cyrilzakka/clinical-trials huggingface dataset:
Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis

Interactions between patients and healthcare providers may have a significant impact on a patient's response to therapy. In this study, patients with osteoarthritis (OA) of the knee will receive either acupuncture or sham acupuncture. The acupuncturists will be trained to interact with the patients in specific ways. The study will evaluate those interactions.

This study will examine placebo responses in the context of practitioner-patient interactions at the time of the encounter. Phase 1 of this study identified patient-related determinants of placebo response, such as beliefs and expectations toward treatment of knee OA with acupuncture. Phase 2 of the study evaluated an assessment tool to measure these determinants. Phase 3 of the study is a randomized controlled trial to evaluate whether placebo effects in patients with knee OA can be enhanced by the acupuncturists' communicative style, which can affect a patient's cognitive expectancies and beliefs.

Patients will initially be randomized to one of two groups, each with a different model for practitioner-patient interaction. Acupuncture practitioners will be trained to follow semi-structured communicative styles, including traditional approaches in Chinese medicine and techniques previously described in patient-doctor communications studies. Within each of these groups, patients will be further randomized to receive either acupuncture or sham acupuncture. Patients will have 6 weeks of biweekly treatment visits. Patients will be followed for 6 months. Visits will be weekly during the first 6 weeks of the study and monthly thereafter.

The study will also include a natural cohort group composed of patients on a study waiting list; these patients will be offered acupuncture 3 months after study entry.

Eligibility Criteria:
Inclusion Criteria:

* OA diagnosis according to the American College of Rheumatology criteria
* Pain in the knee of at least 3 or more on a 0 to 10 scale (0 none, 10 extreme pain) within 2 weeks prior to study entry
* Stable treatment with anti-inflammatory and analgesic medications during the month prior to study entry
* If receiving glucosamine, stable dosage for 2 months prior to study entry
* Adequate cognitive status as determined by the study officials
* Living in the community
* Ability to communicate in English without a translator
* Access to a telephone

Exclusion Criteria:

* Other diagnosed joint diseases, such as rheumatoid arthritis
* Previous treatment with acupuncture (for any condition)
* Intra-articular injections in the knee in the 2 months prior to study entry
Normal Eyelid Sensation Distribution

The purpose of this study is to determine normal eyelid sensation distribution using a Cochet-Bonett Aesthesiometer.

After proper taken consent patients without previous eyelid surgery in the Oculoplastic clinic at Duke Eye Center and Duke Aesthetic Center will be enrolled to test the eyelid sensation distribution using the Cochet-Bonnet aesthesiometer. The aesthesiometer (Luneau ophthalmologie) with a 0.12mm diameter filament was chosen for its ease of use, sensitivity, and safety. This instrument contains a 6 cm long, retractable, flexible monofilament. For any given length, when applied perpendicularly to test surface, the filament will exert a precise pressure before visibly bending. The filament length inversely corresponds to the pressure exerted by the aesthesiometer.

Selection of eyelid laterality will be randomized on the same day of the study. Ipsilateral upper and lower eyelids will be divided in thirds (medial, central and lateral borders) including the margin (fig.2). The eyelid sensation will be tested on every third by applying the tip of the aesthesiometer filament perpendicular to the eyelid skin and tarsal plate until the filament bent slightly. The filament length will be set at 6 cm (longest length) and applied to the test site 3 times. This process will be repeated 3 times and if the patient verbally responded to the 3rd touch, the number 6 will be recorder.

If the patient responded less than 3 of the 3 times, the filament will be shortened by 0.5 cm and the test will be repeated. This process will be continued by shortening the filament 0.5 cm each time, until the patient feels the filament touch 3 of 3 times. This filament length number will be recorded as the touch reading for that time period.

The mean touch thresholds for the various test sites will be compared using a Freidman two-way analysis variant (ANOVA).

Eligibility Criteria:
Inclusion Criteria

* Capable and willing to provide consent
* Has been seen for the first time in the Oculoplastic clinic and does not have previous eyelid surgery
* At least 18 years of age

Exclusion Criteria:

* Unable or unwilling to give consent
* Under 18 years of age
* Previous eyelid surgery
Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD.

The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.

Eligibility Criteria:
Key Inclusion Criteria of the master protocol:

* Able and willing to sign the informed consent (IC)
* Patients with a diagnosis of AD and onset of disease for at least 1 year
* Moderate to severe AD

Key Exclusion Criteria of the master protocol:

* Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)
* Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG
* Participant with any other active inflammatory skin disease
* Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)
* Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)

Additional inclusion and exclusion criteria may apply depending on the intervention specific requirements
A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis

The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 75 years of age, inclusive
* Diagnosed with distal subungual onychomycosis (DSO) of the toenails
* Great toe(s) with intact skin and intact neurologic functions
* Great toenail(s) free of nail polish
* At least one target great toe which has:

  * 25 to 75% involvement of the area of the nail unit (including destroyed or missing parts of the nail plate)
  * at least 2 mm of uninvolved nail growth as measured from the proximal nail fold to the most proximal point to the disease process and with no lunular involvement
  * nail unit hyperkeratosis at the most distal edge which measures no greater than 3 mm
  * a positive KOH and culture

Exclusion Criteria:

* Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments
* Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot
* In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period
* History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal
* Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail which could interfere with study evaluations (e.g., prevent obtaining normal appearing nail, after clearing of onychomycosis, due to chemical damage, genetic or pigmentary disorders, etc.)
* Have white superficial onychomycosis, proximal subungual onychomycosis, yellow spikes, or dermatophytoma
* Have paronychia
* Have a history of chronic alcohol or drug abuse
Non-Interventional F-Two Isoprostane Trial (NIFTI)

Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored.

One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury.

Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Estimated age of 18 - 50 years
2. Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation.
3. Systolic blood pressure of \>90 mm Hg
4. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas

Exclusion Criteria:

1. Those in whom the time of injury is unknown
2. Those with any 2 readings of systolic blood pressure of \<90 prior to enrollment
3. Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment.
4. Those receiving CPR prior to enrollment
5. Known incarcerated individuals
6. Pulse ox reading of \< 90 prior to enrollment
7. Status epilepticus prior to enrollment
8. Penetrating head trauma
Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults

To the investigator's knowledge, there are no data available in the current literature regarding the acute effects of postprandial hyperglycemia and insulin timing on myocardial perfusion in people with type 1 diabetes (T1D). Observational studies using CEU in type 2 diabetes demonstrate that postprandial hyperglycemia determines myocardial perfusion defects. The investigator hypothesizes that the combination of postprandial hyperglycemia and insulin increases pulse wave velocity (i.e., aortic stiffness) and myocardial vasoconstriction, thereby reducing myocardial perfusion in T1D when compared to healthy controls. Furthermore, the investigator hypothesizes in T1D that dosing insulin before meal intake will ameliorate these cardiovascular defects.

The investigator will compare 17 T1D and 17 age-, sex-, and BMI-matched healthy controls (18-35 yrs) measuring pulse wave velocity (PWV), flow-mediated dilation (FMD) and myocardial perfusion (contrast enhanced ultrasound \[CEU\]) before and 2 hours after ingesting a mixed meal (40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively).

T1D participants will have 2 study admissions:

A) injection of insulin 15 minutes before ingesting a mixed meal. B) injection of insulin 15 min after ingesting a mixed meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy with no chronic illness

  * Age 18-35 years
  * BMI ≤ 30 (wt kg/ht m2)
  * Normal screening labs or no clinically significant values
  * T1D participants must have T1D based on WHO diagnostic criteria for \> 1 year

    * A fasting plasma glucose level \>126 mg/dl (7.0 mmol/l)
    * A casual plasma glucose \>200 mg/dl (11.1 mmol/l)
    * In the absence of unequivocal hyperglycemia, the diagnosis must be confirmed on a subsequent day.
  * Subjects using sensor-augmented insulin pump therapy and/or artificial pancreas (closed loop system) will be included

Exclusion Criteria:

* • Smoking presently or have quit \< 2 years.

  * BP \>140/90 mmHg
  * BMI \>30 (wt kg/ht m2)
  * Pulse oximetry \<90%
  * Elevated LDL cholesterol \> 160 mg/dl
  * HbA1c ≥ 9 %
  * Use of statins, calcium channel blocker, ACE, ARB, nitrates, alpha-beta blockers or diuretics
  * History of cardiac, cerebrovascular, gastrointestinal, liver, renal decease or cancer
  * Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
  * Retinopathy (beyond mild non proliferative retinopathy)
  * Urine albumin/creatinine ratio \> 300 mg per g
  * Pregnant or breastfeeding.
  * Known hypersensitivity to perflutren (contained in Definity
Amino Acid Concentrations in Serum After Intake of Different Protein Sources

This study assesses the amino acid concentrations in subject serum after intake of different types of proteins. The study is divided in two consecutive sub-studies. Subjects will be asked to ingest a specific protein blend each visit in a randomized order, after which blood will be drawn on 14 different time points. At least 48 hours will be kept between each visit, and the subjects receive a follow up call within 4-14 days after visit 4.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 70 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health

Exclusion Criteria:

1. Any gastrointestinal (GI) disease or surgery that may interfere with GI function and/or protein metabolism, including but not limited to phenylketonuria, pancreatitis, short bowel syndrome, celiac disease, Crohn's disease, in the opinion of the Investigator
2. Known renal or hepatic diseases that may interfere with protein metabolism, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease, in the opinion of the Investigator
3. Use of systemic antibiotics, anticonvulsants, prokinetics, antacids, medication influencing gastric acid production, systemic anticoagulants, systemic corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants or insulin within the past 3 weeks prior to screening
4. Allergy to soy, pea and/or cow's milk protein
5. Adherence to a weight loss program
6. Current eating disorder, e.g. anorexia nervosa or bulimia
7. Known pregnancy and/or lactation
8. Current smoking or stopped smoking for \< 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month prior to screening)
9. Average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women (on average during the last 6 months prior to screening)
10. Drug or medicine abuse in opinion of the investigator
11. Any known bleeding disorder
12. Known difficulties with placement of and/or blood drawings from a cannula
13. Active participation in any other study with investigational or marketed products concomitantly or within 4 weeks prior to screening
14. Major medical or major surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation
15. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
16. Employees of Nutricia Research and/or their family members or relatives
Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.

The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* In good general health
* Living or working close to the study site
* Intrauterine pregnancy less than 64 days gestation
* Willing and able to sign consent forms
* Ready access to a telephone and emergency transportation
* Willing to provide an address and/or telephone number for purposes of follow-up
* Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
* IUD in place (IUD must be removed first)
* Chronic renal failure
* Concurrent long-term corticosteroid therapy
* History of allergy to mifepristone, misoprostol or other prostaglandin
* Hemorrhagic disorders or concurrent anticoagulant therapy
* Inherited porphyrias
* Other serious physical or mental health conditions
Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
* Measurable disease
* Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* HER2 positive and/or hormonal receptor positive
S-pantoprazole 10mg Phase III Clinical Study

This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 19 and 75 inclusive
* Patient with a history of heartburn or acid regurgitation for at least 3 months.
* Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline
* Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening
* Capable of providing written informed consent, willing and able to a comply with all procedures of the study

Exclusion Criteria:

* History of endoscopic erosive esophagitis(EE) at screening EGD.
* Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
* More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
* Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
* H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening
* Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease,
* Known hypersensitivity to any component of drug
* pregnancy or lactation (F only)
Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised.

The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical picture of these patients more compromised. The literature has not yet demonstrated studies involving indication of physical exercise therapy when AF is associated with HF. Thus, the hypothesis is that physical training improves functional capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma markers, quality of life and cognitive function of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically stable NYHA class II to III heart failure with permanent atrial fibrillation (AF);
* Left ventricular ejection fraction ≤40%;
* Patients refractory and / or no indication of the treatment of reversal to the rhythm;
* Patients in optimization specific drug therapy for HF and AF.

Exclusion Criteria:

* High-frequency ventricular response;
* Neuromuscular / neuropathy disease;
* Physical and mental impairment;
* Chronic obstructive pulmonary disease;
* Diabetes mellitus;
* Decompensated arterial hypertension;
* Autonomic neuropathy;
* Recent myocardial infarction (\<6 months);
* Ventricular arrhythmias;
* Atrial flutter;
* Renal failure;
* Use implantable electronic cardiac device or indication for implantation;
* Pregnancy;
* NYHA Functional Class IV;
* Resting heart rate \<55 bpm;
* Wolff Parkinson White Syndrome;
* Thyroid dysfunction;
* Unstable angina;
* Recent history of thromboembolic event;
* Inability to sign the consent form;
* Participation in regular physical training program;
* Use of alcoholic beverages.
Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects

Primary objective:

To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects.

Secondary objectives:

To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously.

To assess the safety of the different SAR153191 drug products administered subcutaneously.

Up to 35 Days

Eligibility Criteria:
Inclusion Criteria:

* Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
* Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.