cyrilzakka/clinical-trials huggingface dataset:
A Pilot Observational Clinical Survey: Impacts of Tahitian Noni Juice on the Quality of Life of Patients With Osteoarthritis

Tahitian Noni Juice (TNJ) made from Morinda citrifolia (noni) fruits may provide a safe adjunctive treatment for osteoarthritis (OA) due to its anti-inflammatory and analgesic properties. In this study the investigators examined whether TNJ was able to improve the symptoms and quality of life (QOL) of OA patients. The investigators also sought to evaluate the tolerability and safety of TNJ.

This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 40 to 75 of both sexes with a physician diagnosis of OA of the hip or knee who were not taking prescription medicine for arthritis and were willing to drink 3 oz of TNJ daily for 12 weeks

Exclusion Criteria:

* all others
The Effect of Warmed Parenteral Fluids During Delivery

To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal outcomes.

Prospective randomized controlled trial. Assessing the influence of warmed parenteral fluids during delivery/cesarean section on the obstetrical and neonatal outcome. The investigators will randomize parturients during the active phase of labor to receive either body temperature warmed parenteral fluids or room temperature parenteral fluids. Both groups will receive the same fluid composition of 5% dextrose with normal saline. The investigators will compare the obstetrical and neonatal outcomes of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* term pregnancies
* receiving parenteral fluids

Exclusion Criteria:

* high order pregnancies
* preterm pregnancies (before 37 weeks of gestation)
* known fetal major anomaly
* known fetal significant chromosomal/genetic abnormality
Effects of Dynorphin 1-13 on Heroin Addiction - 1

The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal, reduces opiate craving, and is safe at doses required to produce the above effects.

Randomized double blinded study of the effects of a single IV dose of dynorphin A 1-13 on heroin withdrawal in human opiate addicts

Eligibility Criteria:
Inclusion Criteria:

opiate addict between the ages of 18-55

Exclusion Criteria:

Regular abuse of other drugs, unstable medical conditions
MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients

The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.

Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
3. Signed informed consent.

Exclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STEMI);
2. Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
3. Patients with Hemodynamic instability (systolic blood pressure\<90 mmHg, or who requires vasoactive drugs), or patients with tachyarrhythmia, Ⅱ degree atrioventricular block and above that have not returned to normal;
4. Patients who have severe renal abnormality with eGFR \<30 ml/min, or patients who are on dialysis;
5. Patients with malignant tumors with predicted survival of less than 1 year;
6. Pregnant or breastfeeding women;
7. Patients who are unable to enter the MCG device, who are unable to perform MCG examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.
Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.

The aim of the current study is to test the acceptability and efficacy of an updated digital app for IBS patients. The design of the study is experimental. There will be two experimental groups, an immediate treatment group and an active control group. Once consented and enrolled, participants will be randomly assigned to either the immediate treatment group or the active control group by the coin toss feature of random.org. Participants in the immediate treatment group will be able to download the app at no cost. Participants in the control group will be given access to an education and relaxation training control app at no cost to them. At 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up questionnaires (the same that they answered directly after consenting in the beginning of the study as baseline measures). Upon receipt of the 8 week questionnaire data, participants in the control group will be given access to the Zemedy app. After having had access to the app for 8 weeks, control participants will be asked to complete another set of questionnaires. All participants will receive 3 month post-treatment follow-up questionnaires. The research method is experimental, cross over (randomized controlled trial) with a control control. Participation in the study will last approximately 4.5 months, depending on the subjects willingness to participate and rate of completion.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of physician diagnosis of IBS.
* At least 18 years of age.

Exclusion Criteria:

* Severe depression or suicidality
* Comorbid GI disorder such as inflammatory bowel disease or celiac disease.
* Pregnancy
Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: ORIENT Study

This study aims to adopt a multi-center large sample size study to define (1) the normal range of Chinese ONSD; (2) ONSD diagnosis for patients with high intracranial pressure; (3) to analyze the correlation between ONSD and intracranial pressure.

The ONSD, transcranial Doppler parameters and baseline data of the normal intracranial pressure group and the enhanced intracranial pressure group (more than 200 mmH2O) .

Eligibility Criteria:
Inclusion Criteria:

1. People requiring lumbar puncture testing due to brain trauma, intracranial infection, intracranial vascular disease, intracranial tumors, peripheral neuropathy for the raised intracranial pressure group.
2. Healthy people for the normal intracranial pressure group.

Exclusion Criteria:

1. eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma
2. People with poor temporal window penetration.
3. Patients who refuse to sign informed consent.
A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.

N/A study is closed

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.
* Subjects must have adequate vital organ function and functional status for HDM + ASCT
* Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.
* At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.
* Subjects must have measurable disease according to one of the following criteria:

  1. Serum M-spike ≥0.1 g/dl
  2. Urine M-spike \>200 mg in a 24-hour urine collection
  3. Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.
* At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy

Exclusion Criteria:

* Prior allogeneic or autologous hematopoietic stem cell transplant
* Current active infections, including HIV and hepatitis C and B
* Autoimmune disease requiring ongoing immunosuppressive therapy.
* History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.
* History of transient ischemic attack or stroke.
* At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.
Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome

This study addresses the pressing clinical question of optimizing surgical and pharmacological interventions for severe Carpal Tunnel Syndrome (CTS), a prevalent and debilitating condition caused by median nerve compression. Previous research has established the efficacy of Open Carpal Tunnel Release (OCTR) and Endoscopic Carpal Tunnel Release (ECTR); however, the role of neurotrophic supplementation in enhancing surgical outcomes has yet to be fully elucidated. Using a prospective clinical approach involving 497 patients, we evaluated the comparative outcomes of ECTR and OCTR with or without neurotrophic supplementation. Key findings demonstrate that ECTR, particularly when combined with neurotrophic agents, facilitates faster recovery and greater improvements in Sensory Nerve Conduction Velocity (VCS) and Visual Analog Scale (VAS) scores, with reduced complication rates compared to OCTR


Eligibility Criteria:
Inclusion Criteria:

* clinically and electromyographically confirmed severe CTS (SCV \< 35 m/s)
* experienced persistent symptoms unresponsive to conservative treatments for at least six months

Exclusion Criteria:

* mild or moderate CTS
* concomitant neuropathies
* previous carpal tunnel surgeries
* contraindications to neurotrophic supplementation
Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode

The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Depressive episode according to DSM-5 criteria
* Unipolar depression
* MADRS ≥ 20
* Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors)

Exclusion Criteria:

* Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction \< 3 months except for tobacco)
* Depression with psychotic features
* Serious unstabilized somatic illness
* Protected persons
* Dementia suspected at the time of enrollment
Calcaneal Osteotomy for Intractable Plantar Fasciitis

The aim of this study is to clarify the efficacy of plantar displacement calcaneal osteotomy for intractable plantar fasciitis by decreasing the tension of the plantar fascia around the calcaneal attachment while keeping the plantar fascia intact and comparing it with the plantar fascia release in pain control, job return and foot arch preservation.

Plantar fasciitis (PF) is the most common cause of heel pain accounting for 15% of all foot symptoms requiring medical care and 1% of patient visits to orthopaedic surgeons in the United states.

The diagnosis is straight forward; the challenge is finding an effective and economic first line treatment. The annual costs of plantar fasciitis are $284 million, that does not include opportunity cost from lost work and wages, societal burden, and psychologic burden.

Histologic examination shows myxoid degeneration with fragmentation and degeneration of the plantar fascia and supports being a degenerative fasciitis without inflammation. Therefore, plantar fasciopathy is a more accurate descriptor.

Treatment is largely nonoperative, with 85% to 90% of patients experiencing resolution of symptoms within 6-12 months. Partial or complete plantar fasciotomy, either open or endoscopic is indicated only for intractable cases with failed conservative treatment.

Fascia release, being the main surgery, sometimes accompanied by complications, one of which is lateral column pain due to loss of the longitudinal arch height caused by the release of the plantar fascia with no consensus regarding the amount of the plantar fascia which should be released in order to relieve pain without causing lateral column pain.

To avoid this complication, we need to study the efficacy of calcaneal osteotomy for the surgical treatment of PF. Does the calcaneal osteotomy is an effective alternative surgical treatment option compared to the standard plantar fascia release in cases of resistant PF?

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with age range from 18 to 65 years with unilateral or bilateral PF after clinical and radiological diagnosis confirmation, who had failed conservative treatment for at least 6 months or recurrent cases after steroid injection

Exclusion Criteria:

1. All other causes of heel pain including seronegative arthropathies, rheumatoid arthritis in bilateral cases, abscess or neoplasm affecting the soft tissue, and bone occult fracture or infection.
2. age groups below 18 years old and above 65 years old.
3. Plantar fasciitis cases with pes planus.
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with nAMD, eligible for Intravitreal (IVT) aflibercept treatment.

Screening and Baseline could be performed on the same day.

Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea US PI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their individual dosing schedule.

Demonstration of the safe use of the PFS containing SOK583A1 was based on the performance of at least 3 different ophthalmologist teams.

Follow-up visits were performed on-site on Day 8 (±2 days) and on Day 31 (+4 days - end of study visit). Subjects participated for 30 to 34 days in the study including Baseline and treatment on Day 1 (Screening and Baseline could be performed on the same day) and the last safety follow-up on Day 31 (a time window of plus 4 days was allowed for the last safety follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 50 years of age at baseline
* Subjects diagnosed with nAMD (uni- or bilateral)
* Subjects already under IVT Eylea treatment (last injection of the induction period or maintenance phase)

Exclusion Criteria:

* Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis
* Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 26 mmHg, despite treatment with anti-glaucomatous medication)
* History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product
* Visual Acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness
* Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment
* Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening)
* Subjects who do not comply with the local COVID-19 regulations of the study site
Utilization of HIV Clinical Services in Rural India

This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government's partially-decentralized HIV services, offering rural referral clinic testing and urban-based HIV care.

India has one of the highest estimated number of HIV cases globally. Sixty percent of its HIV cases occur in rural residents, yet there is no system of HIV testing or care services for them. Preliminary studies have identified very low HIV testing utilization among men and recently pregnant women in rural Maharashtra, even though these are, by government policy, high-priority target groups for rural HIV testing, diagnosis, and prevention.

This study will compare two models of rural HIV testing and care services in two districts of Maharashtra, India. The "Control" model is the Indian government's current strategy of "partially decentralized" rural-based HIV testing services at a secondary-level Community Health Center clinic, which serves a village group population of 30,000. HIV care including antiretroviral therapy is provided a the rural district headquarters in the district urban center. The "Intervention" model is a novel model of "fully decentralized" rural-based HIV testing which will be offered at the Community Health Center, two Primary Health Centers, and eight village-level sub-center clinics, and HIV care offered at a rural-based clinic.

The primary outcomes of this trial are to assess and compare utilization rates for these two types of HIV services models among rural adult men age 18-49 and pregnant women age 18 and older. Additionally, the secondary outcomes include comparing HIV clinical and behavioral risk characteristics of services utilizers in each model, and characteristics of utilizers versus non-utilizers between and within each model. Clinical care outcomes include WHO Clinical stage at time of HIV diagnosis and at first clinical care visit, and birth outcomes for HIV-infected pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Adult Male Age 18 - 49 or Pregnant Female age 18 and older
* Capacity to give written informed consent

Exclusion Criteria:

* Refusal, or Physical or Mental incapacity to give written informed consent
Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality

Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. About 1 out of every 10 maternal deaths in Sub-Saharan Africa are associated with HDP, and most of these deaths are preventable with timely, implementation of evidence-based strategies, including postpartum blood pressure (BP) monitoring, treatment of elevated BP and comprehensive postpartum follow up as recommended by the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO).

This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability of: 1) postpartum remote blood pressure monitoring and 2) NTproBNP testing for postpartum risk stratification in women with HDP at the University of Abuja Teaching Hospital in the Federal Capital Territory of Nigeria

Aims:

1. To evaluate the feasibility, fidelity, and acceptability of home blood pressure monitoring in postpartum patients (n=90) with HDP. The investigators hypothesize that remote blood pressure monitoring will be feasible, implemented as intended, and acceptable among patients, physicians, and other health care workers to improve awareness and early diagnosis of elevated blood pressures (\>140/90 mm Hg) in postpartum patients with HDP.
2. To evaluate the association between N Terminal-proBNP (NT-proBNP) levels and short-term cardiovascular outcomes (i.e., all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality at 12-weeks postpartum) in patients with HDP.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years of age
* Admitted for delivery
* Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia)

Control participants:

* Adults \>18 years of age
* Admitted for delivery
* with an uncomplicated pregnancy and delivery

Exclusion Criteria:

* Unable to provide consent
* Unable to check blood pressure at home