cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ketoprofen Before Intrauterine Device Insertion

IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.

Eligibility Criteria:
Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to insertion
* No contraindication to Non-steroidal drugs
* Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to device placement
Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study

The present study will analyze if exercise is able to elicit the well-known anti-atherogenic effects in patients with SCI. This will be evaluated by measuring vascular parameters such as endothelial and inflammatory blood markers, echocardiography of the heart and peripheral vessels, as well as blood pressure and arterial stiffness, in subjects performing either wheelchair dancing, wheelchair marathon or no sports. Further, it will be investigated, whether there is an association between neuroplasticity and cardiovascular health, as measured by electroencephalography (EEG), transcranial magnetic stimulation (TMS) and blood levels of the brain-derived neurotrophic factor (BDNF).

We hypothesize that the cardiovascular, physical and psychological benefits of wheelchair dancing and/or wheelchair marathon parallel improved neuroplasticity in SCI-patients


Eligibility Criteria:
Inclusion Criteria:

wheelchair users independent of the cause of the walking impairment, preferably with spinal cord injury.

Exclusion Criteria:

metallic implanters, additional neurologic pathologies, pregnancy
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque

The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.


Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome within 48 hours of symptom onset
* Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation

Exclusion Criteria:

* Cardiogenic shock
* ST segment elevation myocardial infarction within 1 week
* Hematologic disorder: neutropenia (neutrophil\<3000/mm3), thrombocytopenia (platelet\<100,000/mm3)
* Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* Impaired renal function with serum creatinine \> 2mg/dL
* Bleeding diathesis or history of coagulopathy
* Pregnancy
* Hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish
Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions

The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.

The study investigates the effect of combined anesthesia on occurrence of acute kidney injury in robot assisted laparoscopic urogenital surgery.Renal function is assessed according to the new RIFLE and AKIN criteria, and by determining serum and urinary neutrophil gelatinase associated lipocalin.

Eligibility Criteria:
Inclusion Criteria:

* signed the informed consent without previous renal function alteration respiratory and hemodynamic stability

Exclusion Criteria:

* refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases
Perio Treatment & Cerebrovascular Function

Periodontitis has been linked to increased risk of cerebrovascular disease. Impaired brain hemodynamics has been suggested as early markers of cerebral macro and microangiopathy. Therefore, the aim of this clinical trial will be to assess the potential effect of periodontal treatment on cerebral hemodynamics in otherwise healthy patients with severe periodontitis over 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy subjects with severe periodontitis.

Exclusion Criteria:

* \<10 teeth
* current smokers
* undergo periodontal treatment within the last 6 months.
* receive antibiotics or anti-inflammatory drugs within the last 3 months.
Progesterone Treatment in Female Smokers - 12

The purpose of this study is to investigate progesterone effects in female smokers

Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. In addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. The study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. We hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.

Eligibility Criteria:
Inclusion Criteria:

Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.

Exclusion Criteria:

History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.
Heart Rate Sensing and Response in Persons With Anorexia Nervosa

There are two major goals of this investigation. First, to develop pilot data to justify a larger randomized clinical trial of an intervention designed to train interoceptive signals (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the investigators will determine whether persons with AN have similar or different IS and IR for heart rate while exercising as compared to age and gender matched controls.

The purpose of this pilot investigation is to assess AN interoceptive sensitivity and responsivity as it pertains to heart rate during exercise. Thirty adults, 18 years and older will be recruited for a cross-sectional comparison of IS and IR in the context of exercise.

Eligibility Criteria:
Inclusion Criteria: Study participants will include adults with anorexia spectrum disorders and healthy age and gender matched controls. There will be two control groups, one that includes regularly exercising age and gender matched persons and one where controls do not engage in regular exercise.

For those with AN, the following INCLUSION criteria must be met:

* Age ≥ 18 years old
* BMI 25 kg/m2 or less
* Diagnosis of anorexia spectrum disorder
* Medications: Stable use of all medications ≥ three months

For age and gender matched controls, the following INCLUSION criteria must be met:

* Age ≥ 18 years old
* BMI 25 kg/m2 or less
* No diagnosis of anorexia spectrum disorder
* Medications: Stable use of all medications ≥ three months
* Age (+/- 2 years) and gender matched to study participant

Exclusion Criteria:

* History of diabetes, heart disease or taking medications for those conditions
* History of hypertension (high blood pressure) not controlled with medication
* Orthopedic limitations, musculoskeletal disease and/or injury
* Inability to consent
* Lack of transportation to the Duke Center for Living campus
Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases

This study aims to evaluate the predictability of fetal Doppler parameters in terms of perinatal adverse outcomes in singleton pregnancies with mild and moderate idiopathic polyhydramnios

Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton pregnancies without polyhydramnios were included in the study one-on-one by matching their gestational ages. The diagnosis of polyhydramnios was made if the AFI was 24 cm and above.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women diagnosed with mild-moderate IP ,selected low-risk singleton pregnancies without polyhydramnios

Exclusion Criteria:

* Women who had chromosomal or anatomical abnormalities, multiple pregnancies, oligohydramnios (AFI 5 cm), severe polyhydramnios, fetal growth restriction, elective cesarean section (CS), pre-existing conditions (hypertension, diabetes, thrombophilia), or obstetric complications (gestational hypertension, preeclampsia, gestational diabetes) were excluded
A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

The study consists of an screening period, treatment period, and safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* Age ≥ 18 and ≤ 75 years old.
* With Atopic Dermatitis.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Major surgeries are planned during the study period.
Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy

The patient's compliance to his medication therapy, and therefore the success of the treatment, is particularly related to his pharmacy management. Thus, the satisfaction of an individual in their interview with the pharmacist is a very important element.

The pharmacist in his professional activity may have to manage patients with opioid related disorders. Pharmacist activity will result in the dispensing of opioid replacement therapy (ORT), single-use syringes, harm reduction kits and prevention advices for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of ORT has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients undergoing ORT is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed ORT in France.

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with patient suffering of opioid related disorders, which can have an impact on patient's satisfaction.

The objective of this study will be to assess the satisfaction of patients undergoing ORT regarding their management by community pharmacists.

Patients will be recruited in addiction departments, associations for risk management and general practitioners, and a paper questionnaire will be sent to the patients. The questionnaire is anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing opioid replacement therapy

Exclusion Criteria:

* Age \<18 years
* Patient unable to understand or write in French
Factors Associated With Quality of Life in Chronic Low Back Pain

The aim of this study was to identify and validate the factors that may affect quality of life in patients with chronic low back pain.

Participants between the ages of 18-65, who are willing to participate in the study and have low back pain for more than 3 months will be included in the study. The necessary demographic information will be obtained with a data form. For the evaluation; Visual Analogue Scale (VAS), Tampa Kinesiophobia Scale, Fear-Avoidance Beliefs Questionnaire, Roland-Morris Disability Questionnaire, Beck Depression Scale, Self-Efficacy for Managing Chronic Disease 6-Item Scale, Coping Strategies Inventory Short Form (CSI-SF), Pain Catastrophising Scale, Pittsburgh Sleep Quality Index, Short Form - 36 (Quality of Life Questionnaire) will be used. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p\<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Having low back pain for more than 3 months
* Being between the ages of 18-65

Exclusion Criteria:

* History of surgery in the spinal region
* Rheumatoid arthritis
* Tumour
* Autoimmune disease
* Neurological disease
* Psychiatric or cognitive impairment
Urodynamic Changes Following Bladder Injury

This study is a unique one as it si done for first time to all patients following bladder injury in PAS surgery. Bladder function will be assessed by urodynamic study.

Patients will be initially assessed by overactive bladder (OAB) and incontinence questionnaire. Examination was done to determine any neurological, or congenital abnormalities.

Urodynamic study (UDS) will done for all patients. The patients will be asked to drink fluids to obtain a comfortably full bladder. Initially, a pelvic-abdominal ultrasound was done followed by the UDS. Urodynamic study consisted of uroflowmetry (volume: ≥150 ml and Qmax: 20-30 ml/s); filling cystometry in physiological or medium filling rate of 40 ml/min (using normal saline at room temperature through a double lumen urethral catheter); stress leak test; and pressure flow study.

No sedation will be administered during the study as the patient should be aware. The patients were placed in a semi-seated lithotomy position. After a detailed explanation to the patient, the examination will begin by passing a catheter into the bladder (5 Fr) to measure the postvoiding residual urine followed by filling the bladder and measuring the intravesical pressure through the catheter.

A rectal catheter was placed for measuring the abdominal pressure. The systems will be always zeroed at the atmospheric pressure. The patients will be periodically asked to cough to check the operation of the equipment and instructed to report her sensations.

The volume of the first sensation of filling, first desire (1 s) and second desire (2 s) were recorded. When the bladder was filled up to 150 ml, patients were asked to cough (Valsalva) to predict the stress leakage. If not occur at 150 ml, the bladder was refilled, and the stress test was repeated until the leakage occurred or the bladder capacity was reached. Additionally, any unidentified involuntary detrusor contractions will be noted.

When the patient had the urge to void, the permission for voiding will be given. Then voiding cystometrogram (pressure-flow) was performed and the urodynamic parameters, such as maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax) will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years
* Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment
* Bladder injury was diagnosed and repaired during surgery 6 months ago.

Exclusion Criteria:

* Patients with neurological problems
* Presence of congenital urinary system anomalies
* Urinary tract infections (UTIs)
* Previous urologic surgeries
* Patients with stone bladder or tumour
* Diabetic patients
Allogeneic Hematopoietic Stem Cell Transplantation

To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.

To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.

To study overall survival.

Primary criterion

* Hematological reconstitution and chimerism post-transplantation

Secondary criteria

* Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
* Analysis of variations in post-transplantation immunological function profiles
* Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients

Eligibility Criteria:
Inclusion Criteria:

* Patients aged less than 20 years old
* Lansky score \> 60%
* Life expectancy greater than 2 months
* Diagnoses:

  3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.

  4- Malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning.
* Usual criteria for allogeneic grafting (pre-graft profile)
* Having a HLA-identical sibling donor for HLA-A, HLA-B and HLA-DR antigens or a HLA mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood.
* Signed informed consent

Exclusion Criteria:

* Patient presenting rapidly-progressive malignancy
* In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
* Unable to sufficiently understand the treatment and its consequences, even after explanation
Feasibility of Strength Training in Patients Hospitalized Due to COPD

To examine the feasibility of progressive unilateral knee-extension strength training using ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD

We decided that feasibility is indicated if: 1) the absolute training loads increase progressively, 2) more than 80% of the planned training sessions are completed, and 3)if the absolute training loads do not exceed 20 kg (2 x10kg weight cuffs) for 90% of patients.

Eligibility Criteria:
Inclusion Criteria:

* Have a primary diagnosis of COPD
* Be admitted to the pulmonary ward due to an exacerbation in COPD
* Provide informed consent to participation in the study
* Be able to maintain an upright position on a chair
* Be able to be guided to training and understand instructions for participating

Exclusion Criteria:

Patients suffering from diseases that prevents the use of wrist weights such as

* Deep venous thrombosis (DVT)
* Erysipelas
* Painful edema of the limbs
* Lack of ability to walk, habitually
* Predicted hospital stay of less than four days as predicted by a pulmonary physician
* Patients admitted Friday night or Saturday morning cannot be stared up within 24 hours of admittance
BNP Testing in Patients With SOB on Presentation to ED

A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.

We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.

In recent years new tests to diagnose heart failure have become available. We are evaluating a new test called B-type natriuretic peptide(BNP)in patients presenting to the Emergency Department with shortness of breath. Patients are randomised into whether they will receive the new test or not. In the patient group where the test is positive, standardised approach that will optimise heart failure treatment will be introduced. We hypothesise that with this approach we will improve the clinical care of patients who present to the Emergency Department with shortness of breath. Measures of outcomes will be the accuracy of diagnosis 2 hours after presentation, 30 day mortality, hospital and ICU admission rates and quality of life at 30days.

We plan to investigate 600 consecutive patient presenting to the to the Emergency Department with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher. Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease, patients with cardiogenic shock and patients who have early transfer to another hospital(within 24 hrs) will be excluded.

Eligibility Criteria:
Inclusion Criteria:

We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher.

Exclusion Criteria:

Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.