cyrilzakka/clinical-trials huggingface dataset:
Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome

The goal of this randomised controlled trial is to compare a tuberositas transposition (TTT) surgery with a home exercise program (HEP) in patients with patellofemoral pain syndrome (PFPS). The study aims to evaluate the efficiency of TTT in conjunction with a HEP compared to a HEP alone in patients with chronic PFPS.

Participants will randomly be allocated to the surgery or HEP group. Researchers will compare the surgery and HEP groups to see if activity-related pain and patient reported outcome measures (PROMs) are different.


Eligibility Criteria:
Inclusion Criteria:

* Characteristic history of PFPS (patellofemoral pain during knee loading physical activity, such as jumping, running, squatting);
* Symptoms lasting at least 12 months;
* Tibial tubercle trochlear groove (TT-TG) distance of 15mm or more on CT or MRI;
* Patellofemoral pain during daily life activities, such as: standing for an extended period, walking, or walking upstairs or downstairs

Exclusion Criteria:

* Previous knee surgery;
* Reported knee ligamentous or meniscal injuries;

  * Disabling general illness;
  * A history of patellar dislocation; however, subjects with patellar subluxation are included in the study;
  * Other knee problems than PFPS diagnosed clinically (such as jumper's knee);
  * Other knee problems than PFPS diagnosed radiographically (such as osteochondritis - dissecans);
  * Patients who cannot undergo surgery;
  * Pregnancy;
  * Patients with inability to complete follow-up or with limited understanding of the Dutch language
Relevant Factors on Sprint Performance in Adolescent Sprinters

Purpose: To explore the sports performance of the adolescent sprinters, including analyzing the correlations between the results and central nerve sensory, and also between motor control and various muscle mechanical characteristic and sport-related fitness factor.

The sprint performance was determined by various relevant factors, and they were mainly divided into central system factor and peripheral system factor. An effective sprint start requires a quick reaction to an auditory stimulus followed by a determined sequence of activation of particular muscles responsible for maximum movement speed. Both of the skill-related physical fitness, including muscle strength, muscle endurance, muscle power, speed, agility, and balance, and muscle physical characteristic, including muscle tone and muscle architecture, are related to the sprint performance. The 100m race could divided into three different phases, start acceleration, maximum speed, and deceleration. According to Collet, 1999, the determinants of the temporal structure of the sprint start are RT, movement speed and movement frequency, which involves in perfecting sprinters' physical performance. And also, according to Pilianidis et al., 2012; Tonnessen et al., 2013, the start reaction time significantly affects the reduction of running time in 100 m races. In the recent studies, there are researches only showing that the auditory stimulus trainings significantly affected the final results for swimming athletes, and that the visual stimulus trainings significantly affected the final scores for badminton athletes.This study will mainly recruit the healthy adolescent athletes of the athletics sprint and other kinds of sports in the age range 13-18 years, and will evaluate the athletes of anthropometric measurements and physical fitness, 100m sprint performance, muscle characteristic, jump ability, agility, and nerve potential measurements.The outcome of this study will be able to be one of the comprehensive trials for coaches to take into consideration when choosing their own athletes. And also, the athletes may choose their own specialties that fit their own physical conditions. Moreover, the adolescent athletes will be trained more precisely and effectively. These will positively lead to reaching their personal best results and decreasing the occurrences of the sport injuries due to unsuitable events and trainings.

Eligibility Criteria:
Inclusion Criteria:

* the healthy adolescent athletes of the athletics sprint and other kinds of sports

Exclusion Criteria:

* cardiovascular diseases
* lower extremities surgery histories
* musculoskeletal sports injuries that would affect the sports testing
* auditory or visual disabilities
* brain injury histories.
South Asian Women & Yoga Education Study

The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12 week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for cardiovascular disease. Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.


Eligibility Criteria:
Inclusion Criteria:

* 40- 65 years old
* Postmenopausal (amenorrhea for ≥ 12 months)
* Overweight as evidenced by a body mass index (BMI) ≥ 25 kg/m2), or waist circumference ≥ 80 cm, or have a first degree relative with diabetes or essential hypertension
* Sedentary, do not do a regular exercise program (exercising for 20 minutes at sufficient intensity to produce sweating less than 2x/week)
* Self-identify as a South Asian (sometimes referred to as East Indian in Canada and may be defined "as any person who reports an ethnicity associated with the southern part of Asia or who self-identifies as part of the South Asian visible minority group. This definition encompasses people from a great diversity of ethnic backgrounds, including those with Bangladeshi, Bengali, East Indian, Goan, Gujarati, Hindu, Ismaili, Kashmiri, Nepali, Pakistani, Punjabi, Sikh, Sinhalese, South Asian, Sri Lankan and Tamil ancestry. South Asians may have been born in Canada, on the Indian sub-continent, in the Caribbean, in Africa, in Great Britain or elsewhere
* Given consent to research protocol and willingness to be randomized to either the treatment (yoga) or control (no yoga) group.

Exclusion Criteria:

* Have had a period within the last year
* Are not between the ages of 40 and 65
* Have experience with yoga within the last 12 months
* Have any serious disease or condition such as diabetes, serious high blood pressure or heart problems, kidney disease, severe asthma, cancer (except for skin cancer that is not melanoma)
* Have a major brain or nervous system diagnosis, such as Parkinson's disease or stroke
* Have a severe infectious or other medical illness right now such as pneumonia
* Use medications to lower blood sugar levels
* Have serious back, hip, or neck problems or pain in joints or bones that would prevent the safe completion of a gentle 12 week Hatha yoga program
* Regularly use an assistive device (e.g., cane, walker) to walk
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays

The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.

The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval. The results will determine the type of pivotal trial design for a follow-on Phase 2b trial whose objective is to bridge the standard membrane feeding assay (SMFA) to the direct skin feeding assay (DSFA) and direct membrane feeding assay (DMFA) using a monoclonal antibody intervention, TB31F monoclonal antibody (mAb), which interrupts transmission from human to mosquito. The results from this experimental medicine study will inform whether the preferred "Before-After" trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on Phase 2b trial.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed or thumb printed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female aged between 18 years and 55 years inclusive.
* Resident within the study area
* In good general health as evidenced by medical history and clinical examination before entering the study Ability to take oral Coartem and low-dose primaquine anti-malarials upon conclusion of day 2 (2nd direct skin feed) and be willing to adhere to the medication regimen
* For females, she must be of non-childbearing potential or use appropriate measures to prevent pregnancy for 30 days after receiving Coartem and primaquine. Non-childbearing potential means she is surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or Depo-Provera).
* For males, he must be willing to ensure that he does not get his partner(s) pregnant for at least 3 months after treatment with primaquine. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions in either the participant or the partner.
* Positive for P. falciparum gametocytes as measured by polymerase chain reaction (PCR) with cycle threshold (cT) value \< 31.

Exclusion Criteria:

Presence of any signs or symptoms of malaria

* Presence of contraindications to administration of Coartem and primaquine as indicated in the respective drug package inserts
* History of severe allergic reactions to mosquito bites (other than pruritus and local swelling)
* Pregnant (i.e. a positive pregnancy test)
* Current or recent (within the preceding 2 weeks) use of antimalarial treatment
* Current participation in a malaria vaccine study
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.

A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects.

The active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia based on ACR 2010 criteria
* FIQ \> 39 (refractary symptoms)
* Previous use of at least 2 conventional pharmacotherapies

Exclusion Criteria:

* History of substance use disorder
* History of major psychiatric or cardiovascular diseases
* Pregnancy
* Urine THC (+)
Middle School Physical Activity Intervention for Girls

Specific aims are:

1. Evaluate the feasibility of the intervention related to (1) girls' participation; (2) adherence to protocols; and (3) user and provider (nurse and PA Club instructors) satisfaction.
2. Explore if participants in the intervention group, compared to those in the control group, show improvement in the primary outcome of minutes of moderate to vigorous physical activity (MVPA; measured by accelerometer), and also secondary outcomes of self-report of MVPA, cardiovascular fitness, body mass index, percent body fat, and waist circumference at 6 months.
3. Explore if the primary outcome is mediated by cognitive (perceived benefits of PA, perceived barriers to PA,PA self-efficacy, social support, norms, models) and affective (enjoyment of PA) variables.
4. Explore if participants in the intervention group, compared to those in the control group, have greater minutes of MVPA at 7 months.

The purpose of this study is to test the feasibility of and obtain preliminary evidence of efficacy for a 6-month "Girls on the Move" intervention (guided by the Health Promotion Model and Social Cognitive Theory). The intervention involves motivational, individually tailored counseling plus after-school physical activity (PA) to increase moderate to vigorous physical activity (MVPA) and cardiovascular (CV) fitness, as well as improve body composition and cognition and affective responses related to MVPA among 6th-grade girls. Specifically, it consists of a 90-minute after-school PA Club that includes MVPA and 6 one-on-one monthly motivational, individually tailored counseling sessions with a registered (school) nurse during the school day to support each girl's continued MVPA. Applying the motivational interviewing communication style, the school nurse will individually tailor the counseling based upon each girl's key responses gleaned from computerized questionnaires assessing cognitive and affective variables related to MVPA. One middle school will be randomly assigned to receive the intervention and another to serve as attention control.

Eligibility Criteria:
Inclusion Criteria:

(1) 6th-grade girls (ages 10-12) (7th-graders if needed; up to and including age 14) who report not meeting national MVPA recommendations; (2) available and willing to participate 6 mos.; and (3) able to read, understand, and speak English (e.g., school nurse checks that girl is reading at grade level or enrolled in remedial course).

Exclusion criteria:

(1) Involved in school or community sports or other organized PAs or lessons, such as dance, martial arts, gymnastics, or tennis, that involve MVPA and require participation 3 or more days/wk. during every season of the school year; and (2) a health condition limiting or precluding safe MVPA.
Increasing Children's Physical Activity by Policy (CAP)

Levels of physical activity (PA) and physical fitness in children are low and declining, both globally and in Sweden. Preschools are important settings with the potential to influence the majority (\>93%) of Swedish children's PA behaviors in early stage of life (\<5 years). Preschool policy is an organizational level factor associated with children's PA but the casual link remains unclear. A cluster randomized controlled trial will be conducted to explore the feasibility and effectiveness of implementing a policy package for children's PA levels and other relevant health indicators.

The overarching aim of the proposed project is to examine the effects of implementing physical activity (PA) policies in preschools on PA and indicators of health in young children. The proposed project is a unique collaboration between the applicants and Stockholm stad which will result in PA policies, that will be implemented in all 658 public preschools within the Stockholm region, having the possibility to affect more than 38 000 children.

The current study is designed as a cluster randomized controlled trial with 2 conditions (intervention vs. control) and preschools serving as the unit of randomization. Measures of primary and secondary outcomes will be obtained at baseline and at 6-months on an individual level.

This study will provide robust evidence of the effect of structural changes, at the organizational level of preschools, on children's PA and indicators of health. Notably, such robust evidence is urgently warranted as Swedish preschool children's PA levels are low which will have long-lasting effects on their lives. Finally, as the intervention has been developed in co-creation with Stockholm stad it has the possibility to, if proven effective, be implemented rapidly within preschools.

Eligibility Criteria:
Inclusion Criteria:

On preschool level:

* Located in Stockholm county
* Public preschool
* At least 60 children enrolled in preschool
* Chief of the preschool accepted the invitation for participation

On individual level-preschool children

* Enrolled in participating preschool
* 3-5 years old at the time of study start
* Parents signed informed consent
* Can participate in regular physical activity

On individual level-preschool teachers

* Full-time employee at the participating preschool
* Teachers responsible for participating children

Exclusion Criteria:

On preschool level:

* Located outside Stockholm county
* Private preschool
* Less than 60 children enrolled in preschool
* Chief of the preschool not willing to participate

On individual level-preschool children

* Not enrolled in participating preschool
* Outside 3-5 years old age range at study start
* Parents declined informed consent
* Cannot participate in regular physical activity due to mobility disability etc.

On individual level-preschool teachers

* Not full-time employee at the participating preschool
* Not responsible for any participating children
Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly

Fragility fracture is common due to global aging problem, incurring huge healthcare expenditure. The occurrence of fragility fracture is usually caused by a fall incidence of an elderly with low bone quality and poor balancing ability. Therefore, any approach to improve or retard both sarcopenia and osteoporosis will be helpful to prevent osteoporotic fracture incidence. With the intensive research on low magnitude high frequency vibration (LMHFV), many scientific evidences support the application of this biophysical modality on elderly to maintain or improve the musculoskeletal tissues in elderly.

Many previous studies showed the osteogenic properties of vibration treatment and its positive effects on muscular performance and blood circulation. The investigators' previous reports also indicated that LMHFV could enhance the bone quality in spine and tibia in elderly after one-year intervention, as well as the balancing ability with high compliance. In animal studies, the application of LMHFV on fracture healing also demonstrated the significant acceleration of healing by inducing callus formation and maturation, from which upregulation of collagen I, II and BMP-2 gene expression was detected at molecular level. To date, the long-term efficacy of LMHFV on reducing fracture risks and fracture rate is, however, not available, which needs a systematic large-scale study to answer this important research question.

Therefore, the hypothesis of this study is that LMHFV can maintain or enhance the performance of various tissues of the musculoskeletal system in community elderly, thus reducing the fracture risks and fracture rate. A large-scale prospective randomized clinical trial will be conducted in multiple communities to investigate the long-term effect of LMHFV on fracture rate and reduction of fracture risks in community elderly, in which multi-factorial effects, in terms of muscle and bone, on musculoskeletal system will also be evaluated. A total of 704 elderly from 28 community centres will be recruited within 1.5-year time for a 18-month LMHFV treatment, who will be assessed on the fracture risks at fixed time points while their fracture rates on the third year of this study will be regarded as primary outcome for analysis. The findings of this study will provide very useful scientific data to support the application of LMHFV for elderly. The ultimate goal is to reduce the fracture rate and the quality of life of community-living elderly.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old or above
* independent in accessing the centres

Exclusion Criteria:

* having habitual exercise or participate in supervised exercise
* having drug treatment that affects normal metabolism of musculoskeletal system
* having hypo- or hyperparathyroidism, renal, liver or other chronic diseases
* having low-energy fracture history
* previous or current smokers or drinkers
Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance

This study will test the hypothesis that the molecular changes present in ectopic endometriosis lesions correlate with progesterone-resistant disease (using the criteria defined in this study) and are present in matched eutopic endometrium.

Tissues from 100 patients with endometriosis will be analyzed with droplet digital PCR (ddPCR) targeted sequencing and responders (n=50) will be compared to non-responders (n=50) after controlling confounding factors.

From a subset of the 100 cases, whole exome sequencing (WES) and Methylation-Specific PCR (MSP)-based methylation profiling on microdissected epithelium and stroma will be performed in matched eutopic and ectopic tissues from 20 patients with known cancer-associated mutations or 20 controls.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Gender: female.
* Age: 18-45 years at the time of signing consent.
* Clinical or surgical diagnosis of endometriosis undergoing laparoscopy.
* Controls may not have clinical or surgical diagnosis of endometriosis.
* Regular menstrual cycles.
* BMI between 18-40 kg/m2.
* Sexually active or have had a previous vaginal exam that used a speculum.
* English speaking

Exclusion Criteria:

* Use of any kind of steroidal therapy including oral contraceptives, Norplant, estrogen replacement/supplemental therapy, androgens (Danazol, Cyclomen, Danocrine, testosterone) or progesterone. She may not be taking or be on Celebrex.
* Pregnant.
* Presence of pelvic infection.
* Mullerian anomalies with absence of a cervix.
* History of cancer of the reproductive tract.
* Presence of undiagnosed uterine bleeding.
* Treatment with intrauterine device (IUD) or progestin-containing intrauterine device.