cyrilzakka/clinical-trials huggingface dataset:
PRO 140 for Human Immunodeficiency Virus Infection

PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age ≥18 years
2. Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
3. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
4. CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
5. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
6. Clinically normal resting 12-lead ECG at screening visit
7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through three weeks after the last administered subcutaneous dose of PRO 140.

Exclusion Criteria:

1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
3. Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
4. Chronic hepatitis
5. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
6. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
Rural Alliance for Diabetes Prevention

The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas.

This 12 mo. Type II hybrid effectiveness-implementation trial will compare effectiveness (weight loss, physical activity, HbA1c) of Cooperative Extension delivering the Diabetes Prevention Program (DPP) by group video using Zoom® (GV) vs. a self-directed (SD) control. Active vs. passive participant recruitment strategies will be compared on recruitment outcomes including time to full enrollment, participant yield, and retention rates. Ten Cooperative Extension local units/districts serving rural Kansas counties will be allocated to either active or passive recruitment. Each of the sites will recruit adults with prediabetes living in the county served by Kansas State Research and Extension site and will be randomized to one of the 2 intervention arms. A centralized team of Cooperative Extension Agents who complete NDPP lifestyle coach training will serve as interventionists for both the GV and SD arms. Primary (weight) and secondary outcomes (HbA1c, the proportion of participants meeting weight loss (≥ 5%) and physical activity goals (≥150 min./wk.) will be assessed at baseline, 6 and 12 mos. Findings will inform best practices in the delivery of the DPP through Cooperative Extension in rural communities that could reach this high risk population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* BMI ≥25 kg/m2, ≥23 kg/m2 if Asian
* Blood test results in the pre diabetic range within the last year (HbA1C = 5.7%-6.4% or fasting plasma glucose= 100-125 mg/dl or 2-hr. plasma glucose following a 75-gm glucose load = 140-199 mg/dL) or have previous diagnosis of gestational diabetes or a positive screening for pre diabetes based on CDC pre diabetes risk test
* Willing to travel to KSRE site for orientation and outcome testing
* Available to attend pre-specified meeting time of GV for their respective KSRE location
* Medically stable as deemed by primary care provider consent
* English speaking

Exclusion Criteria:

* Previous diagnosis of Type I or II diabetes
* Taking FDA-approved weight loss medications
* Primary care provider stating that patient should not participate
* Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
* Unable to engage in physical activity
Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence

A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera

Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera

Eligibility Criteria:
Inclusion Criteria:

* Patients should be over 18 years of age. Patients should have an acceptable oral hygiene level. Patients must have at least one posterior resin composite restoration

Exclusion Criteria:

Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion.
Thyroid Function of Pediatric Subjects Following Isovue® Administration

This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the required radiologic procedure as part of their standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female from 0 to 3 years of age;
* Is scheduled to undergo a radiologic examination that requires intravascular administration of ISOVUE as part of his/her standard of care;
* Has normal baseline thyroid function tests (TSH, total T3, total T4, and fT4) performed at a local laboratory with blood sample obtained within one week prior to ISOVUE administration;
* Written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) (according to local regulations) who are willing to comply with the protocol requirements.

Exclusion Criteria:

* Has any known allergy to one or more of the ingredients of ISOVUE;
* Has been diagnosed with congenital hypothyroidism;
* Has undergone radiation treatments to the head or neck;
* Is currently on thyroid replacement therapy;
* Is on therapy with dopamine or any treatment which may affect the thyroid function testing results;
* Has been exposed to any topical iodinated product within 30 days prior to enrollment in the present study;
* Has been exposed to an iodinated contrast agent within 1 year prior to enrollment in the present study, including any administration of iodinated contrast agents during placement of a central line;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)

In this experiment, the investigators would like to test the following:

1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?
2. Can these canges correlate with the development of local hyperalgesia?
3. How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?
4. Which mRNA targets are potentially affected by acute pain?


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women in the age 18-80 years
* Speak and understand English

Exclusion Criteria:

* Acute and chronic pain
* Pregnancy or breastfeeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)
* Lack of ability to cooperate
* Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

The purpose of the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer.

This study will evaluate a technique called lymphatic drainage mapping. This is a technique where a radiotracer (a radioactive material that can be seen with a special computed tomography \[CT\] scanner to create 3D images) is injected into a vein around the tumour, either with local anesthesia or under general anesthesia. The radiotracer that will be used for the lymphatic drainage mapping is called 99m-Technetium Sulfur Colloid. Images will be taken of neck to detect the movement of the radiotracer. This will allow the doctors to see the drainage pattern of the lymph nodes in the neck.

The information from this study will be used to better understand the tendency for oropharyngeal cancers to spread to lymph nodes. In addition, the information from this clinical trial will be used in future clinical studies to help specialists identify strategies to help plan treatment based on this type of imaging study.

Eligibility Criteria:
Inclusion Criteria:

* Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline
* Has squamous cell carcinoma, T1-3 tumours, with no contralateral nodes on clinical exam or axial imaging
* Human papillomavirus (HPV) positive or negative
* Patient should have normal organ function as per Investigator judgement
* Patient is planned for definitive or adjuvant radiotherapy (RT) or chemo radiotherapy (CRT) with bilateral neck RT, or surgery
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* T4 tumours
* Contralateral/bilateral nodal disease or node(s) \> 6cm on clinical exam or axial imaging or positron emission tomography (PET)
* Primary tumour involving or crossing midline
* Soft palate or posterior pharyngeal wall tumour subsites
* Previous head and neck cancer
* Previous radiotherapy (RT) to the head and neck
* Previous neck dissection
* Distant metastases
* Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for 3 years
* Prior radiotracer allergy
* Multiple primary head and neck cancers
* Pregnancy
Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease

This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

This is a phase 3 study.

Primary Objective:

• To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial.

Secondary Objectives:

* To evaluate quantitative viral load over time
* To evaluate length of hospital stay and days in ICU
* To evaluate toxicity of the treatment options
* To evaluate rate of readmission after hospital discharge
* To evaluate duration of clinical symptoms

Arm A:

Control Arm - Supportive Care Only

Arm B:

Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5

Arm C:

Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Positive SARS-CoV-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (PUIs).
* Onset of symptoms \< 7 days from date of enrollment
* Oxygen saturation of \>94% on room air with defined risk factors (Table 1) consistent with moderate disease OR oxygen saturation of \< 94% on room air consistent with severe disease
* Ability and willingness to comply with study procedures

Exclusion Criteria:

* QTc greater than 450 milliseconds on screening EKG
* Pregnant or lactating women
* Inability to take oral pills or inability to use a feeding tube
* Inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. For the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals.
* Patients requiring ICU level care
* use of azithromycin or hydroxychloroquine within 30 days prior to admission
The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department

Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux was defined as the percentage total time for which a pH value \< 4 was \>4.2 % in the distal esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The symptom scores were measured by the frequency score multiplied by the severity scores of the predominant symptom before and at the end of the treatment, and the " PPI test " was defined as positive if the overall scores of the predominant dyspeptic symptom in the fourth week decreased by \>50 % compared with those of the baseline.

GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. The symptom of the highest percentage will be the primary symptom.

Primary Objective：To define the primary symptom of GERD in Chinese outpatients in Gastroenterology department Secondary Objective：1. To investigate the symptom distribution of patients who present with symptoms originated from upper gastrointestinal tract and have pathologic esophageal reflux established by 24-hour impedance-pH monitoring, upper endoscopy, or proton pump inhibitor test.

2. To evaluate the life quality of patients with atypical GERD symptoms (symptoms except heartburning and regurgitation) 3. To investigate the diagnostic value of proton pump inhibitor trial to diagnose GERD with atypical reflux symptoms 4. To investigate the predictive value of Gerd Q to diagnose GERD with atypical reflux symptoms with heartburn or regurgitation

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort, such as heartburn, regurgitation, dysphagia, substernal pain, epigastric pain, epigastric burning, early satiety, postprandial fullness.
* Whose previous symptoms should last for at least 3 months and be at least 3 days per week in frequency with moderate severity.
* Able to fill in the questionaires.

Exclusion Criteria:

* gastric or duodenal ulcers, upper GI neoplasms on upper endoscopy
* severe cardiac or pulmonary diseases, diabetes or rheumatic diseases
* history of operations in the upper GI tract
* renal failure or abnormal liver function
* use of non-steroidal anti-inflammatory drugs (NSAIDs)
* allergy to esomeprazole
* Pregnancy or lactating mother
Uptake and Utilization of Amino Acids by Splanchnic Bed

Splanchnic uptake and metabolism contributes significantly to the differences in flux seen between the intravenous and intragastric ingestion of certain indispensable amino acids.

This is the third in a series of studies designed to increase the investigators knowledge of the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed. In the initial two studies the investigators established the neonatal parenteral requirement of threonine and lysine. In the current study, the investigators will be examining the differences in uptake and metabolism of threonine and lysine across the splanchnic bed.

We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as compared to the amount in plasma from the parenterally delivered isotopes. We also believe that the amount of enterally delivered threonine isotope that reaches the plasma will be significantly less than the amount of enterally fed lysine isotope.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males

Exclusion Criteria:

* History of inborn error of metabolism
* Presence of a chronic disease
* Have unusual dietary practices
* Has recently lost weight
* Receiving pharmacological therapy or hormonal treatment
Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study

The project aims to investigate the effect of female sex hormone treatment (both contraceptive treatment and hormone therapy during menopause) on bronchial hyperreactivity in adult women. The study is a prospective cohort study involving 300 women, examining airway responsiveness before and after the initiation of hormone treatment, whether as hormone therapy in menopause or contraceptive treatment. Participants will be recruited from general practitioners in the Capital Region of Denmark. Lung function, bronchial hyperreactivity, airway inflammation, and body composition will be assessed before and after hormone treatment. Blood samples will also be collected and stored for later analysis of inflammation markers. The study will include women aged 18 to 75 who are about to begin hormone treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 75 years
* Planning to initiate HRT/HC within next 30 days

Exclusion Criteria:

* Gynecological, endocrinological or other disease affecting the ovarian cycle
* FEV1 \< 60% of expected or \< 1.5L
* Current hormonal medication
* Pregnancy
Prognostic Impact of Frailty Assessed by Edmondon in Elderly Patient Undergoing Cardiac Surgery

The score on the Edmonton frail scale will be recorded in 250 consecutive patient aged of 75 years or more and undergoing elective cardiac surgery. In those patients the investigators will also record the ITU length of stay, the hospital length of stay, the incidence of complications, the ability to be discharged home and to live independently at postoperative day 30.

The ability of the Edmonton score to predict complication, prolonged hospital and ITU length of stay as well as loss of autonomy at discharge and day 30 will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* 75 yo and older
* Elective cardiac surgery

Exclusion Criteria:

* Refuse or inability to give consent
* Emergency surgery
Tolcapone in Obsessive Compulsive Disorder

The proposed study will consist of a 5-week double-blind cross-over study trial of tolcapone in 20 people (ages 18-65). The study will be divided into an initial 2 week phase and a second 2 week phase, with one of the 2 week phases consisting of active treatment with tolcapone, and the other 2 week phase consisting of inactive placebo treatment. There will be a one-week wash-out phase between the 2-week treatment phases. Participants will be randomized to receive either tolcapone or placebo during the first 2 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in adults with obsessive compulsive disorder (OCD). The hypothesis to be tested is that tolcapone will be more effective and well tolerated in adults with OCD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder where current treatments are often ineffective.

The primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using tolcapone in 20 participants with OCD. The study will consist of two phases: a 2 week active treatment phase with tolcapone, a one-week wash-out phase, and a 2 week placebo phase. The subjects will be randomized to either receive tolcapone or placebo treatment in the first 2 weeks, and the other during the remaining 2 week phase.

This will be one of few studies assessing the use of pharmacotherapy for the treatment of OCD in adults. Assessing the efficacy and safety of tolcapone will help inform clinicians about additional treatment options for adults suffering from this disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18-65;
2. Diagnosis of current OCD based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
3. Able and willing to provide written consent for participation.

Exclusion Criteria:

1. Unstable medical illness, including liver disease, as determined by the investigator;
2. History of seizures;
3. Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
4. Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);
5. Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;
6. Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
7. Previous treatment with tolcapone;
8. Any history of psychiatric hospitalization in the past year;
9. Currently pregnant (confirmed by urine pregnancy test)