cyrilzakka/clinical-trials huggingface dataset:
Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess whether a presently available dietary supplement known as quercetin, which is a flavonoid, can reduce the flushing that occurs with niacin. We will also assess whether using quercetin to prevent flushing from niacin, can improve how niacin lowers cholesterol.

This study involves people between 21 and 75 years. It will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We will test a different dose of quercetin in each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women.
2. Ability to understand and agree to informed consent.
3. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Exclusion Criteria:

1. Contra-indications or known intolerance to the study medications.
2. History of congestive heart failure, carcinoid, rosacea, renal failure (GFR\<60 ml/min/m2).
3. Active liver disease.
4. Active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose\>= 126mg/dL at screening or use of anti-diabetic medications within 12 months, or glucose\>200mg/dL 2 hours after a 75 g oral glucose challenge within 12 months.
5. History of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant.
6. History of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week.
7. Women who are pregnant, plan to conceive or lactate.
8. Peri-menopausal women or women currently experiencing flushing.
9. Currently taking vasoactive medications, anti-hypertensives, anti-histamines, Selective Serotonin Re-uptake Inhibitors (SSRIs), NSAIDS, oral steroids, leukotriene inhibitors, supplemental quercetin and \> 50mg niacin.
PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.

PROSTAC is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel

This study is a prospective biomarker study of patients with mCRPC undergoing treatment with docetaxel or cabazitaxel as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male age ≥ 18 years
2. Histologically confirmed adenocarcinome of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 weeks intravenously.
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.

Exclusion Criteria:

1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Assessing Supported Employment With Veterans With Felony Convictions and Mental Illness or Substance Abuse

This study continues to develop and refine best practices in the delivery of vocational services to veterans with histories of felony convictions and mental health/substance abuse difficulties. There are currently over 225,000 incarcerated veterans and it is estimated 64,000 veterans are released from prisons annually. These veterans encounter significant difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated work skills. Additionally these veterans are more likely to be homeless than other population., Previous work has found that manual based, vocational groups led by trained vocational staff led to quicker employment compared to traditional vocational services and manual based self studies. To attempt to improve on previous results, this study adds principles and components of supported employment including ongoing follow-up, treatment team coordination, and community based assistance.


Eligibility Criteria:
Inclusion Criteria:

* history of at least one felony conviction
* diagnosis of a mental illness including substance use disorders

Exclusion Criteria:

* dementia
* active psychosis
Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy with Central Lymph Node Compartment Dissection

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy with central lymph node compartment dissection.

Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing \[1\]. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons \[1-3\]. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue \[2\].

Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.

Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.

The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy with central lymph node compartment dissection. Moreover, we are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18 years old
2. Patient scheduled for a non-emergency operation
3. Patient eligible for total thyroidectomy

Exclusion Criteria:

1. Patient is participating in another clinical trial which may affect this study's outcomes
2. Prior operation in the neck
3. Primary or secondary hyperparathyroidism
4. Vitamin D deficiency
5. Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
Presence of Enamel Fluorosis in Libyan Children

Fluorosis is caused by hypomineralization in the enamel due to increased fluoride ingestion during early childhood (Cawson.1, Wong et al. 2, and Sudhir 3). A considerable amount of evidence has been reported over the years, which has shown that presence of fluoride ions at up to one part per million in public water supply has reduced the prevalence of teeth decayed with minimal chance of dental fluorosis. The WHO recognized these facts by its resolution in 1969 4 and 1975 5, which stated that water fluoridation, where applicable, should be the cornerstone of any national policy of caries prevention

The optimal concentration is defined as that which gives maximal protection against dental caries, with minimal clinically observable dental fluorosis (Dunning 7). This level is determined according to the climate and the resultant drinking habits (Newborn 6). Cawson 1 stated that mottling of enamel is the most frequently seen and most reliable sign of excessive quantities of fluoride in the drinking water. Dean 8 concluded that a fluoride level of above 1ppm does not significantly reduce caries beyond the optimal effect of 1ppm.

Different classifications have been introduce to score dental fluorosis. (Dean 9, Al -Alousi 10, Thylstrup \& Fejerskov 11, (Fejerskov, 12). and the DDE index by FDI 1982). Aira Sabokseir 13, concluded, fluorosis indices, if used alone, could result in misdiagnosis of dental fluorosis and information about adverse health-related conditions linked to DDEs (Developmental Defects of Enamel) at specific positions on teeth could help to differentiate between genuine fluorosis and fluorosis-resembling defects.Various figures for mouth prevalence of enamel fluorosis have been reported by different investigators. 39.2% by Al-Alousi 10, for Welsh children, 32% by Akpata 14 for Nigerian children. Using the DDE index of the FDI (1982), Al alousi 10 defective enamel of 48.9% in children from south Wales. In England,Tabari 15 found the prevalence of fluorosis was 54% in the fluoridated area and 23% in the fluoride-deficient area. In Iran the prevalence of fluorosis was 61% (Azami-Aghdash et al., 16).

Eligibility Criteria:
Inclusion Criteria:

* Libyan children born and lived in the same area. 2. Limited to incisors only.

Exclusion Criteria:

* Non- Libyan children. 2. Children who born or lived outside the study areas. 3. Incisors with class II fracture (Ellis type 1970) or crowned
DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

The purpose of this study is to compare the different dose of DMTA07 (DM) combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.

To compare the different dose of DM combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.

The purpose of this study is to compare the antihypertensive efficacy and tolerability of different dose of DM combines with amlodipine treatment, further to explore the optimized combination dose of DM.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient aged between 50 to 75 years old (both included);
2. Patient with mild to moderate essential hypertension at enrollment, which defined as the following:

   Patient must have mean sitting SBP ≥140 and \<180 mmHg or mean sitting DBP ≥90 and \<110 mmHg at enrollment;
3. Patient with normal serum potassium;
4. Patient or his/her legally acceptance representative has signed the written informed consent form.

Exclusion Criteria:

1. Patient with severe hypertension (mean sitting DBP ≥ 110 mmHg or mean sitting SBP ≥ 180 mmHg);
2. Patient with secondary hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc;
3. Patient is under treatment with beta-blocker prior to enrollment;
4. A definite diagnosis or unstable of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, arrhythmia and heart failure within 3 months before signing the written informed consent form;
5. Patient with concomitant endocrine diseases or type 1 Diabetes Mellitus;
6. Patient with type 2 Diabetes Mellitus with poor glucose control (glycosylated hemoglobin \> 9% or fasting blood sugar \> 250 mg/dL at enrollment) or under insulin treatment;
7. Patient with clinically unstable disease such as known collagen or auto-immune disease or other malignant disease requiring current medication;
8. Patient with bilateral renal artery stenosis, solitary kidney or post renal transplant;
9. Patient with clinically relevant hematological disease;
10. Hepatic or renal dysfunction as defined by the following parameters:

    * ALT or AST \> 2 times upper limit of normal,
    * Total bilirubin \> 2 times upper limit of normal,
    * Serum creatinine \>2.0 mg/dl;
11. Female patient who is pregnant or lactating;
12. Patient with substance abuse (including alcohol) history for the past two years;
13. Known or suspected contraindications, including allergy to DMTA07 or calcium channel blockers;
14. Patient received other investigational drug or device within 30 days before signing the written informed consent form;
15. Patient with any other serious disease considered by the investigator(s) not in the condition to enter the trial.
Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder

This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.

Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 60 years
* diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).

Exclusion Criteria:

* subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse
* significant head injury, or of any neurosurgical procedure
* pregnant women
* patients with metal implants or illnesses that prevent attendance to sessions
* patients with a history of seizure or bearing pacemakers
Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)

In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in surplus pregnancies. It was found that after 41 weeks, there is a significant increase in pregnancy complications including meconium liquor, shoulder dystocia and fetal death in uterus.

Induction at 41 weeks was found to reduce the risk of complications described above, without taking the risk of cesarean section and, therefore, the recommendation of the Israel Society of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of pregnancy.

Induction is performed mechanically by entering a balloon to the cervix or by medicated prostaglandins and later, intravenous Pitocin to most women. The process takes two to three days with about 60-70% success rate.

In recent years there has been a growing awareness to use natural methods to start labor.

Many women tend to turn to natural medicine in order to reduce the need for conventional drugs to start labor.

Given the lack of research on the issue and considering the rising demand of the involvement of alternative medicine in labor induction process, the investigators decided to carry out research on this subject.

To the study will be recruited women who have completed 40 weeks of pregnancy and have not yet given birth, with proper evaluation of mother and fetus.

Women who are fit to participate and had given their consent, will be computerized randomized to one of three groups.

Research groups:

1. Group who receives acupuncture treatment in order to accelerate the development of birth.
2. Group who receives sham treatment - non acupuncture treatment, but a similar treatment, so that the patient is unable to know whether she is receiving a real acupuncture treatment, or the similar one, which has no effect on the patient.
3. Group who does not receive any treatment and will be reviewed a week later, unless a spontaneous birth will be developed. (Procedure accepted today) The study will be carried out between week 40 and week 41. During the week acupuncture treatment, sham treatment or conservative follow-up will be carried out, depending on the study group differentiation.

All women who will be randomized to the treatment groups, will fill a preliminary questionnaire for acupuncture treatment.

The course of treatment: During the week of study the women in the treatments groups will receive treatment every 48-72 hours, a maximum of three treatments.

Measures will be taken on the following week or two when the women will come to give birth.

Eligibility Criteria:
Inclusion Criteria:

1. Women past their due date (week 40)
2. Proper dating of pregnancy
3. Uncomplicated pregnancy
4. Normal evaluation as part of the mother and fetus routine examination on week 40
5. Singleton pregnancy
6. No contraindication for vaginal birth
7. No significant signs of birth

Exclusion Criteria:

1. Past Cesarean Section
2. Women who have undergone acupuncture treatment during pregnancy
3. Women who did not undergo separation membranes
Genetic Mutation in Recurrent Cervical Cancer

Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
* With available materials for analysis
* With detailed clinicopathological information
* Given consent to participate the trial

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Facts and Attitudes About Clinical Trials

The primary objective of this project is to examine the impact of providing cancer patients with audiovisual information about clinical trials on attitudes towards clinical trial participation. It is hypothesized that patients provided these materials will have more favorable attitudes toward clinical trial participation compared to patients not provided these materials.

Participants will be randomized to either: (1) an intervention condition in which they will be asked to view a short video and read an accompanying brochure about clinical trials developed by the investigative team; or (2) a control condition in which they will be asked to read the National Cancer Institute's brochure entitled "Taking Part in Cancer Treatment Research Studies." Self-report data will be collected at two timepoints: 1) in person following study enrollment, but before receipt of material related to intervention assignment (baseline/Time 1), and 2) by telephone interview between 7 and 28 days following study enrollment (follow-up/Time 2). In addition, data will also be collected from medical records six weeks after study enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed with cancer
2. Have not been asked previously to participate in a clinical trial of a treatment for cancer
3. Be scheduled for a visit with a medical oncologist at the time of recruitment

Exclusion Criteria:

1. Are under the age of 18
2. Do not speak and read standard English
3. Are unable to provide informed consent
Diagnostic Capacity of Keratoconus Match Index and Keratoconus Match Probability in Forme Fruste Keratoconus

Primary objective of this study was to evaluate the diagnostic capability of keratoconus match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste keratoconus (FFK), and their association with a series of Pentacam-derived keratconus (KC) indexes. KMI and KMP parameters are KC-specifc indexes that are measured by Ocular Response Analyzer (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.

Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.

All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
* KISA index between 60 and 100% in the FFK eye (FFKG)
* lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
* uneventful ophthalmologic history (CG)
* no indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography (CG)
* KISA index value less than 60% (CG)

Exclusion Criteria:

for both study groups:

* previous incisional eye surgery
* corneal scars and opacities
* history of herpetic keratitis, severe eye dryness
* pregnancy or nursing
* current corneal infection
* glaucoma
* suspicion for glaucoma
* IOP lowering treatment
* underlying autoimmune disease