cyrilzakka/clinical-trials huggingface dataset:
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability

The aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (QTB) ACLR and MCLR with anteromedial reinforcement performed as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.

Medial collateral ligament (MCL) injuries are one of the most common sports knee injuries, commonly occuring together with anterior cruciate ligament (ACL) injuries. Their effect on the knee joint can be detrimental with patients experiencing medial instability and anteromedial rotatory instability (AMRI), leading to progressive damage of the intraarticular structures. While healing potential of medial knee stabilizing structures is relatively high, medial collateral ligament reconstruction (MCLR) is sometimes indicated. Multiple reconstructions techniques were described, including both procedures utilizing native semitendinosus tendon with distal attachment left intact as well as with auto- or allo-grafts. However, in part of these techniques, AMRI is not addressed.

Therefore, the aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (QTB) ACLR and MCLR with anteromedial reinforcement performed as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.

The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC) and the Knee injury and Osteoarthritis Outcome Score (KOOS).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic knee medial and anteromedial rotatory instability associated with anterior and rotatory instability after an MCL + ACL injury
* Primary cases

Exclusion Criteria:

* Active inflammation of the knee
* Revision cases
* Additional PLC, PCL or PFJ injuries
* fractures around the knee
* removal of more than ½ of medial or lateral meniscus
* contralateral knee injury
* cartilage damage ICRS grade III or higher
* Non-adherence of the patient to the treatment protocol
Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System

The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.

70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.

Eligibility Criteria:
Inclusion Criteria:

* Female over 21 years of age;
* with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
* and in good health (other than having breast lesions);
* and can lie still in a prone position for 30 minutes in an MRI scanner.

Exclusion Criteria:

* Pregnancy;
* unwilling to give informed consent;
* have implanted prosthetic heart valve,
* pacemaker,
* neurostimulator,
* surgical clips or other metallic implants;
* have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
* are claustrophobic;
* have been allergic to contrast agents;
* are diabetic;
* or have a history of kidney disease.
Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.

This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
* Adequate organ function

Exclusion Criteria:

* Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
HD11 for Intermediate Stages

This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d

  1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR \> 50 (A), \> 30 (B-symptoms)
  4. 3 or more lymph node areas involved
* written informaed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
"Night Vision and Carotenoids"

Vision at twilight and night is more difficult and dangerous for the entire population, even more so for the elderly and especially for the elderly with degenerative disease. Multiple worldwide laboratories have demonstrated the ability to raise macular pigment optical density with dietary carotenoids. This proposal further evaluates the relationship between macular re- pigmentation and vision under stressed conditions simulating twilight and night driving.

This is a study of the physiological function of the eyes at night. However, the risk of automobile injury or fatality (driver, passenger or pedestrian) associated with motor vehicle accidents has been determined to increase with age, as a result of the complex interplay of age-related declines in vision, motor and cognitive functioning. However, basic visual function is the foundation for higher order processing whether it is visual spatial or cognitive. Four recent studies reflect the cost of poor vision on driving. (www.visionimpactinstitute.org). For example, visual impairment among European drivers was examined in 2422 drivers from 5 European countries. Visual acuity, visual field, contrast sensitivity, glare sensitivity, and useful field of view were tested. Visual functions not included in the current licensing standards were found to be more impaired among drivers (compared to those functions legally required). Elderly drivers are particularly vulnerable to sensory visual impairment when driving at night, as they suffer declines in both Contrast sensitivity (CS), Glare Disability (GD) and Glare Recovery (GR).6

Justification for study involving humans

Carotenoid science is well developed with respect to the safe utilization of dietary lutein (L) /zeaxanthin (Zx) as studied by the National Institute of Health (NEI). The recently published NEI AREDS2 study- May 2013, further substantiated the safety and usefulness of prescribing the carotenoids (10 mg L / 2 mg Zx) in patients at high risk of AMD. 7 Significantly, the average American and veteran population are typically low dose consumer of these carotenoids (1 to 2 mg/day for the average American).

Eligibility Criteria:
Inclusion Criteria:

* No significant supplementary carotenoids within last 10 weeks. Without significant media opacity, cataract or congenital / acquired retinal disease other than atrophic AMD or diabetic retinopathy. Minimum 20/25 to enroll.

Exclusion Criteria:

* Unwilling or medically / psychiatrically unable to take part in a 6 month study.
* Recent ophthalmologic surgery or treatment.
* Tricare, Retirees \& Enlisted Navy Personnel excluded. Already taking an OTC product to improve their night vision (containing carotenoids, polyphenols like bilberry).
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.

The participants will be treated with TAK-279 for 52 weeks (1 year).

During the study, participants will visit their study clinic 15 times.

The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279.

The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

1. TAK-279 Dose 1
2. TAK-279 Dose 2
3. TAK-279 Dose 3
4. Placebo

This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age.
2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.

Exclusion Criteria:

1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
2. Have complications of CD that might require surgery during the study.
3. Participants with a current ostomy.
4. Participants who have failed 3 or more classes of advanced therapies.
Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection

The purpose of this study is to compare changes in HIV levels and certain immune cells among patients at different stages of HIV infection. This study will also see how a combination of stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) affects these levels.

Current findings in anti-HIV drug treatment have led to a greater understanding of the background of HIV. To find the best anti-HIV treatment to eliminate all HIV viruses, cells and tissues infected with the HIV virus are examined after combination anti-HIV treatment, when the level of HIV infection is low. The ERADICATE study will examine the idea that HIV viruses can be eliminated at any stage of infection over time.

Recent advancements in antiretroviral therapy have led to a better understanding of the natural history and immunopathogenesis of HIV-1 infection. To calculate the degree and duration of antiretroviral effect necessary to eliminate infection, characterization of residual cellular and tissue HIV reservoirs following high-level viral suppression is necessary. The ERADICATE study will evaluate the hypothesis that complete viral inhibition is possible, regardless of HIV disease stage, and leads to HIV eradication from tissues over time.

Patients are divided into 1 of 5 groups based on the stage of HIV infection. Patients receive oral stavudine (d4T), lamivudine (3TC), indinavir (IDV), and nelfinavir (NFV) twice daily for 24 weeks. All patients undergo basic blood sampling to follow HIV-1 RNA levels and absolute T cell subset numbers daily for 5 days; then 3 times a week for 3 weeks; 2 times a week for 4 weeks; every 2 weeks for 12 weeks; and monthly thereafter for a total of 3 years. In addition, the following tissues are sampled at baseline and after 2 weeks and 6 months on therapy: 1) lymph node; 2) tonsillar; 3) perirectal lymphoid; 4) cerebrospinal fluid; 5) and semen.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are infected with HIV and have had certain tests to indicate the stage of their disease.
* Are at least 18 years old.
* Practice birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have received anti-HIV medication for more than 1 week.
* Have a serious AIDS-related infection or other illness.
* Require medication that interferes with the study drugs.
* Have had a peripheral neuropathy, a painful condition affecting the nervous system.
* Have been given drugs that affect the immune system within 2 weeks before study entry.
* Have a bleeding disorder including hemophilia.
* Abuse alcohol or substances.
* Are pregnant or breast-feeding.
Obstetric Complications in Women Who Smoke During Pregnancy

This will be a retrospective study. Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.

This will be a retrospective study using the McGill University Obstetrics and Neonatal database (MOND). This is a comprehensive database the contains details on all women delivering in McGill University Health Center in Montreal Canada.

Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.

Statistic tests would be applied in order to assess relation between smoking and Obstetrical complications.

Eligibility Criteria:
Inclusion Criteria:all

* All women who delivered in McGill University health center between 2001-2008

Exclusion Criteria:

* delivery prior to 24 weeks (data on \<24 weeks not included in the database..)
Pharmacogenetic-Directed Treatment for Major Depression

Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.

This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder (296.2, 296.3) or Depressive Disorder NOS (311.0) by a board certified psychiatrist.
* The patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study.
* The patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons.
* Patient's baseline 17-Item Hamilton Depression (HAMD17) Rating score is \>14.
* Provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine.
* Undergo a medical history that includes a review of major organ systems by either their treating clinician, a subinvestigator physician, or a study-contracted physician assistant in internal medicine.
* The patient has signed the study informed consent form.

Exclusion Criteria:

* Serious medical illness (as ascertained via inclusion criteria 6 and 7, above).
* Diagnosis of a Bipolar Disorder.
* Diagnosis of Schizophrenia or Schizoaffective disorder.
* Evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. Patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. Patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication.
* History of prior pharmacogenomic testing.
Using Nudge Strategies to Promote Healthier Beverage Intake Among College Students

The primary objective of this study is to investigate whether three nudging interventions would affect the beverage selection and consumption behaviors of Chinese university students. These interventions encompass providing information on the sugar content of sugar-sweetened beverages (SSBs), disseminating harmful information about SSBs, and showcasing the social norm that the majority of students opt for mineral water. Through a single-factor between-subjects experiment, we aim to examine the impact of these nudge interventions on the proportion of students choosing sugary drinks versus mineral water, thereby assessing their effectiveness in guiding healthier beverage choices.

As the prevalence of overweight, obesity, and chronic diseases continues to escalate, excessive consumption of sugar-sweetened beverages (SSBs) has emerged as a growing public health concern globally. One approach to reducing beverage intake while conserving resources is the utilization of nudge strategies. Nudge strategies, characterized by their low cost and ease of implementation, facilitate individuals in making more accurate and beneficial choices in a predictable manner, through subtle interventions that do not prohibit any options or significantly alter incentives. This nudge experiment will be conducted in a classroom setting, where participants will be randomly assigned to four groups for beverage selection: No Nudge Intervention Group, Sugar Content Information Nudge Group, Sugar Harmful information Nudge Group and Social Norm Nudge Group. Participants will access the nudge content specific to their respective groups via the professional survey platform of Questionnaire Star and make a choice between cola and mineral water.

Eligibility Criteria:
Inclusion Criteria:

* college students
* 18 years or above of age
* willing to participate

Exclusion Criteria:

* None
Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation

The investigators attempted to evaluate whether the use of PAC is associated with better clinical outcomes after liver transplantation compared with the case without PAC.

Pulmonary artery catheter (PAC) has been used for advanced hemodynamic monitoring during liver transplantation. However, recent advances in less invasive monitoring could provide continuous cardiac output monitoring by arterial waveform analysis. Using this technology, stroke volume variation (SVV) is monitored as a preload index. Calculated systemic vascular resistance (SVR) can be monitored if central venous pressure (CVP) is provided. Therefore, this less invasive form of hemodynamic monitoring may replace the PAC. The investigators attempted to evaluate whether the use of PAC is associated with better clinical outcomes after liver transplantation compared with the case without PAC.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2006 and 2022

Exclusion Criteria:

* Patients with baseline renal dysfunction
* Missing baseline or outcome variables
* Retransplantation
* Patients who received intraoperative transesophageal echocardiography (TEE) monitoring
Tobacco Cessation in Postmenopausal Women (Part II) - 2

The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement


Eligibility Criteria:
Inclusion Criteria:

(Same as Part I)

Exclusion Criteria:

Same as Part I, with the addition of those who have had a past reaction to transdermal nicotine patch or have active skin diseases will be excluded.
Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants

Preterm and critically ill neonates experience many painful manipulations. The aim of the study is to evaluate the influence of these experiences and maternal deprivation on later pain behavior. Using Scoring systems, Prechtl general movements, skin conductance, testing flexor reflex levels with von Frey filaments and measuring salivary cortisol levels the investigators compare pain behavior of preterm (birth weight (BW) \< 1500 grams), term neonates with need of ventilation (\> 48 hours) with healthy neonates at the time of their first vaccination at the age of 3-4 months. The investigators are also testing flexor reflexes and skin conductance and general movements in regular intervals during the initial hospital stay. The investigators hypothesize that pain behavior is different at the age of 3-4 months in children with many early painful experiences.


Eligibility Criteria:
Inclusion Criteria:

* Preterm \< 1500 grams BW, critically ill term newborn on ventilation \> 48 hours

Exclusion Criteria:

* Asphyxia
* ICH grade 3 and higher