cyrilzakka/clinical-trials huggingface dataset:
Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT)

The objective of this protocol is to improve awareness, treatment, and control of metabolic syndrome, within primary prevention of cardiovascular disease, by implementing guidelines, after training of the participating physicians.

Physicians from 20 hospitals or health centres (primary and secondary health care settings) were trained to implement guidelines in treating metabolic syndrome.

There will be a baseline recording of patients with metabolic syndrome and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of the metabolic syndrome. With 6 month intervals (up to 36 months at study completion) physicians will have to complete the same form. Previous training of physicians and the fact that they will have to report their success in treating metabolic syndrome will hopefully contribute to an increase in number of patients with the syndrome at treatment targets, and will minimise the target organ damage (i.e cardiovascular disease). The estimated 10-year reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at the 6th month and at study completion with that of baseline.

Eligibility Criteria:
Inclusion Criteria:

* Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)

Exclusion Criteria:

* Pregnancy
* Lactation
* Malignancies with small life expectancy
* Unwillingness to participate
Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the functional outcomes after primary Total Knee Arthroplasty (TKA).

Following ethics approval by the Ospedale San Raffaele, 84 adults aged between 45 and 80 years old will be recruited for the study, excluding people with unstable serious disease (e.g., heart or lung disease), previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis), pregnancy and intake of psychotropic drugs.

Patients who consent to participate in this study will be randomized into two rehabilitation groups after TKA: experimental (virtual rehabilitation) and control (traditional rehabilitation). In the experimental arm, subjects will undergo a virtual rehabilitation training during the post-surgical rehabilitation period, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). In the control arm, subjects with similar demographic characteristics to those of the experimental arm, will undergo the usual physiotherapy rehabilitation, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). Both control and study interventions will be provided 60 minute daily session.

General status of patients will be undertaken for the following outcomes at the baseline and 10 days after surgery (at discharge).

The primary outcome will be the visual analogue scale (VAS); the secondary outcomes will be: the disability knee assessed by the Western Ontario and McMaster Universities (WOMAC), the health related quality of life assessed by the EuroQol (EQ-5D), the global perceived effect assessed by the GPE score, the functional Independent measure assessed by the FIM questionnaire, the drugs assumption, the isometric strength of quadriceps and hamstrings assessed by dynamometer, the range of motion (R.O.M.) and proprioception assessed by VRRS.

Eligibility Criteria:
Inclusion Criteria:

* primary unilateral TKA for knee osteoarthritis
* informed consent

Exclusion Criteria:

* people with unstable serious disease (e.g., heart or lung disease)
* people with previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis)
* pregnancy
* psychotropic drugs assumption
A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden

Female circumcision (FC) causes both immediate and long-term health consequences. In general, the more severe type of FC, the worse health consequences can be seen. Despite the negative health effects, the practice of FC is still found to be highly prevalent in many countries, mainly in Africa and the Middle East. Many studies have been performed on FC in African countries where the custom is widespread and there have also been many attempts to eradicate the practice in these countries. However, considerably less research exists on FC in non-practicing societies where there has been an influx of immigrants from countries that traditionally carry out this practice. Further, no anti-FC interventions designed using a comparison group have been performed in any country outside Africa.

This cluster randomized controlled trial aims to evaluate the effectiveness of a community-based participatory intervention on changing attitudes towards FC among newly arrived Somali immigrants in Sweden. Included in the research is an assessment of the acceptability of the intervention. Based on social convention theory, we hypothesize that an interaction between established Somali immigrants, thought to be predominantly opponents of FC, and newly arrived Somali immigrants will facilitate changes in attitudes among the newly arrived.

The trial will be implemented in two municipalities in Sweden that have a high proportion of Somali immigrants. Somali organizations in these municipalities will constitute the clusters. In total, 8 clusters will be included, 4 intervention clusters and 4 control clusters.


Eligibility Criteria:
Inclusion Criteria:

* Oral informed consent
* Newly arrived (lived in Sweden for ≤ 4 years) Somali immigrants in Sweden with a residence permit
* Men and women, ≥ 18 years old

Exclusion Criteria:

* None
Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI

This study assess the putative persistence of neural damage using resting state fMRI after concussion in rugby player once they have clinically recovered. The hypothesis is that despite a clinical recovery (absence of symptoms; neurological and neuropsychological examination returned to normal) connectivity map obtained using resting state fMRI are significantly different from a group of control subjects.

Resting state fMRI has shown to be a sensitive tool to assess neural damage after concussion. It seems more sensible than structural MRI including DTI. the study goal will be to assess rugby players using fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3). The study would specifically like to challenge clinical examination supposed to be normal at V2 to connectivity maps using resting state fMRI preformed at the same time. fMRI performed at V1 and V3 will serve as comparators (respectively very altered at V1 and back to normal at V3).

Eligibility Criteria:
Inclusion Criteria:

* no neurological or psychiatric disease
* recent history of concussion (\<3 months) according to the Rugby French Federation criteria.

Exclusion Criteria:

* Inability to be assessed by MRI
VELCADE,Rituximab,Cyclophosphamide and Decadron

Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.

This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Small Lymphocytic Lymphoma
* Follicular Cell Lymphoma (grades I and II)
* Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant
* Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia
* Marginal Zone Lymphoma
* MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.
* Adequate bone marrow function, renal function, and hepatic function as outlined in details below.
* ECOG performance status of 0, 1, or 2
* Able to read, understand, and sign an IRB approved informed consent

Exclusion Criteria:

* Known HIV positive status
* Known CNS involvement
* Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach

Dysphagia is a well-known complication following anterior cervical spine surgery. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The ultrasonography was used to measure the oropharyngeal swallowing function. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

we aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography.

Dysphagia is a well-known complication following anterior cervical spine surgery. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The ultrasonography was used to measure the oropharyngeal swallowing function. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

We aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography. Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged \>= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by ultrasonography and HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, 1 week, and 1 months, 3 months (If needed) by HRIM and ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia 2. Aged from 20-80 years old

Exclusion Criteria:

- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.

2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder

Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults.

The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general.

Research Questions:

Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life?

Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life?

Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?

Q4: Is there a difference in treatment outcome between self-referred and clinical referred patients?

Q5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age,
* Internet access,
* primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),
* Written consent of participation in the study.

Exclusion Criteria:

* Other psychological treatment for OCD during the treatment period,
* Adjustment of concurrent psychotropic medication within the last two months,
* bipolar disorder,
* psychosis,
* alcohol or substance dependence,
* completed CBT for OCD in the last 12 months,
* hoarding disorder or OCD with primary hoarding symptoms,
* suicidal ideation,
* subjects that lack the ability to read written Swedish or lack the cognitive ability to assimilate to the written material,
* Autism spectrum disorder,
* organic brain disorder.
Hydraulic Resistance and Older Adults

The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:

* Does the use of hydraulic exercise equipment decrease fall risk in older adults?
* Does the use of hydraulic exercise equipment improve function in older adults?

Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Age 60+

Exclusion Criteria:

* Age \<60
* Neurological condition
* Surgery within last 6 months
* Current injury
* Inability to follow directions
* Inability to participate in physical activity for any medical reason
SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants

The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc.

A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture. By capitalizing on these wireless and low-cost technologies, it will permit the regular and non-invasive monitoring of infants, which can lead to detailed, non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical developing infants. The investigators will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.

The proposed research is specifically designed to investigate the ability of a novel tool to identify atypically developing infants from their typically developing peers. Twenty-four infants will be recruited to participate, including 12 who are developing typically and 12 who are identified as at-risk for neuromotor delay. Infants with typical development will be at least 3 months and less than 11 months of age, score in the low-risk category on the Bayley Infant Neurodevelopmental Screener (BINS), score a greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic, or neurological condition, and gestational age at least 37 weeks. Infants at risk for neuromotor delay will be at least 3 months and less than 11 months of age (corrected for preterm birth if applicable), score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the Bayley Scale of Infant Development (BSID-II). In an effort to decrease variability of the data, infants in each group will be further stratified into an older group (8-10+ months) and a younger group (3-5 months).

Eligibility Criteria:
Inclusion Criteria:

* Infants exhibiting typical development between 3 months and 11 months of age who score in the low-risk category on the Bayley Infant Neurodevelopment Screener (BINS), score greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic or neurological condition and have a gestational age at least 37 weeks.
* Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age, score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the BSID-II.
* Exclusion Criteria:
* Infants outside age range of 3-11 months
A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically documented invasive metastatic breast cancer
* Human epidermal growth factor receptor 2 (HER2) -positive disease
* Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Left ventricular ejection fraction \>/=50%
* Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B)

Exclusion Criteria:

* History of Grade \>/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
* Investigational therapy or any other anticancer therapy \</=28 days before first study treatment
* Previous treatment with trastuzumab emtansine
* Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
* Current peripheral neuropathy of Grade \>/=2
* Child-Pugh Class C hepatic impairment
* Encephalopathy \>/= Grade 2
* For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C
* Active hepatitis A, B and/or C
* Current unstable ventricular arrhythmia requiring treatment
* History of symptomatic CHF (NYHA Classes II-IV)
* History of myocardial infarction or unstable angina within 6 months of enrollment
* History of a decrease in LVEF to\<40% or symptomatic CHF with previous trastuzumab treatment
* Pregnant or lactating women
* Known HIV infection
Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain

This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on cyclical breast pain.

Cyclical mastalgia is a common complaint of women presenting to their primary care physicians. Cyclical breast pain is defined as prementstrual breast discomfort associated with hormonal fluctuations during the menstrual cycle. A clinical breast examination and sometimes additional imaging, such as sonography or mammography, is required as part of the evaluation to exclude malignancy. For most women, the symptoms are effectively managed with reassurance and conservative treatment measures such as the use of a supportive bra or over the counter pain medication such as acetaminophen or anti-inflammatories. However, a small number of women will require additional drug treatment with danazol after failing to respond to conservative measures. Unfortunately, danazol is associated with significant side effects. In the Mayo Breast Clinic, women with cyclical breast pain are managed with Vitamin E and Evening oil of primrose (EOP) either as single agents or in combination. These over the counter supplements are readily available, acceptable due to minial side effects and appear to lead to significant reduction in breast pain. We propose a randomized placebo controlled trial to determine if any vitamin E or EOP or the combination of both are effective in managing cyclical breast pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* premenopausal
* cyclical breast pain
* breast pain survey indicating 3 or more on scale of 1-10
* if \> 40 years of age, need normal mammogram and/or ultrasound if indicated and if not done within the last year
* if \< 40 years of age, a directed ultrasound in the area of pain
* can be on oral contraceptives
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
* Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

Exclusion Criteria:

* Post-menopausal women, as defined as one or more of the following:

  1. six months or more (immediately prior to Screening visit) without a menstrual period, or
  2. prior hysterectomy and/or oophorectomy
* Subjects with documented endometriosis