cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)

The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.

This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a postmenarcheal and premenopausal woman of child bearing potential.
* Subjects are at least 18 years of age, at the time of signing the informed consent.
* Subject is overtly healthy as determined by medical evaluation.

Exclusion Criteria:

* Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
* History of previous IUD complications
* Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
* Known anatomical abnormalities of the cervix
* Presence of acute pelvic inflammatory disease at the time of screening.
* Postpartum endometritis.
* Known or suspected uterine or cervical malignancy.
* Uterine bleeding of unknown etiology.
* Untreated acute cervicitis or vaginitis or other lower genital tract infection.
* Conditions associated with increased susceptibility to pelvic infections.
* Subjects with Wilson's disease.
Flossing Protocol and Manual Therapy in Young Subjects With Recurrent Ankle Sprains

The most frequent lateral ankle sprain mechanism consists of talocrural plantarflexion added to a subtalar inversion. The anterior talofibular ligament, in plantar flexion, suffers maximum stress, being very sensitive to injury mechanisms with inversion of the foot, being the cause of up to 70% of sprains. The risk of injury recurrence must be taken into account. In sports practice, this percentage of recurrence is especially relevant.

Randomized clinical study. Participants will be randomized to a control or experimental group. The dependent variable will be the range of motion in ankle dorsiflexion. Secondary variables will be pressure pain threshold, and stability of the foot and ankle. Three evaluations will be carried out: before the start of the study (T0), after the intervention (T1) and after a 4-week follow-up period (T2). All evaluations will be performed by one evaluator, blinded to player assignment The intervention consists of the application of a treatment protocol based on an initial active warm-up consisting of 3 active exercises, walking for 1 minute performing slow and controlled movement of the ankle, raising the heels, 15 repetitions, dorsiflexion of the ankle in the standing position. gentleman, 15 reps. Subsequently, the floss band will be placed, performing again the 3 active warm-up exercises with the band on. After this, the passive manual techniques will be carried out for the remaining time, removing the flossing at the end of the latter, and actively mobilizing again.


Eligibility Criteria:
Inclusion Criteria:

* Young people between 18 and 22 years old
* Who have suffered a previous sprain
* No chronic or degenerative musculoskeletal pathologies of the ankle or knee
* That they do physical activity regularly.

Exclusion Criteria:

* Have suffered a sprain in the last 6 months
* Being receiving another physiotherapy treatment at the time of the study
* Not signing the informed consent document.
Vitamin D Supplementation in Conscripts

A longitudinal, triple-blinded, randomized, placebo-controlled trial, with a 7-month follow-up period is conducted between October 2016 to April 2017.

Body mass (kg) and height (cm) is measured by the same person at the medical center using standardized equipment and the body mass index (BMI) is calculated in kg/m2.

Computed randomization is used to divide conscripts into two groups; either the intervention group or the control group. Both types of capsules are administered once per day in the morning before breakfast for 7 months. Standardized coded packages (3 per conscript) and capsules (100 per package) are manufactured on a special order by Innopharma A/S (Denmark). No commercial sponsoring is involved.

The key of the package code is stored in the computer database until unblinding of the results.

Laboratory measurements Serum samples for clinical chemistry analysis are collected into serum clot activator tubes. Calcium measurements are performed using spectrophotometry method. Ionized calcium measurements are performed using ion selective electrodes. The direct chemiluminescent immunoassay method is used for measurement of PTH. 25(OH)D is measured using direct chemiluminescent immunoassay method.

Power calculation The primary variable of the study is the level of 25 (OH)D in the serum. In the power analysis a difference of 20 nmol/L between the intervention and the control group is considered to be meaningful to detect. If the SD would be 25 nmol/L, then 26 participants would be needed in each group to reach a power of 80%.

Statistical analysis The distribution of blood serum values in the study groups is described by means and standard deviations (SD). Differences in mean values of the variables of interest between the groups are evaluated using Welch t-test. The within group comparisons over time are performed using paired t-test with Bonferroni correction. Distributions of categorical variables are described by absolute numbers and percentages and compared between groups using the Fisher exact test. Statistical significance is set at the 0.05 probability level.

Eligibility Criteria:
Inclusion Criteria:

* participating in military service at the Estonian Defence Forces
* voluntarity to participate in the study

Exclusion Criteria:

* inability to continue military service for any reason, during the 7 month follow-up period
HIP: HIV Intervention for Providers

The purpose is to encourage Provider participants to evaluate high risk HIV transmission behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or unknown HIV serostatus. It is hypothesized that patients of providers participating in the HIP intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.


Eligibility Criteria:
Inclusion Criteria:

* Provider participants: (1) licensed MD, NP or PA on staff at the participating institution; (2) has a minimum panel of 5 HIV+ patients; (3) sees patients at least one-half day per week in the clinical setting; (4) is willing to participate in all intervention training sessions; and (5) is willing and able to provide full informed consent.

HIV+ patient participants:(1) report at least 1 encounter of unprotected anal or vaginal sex with known HIV- or unknown serostatus partner in the preceding six months; (2) patient's Primary Provider is enrolled as a participant in the study; (3) age 18 years or older; and (4) willing and able to provide informed consent.

Exclusion Criteria:

-
International HIV Antiretroviral Adherence, Resistance and Survival

Real-time Wireless Adherence Monitoring to HIV Antiretroviral Therapy in Rural Uganda.

The investigators will study use a novel method of real-time wireless adherence monitoring in one of the best established multi-disciplinary HIV antiretroviral treatment cohorts in rural Africa. The investigators will advance our theoretical understanding of HIV antiretroviral adherence behavior, HIV pathogenesis, and to address the monitoring and prevention of HIV antiretroviral treatment failure. Based on a successful pilot study in rural Uganda and favorable cost-effective estimates, the investigators will deploy the Wisepill real-time wireless adherence monitoring system to objectively monitor adherence in real time. The investigators will determine to what extent social capital mitigates economic barriers to long-term adherence and determine if the pervasive impact of stigma on adherence operates through social capital (Aim 1). The investigators will determine the relationship between missed doses, low-level viremia (between 1 and 50 copies RNA/mL), inflammation, bacterial translocation, suboptimal CD4 response, and mortality (Aim 2). Finally, The investigators will examine the relationship between complex adherence patterns and viral failure to both inform selective viral load monitoring and to lay the foundation for the first-of-kind intervention to prevent viral failure after missed doses, but before viral rebound (Aim 3). The investigators will secure behavioral and biologic data over nine years of potential treatment by recruiting 500 additional people to our existing cohort in Mbarara, Uganda for a total of 750 participants.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive patients over 18 years
* ART naive and initiating therapy at the Mbarara Immune Suppression Syndrome (ISS) Clinic
* Live within 60 kilometers of the clinic
* Women who have received a single dose of nevirapine for prevention of mother to child transmission, but have not received other ART, will be included

Exclusion Criteria:

* Patients who do initiate therapy during the course of the study recruitment
* Patients who decline or are unable to give consent
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer

The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

\*\*Calibration Phase:

A.Subjects who are asymptomatic and scheduled to undergo routine screening mammography.

OR

B.Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care (mammography, ultrasound and/or MRI)

\*\*Testing Phase:

A. Subjects scheduled to undergo routine screening mammography and at least one of the following :

* Subjects whose most recent (within 3 years) prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS Breast Density 4).
* Subjects whose current 10-year IBIS breast cancer risk is 5% or higher.

EXCLUSION CRITERIA, valid for both calibration and testing phases:

1. Male by birth.
2. Individual is less than 24 years old.
3. Contraindication to bilateral mammography or MRI.
4. Subjects who are unable to read, understand and execute the informed consent procedure.
5. Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
6. Subjects who have significant existing breast trauma.
7. Subjects who have undergone lumpectomy/mastectomy.
8. Subjects who have undergone breast reduction or breast augmentation.
9. Subjects who have undergone any other type of breast surgery.
10. Subjects who have large breast scar / Breast deformation.
11. Subjects who have undergone a breast needle biopsy within the 6 month period prior to their intended enrollment into the study.
12. Subjects who have a temperature \> 100° F (37.8C) degrees on the day of the MIRA imaging.
13. Subjects who are pregnant or lactating.
14. Subjects who have had placement of an internal breast marker.
15. Subjects with known Raynaud's Disease.
16. Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.
17. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
18. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
19. Subjects affected with epilepsy.
20. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study

Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density.

Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between 70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and the ability to walk with or without a walking aid prior to falling were asked for their agreement to be enrolled and partition occurred after informed consent.A subgroup analysis looking at periprosthetic bone mineral density around the femoral component was part of this level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and future examination of bone remodeling in these patients is now planned.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 70 and 90 years of age with displaced femoral neck fractures
* Intact cognitive function
* Ability to walk with or without a walking aid prior to falling.

Exclusion Criteria:

* Dementia
* Fractures in pathologic bone
* Patients not belonging to the hospital community
* Patients with sepsis or local infection
* Fracture not eligible to be treated with a hemiarthroplasty
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:

1. Does a RP design offer improvement in range of motion over a AP design?
2. Does a RP design have improved wear characteristics over a nonmodular AP design?
3. Is there a clear clinical advantage to the RP design that justifies its increased cost?

Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.

This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.


Eligibility Criteria:
Inclusion Criteria:

* generally accepted clinical and radiographic criteria for primary total knee arthroplasty

Exclusion Criteria:

* substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
* patients whose mental function precluded them from responding to our standard questionnaires
Contemporary Restorative Materials in Primary Molars

This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:

* Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
* Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.

Participants will:

- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.


Eligibility Criteria:
Inclusion Criteria:

For participants:

* no known or suspected history of allergy to medications or restorative materials
* no habits of teeth grinding or clenching
* presence of at least one interproximal carious lesion

For teeth:

* carious lesion reaching at least 1/2 dentin
* in contact with adjacent teeth and in occlusion with antagonist teeth
* have no pathological mobility
* periodontally healthy
* no symptoms of pulpal pathology
* physiological root resorption should not exceed one-third of the root length if seen
* permanent tooth germ present below the tooth

Exclusion Criteria:

* did not attend their follow-up appointments
Study to Compare the Effectiveness of Rivaroxaban (Xarelto) Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism in Routine Clinical Practice in Germany

Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.


Eligibility Criteria:
Inclusion Criteria:

* At least one new diagnosis of VTE during the inclusion period:
* Ambulatory diagnosis, coded as verified,
* Primary hospital discharge diagnosis.
* Secondary hospital discharge diagnosis The quarter of the first VTE diagnosis in the inclusion period will be defined as the index quarter. For hospital diagnoses, the date of admission will be used to define the index quarter.
* The 12 months prior to the index date will define the baseline period for all included patients. Patients treated with anticoagulation regimens other than defined above (e.g. other DOACs) will not be included in the study. All patients will have to fulfill the additional inclusion criteria:
* Continuous enrolment in the baseline period
* ≥ 18 years of age at index date

Exclusion Criteria:

* A verified ambulatory or primary/ secondary hospital discharge diagnosis of VTE in the baseline period;
* A verified ambulatory or primary/ secondary hospital discharge diagnosis of atrial fibrillation in the baseline period; Individuals with documented cardiac valve surgery in the baseline period;
* A verified ambulatory or primary/ secondary hospital discharge diagnosis indicating pregnancy in the baseline period;
* A prescription of any anticoagulation treatment (heparins; vitamin-K antagonists; rivaroxaban; other DOACs) in the baseline period;
* A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period;
* A prescription of contraindicated drug for rivaroxaban due to drug interactions (i.e. azole antifungals and HIV protease inhibitors) in the 60 days before or on the index date.
* Patients assigned to rivaroxaban exposure groups who were initially treated with a dose strength other than 15 mg or 20 mg per tablet.
Beetroot Juice Effects on Contractile or Neuromuscular Properties in Male Trained Sprinters

Beetroot juice is a rich source of nitrate (NO3-), which serves as a precursor to nitric oxide (NO) via the NO3- to nitrite (NO2-) to NO conversion pathway. This pathway is believed to enhance vasodilation and improve neuromuscular function, such as by increasing sarcoplasmic reticulum calcium release and re-uptake, leading to enhanced force production in type II muscle fibers and improved muscle contractile recruitment. Therefore, the aim of this study was to investigate the effects of beetroot juice supplementation on muscle contractile properties, as assessed by tensiomyography, and neuromuscular performance in sprint-trained athletes.

Sports nutrition is a rapidly expanding scientific field that has experienced a significant increase in interest from the academic community over the past decade. Despite the extensive marketing of numerous nutritional products that claim to optimize athlete health, function, and performance, only a limited number of sports foods or dietary supplements have been supported by robust evidence for enhancing performance. Among these, caffeine, creatine, beetroot juice, β-alanine, and bicarbonate are notable for their validated efficacy, though the effectiveness of these supplements can vary based on the specific event, context of use, and the individual athlete's goals and responsiveness.

Beetroot juice, in particular, is a rich source of nitrate (NO3-), which serves as a precursor to nitric oxide (NO) through the NO3- to nitrite (NO2-) to NO conversion pathway. This pathway is believed to promote vasodilation and improve neuromuscular function, such as by increasing sarcoplasmic reticulum calcium release and re-uptake, leading to enhanced force output in type II muscle fibers and improved muscle contractile recruitment. Therefore, the aim of this study was to investigate the effects of beetroot juice supplementation on muscle contractile properties, as assessed by tensiomyography, and neuromuscular performance in sprint-trained athletes. The goal was to gain a deeper understanding of the physiological effects induced by beetroot juice intake in short-distance track and field disciplines.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 to 40 years old.
* With a regular training practise in track and field disciplines \&gt; 5 years.

Exclusion Criteria:

* Intolerance to beetroot juice or NO3- derivatives
* Presence of any chronic pathology or injury within three months prior to the study-
* Use of medications or supplements (e.g., caffeine) during the study.
* Failure to attend all experimental sessions.
* Failure to adhere to the dietary guidelines established in the study
Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI

At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized between study and control group.In the control group no additional intervention takes place on the embryos to be transferred,in the study group, embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* Female

Exclusion Criteria:

* No exclusion criteria, except not possible to give informed consent
Early Diagnostic Biomarkers of Sepsis

A Comparison between CRP, ferritin, and serum zinc as early diagnostic biomarkers of sepsis in critically ill patients


Eligibility Criteria:
Inclusion Criteria:

* All patients with chest infection and UTI.

Exclusion Criteria:

* children