cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)

Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods. "Intrauterine contraception" means that a device is inserted into a woman's uterus by her doctor. The device then releases a birth control treatment into the uterus.

Researchers have found that when women use intrauterine contraception, its effects on the menstrual cycle can cause changes to how often and for how long women will bleed. This is one of reasons women may stop using their intrauterine contraception.

So, the researchers in this study wanted to learn about a tool that can be used to predict future bleeding events. This tool was developed based on the results of previous clinical studies that researched menstrual bleeding. This tool is a smartphone application called MyIUS.

This study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the MyIUS app.

There will be no visits with a study doctor in this study. After the intrauterine contraception has been inserted, the women will start to record any events of bleeding in the MyIUS app. After they have recorded events of bleeding for a total of 90 days, the MyIUS app will give a prediction of menstrual bleeding expected for the next 180 days. The women who sign the electronic informed consent form will continue to record their bleeding events for a total of 6 months.

The researchers will then collect this information. They will use this information to find out how well the MyIUS app can predict future menstrual bleeding.

The aim of this study is to demonstrate that the bleeding prediction algorithm which was developed and validated based on clinical trial data also works in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Insertion of Kyleena, Jaydess, or Mirena IUS
* Female (of legal age to provide electronic informed consent (eIC)) using the MyIUS app
* Submitted eIC to use all data documented in the MyIUS app

Exclusion Criteria:

- None
Physical Activity Level of Norwegian Boys with Duchenne Muscular Dystrophy

The aim of this population based study is to examine, quantify and describe physical activity level in Norwegian boys with DMD, and to compare the level of physical activity level between boys with DMD and age matched healthy boys. A co-project will validate ActiGraph accelerometry to measure physical activity in boys with DMD.

International guidelines recommend regular physical activity for boys with DMD, and participation in physical activity plays a key role in the management. Paradoxically, patients with severe neuromuscular disease like DMD, have considerable limitations to participate in such activities. Limitation may be muscle weakness, pain, fatigue, reduced mobility and overall function, and also limited knowledge of physical activity benefits among health care personnel. Limited participation leads to a sedentary lifestyle, and gradual under-use of still functioning muscles may cause secondary deterioration in DMD.

The current physical activity level amongst Norwegian DMD's are unknown, and physical activity registration and self-reported questionnaire will be examined in this study.

Eligibility Criteria:
Inclusion Criteria:

* Boys with conclusive diagnosis of Duchenne Muscular disease, attending Norwegian pediatric rehabilitation clinics.
* Signed written consent
* Able to answer questionnaires with help from parents, care giver(s) or health care professional with regular follow up of the participants.

Exclusion Criteria:

* Lack of consent.
* Language difficulties
* Cognitive dysfunction or mental retardation leading to difficulties in answering the questionnaires adequately
Effects of Pilates in Risk Fall in Older Population

The intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness.

A study population of elder people will be randomly allocated to intervention or control group, consisted in Pilates and a booklet of balance tips respectively.

The protocol will be performed for 6 weeks.

Eligibility Criteria:
Inclusion Criteria: - Elder population. Not to be a pilates practitioner previous to study enrollment. Exclusion Criteria: - Cognitive issues that dont allow to practice pilates method.

Sensorial alteration or any disease that could altered balance. Any drug or medication that modify balance.
Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial

Background: Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. Overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. Affected women report significant limitations in daily life, as well as social isolation. Despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. Increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. Therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms.

Design: Randomized controlled study

Methods: Intake of OMNi BiOTiC® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months.

Outcome: Reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of Overactive Bladder Symptom Score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms

Exclusion Criteria:

* under age 18
* neurogenic overactive bladder
Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were randomized to receive a placebo or testosterone transdermal system throughout the study. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility Criteria:
Inclusion Criteria:

Eligible women must:

1. Be 40-70 years old and in generally good health
2. Be post-menopausal with no spontaneous periods for 1 year
3. Be receiving a stable dose of hormone replacement therapy for at least 3 months pror to screening with the intention of maintaining that regimen.
4. Be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry
5. Meet the criteria for having hypoactive sexual desire disorder

Exclusion Criteria:

Eligible women must not:

1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
2. Be experiencing any chronic or acute life stress relating to any major life change
3. Be experiencing depression and/or receiving medication for such illness or disorder
4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
6. Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
7. Have diabetes, a history of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
8. Have abnormal laboratory test results upon initial screening for this study
9. Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days
Continuous Labor Epidural Catheter for Tubal Ligation Study

This study is to study the success rate of using the epidural catheter that was placed during the labor for the surgical anesthesia to perform a postpartum tubal ligation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 1-3 postpartum women desiring Postpartum Bilateral Tubal Ligation (PPBTL) for infertility
* Functional epidural catheter placed for labor and delivery analgesia
* The epidural is still taped within 1cm of the original depth when it was functional for labor analgesia
* 1-45 years of age

Exclusion Criteria:

* ASA 4 status
* History of dural puncture ("wet tap") during initial epidural catheter insertion
* History of marginal or inadequate epidural analgesia for labor
* Cesarean section for delivery
* Examination demonstrates that the indwelling catheter has migrated more than 1 cm from the original depth when secured
* The end of indwelling epidural catheter appears to have not been capped appropriately or the cap was not maintained intact
* Prolonged sensory or motor block, bladder or anal sphincter dysfunction, nerve damage, inability to ambulate, post-dural puncture headache (PDHD), or seizures, during or after delivery and following cessation of the epidural catheter dosing
* Pseudocholinesterase deficiency
* Allergy to Nesacaine® (chloroprocaine) or lidocaine
* General anesthesia provided for delivery
* History of substance abuse disorder
* History of major psychiatric disorder
* Non-English reading/speaking participants
Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand

This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images.
* Males or females, 22 years of age or older
* Willing and able to perform hand functionality tests .

Key Exclusion Criteria:

* History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
* History of allergy or hypersensitivity to lidocaine or other amide type anesthetics.
* Previous hand surgery including sclerotherapy, or history of hand trauma.
* Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.
Vedolizumab for the Treatment of Collagenous Gastritis

The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:

* Whether vedolizumab can reduce CG symptoms
* Whether vedolizumab is safe to take for patients with CG

Participants in this study will:

* Receive vedolizumab through an IV ("infusion")
* Complete a survey at each infusion visit
* Have blood collected at each infusion visit
* Undergo an endoscopy with biopsy at 2 timepoints

Eligible participants will receive vedolizumab through an IV ("infusion") at week 0, then week 2, then week 6. Participants who respond well to the treatment after the first 3 infusions and are interested in continuing will receive vedolizumab every 8 weeks for about 1 year. At each visit, participants will be asked about their collagenous gastritis symptoms and any changes in their health or medications.

Blood samples will be collected from participants at every vedolizumab infusion. Some of these samples will be collected for safety purposes, some will be collected to monitor CG progression, and some will be collected for research purposes.

During the screening period and a few months after beginning treatment, the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participant's CG. An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract (the esophagus, stomach, and part of the small intestine). During the procedure, biopsies will be collected to monitor CG and for research purposes. All participants will be given medication to make them comfortable throughout the duration of the procedure, which lasts approximately 10 to 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age 14 or older
* Weight of at least 40kg
* Has a biopsy-confirmed diagnosis of collagenous gastritis
* Agrees to all required study procedures
* Presence of one or more collagenous gastritis symptom at a severity of Grade 1 or higher at the time of enrollment: abdominal pain, nausea, diarrhea, bloating, vomiting, flatulence, constipation, fatigue, headache, rash

Exclusion Criteria:

* Unable to independently provide informed consent or assent
* Allergic to vedolizumab or any of its components
The Expansion of a Parent-focused Physical Literacy Intervention for Early Childhood Called PLAYshop

The PLAYshop program is a novel, brief, theory-based, parent-focused physical literacy intervention, that can help mitigate the impacts of the COVID-19 pandemic on physical activity of children from diverse and vulnerable families who have been disproportionally affected by the COVID-19 Pandemic.

Primary Research Question: Among vulnerable families (e.g., lower socioeconomic status), does the PLAYshop program increase parental capability, opportunity, and motivation to support preschool-aged children's physical literacy development, compared to controls?

The overall objective of this study is to generate evidence for the efficacy of the PLAYshop program in diverse and vulnerable populations, such as families of lower socioeconomic status, who have been disproportionally affected by the COVID-19 Pandemic.

Research Questions:

Primary: Among vulnerable families (e.g., lower socioeconomic status), does the PLAYshop program increase parental capability, opportunity, and motivation to support preschool-aged children's physical literacy development, compared to controls? Secondary: What is the level of, and factors that influence, implementation at the family and program delivery level when working with vulnerable families? Tertiary: Does the PLAYshop program increase preschool-aged children's motivation and enjoyment, compared to controls?

Hypothesis for the primary research question: Increases in parental outcomes, including capability, opportunity, and motivation, will be greater in the intervention group, compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Parents of children aged 3 to 5 years who live in the provinces of Alberta and British Columbia and meet at least one of the following criteria:

   * Statistics Canada's low income before tax cut-off based on household size and the population of the municipality they live in
   * have an education level below a bachelor's degree (participating parent)
   * are unemployed (participating parent)
   * are a single adult in their household
   * are connected with an agency partner that supports vulnerable populations
2. Research staff and any organization partners who lead the workshop

Exclusion Criteria:

1) Parents:

* who do not have internet access to complete the questionnaires and join the virtual workshop. This includes access to a device such as a smartphone, tablet, or laptop/computer and a data plan or WIFI.
* who are not comfortable reading, writing, speaking and listening to at least one the following languages: English, Spanish, Farsi, Mandarin (Simplified Chinese), or Cantonese (Traditional Chinese).
* that have participated in prior PLAYshop pilot and feasibility trials
Rituximab for Prevention of Rejection After Renal Transplantation

Our standard immunosuppressive treatment after renal transplantation is a combination of tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute rejection within the first six months after transplantation has dropped to about 20%. The main challenge at present remains to improve long-term outcome by preventing chronic allograft nephropathy (CAN). Since acute rejection is a strong predictor of CAN, a further decrease in the incidence of acute rejection can improve the long-term graft survival. Current strategies to prevent rejection are mainly directed at alloreactive T cells. Recently, the attention for the role of antibodies in the pathogenesis of acute rejection has increased. In addition, anti-B cell therapy was shown to be effective in diseases that were considered to be mainly T cell driven, like rheumatoid arthritis. In the latter case it has been suggested that anti-B cell antibodies may impair the antigen presenting function of B cells. We therefore decided to investigate the effectiveness and safety of the anti-B cell monoclonal antibody rituximab for prophylaxis of acute rejection after renal transplantation.

Study design: Double-blind, placebo controlled intervention study. One group receives a single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation, and the other group receives a placebo infusion.

Primary Objective:

To determine the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

Secondary Outcomes:

* Renal function as estimated by the endogenous creatinine clearance at 6 months
* Occurrence of chronic allograft nephropathy at 6 months
* Cumulative incidence of infections and malignancies at 6 months
* Medical costs during the first 6 months after transplantation
* Patient and graft survival


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients
* Signed, dated, and witnessed IRB approved informed consent

Exclusion Criteria:

* Pregnancy
* Living donor, who is HLA identical.
* Hemolytic uremic syndrome as original kidney disease.
* Focal segmental glomerulosclerosis that had recurred in a previous graft.
* More than two previously failed grafts and/or PRA \> 85%.
* Previous treatment with anti-CD20 antibodies.
* Diabetes mellitus that is currently not treated with insulin.
* Total white blood cell count \<3,000/mm3 or platelet count \<75,000/mm3.
* Active infection with hepatitis B, hepatitis C, or HIV.
* History of tuberculosis
A Medical Device to Treat Brain Aneurysms

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms.

The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

Patients will be treated with the Nautilus, then will be followed up for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

\* Patients who present with intracranial aneurysm

Exclusion Criteria:

\* Unstable neurological deficit
Comparison of Positional Release and Manual Pressure Technique in Chronic Low Back Pain

The purpose of the study is to compare the effect of positional release technique and manual pressure technique of hip flexors on pain, range of motion, lumbosacral angle and disability in patients with chronic low back pain

This will be Randomized clinical trial. Individuals who met inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups. Pre intervention assessment is made for both groups. Then intervention will apply to both groups. Group A will receive positional release technique and Group B will be treated by manual pressure technique and pain, range of motion, lumbosacral angle and functional disability will be measured before and after the treatment using NPRS, Inclinometer and ODI. Estimated time of treatment protocol will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting. Subjects will be evaluated at baseline and 4th week assessment will be the final.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* age group 25 to 40yrs
* Atraumatic chronic low back pain more than 3 months
* Patients with Anterior pelvic tilt
* Patients with lumbosacral angle \> than 50 degrees

Exclusion Criteria:

* Pregnancy
* history of vertebral fracture
* History of any spinal surgery
* Disc disease
* Osteoporosis
* Bone disease
* Patient unable to give consent
Individualized Approach vs. Fixed Approach

The purpose of the current study is to assess differences regarding the acute efficacy, safety, procedural duration, radiation exposure and long-term success of the novel AFA-Pro in combination of an individualized shortened ablation protocol containing a reduced freezing time to the standard approach of a fixed ablation protocol in patients with symptomatic PAF.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* The patient understands the nature of the study, treatment procedure and provides written informed consent
* Symptomatic paroxysmal atrial fibrillation as defined by the current guidelines
* Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
* Expected to remain available (geographically stable) for at least 12 months after enrollment

Exclusion Criteria:

* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
* Previous AF ablation procedure
* Longstanding persistent AF
* Documented left atrial thrombus on imaging (e.g., transesophageal echocardiogram, angiogram)
* NYHA functional Class IV heart failure
* Unstable angina
* Left ventricular ejection fraction \< 30%
* Valvular disease requiring interventional treatment
* Cardiac surgery within 3 months prior to enrolment
* Left atrial size \> 55 mm as measured in the parasternal antero-posterior view
* Uncontrolled bleeding, diathesis, coagulopathy or pro-coagulant state
* Active systemic infection or sepsis
* Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.