cyrilzakka/clinical-trials huggingface dataset:
NOWDx Test for the Diagnosis of Syphilis

This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human antibodies to syphilis in human whole blood to aid in the diagnosis of infection caused by Treponema pallidum.

The objective of this study is to establish the performance characteristics of the NOWDx Syphilis Test based on comparison to the BioRad Bioplex 2200 series Syphilis Total (IgG/IgM), Wampole Impact RPR Test Kit, and to the Serodia Treponema pallidum particle agglutination assay (TP-PA).

The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx Syphilis Test as an aid in the diagnosis of syphilis infection for at home testing and point of care testing sites. Participants will self test and be tested by Clinical Laboratory Improvement Amendments (CLIA) Waived operators with the NOWDx Syphilis Test at independent sites in WA, AZ, and NV. Two sample types will be tested with the NOWDx Syphilis Test for each participant: fingerstick whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory.

The NOWDx Syphilis Test will be evaluated in diverse populations of sexually active persons who self-select for syphilis testing and expectant mothers.

Eligibility Criteria:
* Sexually active persons who self-select for syphilis testing

  * n=840 participants; \~280 per study site
  * Inclusion criteria:

    - sexually active persons 18-64 years old
  * Exclusion criteria:

    * persons \<18 years old; persons \>64 years old;
    * persons with limited or no reading skills;
    * persons who previously participated in a NOWDx study
* Expectant mothers

  * n=222 participants; \~74 per study site
  * Inclusion criteria:

    - expectant mothers ≥18 years old
  * Exclusion criteria:

    * persons \<18 years old;
    * persons with limited or no reading skills;
    * persons who previously participated in a NOWDx study
* Lay users

  * n=48 participants; \~16 per study site
  * Inclusion criteria:

    * persons 18-64 years old;
    * -½ high risk sexual behavior; ½ low risk sexual behavior
  * Exclusion criteria:

    * persons \<18 years old; persons \>64 years old;
    * persons with limited or no reading skills;
    * persons who previously participated in a NOWDx study
Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

This study aims to investigate the predictive value of quantitative sensory testing (QST) in identifying patients with carpal tunnel syndrome (CTS) who are at risk of developing nociplastic pain.

The study will recruit 120 adults diagnosed with CTS and conduct baseline QST measures. The progression to nociplastic pain will be assessed over a one-year follow-up period to determine the predictive value of QST measures.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-60
* Clinical diagnosis of CTS based on presence of parasthesias and/or pain in median nerve distribution, positive Phalen's test and/or Tinel's sign, and nocturnal symptoms
* Electrodiagnostic evidence of median neuropathy at the wrist:

  1. Prolonged median motor distal latency \>4.2 ms
  2. Prolonged median sensory latency \>3.4 ms
* Symptom duration between 6 months and 2 years (to exclude very early or very late stages)
* Pain severity of ≥5 on 0-10 numerical rating scale
* No evidence of thenar muscle atrophy on physical exam
* No prior surgery or fracture of the affected wrist
* No evidence of comorbid diabetes mellitus, cervical radiculopathy, polyneuropathy, or other neuromuscular disorders

Exclusion Criteria:

* Diabetes mellitus, as a common cause of polyneuropathy, which can confound QST measures.
* Cervical radiculopathy or other upper limb neuropathies, which can cause overlapping sensory symptoms and signs.
* History of wrist fracture or surgery, which may cause structural abnormalities affecting nerve function.
* Pregnancy, due to physiological changes that can affect nerve function.
* Patients with severe thenar muscle atrophy, indicating long-standing severe median neuropathy.
* Patients unable to provide informed consent or comply with study procedures.
Impact of Kolcaba Comfort Theory Training on Dyspnea, Function, and Comfort in COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is the third most fatal chronic disease worldwide, following cardiovascular diseases and cancer. COPD is characterized by chronic respiratory symptoms due to abnormalities in the airways (bronchitis/bronchiolitis) or alveoli (emphysema), leading to persistent and often progressive airway obstruction. Patients frequently experience a range of physical and psychosocial symptoms, including dyspnea, cough, sputum production, fatigue, anxiety, and depression. Dyspnea, in particular, can significantly reduce quality of life, impair daily activities, and affect patient comfort.

Functional status is a crucial metric for assessing disease progression and symptom severity in COPD and is directly related to the intensity of symptoms such as dyspnea. Effective management of symptoms and enhancement of comfort levels are critical in COPD treatment. Kolcaba's Comfort Theory provides a comprehensive approach to nursing care by addressing physical, psychospiritual, social, and environmental dimensions of patient needs. This theory can be an effective guide for improving comfort in COPD patients.

The objective of this study is to evaluate the effects of using Kolcaba's Comfort Theory as a guide in managing symptoms and enhancing the quality of care for COPD patients, focusing on dyspnea, functional status, and comfort. The research aims to provide innovative insights into the impact of Comfort Theory-based nursing care in sensitive patient populations like those with COPD and to contribute valuable information for developing effective treatment and management strategies for symptom control.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older.
* Have been diagnosed with COPD for at least 6 months.
* Be in GOLD stages 1, 2, or 3 of COPD.
* Be able to read and write in Turkish.
* Have access to a phone for communication.

Exclusion Criteria:

* Patients experiencing an acute exacerbation.
* Presence of non-COPD pulmonary problems or diagnosed cardiovascular diseases.
* Psychiatric disorders that disrupt thought processes, such as dementia or schizophrenia.
* Respiratory issues caused by diseases other than COPD.
* Problems with communication or speech.
* Use of a respiratory exercise device (PEP).
* Inability to tolerate PEP use.
* Desire to withdraw from the study at any point.
Effects of Cardiac Rehabilitation on Postoperatory of Coronary Artery Bypass Graft.

Randomized Clinical Trial to evaluate the use of different techniques of physical therapy on recovery of functional capacity, pulmonary function and respiratory muscle strength in the period of hospital stay after coronary artery bypass graft.


Eligibility Criteria:
Inclusion Criteria:

-Patients are recruited from the waiting list for a first CABG intervention at the Porto Alegre Clinical Hospital.

Exclusion Criteria:

* chronic renal failure,
* unstable angina,
* moderate or severe valve disease,
* complex cardiac arrhythmia,
* stroke,
* inability to exercise the lower limbs,
* subjects with forced expiratory volume in 1 second less than 70% of predicted
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 70 years of age (inclusive)
* History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
* Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
* Willingness to consume a moderate amount of gluten
* Able to read and understand English
* Worsening of GI symptoms in response to an oral gluten challenge
* HLA DQ 2.5 positive

Exclusion Criteria:

* Unwilling or unable to perform self-injections
* History of inflammatory bowel disease and/or microscopic colitis.
* Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
* Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
* Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
* Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
* Females who are lactating or pregnant
* Receipt of any vaccine within 1 week prior to planned first day of the treatment period.
The Role of Synovitis in Osteoarthritis

To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.

Methods:

sixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with OA knee according to ACR guideline

  1. stiffness less than 30min
  2. cracking sound during activity
  3. more than 30min pain for last 2 months
  4. non-bed ridden patients
  5. no structure abnormality
  6. synovitis was proved by US

Exclusion Criteria:

1. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process
Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients

Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients

Platelet indices can be utilized as a non-invasive predictor of SBP.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients and ascites

Exclusion Criteria:

* patients with ascites due to causes other than cirrhosis- immunocompromised patients,
* patients with abnormal thrombocytes due to non-hepatic causes.
The Factors Affecting IPP in Peritoneal Dialysis Patients with Polycystic Kidney Disease

Background: Polycystic kidney disease (PKD) is the most common hereditary kidney disease. Peritoneal dialysis (PD) in such patients is restricted because the significantly enlarged kidneys and liver may lead to the increase of intraperitoneal pressure (IPP). Increased IPP points to higher risk of abdominal wall complications and limited infusion volume that cause insufficient dialysis adequacy. Therefore, monitoring IPP is especially important in patients with polycystic kidney disease. However, the standard measurement of IPP is limited due to its cumbersome procedures, the application value of equation for estimating IPP among general peritoneal dialysis patients is not clear in the PKD population and the variables influence the IPP is yet to be explored..

Objective: The main purpose of our study was to validate the existing IPP equations in the PKD patients. Further, more relevant variables were included to optimize the IPP equation. Monitoring IPP can guide the formulation of peritoneal dialysis prescription for ADPKD patients, reduce the occurrence of abdominal wall complications, and the clinical utility and efficiency of PD was expanded.

Methods: A multi-center cross-sectional study. The IPPs were measured using the Durand method, with whole-body and abdominal anthropometry indices, the volume of abdominal cavity, the total kidney volume and liver volume were collected. New equation for estimate IPP in PKD patients were generated by stepwise linear regression modeling. The eIPP were calculated using two developed equations previously. Then The bias, accuracy and precision of eIPP derived from new equation were compared with actual IPP by Durand method respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years;
2. A confirmed diagnosis of polycystic kidney disease, with a history of peritoneal dialysis catheter placement and regular peritoneal dialysis;
3. Able to tolerate the infusion of more than 1500 mL of dialysis fluid.

Exclusion Criteria:

1. Acute complications such as peritonitis or cardiovascular and cerebrovascular events within the past month;
2. History of abdominal surgery or trauma within the past month;
3. History of kidney cyst rupture, infection, or bleeding within the past month;
4. History of abdominal or pelvic organ tumors;
5. History of abdominal pressure-related complications, such as hernias, leaks, or chest-abdominal fistulas;
6. Unable to attend follow-up visits during the study period;
7. Refusal to participate in the study. -
The Effect of Weight Loss on Bone in Men

The purpose of this study is to determine the effect of weight loss on bone health in men.

This pilot study of the effect of weight loss on bone health in men is being undertaken in conjunction with studies of the effect of weight loss on bone health in women for comparison purposes. See NCT00473031, NCT00472680, and NCT00472654. This information is important for determining optimal nutrient requirements during weight loss.

Participants will be recruited for both weight loss and weight maintenance. All participants will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Weight loss participants will attend regular counseling sessions (about 45 minutes each) with a dietitian for approximately 6 months; they will be asked to attend 6 sessions but will be given the opportunity to attend 13 sessions. Body composition will be measured by a dual-energy x-ray absorptiometry (DXA) machine, ultrasound, and peripheral quantitative computer tomography (pQCT) before and after 6 months of weight loss. Bone, mineral, protein and lipid markers, and hormones that influence bones will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Obese or overweight
* Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

* Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal EKG\], active malignancy or cancer therapy within the past year)
* History of kidney stones
* Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
* Participation in other investigational studies during the 12-month study period
* Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection

The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body.

The sponsor will also look at the safety and tolerability of the test medicine.


Eligibility Criteria:
Inclusion Criteria:

* Male between 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
* A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
* Having a regular daily defecation pattern (i.e. 1 to 3 times per day).

Exclusion Criteria:

* Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
* History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection).
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first investigational medicinal product (IMP) administration.
* Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.
Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature

The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive propranolol eye drops treatment until retinal vascularization will be completed.

Propranolol concentrations will be measured on dried blood spots during the first 3 days of treatment and at the steady state. Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.


Eligibility Criteria:
Inclusion Criteria:

* Preterm newborns (gestational age 23-32 weeks) with stage 2 ROP, zone II without plus.
* A signed parental informed consent.

Exclusion Criteria:

* Newborns with heart failure;
* Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects;
* Newborns with recurrent bradycardia (heart rate \< 90 beat per minute);
* Newborns with second or third degree atrioventricular block;
* Newborns with hypotension;
* Newborns with renal failure;
* Newborns with actual cerebral haemorrhage;
* Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives

This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects. Women will be randomized to receive either Ortho tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any symptoms or bleeding experienced. Once a month, participants will be asked to complete a survey.

The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with respect to side effect profiles including bleeding patterns, mood changes, nausea and vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure, stroke, blood clots and patient compliance.

This is a double blind randomized controlled trial of Ortho tricyclen™ vs. Trinessa™ (generic equivalent) to determine if they have similar effects on bleeding patterns, namely days of menstrual flow, amount of bleeding, and intermenstrual bleeding. Women will score these parameters using a survey with objective measures for days of bleeding, amount of flow, and days of breakthrough bleeding. As secondary outcomes, we will compare the side effect profiles of each in regards to nausea, vomiting, breast tenderness, menstrual cramps, mood changes, and thromboembolic events.

Patients will record in their daily diary if one of the outcomes occurs or not. We will observe whether the events occur and the number of occurrences within the six month time period.

Eligibility Criteria:
Inclusion Criteria:

* nonsmoker
* not pregnant
* not planning to become pregnant in the next 6 months
* not taking hormonal birth control for at least 3 months previous to entering the study
* no history of fibroids
* no history of ovarian cysts
* no history of dysfunctional uterine bleeding

Exclusion Criteria:

* pregnant
* under the age of 18
* over the age of 35
* history of irregular uterine bleeding
* history of ovarian cysts
* history of fibroids
* history of migraines with aura
* history of liver disease
* family or personal history of Blood clots (thromboembolism)
* mental disabilities
* desire to become pregnant in the next six months
Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration

The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories.


Eligibility Criteria:
Inclusion Criteria:

* Non-exudative age-related macular degeneration

Exclusion Criteria:

* Exudative age-related macular degeneration