO class 3).


Eligibility Criteria:
Main inclusion criteria:

* Patients with severe, chronic pain

Main exclusion criteria:

* Hypersensitivity of fentanyl
* Co-administration of monoaminooxidase-inhibitors
* Pregnancy
* Respiratory depression
* Chronic obstructive pulmonary disease (COPD)
* Drug abuse
* Impairment of CNS functions
* Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Eligibility Criteria:
Inclusion Criteria:

* Brazilian patients with metastatic non-small cell lung cancer.

Exclusion Criteria:

* Small cell lung cancer and non-metastatic patients.
Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial

Nerve blocks are an effective way to control pain after surgery. There are two major nerves that provide sensation to the knee: the femoral nerve provides sensation to the front of the knee and sciatic nerve provides sensation to the back of the knee. The femoral nerve has two branches. To locate the nerve, we use a machine called (Nerve stimulator) which is attached to the needle used for nerve block. Use of a nerve stimulator is standard practice for this procedure. Ultrasound is being increasingly used to locate nerves but is not used universally. We will use the nerve stimulator and ultrasound to locate the femoral nerve but patients will randomly be selected to enter a group looking at the stimulation of one or the other branches of the femoral nerve. The two branches when stimulated produce different muscle contractions in the thigh. We do not know from research which is the optimal contraction to position the needle to get the best block. After the knee replacement patients will still have the same analgesic medication available as patients would have received if they were not in the study.

To determine if needle insertion at the inguinal crease with stimulation of sartorius muscle (anterior branch) causes an equivalent block to the classical method with stimulation of the quadriceps femoris muscle (posterior branch), for femoral nerve blockade. To test this hypothesis, we plan to conduct a randomised controlled double-blind study comparing success of femoral never block (motor and sensory) using sartorius twitch versus quadriceps femoris twitch as an end point.

We will also evaluate the local anesthetic distribution under the facia iliaca sheath using ultrasound imaging.

Methods: Following institutional ethical approval and obtaining written informed consent, we plan to recruit 60 patients aged 18-80, ASA I-III scheduled to undergo unilateral total knee arthroplastly in this prospective, randomised, double blinded controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80
* ASA Status I-III
* Unilateral total knee arthroplasty Patients

Exclusion Criteria:

* Patients with a history of significant medical or psychiatric problems
* Patients with BMI \> 35
* Unable to cooperate with the study protocol or unable to understand English
* Had allergy to local anaesthetics or fentanyl
* Prior surgery in the inguinal region
* Sensory or motor disease
* Diabetic neuropathy.
Optimal Haloperidol Dose for Postoperative Nausea and Vomiting Prevention in High-risk Patients

Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.

Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II women
* Aged 20 65 years, and scheduled for gynecologic laparoscopic surgery and IV patient-controlled analgesia (PCA) for postoperative pain control.

Exclusion Criteria:

* Known allergy or intolerance to the study drug
* History of cardiac arrhythmia
* Psychiatric illness
* Chronic treatment with a dopamine antagonist
* Use of opioids or steroids within one week of surgery
* Use of antiemetic within 24 hours before the study
* No ability to use the PCA device
* Gastrointestinal, renal, or hepatic disease
* Insulin-dependent diabetes or obesity with a body mass index \> 35 kg/m2.
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Women and men age 18 and older.
* Diagnosis of type 1 diabetes within 2 years of randomization.
* Peak stimulated C-peptide levels ≥ 0.15 ng/mL.

Exclusion Criteria:

* Anticipated ongoing use of diabetes medications other than insulin.
* Evidence or history of diabetic complications with significant end-organ damage.
* Episode of severe hypoglycemia within 60 days of randomization.
* Multiple hospitalizations for diabetic ketoacidosis.
The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study

After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.

The pupils inside the eyes constrict in response to light stimulation. Different classes of cells within the human retina initiate this response. Recent research suggests that one of the ganglion cell types involved in this pupil response also plays a role in the photophobia experienced by migraine sufferers. The main aim of this study is to determine whether this type of ganglion cell becomes 'hypersensitive' after traumatic brain injury, thereby contributing to symptoms of increased photosensitivity experienced by many of these individuals.

In the first session of this study, subjects will be asked questions about their sensitivity to light and the reaction of their eyes' pupils to flashing red and blue lights will be measured. The subjects will be given a full eye examination to rule out other causes of increased photosensitivity.

In some cases, subjects will be asked to attend a second session roughly two weeks later. They will be asked to wear a watch that measures their daily activity/sleep rhythms and light exposure during this inter-session period. During the second session, further testing of the pupil responses to blue and red flickering light will be performed.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* reports a previous head injury that occurred at least 6 months ago
* score of 2 or 3 (mild TBI) on OSU-TBI ID Survey
* best-corrected visual acuity of at least 20/30 in both eyes
* reliable visual field

Exclusion Criteria:

* pregnancy
* significant afferent pupillary defect
* previous history of neurodegenerative disease
* intraocular pressure more than 21 mm Hg
* significant visual field defect
* active corneal pathology
* history of retinal or optic nerve disease
* strabismus (eye turn)