cyrilzakka/clinical-trials huggingface dataset:
Effects of Massage With Peppermint Oil on Labor Pain

Birth is a very special experience for a woman and her family. Labor pain is one of the strongest known and defined pains today. In the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration.

When birth pain is not controlled, the vicious cycle of stress, fear and pain can continue and affect the mother and fetus negatively.

In this study, our aim is to determine the effect of applying peppermint oil diluted with pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the labor pain.

The study is a Prospective Cross-sectional Case Control study. Pregnant women whose mother tongue is Turkish, who are term pregnant and who are in active labor, who are hospitalized in the delivery room of our hospital for delivery, that is, who have a gap of at least 70% 5-6 cm in the examination and who have at least 4-5 severe contractions in 10 minutes, who have a single, vertex-presented fetus will be included in our work. Pregnant women with co-morbidities, chronic diseases, complications related to childbirth, anemic inactive labor, thyroid disease, skin lesions or infections, allergies, multiple pregnancies, use of any medication, and risky pregnancy will be excluded from the study.

For this, 30 pregnant women who were applied peppermint oil and 30 control group pregnant women who were not applied will be included in the study. Following the signed consent form obtained from our patients, visual analog scoring (VAS) will be provided to the patient during the painful period, and then peppermint oil will be applied to the abdomen and lumbar region where he feels the most pain, with 1/10 diluted peppermint oil by hand massage or with the help of a compress moistened with warm water. After the application, visual pain scoring will be applied to pregnant women again.The study is terminated when sufficient data is obtained.

The data will be entered into the computer in the SPSS program.

Eligibility Criteria:
Inclusion Criteria:

* normal pregnant with vertex presentation
* at least 70% 5-6 cm gap in the examination at least 4-5 severe contractions in 10 minutes
* Turkish-speaking

Exclusion Criteria:

* Pregnant women with co-morbidities, chronic diseases
* complications related to childbirth
* inactive labor
* anemic, thyroid disease, skin lesions or infection, allergies, multiple pregnancies
* use of any medication
* risky pregnancy
Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain

We aimed to investigate the effects of instrument assisted manipulation (IAM) and Mulligan mobilization with movement (MWM) on joint range of motion (ROM), pain, proprioception, endurance, back awareness and disability in individuals with chronic non-specific low back pain (CNSLBP). Fifthy one participants were randomly divided into 3 groups. The first was the Mulligan group, the second was the IAM group, and the third was the core exercise group. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.

IAM and Mulligan MWM interventions were applied 3 days a week for 2 weeks in total 6 sessions. All 3 groups did same core exercise program. The exercise program was done from the baseline for 6 weeks, 3 days a week, for a total of 18 sessions. Outcome measurements were done at baseline, at the end of the 2nd week, and at the end of the 6th week. The researcher who performed the outcome measurements did not know the participant's group. Assessment and treatment were performed by two different researchers with 8 years of professional experience. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. The measurement of the joint ROM in the lumbal region with the dual inclinometer technique is a reliable method. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.

Eligibility Criteria:
Inclusion Criteria:

* LBP for at least 3 months
* Diagnosis of non-specific LBP
* 20-55 ages.

Exclusion Criteria:

* Red flag symptoms related to LBP
* Neurological findings
* Pain radiating to the leg
* Undergone spinal surgery
* Pathology of the spine (fracture, tumor, spondylolisthesis, spinal stenosis, cauda equina syndrome).
Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment

The aim of this study is to evaluate the financial toxicity reported by Italian patients affected by GEP-NEN during the first year of treatment after diagnosis and its correlations with patient-reported outcomes (PROs) and quality of life (QoL).

Gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) are rare tumours whose incidence has increased during the years. However, referral centers specialized in diagnosis and treatment of these diseases are few. So, patients may be forced to travel long distances in order to reach a disease specialized center (ENETS certification) to plan the correct management and receive the better treatment. On the other hand, patients could research different clinical consulting by several medical specialists without clear indication. Moreover, today also advanced disease allows the patients a good prognosis with long survival. The resulting emotional and psychological burden may contribute to the worse quality of life. Therefore, patients with GEP-NEN have a deal with the financial consequences related to the diagnosis and treatment of their disease including out of pocket costs, loss of income and caregiver burden. Financial toxicity, defined as subjective financial concerns of cancer and objective financial consequences, has been investigated in this study in Italian patients affected by GEP-NEN

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* New diagnosis of gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)
* Patients who are candidates for surgical and/or medical treatment \[including somatostatin analogues (SAA), peptide recector radionuclide therapy (PRRT), target therapies (everolimus or sunitinib) and chemotherapy\];
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Patients diagnosed with GEP-NEN who are candidates for a surveillance management.
* Patients diagnosed with GEP-NEN who are candidates for best supportive care and/or have a life expectancy \< 6 months.
Nursing Students' Recognition of and Response to Deteriorating Patients

The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention in undergraduate nursing education developed to identify recognizing and responding to patient deterioration. Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention.

Simulation-based nursing education is an increasingly used pedagogical approach.

The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention developed to identify how recognizing and responding to patient deterioration improves the knowledge and self-confidence of undergraduate nursing students.

Specific aims:

1. To describe and estimate the change in undergraduate nursing students' knowledge and perceived self-confidence after an high-fidelity simulation intervention.
2. To identify the barriers and enablers that may impact on a successful implementation of the high-fidelity simulation intervention.

Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention. All participants will answer a questionnaire developed to measure perceived knowledge and levels of self-confidence pre- and post-intervention or before and after a meeting (control group). Five students and six faculty members will also be interviewed as a part of a process evaluation.

The study is part of a PhD project.

Eligibility Criteria:
Inclusion Criteria:

* All undergraduate nursing students at two universities enrolling in a specific course that includes high-fidelity simulation

Exclusion Criteria:

- None
Cryosurvival of Embryos From Dysmorphic Oocytes

Various morphological abnormalities of human oocytes were reported to detrimentally affect embryo development. We observed development of frozen thawed embryos derived from oocytes with normal or abnormal morphological features to the blastocyst stage. Cytoplasmic abnormalities of the oocytes were found to negatively affect cryosurvival potential of the embryos.


Eligibility Criteria:
Inclusion Criteria:

* Human embryos derived from morphologically normal or abnormal mature oocytes that fertilized normally by microinjection procedure.
* Embryos were obtained from couples who refused to freeze their supernumerary embryos after fresh embryo transfer in an assisted reproduction treatment cycle.

Exclusion Criteria:

* Embryos obtained after microinjection to immature oocytes taht were in vitro matured in culture.
* Embryos obtained from abnormally fertilized zygotes.
Heweizhixie capsuleTherapy on Patients With Diarrhea

The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.

The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea Primary Outcome Measure:Percent of subjects with treatment Success

Secondary Outcome Measures:

Number of unformed stools passed per 24 h period Time (hours) from first intake to the last unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of subjects with AE.

Eligibility Criteria:
Inclusion Criteria:

3 or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent

Exclusion Criteria:

Subjects with serum ALT more than 5ULN or serum Cr more than 442umol/L Subjects are pregnant now, likely to become pregnant Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment.
Evidence of Haloperidol Absorption After Topical Administration

This will be a blinded study to compare the absorption of topical haloperidol with placebo


Eligibility Criteria:
Inclusion Criteria

* Age: patient must be 18 years or older and less than 70 years of age.
* Provision of informed consent
* No previous adverse reaction to haloperidol
* No current use of haloperidol
* Good health
* No alcohol within 24 hours of the study
* No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
* Normal neurologic exam

Exclusionary Criteria

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
* Recent cerebral trauma
* Study will exclude women who are pregnant and/or nursing
* Women who are of child bearing potential must have a negative urine pregnancy test.
* History of seizures
* Taking medications that can interact with haloperidol
* Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

Purpose:To compare visual performance, total and high order wavefront aberrations (coma, spherical aberration and other terms) and contrast sensitivity in eyes implanted with one monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO, Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral visually significant senile cataract, corneal astigmatism less than 2.0 diopters and potential acuity meter (PAM) better than 0.2 LogMar

Exclusion Criteria:

* any other ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, decentration (estimated by retro illumination and digital photo) greater than 0.4mm13 or loss of follow-up
A Comparative Study of SPARC's SDP-133 Once Daily and Lumigan in Subjects With Open Angle Glaucoma or Ocular Hypertension

To evaluate the efficacy of once daily dosing with SPARC's novel ophthalmic formulation of bimatoprost compared with Lumigan 0.01% in subjects with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Be male or female, of 18 years of age or older
2. Provide signed and dated informed consent in accordance with good clinical practice (GCP) and local legislation prior to any study procedure.
3. Have open-angle glaucoma, (with or without pseudo exfoliation, pigment dispersion component) or ocular hypertension in both eyes and likely to be controlled on monotherapy.
4. Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. A sterile sexual partner is not considered an adequate form of birth control. Subjects on hormonal contraceptives must have been on the same hormonal contraceptive for at least one month before the Screening and continue throughout the duration of the study. A female is considered of childbearing potential if she has had her first menses and she is either

   1. not postmenopausal for at least 12 consecutive months prior to enrollment;(Visit 1) or
   2. not surgically sterilized by bilateral tubal ligation, or bilateral oophorectomy, or hysterectomy
5. Male subjects with partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg. Condom) if not surgically sterile (ie, vasectomy).
6. Be able and willing to follow study instructions and complete all required visits.

Exclusion Criteria:

1. In the opinion of the investigator have uncontrolled or unstable systemic disease (eg, diabetes) which might interfere with the study. Subjects with a history of cancer or requiring cancer treatment within the past 5 years. Basal Cell and its treatment are allowed.
2. Current or history of subjects with depression, cerebral or active coronary insufficiency or orthostatic hypotension.
3. (If female of childbearing potential) Be pregnant, nursing, or planning a pregnancy from study entry and through the duration of the study.
4. In the opinion of the investigator the subject has clinically relevant, abnormally low or high blood pressure or pulse rate.
5. Have any known allergy or sensitivity to the study medications or their components.
6. Have any contraindications to bimatoprost therapy.
7. Be enrolled in an investigational drug or device study or have participated in such a study within 30 days prior to Visit 1.
8. Subject who may be involved in any aspect of the trial conduct, may not be an investigator, sub-investigator, or other site staff , or related to any site staff.
Effectiveness of Cryotherapy on Endodontic Pain

This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis

Diagnostic procedures to include patients history taking , clinical and radiographic with all findings being recorded in patients .

patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis.

patients will be asked to rate their pre treatment pain on visual analogue scale from 0-10

patients with pain score \<8 will be considered

Anesthesia and isolation : after administration of local anesthesia , rubber dam application will be done

Acess cavity : acess will be gained with round bur using air turbune handpiece with copious water cooling

Working length : a size 10k file will be inserted into the canal to determine the working length with the help of radiograph

Cleaning and shaping : Extirpation of pulp will be done followed by canal preparation with manual and endodontic motor using naocl and EDTA .

final irrigation will be performed using 17% EDTA and 5.25% NaOCl

Patients will be divided into 2 group in control group : final irrigation will be done using 5ml of saline at room temperature in cold group : final irrigation will be done using 5ml of cold saline at 2.5°C

the solution will be stored in the refrigerator until use irrigation will be performed for 5 min in both groups using 27 G beveled needle tip inserted 2mm short of WL.

Obturation ; In both groups , canals will be dried with paper points and obturated using gutta percha cones with zinc oxide eugenol sealer

Restoration : acces cavity will be restroed with direct composite restoration or high viscosity glass ionomer cement

each patient will be given instruction to acess the post operative pain .

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis
* maxillary or mandibular single rooted teeth
* systemically healthy patients
* patients having pain score \< 8

Exclusion Criteria:

* patients on preoperative analgesics or antibiotics within past 12 hours
* teeth with calcified canals and previously treated teeth
* tooth with immature apices or resorption
* patients allergic to local anesthesia
* pregnant or lactating mothers
* patients who are immunocompromised .
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease

Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are lacking data in respect to whether differences in composition of various marine oils may influence the inflammatory status differently.

The hypothesis of the current study is that extract from the antarctic krill (Euphausia superba) is better than traditional fish oils when compared head-to-head with balanced composition of omega 3 content on inflammatory status.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years
* Sex: Male and female
* Stable atherosclerotic coronary heart disease (heart attack \>3 months ago or objectified angina pectoris).
* No hospitalization for heart disease last 3 months.

Exclusion Criteria:

* Unstable heart disease.
* Heart failure NYHA class III and IV.
* Previous valve and/or aortic surgery
* Significant concomitant disease (i.e. diseases with known inflammatory activation - e.g. various autoimmune diseases, chronic infections, significant acute infections three weeks before or during the study, connective tissue disease, arthritis, chronic pulmonary disease or serious liver- or kidney-disease).
* Simultaneous involvement in other clinical studies involving intervention.
* Planned operation or other invasive procedures (e.g. PCI etc.) during the study period.
EEG - Guided Anesthetic Care and Postoperative Delirium

The study is a prospective, double blinded, randomized and controlled parallel trial to investigate the effect of the anesthetic care guided by EEG monitor (SedLine) on postoperative delirium. EMODIPOD = Electroencephalography Monitoring tO Decrease the Incidence of PostOperative Delirium

To investigate the impact of the anesthetic care guided by EEG monitor (SedLine) on (1) the incidence of delirium in post-anesthesia care unit (PACU) and within the first five days after laparoscopic surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years;
2. ASA Physical Score I-III
3. Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation;
4. Extubation expected after surgery;
5. Scheduled to stay in hospital for \> 3 days after surgery.

Exclusion Criteria:

1. Refuse to participate;
2. Emergent surgery;
3. Trauma patients;
4. Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less;
5. Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia;
6. Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment;
7. Inability to complete MMSE and delirium survey;
8. Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction \< 30%, or arrhythmia with pacemaker or AICD placement;
9. Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification;
10. Severe renal dysfunction requiring renal replacement therapy before surgery;
11. Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male and/or female subjects of non-childbearing potential.
* Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.

Exclusion Criteria:

* History of sensitivity to lorazepam or other benzodiazepines.
* Evidence or history of acute narrow-angle glaucoma or sleep apnea syndrome.
* Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk.