cyrilzakka/clinical-trials huggingface dataset:
Recall by Genotype: Neuropeptide Stimulation

The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.

Assignment: All study subjects will undergo the same interventions. Individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility).

Delivery of Interventions:

* Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
* On the day of the study, the subjects will have an intravenous (IV) line placed and

  * Undergo up to q10 min blood sampling x 12 hours
  * Receive a single kisspeptin IV bolus at hour 8
  * Receive a single GnRH IV bolus at hour 11

Eligibility Criteria:
Inclusion Criteria:

* No prescription medications that could interfere with hypothalamic reproductive function
* No illicit drug use
* No excessive alcohol consumption (more than 10 drinks/week)
* No history of an allergic medication reaction requiring emergency medical care
* Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg)
* White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range
* Normal hemoglobin
* Blood urea nitrogen (BUN), creatinine not elevated
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal
* Enrolled in the Partners HealthCare Biobank and genotypically characterized
* For women

  * No oral contraceptives for at least 1 month
  * No contraceptive implants for at least 3 months
  * Not breastfeeding and not pregnant
  * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)
Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

The aim of this study is to compare anti-gravity treadmill training with traditional treadmill training in patients with moderate to severe knee osteoarthritis.

Patients with moderate to severe OA have persistent pain that significantly affects their functional status, activity participation, and quality of life. As with mild OA, non-pharmacological interventions that focus on education, exercise, and weight management are first-line treatments for patients with moderate to severe knee OA.

Exercise is recommended for all patients with moderate to severe knee OA to reduce pain and protect the joint. A meta-analysis showed that exercise has beneficial effects on pain, even in patients with severe disease and awaiting total knee replacement.Therefore, the objective of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training on pain levels, quality of life and functional capacity in patients with moderate and severe knee osteoarthritis.

In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 50 and ≤ 75 years old
* Patients with a diagnosis of knee OA in at least one knee according to the classification criteria of the American College of Rheumatology
* Patients with Kellgren-Lawrence (K-L) knee OA staging III to IV
* Patients reporting knee pain on most days of the past month
* Patients with stable medical and psychological status
* Patients willing to participate in the study

Exclusion Criteria:

Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking

* Patients with a history of corticosteroid injection to the knee in the last 3 months
* Patients who have received opioid analgesics or systemic corticosteroids in the last 3 months
* Patients who have undergone any exercise program or physical therapy program for the lower extremities in the last 3 months
* Patients with severe vision, hearing and language problems
* Patients with a body mass index ≥35 kg /m²
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.

Patients will undergo a medical evaluation every three months during the 24-month study period. Liver biopsy will be performed only at baseline and at the end of treatment. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography and Fibroscan of the liver will be repeated at the end of the study period.

Eligibility Criteria:
Inclusion Criteria:

* persistently elevated serum aminotransferase levels
* diffusely echogenic liver on imaging studies suggestive of fatty liver
* biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria:

* hepatic virus infections (HCV RNA-PCR negative)
* Hepatitis A, B, C, D, E and G
* cytomegalovirus and Epstein-Barr virus
* alcohol consumption
* history of parenteral nutrition
* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
* autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria
Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response

The primary objective of this study is to investigate the influence of a standardized noxious stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and sufentanil TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction.

In addition the investigators compare the performance of ANI and SPI against one another as well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.

During general anesthesia hypnosis can be monitored routinely using EEG derivates like Bispectral index (BIS), entropy,.... However, monitoring analgesia or more precisely the nociceptive-antinociceptive (analgetic) balance during anesthesia proved more difficult. Clinical signs such as heart rate (tachycardia) or blood pressure (hypertension) are usually observed and used to assess nociception and a patient's autonomic unbalance. During general anesthesia administration of opioids like sufentanil and remifentanil decrease the ANS reactivity to noxious stimulation. Recently two variables based on standard anesthesia monitor equipment have been introduced into clinical practice: the Analgesia Nociception Index (ANI), derived from analysis of the small beat-to-beat oscillations of the heart rate during respiration, the heart rate variability (HRV), and the Surgical Pleth Index (SPI), calculated from the plethysmographic amplitude and heart beat interval.

Eligibility Criteria:
Inclusion Criteria:

* Male
* non-pregnant female participants
* ASA II-III
* \>18-65 years
* Weight not exceeding 30% under or above ideal body weight
* Elective intracranial surgery or circumcision.

Exclusion Criteria:

* Use concurrent opioid containing drugs
* Use of any autonomic nervous system altering drugs
* History of opioid or alcohol abuse
* Hepatic, renal, metabolic, neuromuscular or cardiovascular disease
* Known allergies to anesthestetic / analgesic drugs
* Use of a peripheral nerve block, penile block
Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?

Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.

Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.

An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.

It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* A female patient who needs IVF to become pregnant.
* Regular menstrual cycle.
* Antral follicular count (AFC) \> 18
* Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the medications used.
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
* Pregnancy.
* Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
* Primary ovarian failure.
* Ovarian cysts or enlarged ovaries.
* A history of Ovarian Hyperstimulation Syndrome (OHSS).
* A previous COS cycle that resulted in more than 30 follicles \> 11 mm measured by ultrasound examination.
* Fibroid tumours of the uterus incompatible with pregnancy.
* Malformations of the reproductive organs incompatible with pregnancy
Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax

The study aims to determine the level of knowledge and skills to recognize and decompression of tension pneumothorax


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy
Biomarkers of Acute Kidney Injury in Cardiac Surgery

Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)
* older than 18 years

Exclusion Criteria:

* previous known renal disease
* patients on chronic dialysis
Digital Versus Conventional Impression Technique in Mandibular Arch

Objectives: Passive fit of screw retained frameworks is essential to avoid biological and mechanical failures in addition to transmission of unfavourable stresses to the bone-implant interface. However, Several factors contribute to the passive fit of screw retained prosthesis such as relative parallelism between the implants, implant number, impression material, impression technique and method of prothesis fabrication. The current study aims to evaluate the accuracy of three different impression techniques on the fit of screw retained bar splinting two inter-foraminal implants.

Methods: The study presents evaluation of the passive fit of screw retained bar fabricated with three different impression techniques.

Surgical guide will be designed for completely edentulous patients. It will be inserted into the patient's mouth, stabilized against the upper denture and secured in place. dental implants will then be placed.

For bar fabrication using the first impression technique, closed-top primary impressions will be made followed by open top secondary impression. Extraoral scanning of the impression will be done followed by digital fabrication of the bar.

For bar fabrication using the second impression technique, scanning of the lower arch will be done using Omnicam intraoral scanner. Scanning will be done by a single calibrated operator who is trained on intraoral scanning techniques.

Scan bodies will be then screwed to the implants and scanning will be done. Both scans will be previewed on the computer desktop and superimposed together. A Standard tessellation language file will be then exported, downloaded and previewed in Inlab Exocad software .Implant system and the bar design will be selected from the software library. Then, the Standard tessellation Language file will be exported to the milling machine and milling of Cobalt chromium bar will be done.

For bar fabrication using the third technique, splinting of scan bodies will be done followed by intraoral scanning of the lower arch.

Eligibility Criteria:
Inclusion Criteria:

* - Patients' age range from 50 to 65 years old.
* Good oral hygiene is mandatory.
* Sufficient restorative space (15mm) to accept implant supported over denture diagnosed by mounting the diagnostic casts.
* Firm and healthy mucosa covering the alveolar ridge.
* Minimum bone width 5.5 mm buccolingually and of 12 mm bone height as diagnosed from the pre-operative cone beam computed tomography scan.

Exclusion Criteria:

* Heavy smokers.
* Patients with para functional habits.
* Tempromandibular Joint Disorders. (TMJ disorders)
* Patients with systemic disorders that may affect the results of this study.
* V-shaped dental arch.
Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice

The purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .

On the basis of "The Danish general medical database" it is possible to develope a computerised decision-support tool, which enables the general practitioner (GP) in a "pop-up" window to get information on each patients risk-factors, when prescribing NSAID and aspirin to a patient at risk. This will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time.

The decision-support tool will be tested in a randomized trial among general practitioners. The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a reduction in half of the total numbers of peptic ulcers.

The background of the study is that NSAIDs and Aspirins increase the risk of peptic ulcer bleeding. On average 1-2% of patients using NSAID and Aspirin will develope gastric ulcer bleeding. But for patients with one or more risk-factors, the risk increases to 9% per 6 months. The mortality in this case is 10-15%. Approximately 3200 patients are admitted to the hospital with bleeding ulcer annually in Denmark.

Danish investigations have shown that 80% of all peptic ulcer bleedings admitted to hospital are related to the use of NSAID or Aspirin.

The consumption of NSAID and Aspirin is large. A third of people over 60 are treated within a year with these preparations. The risk of developing gastric ulcer related to NSAID and Aspirin can be reduced by concomitant therapy with antacids. Several studies have shown that only 20-30% of patients with risk-factors receive ulcer preventive medicine.

Eligibility Criteria:
Inclusion Criteria:

* General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months

Exclusion Criteria:

-
Circulating Tumor Cells Screen for Breast Cancer

A prospective study was used to collect patients considering breast cancer admitted to our general surgery department from 2019-6 to 2023-8, to identify the case group (breast cancer) and the control group (non-breast cancer), to compare the differences in CTC in peripheral blood between the two groups, and to draw conclusions after statistical analysis.

This project is a prospective study by collecting clinical data from breast cancer and non-breast cancer patients admitted to our general surgery department from 2020 to 2023, and drawing peripheral blood for CTC testing. The clinical data of 200 patients were initially collected and grouped, with the study group positioned as breast cancer patients (patients with pathologically determined breast cancer) and the control group as non-breast cancer patients (patients with benign breast tumors and healthy women), to investigate the expression of CTC in breast cancer and correlation with the degree of metastasis, as well as to further understand the relationship between CTC in peripheral blood and breast cancer clinicopathology. The circulating tumor cell enrichment was compared between the two groups, and the data were derived for statistical analysis to draw conclusions, as well as to identify shortcomings and make improvements to the existing problems.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of breast cancer Must be able to cooperate with the examination

Exclusion Criteria:

patients were currently undergoing or had prior cancer treatment; patients had other conditions which investigators thought not suitable for the study.
Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three months.

This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma de México (UNAM) will be included. All Patients will complete a total of 15 sessions of treatment in any of four groups: A group of patients will be randomly assigned to receive either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of a 3-month follow up. In addition, neuropsychological evaluations will be applied at baseline and at the end of the 15 session's treatment. Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%. Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment groups will be compared using repeated measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of major depressive disorder
* Having a greater or equal score to 18 points in the Ham-D scale at the moment of the initial evaluation
* Treatment free patients

Exclusion Criteria:

* Epilepsy or seizure risk record
* Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
Smartphone for Assessing Balance in Patients With Ankle Instability

This study aims at investigating the validity and reliability of a smartphone application "MyAnkle: in assessing the balance component of postural control in patients with chronic ankle instability (CAI).

Lateral ankle sprain (LAS) is a common injury in athletic and regular activities; with an incidence of 7 per 1000 exposure. After LAS, residual symptoms may persist leading to chronic ankle instability (CAI). This instability is believed to arise from dysfunctional postural control, defective proprioception, weak muscles, or reduced ankle range of motion (ROM).Thus, assessment of postural control is essential for proper clinical decision-making and treatment selection.

With advances in technology, smartphone has been introduced as an assessment tool for the musculoskeletal system. For example, it was used in assessment of ROM and mobility in stroke patients and frail elderly conditions. Further, it was used to assess balance and falling risk in those population. In addition, it was used to assess balance in healthy and participants with chronic ankle sprain. These studies proved that smartphone is a valid and reliable tool that is light in weight and inexpensive. Yet, these studies have some methodological concerns. For example, the application was not validated against gold standard or was validated only in healthy volunteers rather than in patients with musculoskeletal dysfunction. Further, a few of these studies did not establish the application discriminative validity between patients and healthy controls. Thus, this study will try to answer the following question: "Is smartphone application a valid and reliable tool to assess balance in patients with CAI compared to gold standards?

Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females aging from 18 to 35 years old.
2. Referred with a confirmed diagnosis of CAI, with a Cumberland Ankle Instability tool score lower than 27 points.
3. Had a recurrent sprain within the previous year.

Exclusion Criteria:

1. History of major surgery of lower limb or spine.
2. History of ankle fracture or any other lower limb fracture in the past 2 years.
3. History of lower limb injury 3 months prior to study.
4. Presence of problems that affect balance performance as visual or vestibular deficits, neurologic disease, or cerebral concussions during the past 3 months.
5. Being currently enrolled in a balance training rehabilitation program.
6. Weakness of lower limb musculatures or trunk upon screening muscle testing by the investigator.