cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy

Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity.

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis. Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity. It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space. The methods for اigh tibial osteotomy include opening-wedge osteotomy and closed wedge osteotomy. An opening-wedge osteotomy has become increasingly popular compared to the other technique. One of the disadvantages of this technique is that the plate is placed subcutaneously on the medial aspect of the proximal tibia. Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy. Few papers assessed regeneration of the articular cartilage after medial opening-wedge osteotomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age younger than 65 years
2. Medial joint line tenderness
3. BMI less than 30
4. Varus tibiofemoral malalignment
5. Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture
6. Osteoarthritis of the knee with any degree of cartilage damage provided that the cartilage damage in the lateral compartment not exceeding Outerbridge grade 2
7. No associated ligamentous functional instability

Exclusion Criteria:

1. Age older than 65 years
2. Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4)
3. Flexion contracture of greater than 15 degrees
4. Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection
Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Have sustained cervical (neurological level C1-C8) SCI
* Any ISNCSCI severity classification (A, B, C or D)
* Have therapist-reported and self-reported spasticity in the arm or hand
* Ability to pick up, move, and release at least one block (on the Box \& Blocks Test)
* May participate if utilizing prescription medications, including baclofen pump for control of spasticity

Exclusion Criteria:

* Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
* Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump.
* Severe pain or hypersensitivity of the arm/hand
* Current pregnancy
Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes

Many postmenopausal women have vasomotor symptoms during adjuvant hormonal treatment for breast cancer. PCC-100 is a pollen extract used for alleviation of postmenopausal symptoms. In a randomised, double blinded study pollen extract PCC-100 will be used to treat vasomotor complaints in postmenopausal women under adjuvant hormonal treatment and also in menopausal women without a history of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, between 50 and 65 years old (extremes included) at the time of signing the informed consent form;
* spontaneous amenorrhea for at least 6 consecutive months in combination with a hormonal diagnosis of being postmenopausal (FSH \> 40 mU/ml and E2 \< 20 pg/ml. In subjects using Tamoxifen, only E2 needs to be determined) or spontaneous amenorrhea for at least 12 consecutive months or having had a bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy);
* a history of breast cancer, whatever the received treatment, and currently taking aromatase inhibitors or Tamoxifen since at least 4 weeks. This criterion is not applicable to the 100 subjects entering the study without a history of breast cancer;
* a minimum of 49 moderate to severe hot flushes or night sweats during 7 consecutive 24-h periods;
* a body mass index \[BMI\] between 18.0 and 35.0 kg/m2, inclusive;
* proven normal glycaemia and normal thyroid function as evidenced in a recent serum analysis (in the last year) performed by the General Practitioner or gynaecologist;
* The subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.

Exclusion Criteria:

* Recently, an abnormal cervical Pap smear that requires surgery within 6 months;
* acute or chronic thromboembolic disease, liver disease and/or renal impairment;
* uncontrolled diabetes mellitus;
* uncontrolled hypertension;
* uncontrolled thyroid disorders;
* the subject has a history of a major depression or post-traumatic stress disorder \[PTSD\] within 2 years of screening. Women taking antidepressants can be included after a wash out period of 6 weeks;
* use of (non-)hormonal treatments to reduce hot flushes, unless a wash-out period is respected;
* a history or presence of allergy or intolerance to the investigational product or any component of the investigational product or drugs in this class. Or history of drug or other allergy that, in the opinion of the investigator contraindicates subject participation;
* a history of alcohol or substance abuse or dependence in the 12 months before screening as determined by the investigator;
* judged by the investigator to be unsuitable for any reason.
The OPTIMAL Randomized Controlled Trial

The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure.

Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and 24 months (outpatient clinic visit or telephone call) after the index procedure.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥ 18 years of age;
2. De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team\*.
3. Stable or unstable angina, non-ST segment myocardial infarction, documented silent ischemia or a positive functional study (e.g. by pressure or angiography derived indices).
4. Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included.
5. A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included.
6. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.

Exclusion Criteria:

1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential).
2. Ongoing MI or recent MI with cardiac biomarker levels still elevated.
3. Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary.
4. Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment.
5. Prior PCI in LCA (e.g. mid LAD) within the previous 30 days.
6. Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration
7. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization.
8. Non-cardiac co-morbidities with a life expectancy less than 2 years.
9. Currently participating in another trial and not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrolment.
The Role of Resistant Starch in COVID-19 Infection

This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.

The COVID-19 pandemic has caused a substantial strain on the healthcare system, with at least 14% of infected patients requiring hospitalization. Identifying ways to ameliorate the progression and severity of the COVID-19 infection and preventing hospitalization is critical. Patients suffering from COVID-19 have been shown to have a significant inflammatory response resembling that of cytokine release syndrome, and it is this inflammatory phase that is thought to drive fatality.

To this end, a multi-center randomized clinical trial to determine the efficacy of resistant starch in reducing the need for hospitalization for COVID-19 positive patients will be studied. This study will enroll 1500 non-hospitalized COVID-19 positive individuals who are being monitored in the outpatient setting. Patients will be randomized to either a dietary supplement containing resistant starch or a placebo for 14 days. Our primary outcome is the rate of hospitalization for COVID-19 related complications. Secondary outcomes will look at time to recovery and symptom severity scores.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* COVID-positive status
* Being monitored in an outpatient setting at one of our study sites:
* Yale New Haven Hospital (YNHH)
* University of Michigan
* University of Minnesota

Exclusion Criteria:

* inflammatory bowel disease
* history of gastric bypass surgery
* active Clostridium difficile infection
* active participation in another COVID-19 interventional trial
* any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with the protocol procedures.
* Reported allergy to starch
* Difficulty swallowing in order to prevent any aspiration risk
* Currently taking any IL-6 inhibitors such as Tocilizumab for any disease condition
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis

This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18-70
* The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)

Exclusion Criteria:

* Folic acid \>400 mcg taken at any time during the study
* Psychotic features in the current episode or a history of psychotic features
* Any bipolar disorder (current or past) or any psychotic disorder (current or past)
* Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
* Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX

The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.

The switch to BeneFIX has already been decided by the investigator. Patients will be followed up to 3 months after the switch.

Eligibility Criteria:
Inclusion Criteria:

* Moderately to severe haemophilia B patient (FIX activity \< or equal to 2%) for whom the switch from pdFIX to BeneFIX has already been decided by the investigator
* Previously treated patients (PTP) with \> or equal to 150 ED to any FIX product
* Male patients, aged \> or equal to 12 years
* Absolute CD4 count \> or equal to 300/microL
* Normal platelet count (\> or equal to 100 000/microL)
* Patient is in a non-bleeding state and has not received any coagulation FIX within five (5) days of recovery
* Written informed consent obtained prior to study entry (for patients aged \< 18 years, parents' signature or subject legally acceptable representative obtained prior to study entry)

Exclusion Criteria

* Any other known bleeding disorder in addition to haemophilia B
* History of, or current detectable factor IX inhibitor (\> or equal to 0.6 BU by Bethesda inhibitor assay)
* History of anaphylaxis to any coagulation factor IX
* Patient with a known hypersensitivity to hamster protein
* Patient with a hypersensitivity to the active substance or to any of the excipients
* Patient unable to be off FIX replacement therapy for at least 5 days without bleeding Patient with hepatic or renal impairment (ALT \[SGPT\] and AST \[SGOT\] \> 5 x Upper Limit Normal (ULN), total bilirubin \> 20mg/l, albumin \< 25 g/l, prothrombin time \> 1.25 x ULN, serum creatinine \> 1.25 x ULN)
* Treatment with any investigational drug or device within the past 30 days
* Any condition that, in the Investigator's judgment, makes participation in the study not advisable
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Self reports having a full eye examination in the previous two years;
* Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
* Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
* Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
* Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Habitually wears one of the study contact lenses;
* Has any known active ocular disease and/or infection that contraindicates contact lens wear;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
* Has known sensitivity to the diagnostic sodium fluorescein used in the study;
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery or intraocular surgery.
Partially Hydrolyzed Guar Gum (PHGG) for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)

Some components of the diet could promote the growth of certain bacterial strains present in the intestine, which are closely associated with benefits for host health. An intestinal commensal Parabacteroides goldsteinii (Pg) was highlighted to be significantly negatively associated with severity of COPD. Furthermore, the investigators identify the potential prebiotics (PHGG) which may enrich the abundance of P. goldsteinii and increase the probiotic effect of P. goldsteinii.

The investigators designed a randomized control study, which enroll adults diagnosed with COPD. Then the two groups will receive PHGG or not. Stool samples will be collected. The ameliorative efficacy will be evaluated by questionnaire and lung function test. Intestinal microbiota and metabolome will be analyzed and the correlation with lung function indices will be further investigated.

It is well known that some components of the diet could promote the growth of certain bacterial strains present in the intestine, which are closely associated with benefits for host health. In the previous study, the investigators found that an intestinal commensal Parabacteroides goldsteinii (Pg) was highlighted to be significantly negatively associated with severity of COPD. Furthermore, the investigators identify the potential prebiotics (PHGG) which may enrich the abundance of P. goldsteinii and increase the probiotic effect of P. goldsteinii. However, the effect of PHGG supplement on compositional and functional properties of the human microbiota with COPD still remains unclear.

In this proposal, the investigators designed a randomized control study, which enroll adults diagnosed with COPD. The investigators will review their past medical records and related image and lung function test. Then the two groups will receive PHGG or not. Stool samples will be collected. The ameliorative efficacy will be evaluated by questionnaire and lung function test. Intestinal microbiota and metabolome will be analyzed and the correlation with lung function indices will be further investigated. In the future, it may be used to investigate and analyze the change of microbiota and metabolome, then develop possible treatment options of COPD.

Eligibility Criteria:
Inclusion Criteria:

* age of 40-85 years
* diagnosis of COPD made by pulmonologist
* provision of written informed consent

Exclusion Criteria:

* severe and unstable comorbidities or active malignancy
* COPD exacerbation within the 4 weeks prior
* cognitive impairment or a psychiatric disorder
* pregnancy
Motor_Control_Neck_SSED

Neck pain is a common problem in the western world. There is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function.

The aim of the study was to evaluate a motor control intervention for patients with persistent neck pain and a forward head posture.

This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and multiple baselines.

The tailored motor control intervention addressed the faulty postural alignment and the deep muscles of the cervical spine.


Eligibility Criteria:
Inclusion Criteria:

* 20 - 50 years of age with pain originating from the neck for at least three months.
* A visual forward head posture.
* Less than105 points on the Örebro musculoskeletal pain screening questionnaire

Exclusion Criteria:

* neurological dysfunction.
* former cervical surgery or compression fracture of the spine
* no mental retardation
* no physiotherapy treatment during the last 6 months.
The Effects of Mindful Eating Education on Increasing Satiety Signals

The purpose of this graduate student research study is to is to examine the effects of mindful eating education on increasing satiety signals.

Reasons for conducting the study: Add to the body of knowledge on the science of mindful eating.

The procedures include:

Visit 1:

* The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion, sign an informed consent form, sign in, and provide an email address and phone number.
* After the initial briefing, the subject will be asked to eat their meal with an investigator present.
* The subject will inform the investigator verbally when they are feeling full.
* After the subject decides to end their meal, the subject will be asked to fill out a questionnaire and be reminded to bring the same meal the following week.

Visit 2:

* The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion with the same meal as the previous week.
* After receiving a brief education session, the subject will be asked to eat their meal with an investigator present.
* The subject must inform the investigator verbally when they are feeling full.
* After the subject has decided to end their meal, they will be asked to fill out a questionnaire and be reminded to meet the investigator at the same time the following week.

Visit 3:

* The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion.
* The subject will be asked to complete a follow-up survey on the study.

Eligibility Criteria:
Inclusion Criteria:

* currently enrolled at Loma Linda University
* pack or purchase their own lunch on a regular basis (willingness bring/buy the same lunch the following week)
* have a 1 hour or less lunch period.

Exclusion Criteria:

* skip breakfast
* have exercised within 2 hours of their lunch time
* smoke nicotine or marijuana
* have the condition of Type 1 or Type 2 diabetes
* have newly prescribed medications 2 weeks prior to testing.
Bioimpedance Analysis in Chronic Heart Failure

The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation

Exclusion Criteria:

* High level of fatigue (the patient cannot stand on a scale)
* Amputated upper and/or lower limb(s)
* The BCM analysis is not possible technically (e.g. open wounds on the limbs)
* Severe obesity (\>130 kg)
* Patients on chronic hemodialysis or peritoneal dialysis
* Severe fluid volume in the transcellular space
* Patients with a unipolar pacemaker whose sensitivity threshold is very low
* Pregnancy, lactation