cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement

We propose to evaluate a preoperative education of the patient and a new surgical technique (the mini-invasive THR) that could reduce the time to achieve functional independence.

The primary objective of the trial is to assess the time to reach functional independence after total hip replacement depending on the treatment groups: preoperative education versus no preoperative education and mini-invasive procedure versus standard procedure. The study hypothesis is that education and mini-invasive procedure will reduce the time to reach functional independence.

This is a prospective trial with a double randomization.

We propose to evaluate a preoperative education of the patient and a new surgical technique (the mini-invasive THR) that could reduce the time to achieve functional independence. Preoperative education is compared to no education and the mini-invasive surgery is compared to the standard group.

The education is based on explaining to the patient what will the postoperative rehabilitation be like.

The mini-invasive THR is based on the minimisation of soft tissue trauma. It requires a specific instrumentation to allow dissection and implantation of the prosthesis. Only few studies have evaluated such a technique. However, these studies were retrospective or non-randomised and results are contradictory. Therefore, a randomised controlled clinical trial is necessary to evaluate the possible benefits and feasibility of this technique.

The primary outcome is the time to reach functional independence. Secondary outcomes evaluate the duration of hospital stay, the quality of implantation of the prosthesis, the postoperative morbidity, the functional benefits and the quality of life.

Methods: this monocentric randomised controlled clinical trial compares the preoperative education versus no preoperative education (first randomization) and the conventional THR to the mini-invasive THR (second randomization). One hundred and forty patients will be included in each group.

Expected results: preoperative education and the mini-invasive THR are prone to decrease time to functional independence, postoperative morbidity and duration of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the hip
* avascular necrosis of the hip
* patient between 40 and 90 years old (included)

Exclusion Criteria:

* history of previous hip operation (bone)
* patient \>90 or \< 40
* inflammatory arthritis
* important proximal femur or acetabular deformity
* complete functional independence not possible
* BMI \> 30
Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor

Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor.

Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in.

Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment.

When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.


Eligibility Criteria:
Inclusion Criteria:

* Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
* Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
* Gestational age 23(+0)-32(+6) weeks.
* Consent to taking part in the study.

Exclusion Criteria:

* Placenta previa
* Preterm premature rupture of membranes at presentation
* Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
* Known major fetal anomaly detected on ultrasound
* Multiple pregnancy
* Maternal seizure disorder
* Active or history of thromboembolic disease
* Maternal liver disease
* Known or suspected breast malignancy or pathology
* Known or suspected progesterone-dependent neoplasia
* Plans to move to another city during pregnancy
* Previous participation in a progesterone trial during this pregnancy
* Known sensitivity to progesterone
Effects of Aerobic Exercise Detraining

The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.

Eligibility criteria include having successfully completed the main E-Mechanic study, be willing to archive blood samples and not being currently enrolled in another study that may effect body, energy intake or energy expenditure. The investigators will measure body weight, waist/hip circumference, blood pressure, body composition, physical activity, questionnaire about appetite/food intake and physical fitness.

Eligibility Criteria:
Inclusion Criteria:

* Completed the E-Mechanic study
* Be willing to archive blood samples
* Not participating in a study that would alter body weight, energy intake, or energy expenditure.
Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.

Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.

An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.

The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged at least 18;
* who underwent Kyphoplasty between T11 and L5,
* Patients who had Kyphoplasty at a single level without associated surgery,
* Magerl type-A fracture.
* Non-tumoral and non-osteoporotic cause.

Exclusion Criteria:

* Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
* Osteoporotic vertebral fracture
* Association with other post-traumatic fractures.
* History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
* Pregnant or breast-feeding women
* Patients not covered by national health insurance
Effects of Preoperative Using of Eye Patches on Prevention of Emergence Agitation After Cataract Surgery

This study is a single-center, prospective, randomized, controlled trial. To investigate if preoperative using of eye patch will decrease emergence agitation, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.

This study is a single-center, prospective, randomized, controlled trial. To investigate whether preoperative using of eye patches will decrease emergence agitation or not, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists. The investigators will recruit 180 children undergoing elective cataract surgery, divided into 2 groups by random method. experimental group will cover the effected eye for 3 hours before the operation, while the control group will not. Then the investigators will observe and mesure the incidence of emergence aditation in each group, to assess whether preoperative patch shading can reduce the incidence of postoperative agitation.

Eligibility Criteria:
Inclusion Criteria:

1. Preschool patients undergo elective cataract surgery, whose age are 3 to 7 years.
2. Patients' parents agree to participate in the trial, and sigh the informed consent.

Exclusion Criteria:

1. Patient who can not communicate with medical workers preoperatively.
2. Both of patient's eyes are covered postoperatively.
3. Patient's parents refuse to sign informed consent.
4. The investigators do not think such patient is suitable for our research
5. The patient has serious arrhythmia, abnormal cardiac defect.
6. The patient has suffered from pneumonia, asthma symptoms, bronchitis, or upper respiratory tract infection recent two weeks.
7. The patient has serious disease of the nervous system.
8. The patient has the allergic history of any drug involved in this clinical trial.
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow in Healthy Adults

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cerebral blood flow during a series of cognitive, mathematical subtraction tasks and subjective ratings of task difficulty before and after 26 weeks of supplementation


Eligibility Criteria:
Inclusion Criteria:

* Aged 25 to 49 years inclusive
* Males and females
* Self-report of good health

Exclusion Criteria:

* English is not first language (some of the cognitive tasks have only been validated in native English speakers)
* Habitual consumption of oily fish exceeds one fish meal per week (see Appendix I)
* Habitual consumption of omega-3 dietary supplements in the previous 6 months
* Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
* Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)
* Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
* Pregnant, trying to get pregnant or breast feeding
* Body Mass Index outside of the range 18-35 kg/m2
* High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Currently taking blood pressure medication
* Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
* Have frequent migraines that require medication (more than or equal to 1 per month)
* History or current diagnosis of drug/alcohol abuse
* History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
* History of neurological or psychiatric illness (excluding depressive illness and anxiety)
* History of head trauma
* Sleep disturbances and/or are taking sleep aid medication
* Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
* Diagnosis of type I or type II diabetes
* Heart disorder, or vascular illness
* Current diagnosis of depression and/or anxiety
* Over- or under-active thyroid
* Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
* Any known active infections
* Diagnosed with syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
* Current or past breast cancer diagnosis and/or a mastectomy
* Health condition that would prevent fulfilment of the study requirements
* Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine

The purpose of the study is to develop, evaluate, and optimize "MigraineManager", the first web-based comprehensive self-management tool for adolescents with migraine, their parents, and clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with migraines using current International Classification of Headache Disorders criteria (ICHD-3 beta) for migraine with or without aura
* Patient has headache frequency of 8+ per month
* Access to the internet whether public (e.g., library) or private (e.g., home, personal)
* English fluency for patient, caregiver, and clinician

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery

Available studies suggest that regional anesthesia-analgesia may decrease the occurrence of recurrence/metastasis in patients after cancer surgery. However, evidences from prospective studies are still lacking. The purpose of this randomized controlled trial is to investigate the effect of epidural anesthesia-analgesia on recurrence-free survival in patients undergoing lung cancer surgery.

Lung cancer is increasing and is the leading cause of cancer death. Surgical resection is the mainstay of treatment for early stage non-small cell lung cancer. However, long-term survival after lung cancer surgery is far from optimal, and cancer recurrence or metastasis is the main reason leading to cancer death in these patients.

The development of cancer recurrence/metastasis largely depends on the balance between tumor-promoting factors and immune function of the body. Studies showed that surgical manipulation releases cancer cells into circulation; and stress response induced by surgery inhibits the cell-mediated immunity. In addition, volatile anesthetics and opioids may also aggravate immunosuppression and potentially worsen long-term outcome. On the other hand, regional anesthesia can blunt surgical stress and reduce anesthetic consumption. These effects may help to preserve immune function and reduce recurrence/metastasis. However, existing evidences are insufficient to draw conclusion in this topic.

The purpose of this randomized controlled trial is to test the hypothesize that regional anesthesia-analgesia may reduce recurrence/metastasis and improve long-term survival in patients after lung cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged 18-80 years);
2. Clinically diagnosed as primary non-small cell lung cancer of stage IA to IIIA, and scheduled for radical surgery;
3. Agreed to receive patient-controlled analgesia after surgery.

Exclusion Criteria:

1. Distant metastasis, malignant tumor in other organs, or chemo-/radiotherapy or other anti-cancer therapy before surgery;
2. Comorbid with autoimmune diseases, or glucocorticoid/immunosuppressant therapy within 1 year;
3. History of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier, or end-stage disease;
4. Severe hepatic disease (Child-Pugh classification C), renal failure (serum creatinine \>442 umol/L or receiving renal replacement therapy), or American Society of Anesthesiologists classification IV or higher;
5. History of anesthesia and/or surgery within 1 year;
6. Contraindications to epidural anesthesia, including spinal deformity, coagulation dysfunction, local infection, and history of spinal trauma/surgery;
7. Allergic to any medications used during the study.
Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function

The number of people with kidney disease is constantly rising and renal failure represents one of the major health care burdens globally. An accurate measurement of kidney function is urgently needed to better understand and treat loss of renal function. Kidneys have an intrinsic reserve capacity to respond to a higher work load by increasing filtration in their nephrons. The number of nephrons and their reserve capacity define how well kidneys can adapt to an increased demand and disease.

The degree of renal reserve capacity becomes particularly important when the number of functioning nephrons is significantly reduced either due to surgical removal of one kidney as in living kidney donation or in tumor nephrectomy or due to progressive injury as in autosomal dominant polycystic kidney disease (ADPKD). A reduced functional reserve likely reflects an impaired adaptive capacity and increased risk of accelerated loss of function in the remaining single kidney or in kidneys exposed to a disease. Despite the importance of accurately measuring baseline and reserve capacity renal function, due to the time- and laborintensive procedure, in clinical routine this testing is rarely done.

Investigators aim to measure renal functional reserve (RFR) and loss of function in patients undergoing nephrectomy (living kidney donors and renal tumor patients) as well as in patients with ADPKD.

The results should provide evidence whether renal functional reserve indeed predicts adaptive capacity and functional loss after removal of a healthy kidney (living donors), of a tumor kidney (cancer patients) or in progressive kidney disorders (ADPKD patients).

Investigators are confident that the proposed project will enhance the understanding of progressive kidney disease and with this improve donor safety, planning of tumor nephrectomy, and prediction of renal functional loss as well as provide a strong argument that dynamic renal function testing, i.e. accurate measurement of baseline and reserve capacity, is necessary in certain disease entities.

The measurement of RFR will be performed by dynamic testing of the changes in baseline glomerular filtration rate (GFR) induced by an oral protein load. Sinistrin (a polyfructosan with identical clearance characteristics to inulin) will be used to measure GFR.

Eligibility Criteria:
Inclusion Criteria:

* Potential living kidney donor
* Patients with diagnosed ADPKD
* Patients with primary kidney tumor requiring nephrectomy
* Female and male patients over 18 years of age

Exclusion Criteria:

* Bilateral kidney tumor
* Kidney metastases of a tumor of other origin
* Renal failure that requires dialysis
* Pregnant patient
* Incomplete medical records
* Patients with diabetes mellitus
* Patients who cannot tolerate iv fluids
* Hypersensitivity to the active substance (sinistrin) or to any of the excipients
Person-Centered, Occupation Based Therapy for Type 2 Diabetes

This study was conducted to investigate the effect of a person-centered, occupation-based intervention program supported with problem-solving strategy in individuals with type 2 diabetes (T2D).

Method: The study was a randomized controlled trial, that included intervention (n=33) and control group (n=34), between the ages of 18 and 65 years.

It was planned as a single-blind, randomized controlled study with 3-month follow-up in adults. A total of 67 subjects were randomly allocated to the intervention (n=33) or the control group (n=34). This program prepared with consider to meaningful activities for individual and overcome to barriers via problem solving. That was designed as 6 modules including evaluations, diabetes education and problem-solving therapy. Each module was implemented at least 1 session per week, about 60 minutes, and was arranged according to individual needs.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Able to read and write turkish

Exclusion Criteria:

* Cancer
* Mental disorder
Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects

This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people.


Eligibility Criteria:
Inclusion Criteria:

* Fasting blood sugar levels from 100 to 125 mg/dL
* Glycated hemoglobin levels from 5.7 to 6.4%
* 2-hour OGTT levels from 140 to 199 mg/dL

Exclusion Criteria:

* Pregnant women or preparing for pregnancy.
* Lactating women.
* Women gave birth 6 months before the study.
* Poor kindy funciton
* Severe cardiovascular or other chronic diseases
* Patients with type I or II diabetes
* Poor compliance
* Alcohol abuser
* Using anti-diabetic or weight managent supplements
* Blood transfusion three months before the study
* Pumpkin seed allergy
A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants

The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.

The drug being tested in this study is called esomeprazole. Esomeprazole is being tested in healthy participants in order to evaluate the bioequivalence between a single oral dose of esomeprazole tablet and capsule. The study will enroll 52 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences:

* Esomeprazole 40 mg capsule + Esomeprazole 40 mg tablet
* Esomeprazole 40 mg tablet + Esomeprazole 40 mg capsule

All participants will be asked to take one capsule or tablet on Day 1 of each Intervention Period based on the treatment sequence to which the participant has been assigned.

This single center trial will be conducted in the United States. The overall duration to participate in this study is 36 days. Participants will visit the clinic on Day -1 and remained confined until Day 1 of Intervention Period 1 and 2. A washout period of minimum 6 days will be maintained between the dose in each Intervention Period.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy adult male or female participant.
2. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -1.

Exclusion Criteria:

1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda Medical Monitor may be warranted.
2. Has a history of significant gastro intestinal (GI) disorders manifested with persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease or erosive esophagitis), or any gastrointestinal-related surgical intervention..
3. Has a known hypersensitivity to any component of the formulation of esomeprazole capsules or tablets or compounds with the same mechanism of action (dexlansoprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole), or related compounds.