cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Nutritional Status, Eating Habits and Improvement of Symptoms With a Nutritional Intervention in Women With enDometriosis

The study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention.

The primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain.

The first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) .

The second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of endometriosis +/- chronic pelvic pain
* No menopause (at least 1 menstrual cycle in the previous 6 months)
* Informed consent from the patient and / or an authorized legal representative

Exclusion Criteria:

* Postmenopause
* Pregnancy
* Hysterectomy or oophorectomy
* Chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, Chron's disease, ulcerative colitis, cystic fibrosis)
* History of kidney stones, cancer (except basal cell carcinoma) or diabetes
* Modification in the course of the therapeutic intervention of the therapy for endometriosis
Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study

Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.

The present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.


Eligibility Criteria:
Inclusion Criteria:

1. Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification
2. Neurological signs persisting≧ 1 day from onset
3. Defined onset of symptoms, and stable condition at the period of enrollment
4. CT or MRI detection of responsible site
5. age≧20
6. Systolic pressure≦180 mmHg, Diastolic pressure≦110 mmHg
7. The maximum intensity of platelet aggregation is above 15 % induced by serotonin (1µM) and epinephrine (3µM) on the day of prior to the first medication
8. Written informed consent must be obtained from the patients before enrollment into the study

Exclusion Criteria:

1. Functional outcome at randomization: Modified Rankin Scale=4, 5
2. Previous or planned for vascular surgery to cerebral infarction
3. History of intracranial hemorrhage
4. History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
5. With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on )
6. Treating malignant tumor
7. Pregnant or possibly pregnant women, or nursing mothers
8. History of sarpogrelate sensitivity
9. Previously entered in other clinical trials within 3 months
10. Less than 3 months since any other clinical trial
11. Judged by investigator to be unsuitable for the study
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Implantation of joint prostheses is currently the second largest diagnosis-related group in the Danish health service, and in view of the demographic development and spread of lifestyle diseases, this type of intervention is expected to continue to increase.

Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis.

Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy.

The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .


Eligibility Criteria:
Inclusion Criteria:

* revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection

Exclusion Criteria:

* surgery within the last 4 months. The same applies to patients with short history of illness, pronounced acute symptoms and systemic response (reducing the likelihood of biofilm infection).
Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients

The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).


Eligibility Criteria:
Inclusion Criteria:

* Seropositive for HCMV IgG antibodies before transplantation
* First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
* Evidence of post transplantation engraftment
* Able to swallow tablets.

Exclusion Criteria:

* Previous anti-HCMV therapy after this allogeneic HBPC transplantation
* Mismatched or cord blood transplant recipients
* Current or history of end-organ HCMV disease
* Graft versus host disease (GVHD)
* Impaired liver function
* Reduced renal function
Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair

By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under laparoscopy and provide evidence based medicine. with In the research process of the research group, a database on abdominal wall hernia will be established for the future Further study of hernia has laid a solid foundation.


Eligibility Criteria:
Inclusion Criteria:

* Conform to the diagnostic criteria of abdominal wall hernia;

  * Patients with general physical condition and can tolerate general anesthesia and laparoscopic surgery; ③ After explaining the situation to the patients and their families, they agreed to join the research group.

Exclusion Criteria:

* The diagnostic criteria of abdominal wall hernia were not met; ② Patients who have serious medical diseases and cannot tolerate laparoscopic surgery; ③ Patients with mental illness; ④ The judgment is affected by incomplete data.
Exercising With a Screen or Music and Post-exercise Energy Compensation in Adolescents

OBJECTIVE AND HYPOTHESIS:

The objective of this study will be to examine the effects of watching a screen or listening to music while exercising on acute energy intake and expenditure. It is hypothesized that the post-exercise energy compensation will be greater in both conditions with stimuli (i.e., screen and music) compared with the control condition (i.e., exercise alone).

STUDY DESIGN:

Randomized, 3-condition crossover study (within-subjects experimental design).

PARTICIPANTS:

The present study will recruit 25 male adolescents between the ages of 13 and 17 years. Participants will be recruited via advertisements and word of mouth (first come first served approach).

OVERVIEW OF THE STUDY PROTOCOL:

Preliminary Visit The participants will attend one baseline session and three experimental sessions. The preliminary visit will include measurements related to anthropometry (body weight, height, waist circumference) and resting metabolic rate. Participants will also complete questionnaires in order to better characterize them.

Experimental Sessions Each participant will be engaged in each of the following three 30-min experimental conditions followed by an ad libitum lunch: (1) walking/jogging on a treadmill at 60% of VO2 peak while watching a screen (exercise + screen); (2) walking/jogging on a treadmill at 60% of VO2 peak while listening to music (exercise + music); and (3) walking/jogging on a treadmill at 60% of VO2 peak with no other stimulus (control condition).

MEASUREMENTS:

The main measures for this study include: anthropometric measurements, food intake, appetite sensations, energy expenditure, resting metabolic rate, and ratings of perceived exertion.

OUTCOME MEASURES:

The primary outcome measure will be post-exercise energy compensation. The food intake outcome will be assessed by using an ad libitum test meal immediately after the conditions and a dietary record for the remainder of the day. The energy expenditure outcome will be assessed by using an Actical accelerometer until bedtime. The secondary outcome measures will include appetite sensations and the ratings of perceived exertion (OMNI scale).


Eligibility Criteria:
Inclusion Criteria:

- Male adolescents between 13 and 17 years

Exclusion Criteria:

* Smoking
* Unstable body weight (±4 kg) during the 3 months preceding testing
* Excessive alcohol intake (\>15 drinks/week)
* Celiac disease
* Metabolic disease (e.g., thyroid disease, heart disease, diabetes)
* Medication use that could interfere with the outcome variables
* Irregular sleeping pattern (e.g., shift work or working overnight shifts)
* Iinability to comply with the protocol.
Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation

The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.

The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.

This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery.

The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.

The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.

Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Clinical and imaging evidence of knee osteoarthritis
* Indication for total knee replacement according to the patient´s orthopedic surgeon
* Ability to walk unaided, with unilateral or bilateral support
* Availability of a carer to assist the patient after surgery

Exclusion Criteria:

* Patients admitted for revision of total knee replacement
* Contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
* Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
* Respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity
* Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after the surgery
* Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
* Blind and/or illiterate patients
Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment

To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy

This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and effectiveness in patient examinations, while improving examination efficiency and reducing failure rates, it will provide safety assurance for the early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Upcoming upper gastrointestinal sedation procedure;
3. Classification under the American Association of Anesthesiologists (ASA) status I-III;
4. Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.

Exclusion Criteria:

1. Individuals with previously documented difficulties in mask ventilation (DMV);
2. Patients predisposed to aspiration risks or episodes of vomiting;
3. Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible;
4. An inability or unwillingness to utilize the novel disposable anesthesia face mask.
A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.

This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up.

Eligibility Criteria:
Key Inclusion Criteria Before Surgery:

* Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned.
* Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.

Key Exclusion Criteria Before Surgery:

* Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject.
* Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.
* Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase.
* History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs.

Immediate Postoperative Exclusion Criteria:

* Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
* Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.
* Evidence of hemodynamic instability or respiratory insufficiency.
Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.

This observer-blind crossover intervention study aims to determine the most effective type of device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three types of devices: standard, prefabricated and manufactured in the dental laboratory.

Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge will use the three devices at a random sequence during the twelve treatment sessions, so each device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.

Treatment with electroconvulsive therapy will involve the application of 12 m-ECT sessions at the rate of two sessions for six weeks according to the protocol established in the ECT Unit of the Department of Psychiatry at the University Hospital of Bellvitge.

Two devices, SB and CA, will be prepared for each patient and placed in mouth before anesthesia by one operator. This operator will assign a randomized sequence of use of the three devices (SB, CA or SM). Device SM will be the sole protector that will be placed after the anesthesia by nurse.

The outcome assessor will the scans pre- and post-session m-ECT and collect data, accede the surgery room before the session with the patient conscious and perform the exploration. This outcome assessor will leave the operating room during the procedure for the application of m-ECT an come back an hour later for the post-examination session.

Eligibility Criteria:
Inclusion Criteria:

* Patients should have an intellectual level that allows a proper communication and must agree to cooperate in all tests and exams required by the study protocol.
* Obtaining written informed consent for participating in the project (model consent form)
* The patient must have enough teeth in the upper arch or being a carrier of a stable removable prosthesis.

Exclusion Criteria:

* Being in a maintenance ECT program.
* Receiving ECT during the six months prior to the index episode.
* Pregnancy and lactation.
Suhexiang Pill for Acute Ischemic Stroke: A Registry Study

The primary purpose of this study is to investigate the effectiveness and safety of the Suhexiang Pill for patients with acute ischemic stroke in real-world settings.

Suhexiang Pill, a traditional Chinese patent medicine, is widely used in China for acute stroke. However, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. This registry study will recruit 1000 patients who receive Suhexiang Pill treatment after acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke within 7 days of symptom onset.
* Age ≥ 18
* Patient who has received Suhexiang Pill treatment
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Be allergic to Suhexiang Pill
* Known to be pregnant or breastfeeding.
* With conditions that render outcomes or follow-up unlikely to be assessed.
A Study of Cardiovascular Disease Awareness and Cardiovascular Health

The objective is to increase awareness of various cardiovascular diseases (CVDs) through an interactive, educational experience to promote cardiovascular health (CVH) via an inflatable heart model exhibit and assess community CVD knowledge and whether this experience is an acceptable tool to promote and provide education on CVH.


Eligibility Criteria:
Inclusion Criteria:

* MN resident
* Active email address
* ≥18 years of age

Exclusion Criteria:

- Inability to speak, read or understand English
Anti-mullerian Hormone in Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy, with current survival rates exceeding 90%. As cure rates improve, increasing attention is focused on survivor quality of life, including fertility. It is generally accepted that cancer treatments in childhood may interfere with gonadal function, reducing the pool of primordial follicles and consequently causing premature menopause in women. Anti-Mullerian hormone (AMH) levels is a valuable quantitative indicator of ovarian reserve, being directly related to the number of antral follicles. The evaluation of this hormone makes it possible to identify women at risk of early menopause and to propose them interventions for monitoring and preservation of oocytes, allowing girls to be able to have children once they reach adulthood. The objective of this study is to determine ovarian reserve in girls with ALL before and after treatment by means of the evaluation of the AMH assay.


Eligibility Criteria:
Inclusion Criteria:

* Female less than 18 years of age
* Diagnosis of acute lymphoblastic leukemia
* enrollment within the first month after diagnosis

Exclusion Criteria:

* Previous treatments with cytostatics drugs
* ALL as a second malignancy
* Syndromic patient or primary hypogonadism
Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults

The aim of this study was to adapt the Chalder Fatigue Scale to Turkish and to examine its psychometric properties in young adults. Within the scope of the study, firstly the Turkish version of the scale will be developed and then its reliability and validity will be examined in healthy young adults in Turkey.

Fatigue is a subjective experience that can affect all individuals. It is a protective symptom against physical or psychological stress for healthy individuals. However, it can negatively affect the performance of individuals in activities of daily living. In the clinic, fatigue is assessed by self-reported scales. Different fatigue scales have some advantages and disadvantages compared to each other. Moreover, it is stated that only one scale cannot fully measure the fatigue of individuals in different health status, therefore different scales have been developed.Chalder Fatigue Scale (CFS) is an easy-to-understand, short, fast and useful fatigue scale that evaluates fatigue with two dimensions (physical and mental) and enable individuals to express perceived fatigue clearly. Psychometric properties of CFS have been investigated in general population and different disease groups but not in only healthy young adults.

Eligibility Criteria:
The inclusion criteria for participants are: to be aged between 20 and 40 years old, volunteer to participate the study, able to read and speak Turkish.

Exclusion criteria are determined as individuals with known acute or chronic health conditions and illnesses and who had surgery in the past 6 months.

Further exclusion criteria are to take over-the-counter medication or food supplement, have abnormal body mass index (BMI) (lower 17 kg/m2 or higher 30 kg/m2), self reported depression as indicated by a score of \> 21 on the Beck Depression Scale (BDS), pain as indicated by a score of \> 0 on pain subscale of Nottingham Health Profile (NHP). Additionally, female participants were excluded if they use oral contraceptives, experience premenstrual syndrome or were pregnant within the last one year period.