cyrilzakka/clinical-trials huggingface dataset:
Use of Eye Exercises to Improve Vision

Children in the United States watch an average of twenty-eight hours of television and play around thirteen hours of video games per week. The objective of this experiment was to see if a specific eye exercises could strengthen the eye muscles and improve the peripheral vision range of children and adults.

Children in the United States watch an average of twenty-eight hours of television and play around thirteen hours of video games per week. When their eyes are focused, people tend to blink their eyes less, exacerbating the problem of eye fatigue or stress. The objective of this study is to see if a novel exercise technique can increase eye muscle strength and widen peripheral vision. Experiments were conducted by asking the test subjects to follow, with their eyes, a set of blinking LED lights on 3 vision exercise devices. These LED lights were laid in circular or diagonal configurations, and programmed using a microcontroller to blink or 'move' in certain directions and at certain speeds. An endurance score, measured as total time that the test subject completed while following the blinking LED lights before his/her eyes became tired, was recorded. Nineteen test subjects aged 12-81 were asked to exercise their eyes four times over 2 weeks using the devices for as long as they could until they experienced mild eye fatigue. Endurance scores, peripheral vision, and peripheral reading ranges were assessed before and after the training sessions.

Eligibility Criteria:
Inclusion Criteria:

* Able to read English

Exclusion Criteria:

* Cannot be colorblind
Impact of Wearing a Support Garment Following Parietal Gastrectomy

Custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. However, research is needed to quantitatively document their short and long term effects on a wide range of parameters related to mobility, quality of life, lower back pain and skin maceration following parietal gastrectomy. The objective of this study is to characterize the effect of a support garment in an experimental design where a subgroup of participants will be randomized and followed for the first 12 months after a gastrectomy. The measures will be: physical activity, lower back pain, self-esteem, quality of life, skin maceration and infections. This study will scientifically document the usefulness and effectiveness of support garments throughout the weight loss surgery process.


Eligibility Criteria:
Inclusion Criteria:

* meeting the NIH criteria for bariatric surgery
* BMI \>= 35 kg/m2

Exclusion Criteria:

* chronic pulmonary obstructive disease
* gastric stoma
* psychiatric disease contraindicated for bariatric surgery
Effects Of Power Ball Exercises In Addition To Routine Physical Therapy In Patients With Carpal Tunnel Syndrome

The purpose for doing this study is to determine that whether use of Power Ball in form of resistance training will be effective in increasing grip strength in carpel tunnel syndrome patient and possible benefits of the regime as effective means of rehabilitation for wrist and hand injuries. Moreover for increasing grip strength it can be used as an adjunct for physical therapy treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age group 45-60 years
2. Both male and female
3. Clinically diagnosed carpal tunnel syndrome
4. Carpal Tunnel Syndrome for a duration of more than 02 months
5. Tingling sensation and numbness over the dorsal surface of thumb, index, middle, and lateral 1/3rd of ring fingers
6. Positive Tinel's sign
7. Positive Phalen's Maneuver

Exclusion Criteria:

1. Any previous trauma, fracture, subluxation, dislocation, surgery or bony abnormalities around wrist joint in the past 5 years.
2. Symptomatic Arthritis of wrist joint
3. Cervical radiculopathy
4. Corticosteroid injection within 3 months
Koa Family: California's Obesity Prevention Project

The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.

This study will employ a randomized controlled trial (RCT) design to test a newly developed obesity reduction program, Koa Family, among overweight or obese mothers. An exploratory, uncontrolled study will assess its acceptance among normal-weight mothers.

Koa Family consists of a 6-month whole-person lifestyle program (WPLP) combined with text messaging and social media support and the opportunity to take part in a neighborhood tree planting campaign. This multi-pronged program is intended to reduce weight in the short-term while building self-empowerment and connections to community resources so that participants can sustain long-term weight loss.

Koa Family will be implemented in select communities in Yolo and Sacramento counties, California. Overweight or obese study participants will be randomized to either an intervention or control group; all normal-weight participants will be assigned to the intervention. All participants will complete a survey and have their height and weight measured at baseline and 3-, 6-, 9- and 12-month follow-up. Intervention participants will also take part in a focus group at the 3-month midpoint of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Comfortable speaking and reading English
* Primary caregiver for ≥1 child, aged 3-17, who lives at home
* Living in a low-income household (at or below 185% of the Federal Poverty Level)
* Living in the study site catchment area
* Ability to receive and send text messages
* BMI ≥ 25 kg/m2 for RCT study
* BMI ≥18.5 and \<25 kg/m2 for exploratory study

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Within 2 years postpartum
* Life-threatening illness
* Institutionalization (i.e., not free-living in the community)
* Moderate to severe mental illness
* Receiving nutrition therapy from a health or health care provider (licensed or unlicensed)
* Had or are considering bariatric surgery
* Medically diagnosed eating disorder
* Taking medication that affects weight
* Thyroid disease
* Type 1 or Type 2 diabetes without medical clearance from the participant's physician
* Plans to move away from study site catchment area during the one-year study period
Subpectoral Plexus Block With Multi-level TPVB for Surgical Anesthesia During Primary Breast Cancer Surgery

The objective of this study is to compare two different doses of local anesthetics (10ml vs 20ml of 0.25% levobupivacaine) for subpectoral plexus block (SPPB) in addition to ultrasound guided multi-level of thoracic paravertebral block (m-TPVB) for surgical anaesthesia for major primary breast cancer surgery.

Primary breast cancer surgery is one of the most commonly performed surgeries worldwide. It is associated with significant acute postoperative pain and a high incidence of chronic postsurgical pain. Regional anaesthetic techniques are shown to improve outcomes such as postoperative analgesia, nausea, vomiting, delirium and promote early recovery. Currently majority of the breast cancer surgery is performed under general anaesthesia with a multimodal analgesic regimen with or without regional blocks. In fact, it is proved that breast cancer surgery can be done solely under regional anesthesia using multilevel thoracic paravertebral block (TPVB) with deep sedation, but rescue analgesia are often required intraoperatively, especially when surgeons handles the pectoralis muscle. Current evidence suggest that pectoral nerves, which are often described as a pure motor nerves that control movements only, also able to send noxious stimulation such as pain from the pectoral muscles and its deep fascia (via afferent nociceptive fibers) to the brain. Principal investigator proposes that adding a subpectoral plexus block (SPPB) will stop a wider spectrum of afferent nociceptive fibers from sending any pain signals than having thoracic paravertebral block alone. However, there is no report on the amount of local anaesthetic (LA) required to achieve surgical anaesthesia for breast surgery. The aim of this study is to evaluate the effectiveness of two different doses (10ml vs 20ml of 0.25% levobupivacaine) of local anaesthetic (LA) for subpectoral plexus in addition to 3 levels of TPVB injections at T2, T4, and T6 under ultrasound guidance for surgical anaesthesia for major breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for mastectomy, modified radical mastectomy or breast conservative surgery with lymph node biopsy and with or without axillary dissection

Exclusion Criteria:

* local skin site infection
* coagulopathy
* history of allergy to local anesthetics
Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus

OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease activity in women with systemic lupus erythematosus.

II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome.

PROTOCOL OUTLINE: This is a case-controlled study. Intensive data collection begins when a patient becomes pregnant.

Pregnant women are evaluated with interval pregnancy/exposure history and a clinical exam, including the Systemic Lupus Activity Measure (SLAM). Assessments are scheduled every 3 months as follows: visit 1 when the pregnancy is confirmed, visit 2 during the second trimester, visit 3 during the third trimester, visit 4 at 3 months postpartum, and visit 5 at 6 months postpartum. Visits 4 and 5 include an infant exam for growth and morphologic parameters; these visits occur on the same schedule if there is a miscarriage or stillbirth.

Patients not currently pregnant are randomly chosen to be followed as controls. These patients undergo a review of current pregnancy status and measures of disease activity, including SLAM, every 3 months for 5 visits.

Eligibility Criteria:
* Definite or probable systemic lupus erythematosus meeting American College of Rheumatology criteria
Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fed Conditions

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fed conditions

The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin® 40o mg) amoxicillin (as the trihydrate)/57 mg clavulanic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fed conditions A total of 40 Subjects, 20 males and 20 females; were enrolled in the study, and 39 subjects, 20 males and 19 females, completed the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female volunteers, 18-55 years of age
2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
3. Medically healthy subjects with clinically normal laboratory profiles;
4. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:

   surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; barrier methods (condom, diaphragm) with spermicide for at least 14 days pror to the start of the study and .throughout the study; surgical sterilization of the partner (vasectomy for 6 months minimum); hormonal contraceptives for at least 3 months pdor to the start of the study. Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible;
5. Voluntarily consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
2. In addition, history or presence of:

   alcoholism or drug abuse within the past 2 years; hypersensitivity or idiosyncratic reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin and/or clavulanic acid
3. Female subjects who are pregnant or lactating.
4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose.
5. Subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 30 days prior to the study.
6. Subjects who have made a plasma donation within 7 days prior to the study
7. Subjects who have participated in another clinical trial within 30 days prior to the first dose.
Effects of Measurement of Handgrip Strength on Physical Activity Level for Patients With Diabetes Type 2

Background: It is recommended that patients with diabetes type 2 keep themselves physically active and it is known that good muscular strength has a positive effect on these patients.

Aim: To determine whether physical activity level increases and whether other risk factors for cardiovascular disease are positively affected by including measurement of handgrip strength as part of the regular care program for patients with diabetes type 2 in primary care.

Method: Patients with diabetes type 2 who go to regular check-ups by participating diabetes-nurses in primary care are randomized to either intervention or control group. In the intervention group, handgrip strength is measured in addition to standard care. the control group receives standard care at inclusion. Handgrip strength is measured in both groups at 1 year follow-up. Physical activity level is measured in both groups at inclusion and 1 year follow-up with a questionnaire. Measurement of other risk factors for cardiovascular morbidity are measured at both inclusion and follow-up in both groups as dictated by standard care routines.

Expected results: Measurement of handgrip strength can give health care personnel greater possibilities to identify those patients with diabetes type 2 who need to increase their activity level and to give them more concrete support. It is possible that the attention given to handgrip strength and physical activity may motivate patients to increase their activity level, become stronger and eventually reduce other risk factors for cardiovascular morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes type 2 who go to regular check-ups with participating diabetes-nurses at primary health care centres in Region Västra Götaland, Sweden.

Exclusion Criteria:

* No gender, age or language restrictions.
Anterior Cruciate Ligament Reconstruction

This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

This is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities.

Recruitment will focus on adult patients with anterior cruciate ligament rupture and scheduled anterior cruciate ligament surgical reconstruction. Patients will be randomized into 2 arms, an experimental arm A (pre-habilitation management) and a control arm B (conventional management).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 ;
* Partial or complete primary anterior cruciate ligament rupture;
* Partial or complete primary rupture of the anterior cruciate ligament;
* Scheduled anterior cruciate ligament reconstructive surgery;
* Patient with a tablet, computer or smartphone with an internet connection;
* Patient able to understand and read French;
* Willingness to complete questionnaires at regular intervals;
* Membership of a social security scheme;
* Signed informed consent.

Exclusion Criteria:

* Recurrence / contralateral lesion ;
* Stage III collateral ligament injury;-
* Osteotomy ;
* Neurological (motor and/or sensory), vestibular or rheumatic pathology;
* Pregnant or breast-feeding woman;
* Protected adult patient (under guardianship, curatorship or deprivation of liberty).
Effects of Melatonin on Insomnia Symptoms in Older Adults

This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.

Melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. Melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. Clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia, regardless of their endogenous melatonin levels. Data indicate, however, that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin. Generally, melatonin levels decrease with age; therefore, older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep. This study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep.

Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints, the beginning of Week 1 and the end of Week 6. At study entry, participants will be admitted to the General Clinical Research Center for a 3-night stay, beginning with an overnight urine screen to confirm low melatonin levels. Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity; the diary will be used throughout the study. During Night 1 at the clinic, participants will have urine samples collected throughout the night. Night 2 will be an adaptation night to allow participants to get used to their surroundings. On Night 3, participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency. Participants with sleep efficiencies of 80% or higher will complete their study participation. Participants with sleep efficiencies less than 80% will be randomly assigned to one of three study treatments daily for 6 weeks: high-dose melatonin (4.0 mg), low-dose melatonin (0.4 mg), or placebo. Participants will have study visits at Weeks 1, 3, and 6 to monitor for adverse events. After 6 weeks, participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study. Sleep questionnaires, cognitive tests, and psychomotor tests will be used to assess participants at the beginning of the study, after 6 weeks, and at the end of the study. One month after the end of the study, participants will have a follow-up visit to be reassessed for adverse events.

Eligibility Criteria:
Inclusion Criteria:

* History of insomnia
* Low melatonin levels at study entry

Exclusion Criteria:

* History of sleep apnea (temporary cessation of breathing during sleep)
* Diagnosis of restless legs syndrome
* Current alcohol or substance abuse
* Dementia
* Anemia
* Liver disease
* Leukemia or lymphoma
* Asthma
The Retrain Your Brain for Healthy Eating Study

The aim of this mixed methods, single-group, single-center study will be to examine the feasibility of a food response training (FRT). This study will be conducted in patients with obesity recruited from NYU Langone Health. Measurements will occur at screening, baseline, and 3 months, for a subgroup of participants for we will collect saliva samples for genetic analysis at baseline assessment (ancillary study).


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 to 80 years of age
2. BMI ≥30.0 kg/m2
3. access to a computer or an iPhone/iPad or be willing to use a study loaner smart phone

Exclusion Criteria:

1. pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study
2. taking any medication that may impact dietary intake and weight:

   a. Immunosuppressants, steroids, medications for weight loss or to manage blood sugars or a psychiatric condition other than anxiety/depression
3. enrolled in another intervention that could influence dietary intake
4. have had bariatric surgery within the past 2 years
5. unwilling to delay bariatric surgery for the next 6 months
6. who have gained or loss more than 5.5 kg in the previous 3 months
7. unable to participate meaningfully in an intervention that involves using software available in English. The reason for this is that the food training apps have not been designed or validated in audio form or in other languages. (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
8. institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet), unwilling or inability to provide informed consent.
Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact

Schistosomiasis is increasingly encountered among travellers returning from the tropics and is known for its focal endemicity, associated with the presence of the snail intermediate host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic due to the low intensity of infection, many infections likely go undiagnosed and will develop into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of schistosomiasis relies on egg detection, which has a poor sensitivity in low burden infections, or serology, which is inadequate to monitor cure. The department of parasitology of the Leiden University Medical Center has developed a novel diagnostic test based on the up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test can be performed on serum and urine to detect low intensity schistosomiasis infections and confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA in travellers with high-risk water contact.


Eligibility Criteria:
Inclusion Criteria:

1. Any self-reported high risk water contact, including wading, showering, surfing, walking along wet shore bare-footed or washing with water from a high-risk source, within 12 weeks prior to reporting to the outpatient department
2. Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection
3. Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures
4. Able to provide informed consent

Exclusion Criteria:

1. Previous treatment for schistosomiasis
2. Known positive schistosomiasis serology
3. The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

Exclusion Criteria:

* Patients who are contraindicated based on the product label.