cyrilzakka/clinical-trials huggingface dataset:
Antioxidants for Prevention of Cataracts Follow-up Study

Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from 1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no significant difference in cataract formation between the antioxidant group and placebo. In this follow-up study, we will return to study villages to determine whether rates of cataract surgery are different in the 2 groups.

1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. The British journal of ophthalmology 2006;90:847-51.


Eligibility Criteria:
Inclusion Criteria:

* participation in previous cataract study

Exclusion Criteria:

* refusal to participate
Efficacy of the Individual Placement and Support (IPS) Model

Hypothesis 1. Consumers with disabilities and co-occurring SUD receiving IPS will be more likely to be competitively employed (defined as 1 or more days of work over the past 30 days) at 3, 6 and 12 months following the initiation of vocational treatment goals when compared to a group receiving standard services.

Hypothesis 2. Consumers with disabilities and co-occurring SUD receiving IPS when compared to the comparison group will 1.) be more successful in achieving their employment goals as indicated by the ratio of hours worked to desired hours worked; 2.) become competitively employed sooner; 3.) earn higher wages, 4.) have greater job satisfaction, 5.) have greater economic satisfaction; 6.) have greater life satisfaction, 7.) have greater self-esteem, and 8.) have fewer days of using substances during follow-up points.

Hypothesis 1. Consumers with disabilities and co-occurring SUD receiving IPS will be more likely to be competitively employed (defined as 1 or more days of work over the past 30 days) at 3, 6 and 12 months following the initiation of vocational treatment goals when compared to a group receiving standard services.

Hypothesis 2. Consumers with disabilities and co-occurring SUD receiving IPS when compared to the comparison group will 1.) be more successful in achieving their employment goals as indicated by the ratio of hours worked to desired hours worked; 2.) become competitively employed sooner; 3.) earn higher wages, 4.) have greater job satisfaction, 5.) have greater economic satisfaction; 6.) have greater life satisfaction, 7.) have greater self-esteem, and 8.) have fewer days of using substances during follow-up points.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria includes consumers who are between the ages of 18-65, able to provide informed consent for participation, and are initiating an employment goal in their treatment plan.

Exclusion Criteria:

* Exclusion criteria includes anyone who is currently employed and has been for the past 30 days, have an open case with the Ohio Rehabilitation Services Commission, or have an open case with another vocational rehabilitation provider.
Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease

The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

1. patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
2. eGFR \< 20 mL/min/1.73 m2
3. taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor
4. K \< 5.5 mEq/L

Exclusion Criteria:

1. Being planned to intitate renal replacement therapies within 3 months
2. Having inflammatory bowel diseases
3. History of gastrointestinal tract surgery
4. Taking antibiotics within 1 month before the entry
5. Taking or being planned to start warfarin
6. Having dietary allergies
7. Having difficulty in oral intake
8. During pregnancy or breastfeeding
9. Unsuitable for participant in the trial by an attending physician
Chloroquine Outpatient Treatment Evaluation for HIV-Covid-19

Clinical manifestations of Covid-19 are poorly characterised in HIV co-infection, which may predispose to more severe disease. Reducing hospitalisation and severe illness in this population has important individual and public health benefits. The investigators propose a pragmatic multi-centre, randomized controlled trial in South Africa to evaluate the efficacy and safety of chloroquine or hydroxychloroquine to prevent progression of disease and hospitalisation amongst HIV-positive people with Covid-19 not requiring hospitalisation at initial assessment.

The trial objective is to compare chloroquine (or hydroxychloroquine) versus standard of care for the primary endpoint of hospitalisation or death at 28 days. Consenting adults who meet criteria for a Covid-19 person under investigation and who are ≥18 years, known to be HIV-positive, not requiring immediate hospitalisation and are not at risk of cardiac toxicities related to the study drug will be enrolled. The total sample size will be 560 participants (280 in each arm).

Eligibility Criteria:
Inclusion Criteria:

* Tested for Covid-19 at a trial recruitment site as an outpatient;
* Age 18 years or older;
* Not requiring immediate hospitalisation;
* Mild disease, defined as respiratory rate \<25/min, pulse rate \<120/min, SpO2 \>94%;
* HIV-positive by rapid test or documented history;
* Suspected or confirmed Covid-19;
* Signed informed consent.

Exclusion Criteria:

* Covid-19 diagnosed \> 5 days prior to randomization;
* Active tuberculosis;
* Need for concomitant drugs that are contraindicated with the use of Chloroquine/hydroxychloroquine;
* QTcF interval \> 480 ms;
* Known glomerular filtration rate \< 10 ml/min;
* Known with glucose-6-phosphate dehydrogenase deficiency (G6PD);
* Previous adverse drug reaction to investigational product;
* Concurrent involvement in other research or use of chloroquine, hydroxychloroquine or any other 4-aminoquinolone or another experimental investigational medicinal product that is likely to interfere with the study medication.

Note: Pregnancy and breastfeeding are not exclusions for entry
Study of the Angiogenesis by PET/CT in Patients With Lymphoma

The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass

After inclusion PET scans with FDG tracer and with a specific tracer of angiogenesis will be performed on patient with lymphoma. After two cycles of chemotherapy PET scans with the same tracers will be performed.

Overall survival and disease free survival will be monitored during 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age ≥ 18 years old
* OMS ≤ 1
* Histological diagnosis of diffuse large B-cell lymphoma what ever the subtype
* Presence of measurable tumor with at least a node mass superior to 3 centimeters
* Stage I to IV
* Inform consent signed

Exclusion Criteria:

* Primary cerebral lymphoma
* Absence of fixing on FDG-PET exam
* Pregnant , child bearing, breast feeding or without effective contraception method woman
* Hypersensitivity to RGD-K5
* Hypersensitivity to FDG
* Poorly controlled diabètes (glycemia ≥ 10 millimoles/liter)
* Neoplastic disease (less than 2 years or in progression)
Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients

efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 yrs or greater
2. Patients diagnosed with BPS(Bladder Pain Syndrome)
3. Symptom persisted more than 6 months
4. Pain VAS ≥4
5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores \> 2.
6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) \>13
7. No history of cystoscopy within 2yrs.

Exclusion Criteria:

1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
2. Child-bearing potential, pregnant or nursing women.
3. Mean voided volume lesser than 40ml or over than 400ml.
4. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
5. Urinary tract infection during run-in periods.
6. Genitourinary tuberculosis or bladder,urethral and prostate cancer
7. Recurrent urinary tract infection
8. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
9. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
Aurora Test for ART Donor Patients (AURORA-Donor)

This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger.


Eligibility Criteria:
Inclusion Criteria Donor:

* Patients are 18 to 35 years old
* BMI between 17-30
* Regular menstrual cycles
* AFC \> 8
* Patient profile in compliance with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)
* Patients' stimulation: GnRH Antagonist \& hr-FSH with GnRH Agonist trigger or Progesterone \& hr-FSH with GnRH Agonist trigger
* Patients agree that the oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study

Exclusion Criteria Donor:

* BMI \< 17 or \> 30
* Extreme irregular menstrual cycles (\<20 days or \>40 days)
* AFC \< 8
* \<8 MII on previous egg retrieval
* Women with history of poor oocyte maturation or known maturation defect or unexplained failure in previous treatments
* Patients that fail to comply with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)

Inclusion Criteria Recipient:

* Patients applying for ART egg donation with fresh/frozen sperm from the partner or frozen donor sperm. With eSB-FET in modified natural cycle or an HRT cycle.
* Patients are from 18 to 50 years old.
* Patients will be treated by ICSI (intracytoplasmic sperm injection) and eSB-FET (elective Single Blastocyst Frozen Embryo Transfer)
* Recipient patients agree that the donors' oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study

Exclusion Criteria for oocyte Recipients

* Patient included in any other prospective study.
* BMI \< 17 or \> 35
* Severe uterine factor: Multiple myomectomy, multiple fibroids, major uterine malformation (unicorn, septum), Asherman Sd, severe adenomyosis
* Repeated Implantation Failure or Repeated Pregnancy Loss after euploid Single Blastocyst Transfer
* Severe male factor: Abnormal Caryotype or FISH, severe OAT / Cripto-Azoospermia, DNA Fragmentation \>50% after medical treatment
* TESE / TESA (testicular sperm extraction/aspiration)
Systems Aligning for Equity (SAFE) Spaces

The goal of this 2-arm cluster randomized clinical trial is to test whether an evidence-based staff training and coaching model specifically designed as a response to legal system-involved youths' and frontline staff's mental health needs can improve the safety and suicide outcomes, mental health challenges, and wellness and facility climate for youth and staff in facilities assigned to the intervention condition. Staff in facilities assigned to the intervention are eligible to receive evidence-based programming in suicide detection and prevention (Shield of Care; SOC) and wellness skill-building (Skills for Life) through training and personalized coaching. Multiple training sessions will be offered to small groups of staff in-person in residential facilities and paired with personalized in-person and virtual coaching. Staff and youth in all facilities will be asked to complete periodic surveys assessing experiences in the facility, suicide and safety knowledge and risk, and their mental health and wellness. Researchers will compare outcomes of staff in youth in facilities assigned to the intervention compared to facilities in the training-as-usual condition.


Eligibility Criteria:
Inclusion Criteria:

* Placement in in ACS-run or contracted residential facilities enrolled in the study during the first 2 years of the intervention period
* Proficiency in English

Exclusion Criteria:

* Not placed in an ACS run-or contracted facility enrolled in the study during the study period
* Lack of proficiency in English.
Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects

The study is being performed in order to learn more about AZD3480 (potential as treatment for patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as to investigate the period of time for this binding.


Eligibility Criteria:
Inclusion Criteria:

* Physically Healthy volunteers
* Genotyped with regard to CYP2D6
* Normal MRI scan at Visit 2

Exclusion Criteria:

* Known or suspected drug or alcohol abuse or positive drugs of abuse screen as judged by the investigator.
* Participation in a PET examination as part of a scientific study during the past twelve months.
* Prescribed or non-prescribed from two weeks prior to the first PET examination. Occasional paracetamol and nasal spray for congestion will be allowed as medication.
Tai Chi for Comorbid Depression in T2DM Patients

Previous studies suggested that Tai Chi may be beneficial for T2DM patients. However, no studies have investigated the effectiveness of Tai Chi for comorbid depression in T2DM patients, as well as the optimal frequency of Tai Chi. Thus, we intend to investigate the effectiveness of Tai Chi for comorbid depression in T2DM patients and test whether the effectiveness of Tai Chi depends on its frequency.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with depression by experienced psychiatrist;
* Participants diagnosed with T2DM by experienced endocrinologist;
* Participants aged between 18\~75 years;
* Participants with HbA1c ranges from 6.5% to 8.5%;
* Participants with Hamilton Depression Scale (HAMD) (24-item-version) ranges from 20\~35 scores;
* Participants passed the Physical Activity Readiness Questionnaire (PAR-Q);
* Participants willing to complete 12-week intervention and 12-week follow-up.
* Participants willing to sign informed consent form.

Exclusion Criteria:

* Participants with uncontrolled hypertension (SBP \>160mmHg or DBP \>100mmHg after taking hypotensive drugs);
* Participants with severe diabetic complications;
* Regular exercisers (at least 20 minutes/time, 3 times/week) in the last 3 months;
* Participants with cognitive impairment (Montreal Cognitive Assessment \[MoCA\] scores \<26);
* Participants with history of bipolar disorder or schizophrenia or other mental illness;
* Participants with contraindications to exercise;
* Participants with acute, infectious diseases, cancer, or serious neurological disease, cardiovascular disease, pulmonary disease or other serious medical conditions limiting the ability;
* Participants taking psychoactive drugs;
* Participants participating in other clinical trials at the same time.
Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy

The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer
* Underwent neoadjuvant chemotherapy
* Eastern Cooperative Oncology Group Performance Status Scale 0-2
* ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy
* No distant metastases
* No internal mammary nodes metastases based on images before system therapy
* Willing to follow up
* Written,informed consent

Exclusion Criteria:

* Without neoadjuvant chemotherapy
* Distant metastases
* Simultaneous bilateral breast cancer
* Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy
* Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
Reduction in IV Associated Contamination

The purpose of this study is to investigate whether implementing a novel syringe and IV stopcock cap system impregnated with alcohol will reduce IV catheter bacterial contamination and infections in patients.

Bacterial contamination of patient intravenous stopcock sets is a common intraoperative event associated with increased patient mortality, possibly via an infectious mechanism. The most common type of intravenous tubing used in operating rooms is the open lumen stopcock set which lacks a barrier between the environment and intraluminal space, and thus the intravascular space of the patient. The stopcock connector can be easily contaminated by provider hands due to improper handling of the device and/or contaminated by soiled syringe tips subsequently connected to the device. Further, the stopcock connector is often left uncapped by the provider and directly exposed to the environment. Thus, common breaches in intraoperative aseptic practice of healthcare providers can lead to bacterial contamination of the endoluminal space of the open lumen device. The primary aim of the current study is to assess the efficacy of a passive bundle designed to decrease intravenous stopcock and tubing intraluminal bacterial contamination. This passive bundle includes two novel interventions, a DOCit station and HubScrub caps. The HubScrub is designed to clean the needleless connectors and open lumen stopcock systems. The DOCit station is designed to simultaneously clean the interior and exterior of needle-less luer connectors of syringes with isopropyl alcohol while also providing a method of storage and organization of multiple syringes. The investigators hypothesize that the application of this passive bundle to the standard open lumen system commonly employed by anesthesia providers in the operating room will significantly reduce bacterial contamination of standard 3-way open lumen stopcock sets and improve patient safety.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient undergoing surgery or procedure in operating room
* Undergoing general anesthesia

Exclusion Criteria:

* Children (age \< 18 years)
* Lack of intravenous access
* failure of anesthesia provider to complete training on experimental device
Program for Caregivers Involved With Mental Health Services

The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting intervention for implementation with female adult caregivers who have or are at risk for long-term interpersonal conflict with family members, children, or significant others and are caring for a child between the ages of birth and 7 years.

The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting intervention (Parenting from the Inside Out or PIO) originally developed for substance abusing mothers (as part of an ongoing NIDA-funded treatment development study; R01 DA17294) for implementation with female adult caregivers who have or are at risk for long-term interpersonal conflict with family members, children, or significant others and are caring for a child between the ages of birth and 7 years. The PIO intervention involves 12-24 weekly 1 hour individual therapy sessions with Masters level therapists who are trained and supervised by Dr. Suchman (the Principal Investigator) in the PIO approach.

Eligibility Criteria:
Inclusion Criteria:

* receive psychiatric services through the adult or young adult treatment team at the West Haven Mental Health Clinic
* have a child receiving psychiatric services through the child treatment team at the West Haven Mental Health Clinic
* express interest in receiving a parent intervention at the West Haven Mental Health Clinic

Exclusion Criteria:

* severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
* severely cognitively impaired
* have psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
* are not fluent in English
* child has a serious illness or significant developmental delay (e.g., cognitive, language, or motor)
Post-op Ketamine Study

The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 85 years of age
* ASA I - IV
* Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia

Exclusion Criteria:

* BMI over 40\*
* Contraindication or allergy to opioid pain medication or ketamine\*
* Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg\*
* Ejection fraction (EF) less than 30%
* Creatinine clearance less than 30 mL/min\*
* History of chronic liver failure
* Desire for nerve block or general anesthesia
* Any neurologic or psychiatric disorder (including bipolar disorder, post traumatic stress disorder, schizophrenia)
* Prior surgery on ipsilateral knee within the last 6 months
* Alcohol abuse