cyrilzakka/clinical-trials huggingface dataset:
Does Placebo Information Affect the Trial Outcomes and Participant Blinding?

This is a randomised sham-controlled trial involving healthy volunteers to determine the effect of information on placebo, i.e., sham acupuncture, given in the informed consent, on the trial outcomes and blinding status of participants in a trial.

A total of 89 healthy volunteers will be recruited and randomly allocated to one of the 4 groups at an identical ratio. Four groups differ in acupuncture and placebo information. It is summarized as follows:

1. to receive real acupuncture and to read fully disclosed sham acupuncture information (e.g., fake acupuncture) written in the informed consent
2. to receive real acupuncture and to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent
3. to receive sham acupuncture (Park Sham Needle) and to read fully disclosed sham acupuncture information written in the informed consent
4. to receive sham acupuncture to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent.

They will read informed consent with differently described placebo information following their allocation. After participants repeatedly lift a dumbbell with their non-dominant arm to induce delayed onset muscle soreness (DOMS) in their biceps brachii, they are given allocated acupuncture treatment once a day for three consecutive days including the very first visit to compare outcomes (i.e., relief of DOMS measured with pressure pain threshold and visual analogue scale) and blinding property (the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know options).

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* not participating in other studies at the time of study participation
* voluntary participation

Exclusion Criteria:

* resistance training for more than 6 months
* experience of fracture of any of four limbs
* pregnancy or breast-feeding at the time of study participation
* analgesics within 24 hours before participation
* any other diseases or conditions that might prevent the participant from receiving acupuncture
Correlation of Gene Abnormalities and Clinical Manifestations of Aniridia

This study will examine specific gene changes in patients with aniridia, a disease in which the iris (colored part of the eye) is absent or partially absent, and will correlate the changes with clinical manifestations of the disease. In aniridia, the eye often appears to have no color, but only a larger than normal pupil. Patients may have impaired vision and cataracts, glaucoma, nystagmus (rapid, involuntary eye movements), photophobia (light sensitivity), displaced lens, underdeveloped retina, and thickened cornea. This study will focus particularly on corneal changes.

Patients 4 years old and older with aniridia may be eligible for this study. Candidates are screened with a family history and complete eye examination, including the following:

* Visual acuity testing using a vision chart.
* Eye pressure measurement.
* Fundus photography to examine the back of the eye: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that may occur over time. The camera flashes a bright light into the eye for each picture.
* Slit lamp examination: Evaluation of the front part of the eye with a special microscope called a slit lamp biomicroscope.
* Corneal thickness measurement.

Participants have blood drawn for genetic testing related to aniridia. Relevant medical information, including disease severity and complications, is obtained over time. Family members may also be requested to provide blood samples for genetic testing.

This project, Phenotype-Genotype Correlation in aniridia, will study the specific mutations in patients with aniridia and attempt to make a phenotype-genotype correlation. Specifically, the study will determine whether specific mutations are more prevalent in aniridic patients who have a predominant involvement of the corneal epithelium. A blood sample will be collected from each individual for isolation of DNA and the PAX6 gene will be sequenced and analyzed. The principal investigator is Brian Brooks and the associated investigators are James Fielding Hejtmancik at the OMGS/OGVFB/NEI and Chi-Chao Chan, LI/NEI. Associate Investigators at collaborating institutions include Edward Holland (University of Cincinnati) and Ali Djalilian (University of Illinois, Chicago).

Eligibility Criteria:
* Patients that meet diagnostic criteria for aniridia will be recruited from the NEI and Collaborating clinics. While diagnosis of aniridia is not expected to create significant difficulty, every attempt will be made to document the clinical status of each family member included in the study, and to document the clinical syndrome in at least one affected individual by slit lamp photography. A total of 100 subjects will be recruited for this study. There are no specific exclusion criteria other than young age (less than 4 years old) which may pose difficulty in obtaining blood.
The Reliability and Validity of Family Report Chewing Evaluation

The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation.

Chewing is a function that is defined as the grinding of solid food and making them ready for swallowing. Chewing begins with the acceptance of solid food with the lips. The rotational and lateral movements of the tongue is also necessary during grinding the solid food in the molar region. In the molar region, grinding is carried out with the help of salivary and salivary enzymes. Chewing behavior is a learned function. The child begins to chew at 6 months and the coordinated movement to the 9th month continues to develop. Together with experience, chewing activity continues to develop. The families have a primary role in chewing training. In some children, the chewing function does not develop as desired. Many children with developmental, medical, or oral motor problems have difficulty in grinding and swallowing solid foods. Therefore, it is very important to assess the ability of the child's chewing and determine the treatment goals. Assessment of the child's ability to chew should begin by considering chewing as a function. For this reason, the Karaduman Chewing Performance Scale (KCPS) was developed at the Hacettepe University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation. The chewing performance of the child during chewing a biscuit is scored by the therapist between 0-4. 0 refers to normal chewing, 4 means no bite and chew. The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation (Karaduman Chewing Performance Scale-Family report).

Eligibility Criteria:
Inclusion Criteria:

* Children above the age of 18 months
* Children with chewing disorders

Exclusion Criteria:

* Children below the age of 18 months
* Children without chewing disorders
Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma

The purpose of this study is to determine the survival rate after 1 year of treatment with ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or Stage IV melanoma.


Eligibility Criteria:
Key inclusion criteria:

* Japanese patients with histologic diagnosis of malignant melanoma
* Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma
* Prior adjuvant melanoma therapy permitted
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Life expectancy of at least 16 weeks in this study
* Adequate bone marrow and renal and hepatic function, specifically:

  * white blood cell count ≥2500/uL, absolute neutrophil count ≥1000/uL, platelet count ≥75,000/uL, hemoglobin level ≥9.0 g/dL, creatinine level ≤2.5\*upper limit of normal (ULN), aspartate transaminase/alanine transaminase level \<2.5\*ULN for patients without liver metastasis and \<5\*ULN for patients with liver metastasis, total bilirubin level \<1.5\*ULN (for those with Gilbert's Syndrome, lower than 3.0 mg/dL)

Key exclusion criteria:

* Evidence of brain metastases on brain imaging
* Active brain metastases with symptoms or requiring corticosteroid treatment; patients with any other malignancy from which they have been disease-free for fewer than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* Primary ocular or mucosal melanoma
* History of or current active autoimmune disease
* History or concurrent disease of gastrointestinal perforations
* HIV infection; active Hepatitis B or C or human T-lymphotropic virus type1 infection, based on testing performed during the screening period of this study
* Prior or concomitant therapy with any anticancer agent for melanoma, or other investigational anticancer therapies
* Prior adjuvant therapy \<4 weeks prior to the start of study drug administration
* Concomitant therapy with immunosuppressive agents, surgery, or radiotherapy
* Prior treatment with CTLA-4 inhibitors/agonists or other experimental immunotherapy drugs
* Treatment with other investigational products within 4 weeks prior to initial treatment of study drug
Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis

In cooperation with Merck \& Co, Inc. we will identify and form a database of 35 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes.

This study is an observational study, and not a comparative trial. The major outcome is represented by the fraction of subjects with long term healed lesions.

Eligibility Criteria:
Inclusion Criteria:

* Exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy

Exclusion Criteria:

* Pregnant patients
* Patients less than 30 yrs of age or greater than 90 yrs of age
* Mentally incompetent individuals
An Evaluation of the Effect of Vitamin D Supplementation on Depressive Symptoms Among Chinese Adolescents

The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese adolescents with elevated depressive symptoms and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can reduce depressive symptoms.

Participants in the intervention group will receive vitamin D3 capsules and mental health education. The control group will receive vitamin D3 placebo and mental health education.

Researchers will compare the change in depressive symptoms from baseline to post-intervention at 12 weeks between the intervention and control groups.

Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve depressive symptoms. A total of 310 participants will be recruited from two middle schools. Inclusion criteria are grades 7th and 8th students whose caregivers signed informed consents, self-reported mild and moderate depressive symptoms with scores of BDI-II\>13, and serum 25(OH)D concentration of 12-20 ng/mL. Exclusion criteria are the use of anti-psychotic treatments or interventions in the past 3 months; serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases); the use of vitamin D supplements in the past 3 months; self-reported suicidal plans/attempts in the past 3 months; intellectual disability. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks; placebo arm will receive placebo every day for 12 weeks. Both of these two groups will receive additional mental health education. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every three weeks. The primary outcome of this study is to compare the change of depressive symptoms between supplementation or placebo group from pre- to post-intervention at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. students whose caregivers signed informed consents;
2. students with serum 25(OH)D concentrations below 20 ng/mL;
3. students with self-reported depressive symptoms (BDI-II score of 14 or higher)

Exclusion Criteria:

1. students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;
2. students who have serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases);
3. students who are currently taking or have taken vitamin D supplements in the past 3 months;
4. students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months;
5. students with intellectual disability.
Comparison of TKAs Using Force Plate Analysis

The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.

48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies.

The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
* Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.

Exclusion Criteria:

* Subjects who are unsuitable candidates for the two types of knee implants under investigation.
* Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
* Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
* Subjects who are unwilling to sign Informed Consent/HIPAA documents.
* Subjects who cannot perform the required activities after the surgery.
A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone

The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop \| Premium 'On Track' in combination with Afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) \> 7.0% already prescribed an injectable rapid-acting insulin.

Eligible participants (N=400) with an A1c \> 7.0% already prescribed a rapid-acting insulin will be randomized to one of two groups: (1) One Drop \| Premium 'On Track' (i.e., use the One Drop \| Mobile app with in-app diabetes education accredited by the American Diabetes Association with supplemental Afrezza content and a live Certified Diabetes Educator messaging in the app, the 'Chrome' Bluetooth-connected blood glucose meter that uploads blood glucose values in the app, and 150 test strips per month) in combination with Afrezza treatment (n=200) or (2) One Drop \| Premium 'On Track' plus their current rapid-acting insulin (n=200).

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Self-reported diagnosis of T2D
* Diagnosed with diabetes for at least 12 months
* Prescribed a prandial rapid-acting insulin
* Willing to take Afrezza rapid-acting insulin for 3 months instead of current rapid-acting insulin
* Willing to get a physician's prescription for Afrezza
* Self-reported A1c \> 7.0% (later confirmed with a mail-in A1c laboratory test)
* Owns and uses an iPhone or Android phone with an operating system compatible with the One Drop \| Mobile app
* Has successfully downloaded and used a smart phone application previously

Exclusion Criteria:

* Currently pregnant or planning to become pregnant during the trial period
* Cannot read or write in English
* Currently in a diabetes education or coaching program
* Had previously used One Drop \| Premium or One Drop \|
* Experts coaching
* Had previously used or is currently using Afrezza
* Currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime in the past 6 months
* Has chronic lung disease, e.g., COPD and asthma
Comparison Between VCV and FCV Through Ultra-thin Tube in Upper Airway Surgery

Ventilation through the small endotracheal tube is not an uncommon situation. The indications for it differ from elective upper airway surgery to emergency ventilation through needle cricothyrotomy. Conventionally, ventilation through small endotracheal tubes has been challenging by jet ventilation with subsequent risk of barotrauma and inadequate gas exchange. Expiration during jet ventilation occurs passively.

Upper airway endoscopy (micro laryngoscopy (MLS), pan endoscopy) is a minor upper airway procedure needing short duration general anesthesia, small calibrate endotracheal tube and manipulation of the airway. Because of airway manipulation and the surgery involves the airway, which is being shared with the anesthesiologist, there is a risk of interruption of ventilation, oxygenation and loss of airway in addition to inherent complications of surgery.

Methods:

After the patients will receive information about the study and informed consent will be taken. The patients will be randomized. In the control group, (group A) ventilation will be performed according to the routine big endotracheal tube. In the treatment group (group B), the ultra-thin ventilation tube will be placed using laryngoscopy. All other treatment will be unchanged. Data collection will be started 5 min after the initiation of the study. Demographic data, Past medical history, and examinations data will be collected after acceptance of the patient to be enrolled into the study and other ventilation parameters will be collected 5 min after the start of the the study which is Skin incision Primary endpoint is; to evaluate whether the Flow Controlled Ventilation (FCV) can also achieve adequate oxygenation and ventilation through small tube or not.

Eligibility Criteria:
Inclusion Criteria:

* Adult population of both sex (ASA I, II).
* Between18-65 years of age.
* Patients for the upper airway.
* Patients need intubation/invasive mechanical ventilation.

Exclusion Criteria:

* ASA \>II
* Advanced Respiratory disease.
* Advanced cardiovascular disease.
* Smokers.
* Pregnancy.
* Recent upper airway trauma.
* Age less than 18 years or more than 65 years.
* Patients BMI of more than 35
* Refuse to sign the consent.
Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in children aged 3 months - 17 years who are treated for urinary tract infections.


Eligibility Criteria:
Inclusion Criteria:

* age between 3 months and 17 years of age
* confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample.
* indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician.

Exclusion Criteria:

* pregnancy
* impaired renal function as defined by 2x serum creatinine level for age and sex
* epilepsy
* myasthenia gravis
* long QT-syndrome
* glucose 6 phosphatase deficiency (G6PD)
* allergy to one of the substances of cipro
* concomitant use of corticosteroids
* for the oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.
Return Physical Activities After Total Knee Arthroplasty

The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. The aim of this study was to evaluate whether an individualized goal-centered rehabilitation protocol leads to high patient-reported physical activities and satisfaction after TKA.

A prospective study was conducted in patients who underwent primary TKA (Journey II, Smith \& Nephew) from the same surgeon from July 1, 2013 to December 31, 2015. Patients completed patient-reported outcome measures (PROMs) before the operation and then at 1, 2, and 4 years postoperatively.These included the Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS JR) 7-item score; questions from the Cincinnati Knee Rating System related to the overall knee condition, pain, and swelling; selected questions from the Veterans RAND 12-Item Health Survey; questions about general fitness level; and questions regarding patient expectations before and after surgery. Patients were asked to list all physical, recreational, and work activities they participated in after surgery. An experienced research associate interviewed the patients postoperatively, with data reduction and patient ratings blinded to the treating surgeon and therapist.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 70 years
* Patient goals to return to recreational and occupational activities
* Agree to participate in a postoperative rehabilitation and home exercise program

Exclusion Criteria:

* Osteoarthritis in other joints
* Co-morbidities limiting physical activity
* Presence of a connective tissue disease
* Autoimmune disease or immune deficiency
* Age 70 years or more
* no desire to return to recreational and work activities
* Refusal to participate in rehabilitation program