cyrilzakka/clinical-trials huggingface dataset:
The Influence of Oral Contraceptive Use on Muscle Recovery

There is still no one who has studied how oral contraceptive use affects recovery in trained women after repeated high-intensity workouts. Consequently, a well-controlled study is needed.

The project is designed as a controlled cohort study, where 20 oral contraceptive users will be compared with 20 non-users. After initial preliminary examination and habituation to the test procedures, the subjects will start the intervention in week 2 of their menstrual cycle / active contraceptive pill cycle. Before and 3h, 24h and 48h after 3 intense strength training sessions performed 2 days in a row, blood samples will be taken, muscle soreness measured and performance tests performed. The day before the first training session and over the 4 trial days, the subjects will receive a standardized diet.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-30
* Regular training minimum. 4 times a week (1≤ times strength training, 1≤ times endurance training / interval training or interval-based sports. If the interest in participation is greater than necessary, we will prioritize people who perform strength training at least twice a week)

Exclusion Criteria:

* Irregular menstruation over the last 6 months (shorter than 24 days or longer than 35 days cycle)
* Used birth control pills for less than 6 months
* Non-birth control pill users must not have used birth control pills, IUDs, birth control pills, or mini- pills for a maximum of 1 month during the last 6 months and not within the last 3 months up to the trial. .
* Injuries / pain in the lower body, which prevents participation in intense strength training
* Medication consumption that may affect protein metabolism and inflammatory parameters.
* Diabetes
* Smoking
* Unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months)
* Eating disorder
* Pregnancy
* Cannot read or understand Danish
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)

The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>=18 years of age
* High risk of poor enteral medication absorption, based on the effects of cytotoxic chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and diarrhea, at baseline.
* High risk of invasive fungal infection (IFI) based on anticipated or documented prolonged neutropenia (absolute neutrophil count \[ANC\] \<500/mm\^3 \[0.5 x 10\^9/L\]).
* Clinical laboratory safety tests within normal limits or clinically acceptable to the investigator or sponsor.
* Free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the study evaluations.
* Subjects must be willing to give written informed consent and able to adhere to dosing, study visit schedule, and mandatory procedures.

Exclusion Criteria:

* Female subjects who are pregnant, intend to become pregnant, or are nursing.
* Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral, intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days of Enrollment (ie, voriconazole, fluconazole \[FLU\], or itraconazole \[ITZ\]).
* Subjects receiving posaconazole for prophylaxis against IFI 10 days prior to enrollment. (Subjects who are receiving either voriconazole or micafungin for prophylaxis against IFI should discontinue those therapies upon enrollment.)
* Subjects with moderate or severe liver dysfunction at Baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than two times the upper limit of normal (ULN), or a total bilirubin level greater than two times the ULN.
* Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment.
* Subjects who must take prohibited medications during the study.
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
* Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
* Subjects who are part of the staff personnel directly involved with this study.
* Subjects who are a family member of the investigational study staff.
* Prior enrollment in this study.
* Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status \>2 prior to induction chemotherapy for their underlying disease.
* Subjects with proven or probable invasive or systemic fungal infection at Baseline.
* Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.
Opioid Sparing Anesthesia in Cervical Spine Surgery

The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.

Cervical spine surgery is associated with medium pain scores and perioperative disability. Ketamine and lidocaine have all proven but varied analgesic effects. High opioid consumption has been associated with multiple side effects.

This double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine and lidocaine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Ketamine-Lidocaine (KL) group will receive a continuous infusion of ketamine and lidocaine, during the surgery and shortly after.

Both infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.

Multiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patents
* American Society of Anesthesiologists (ASA) class I-III
* elective spine surgery

Exclusion Criteria:

* body mass index (BMI) \>35 kg/m2
* contraindications to local anesthetic administration
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* bradycardia(\<55 beats/minute)
* drug or alcohol abuse
* language or communication barriers lack of informed consent
Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening

The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes.

Participants will be asked to take either

* 2 g of amoxicillin + clavulanate, or
* placebo, one hour prior to surgery and without knowing what medicine they took.

Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.


Eligibility Criteria:
Inclusion Criteria:

* in need of surgical crown lengthening operation in one/two teeth

Exclusion Criteria:

* systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus
* antibiotic or anti-inflammatory drug use in the last 3 months
* pregnancy/lactation
* chronic steroid, immunosuppressant or NSAD use
* age \<18 years
* positive bleeding on probing at the surgical site and/or active periodontal disease
* \<2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation)
* Miller 2 or 3 tooth mobility
* penicillin allergy
* unwilling to participate
Role of Surgery in Management of Pineal Region Tumors in Children

The aim of this observational study is to learn about the role of surgery with its different approaches and modalities in the management of pineal region tumors in pediatric population.the main question it aims to answer is : How can surgery affect the outcome in children with pineal region tumors ?


Eligibility Criteria:
Inclusion Criteria:

* All patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention

Exclusion Criteria:

* patients with pineal region tumors older than 18 years old
* and pediatric patients younger than 18 years ild and unfit for surgical intervention
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy

The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach.

The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent. In addition, if the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale \[BBPS\] score \<2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.

A randomization list was generated with the randomization algorithm of random sorting, using Excel program. Included patients were randomly assigned to one of the two groups: segmental re-examination group, in which the each segment (right colon, mid-colon, and left colon) was examined twice segmentally; or control group, in which the withdrawal time in the each segment was about 2 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy

Exclusion Criteria:

* Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
* If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale \[BBPS\] score \<2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
The Correlation Between Oxidative Stress and Indinated Contrast-Media Nephrotoxicity

Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM. Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists, cardiologists, and radiologists.

The present study is aimed to determine the norepinephrine concentration, oxidative markers, and tubular damage markers in the urine samples of patients undergoing intravenous pyelography (IVP).

The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress and greater tubular damage than iso-osmolarity contrast media (IOCM).


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (\> 18 years old)
2. Undergoing IVP with an appropriate medical indication
3. Signing informed consent

Exclusion Criteria:

1. Without signing informed consent
Effects of Kinesio Taping vs Jones Technique on Myofascial Trigger Points in Cervicalgia.

A large number of workers in different sectors suffer from musculoskeletal neck disorders, which are the most common work-related illness in Europe. A multitude of combinations of techniques can be used to treat these conditions, including recorded film and the Jones technique. This pilot study examines the efficacy of Kinesio taping and the Jones technique in improving pain, joint range of motion and muscle tension in active subjects with latent myofascial trigger points. A clinical trial was conducted with 38 patients with neck pain. The sample was randomly distributed into three groups: a Jones technique group, a kinesio taping group and a combined therapy group in which both techniques were performed. The duration of treatment was 4 weeks, with a follow-up of 2 weeks. Cervical spine joint range of motion, pain and functional disability were assessed with the goniometer, the visual analogue scale, the pressure algometer and the cervical disability index.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of latent PGM in the upper trapezius
* Have been working for more than 6 months in the center or company
* Work more than 4 hours a day with the computer
* Be over 18 years of age and under 64 years of age

Exclusion Criteria:

* Diagnosis of fibromyalgia
* Having suffered a cervical sprain
* Diagnosis of radiculopathy, cervical spine surgery
* Medical contraindications to neuromuscular bandaging or Jones technique
* Diseases such as diabetes and cancer, pregnancy, and any other pathology that produces neck pain other than that specified in the objective of the study
Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia

Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.

Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia

Exclusion Criteria:

* multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication
Comparison of Blood Pressure Throughout Pregnancy

The purpose of this study is to observe and analyze variation of diastolic blood pressure measurements at third trimester of pregnancy and when they present for delivery in comparison to healthy volunteers.

When patients present for delivery, we expect blood pressure to be lower than normal. However this is not the case. We aim to determine where this trend occurs throughout to duration of pregnancy, and propose possible explanation as to the source of this event.

After discharge, the information recorded includes each patient's blood pressure upon admission to the labor floor, and several blood pressure measurements from prior clinical visits.


Eligibility Criteria:
Inclusion Criteria:

* Females age 18-40
* Parturients who present for delivery who are not yet in labor

Exclusion Criteria:

* Patients with hypertension, cardiac disease, diabetes, or thyroid disorders
* Parturients who are already in labor upon presentation to the labor floor
PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars

this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis


Eligibility Criteria:
Inclusion Criteria:

* spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain
* Responded to cold and electric pulp testing

Exclusion Criteria:

* pain on palpation, percussion,
* mobility or swelling
* peridontall widening
* Teeth with marginal periodontitis or crestal bone loss
* resorption
* calcified canals
Neurofibromatosis Type 1 Brain Tumor Genetic Risk

This study will analyze DNA samples to determine associations between maternal and offspring genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type 1. Participating families (mother, father, child) will be asked to complete a short questionnaire and provide DNA samples (either saliva or blood). The information gained from your participation may one day help doctors develop strategies to reduce brain tumor risk in individuals with NF1. Please note: there is no therapy associated with this study.

The prenatal period is a developmentally vulnerable time point during which environmental conditions, including nutrition, can have life-long impacts on health.1,2 This is particularly relevant to many childhood cancers that are thought to initiate during pregnancy.3 As a consequence, there has been intense interest in whether prenatal exposures can modulate childhood cancer risk.4-6 It is important to recognize that both maternal and offspring genetic factors including those in nutritional pathways may play an important role in pediatric cancer risk through their effect on the child's exposure to nutrients important in development during the prenatal period. The purpose of this research study is to evaluate whether there are any maternal or offspring genetic factors in the folate pathway that may contribute to the development of brain tumors in children with Neurofibromatosis Type 1 through analysis of DNA samples collected from families.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric participant (born during 1994-2012) with NF1 and diagnosed with a brain tumor
* Biological mother or father (or full sibling if mother or father is unable to participate) able to participate
* All family members (pediatric participant, biological mother, and biological father or full sibling) must be willing to contribute a blood or saliva sample
* ability to understand consent forms

Exclusion Criteria:

-those who do not meet inclusion criteria
Efficacy Study of Amazing Me Program

The objective of the Efficacy Study of Amazing Me Program is to deliver the Amazing Me intervention and assess its efficacy. The Amazing Me intervention aims to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. The Amazing Me intervention teaches students to be kind to themselves, their bodies, and to others.

Body dissatisfaction is one of the most robust risk factors for developing unhealthy behaviors, low self-esteem, and contributes to anxiety and depression in adolescence. Despite evidence that body dissatisfaction can emerge during the elementary school years, the majority of body confidence programs are for girls over the age of 15. There is very little to no research on interventions for elementary school children. The Body Project is an empirically supported body confidence prevention program for high school girls with over 100 articles to support its efficacy, effectiveness and theoretical model; it is the only body confidence program for youth to acquire the Blueprints Certification. Together with two 4th and 5th grade teachers, the investigators have adapted the Body Project curriculum for youth between the ages of 9 to 11 years old (i.e., 4th and 5th graders). The curriculum is called Amazing Me and will be implemented in classrooms by teachers. The curriculum was developed meeting several competencies for national health and wellness standards for elementary students. The aim of the current study is to conduct a national randomized control trial of the curriculum 100 classrooms with 4th and 5th graders.

The primary aim of the current study is to deliver the Amazing Me intervention and assess its efficacy. It is hypothesized that compared to controls, children that undergo the body confidence curriculum will report higher body satisfaction and body esteem scores, overall greater self-esteem, and will report less engagement in appearance comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Educators teaching 4th and 5th graders. Thus students will be on average between 9 and 11 years old.

Exclusion Criteria:

* None.
Aliskiren for Immunoglobulin A (IgA) Nephropathy

Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA nephropathy, which has no specific treatment at present.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* requires anti-hypertensive therapy
* renal biopsy within the past 3 years and confirmed the diagnosis of IgA nephropathy
* proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or ARB treatment for at least 3 months
* estimated glomerular filtration rate \> 30 ml/min/1.73m2
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* Patients who are diabetic, and patients with systemic diseases that may cause IgA nephropathy or another nephropathy.
* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years
* Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Participation in any previous trial on aliskiren or other renin inhibitor
* Previous treatment with fish oil, steroid, cytotoxic agents, or aldosterone antagonist
* History of treatment with other drugs that may affect proteinuria within past 2 years
* Patients receiving treatment of corticosteroid
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance
* Known history of sensitivity or allergy to aliskiren or other renin inhibitor