cyrilzakka/clinical-trials huggingface dataset:
Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus

The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c \> ≥6.5% (48 mmol/mol)).

Exclusion Criteria:

* pregnancy,
* participants on exogenous insulin therapy,
* HbA1c \>8.5%,
* BMI \<22 or \>35 kg/m²,
* regular smokers (\>1 cigarette per day),
* participants with established cardiovascular disease,
* neurological disease,
* cancer,
* renal disease.
* Participants who are unwilling to consume any of the standard foods/drinks
Quantification of Cerebral Blood Flow by Arterial Spin Labeling in Vasospasm in Subarachnoid Haemorrhage

A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume

The subarachnoid hemorrhage (SAH) is a relatively severe disease whose prognosis is particularly related to the early onset of arterial vasospasm, maximum between the 5th and 14th day after SAH. Many obstacles make it difficult screening and monitoring of such complication. The challenge is to be able to demonstrate a reduction in regional cerebral blood flow before the onset of irreversible parenchymal sequelae, responsible for the majority of long-term morbidity among survivors. In clinical routine, screening vasospasm is achieved by Doppler intracranial arteries (DTC). However, its sensitivity is poor with regard to the middle and anterior cerebral arteries. The gold standard for diagnosis is cerebral arteriography. However, vasospasm in arteriography or trans-cranial Doppler does not prejudice the appearance of a delayed ischemic deficit.

A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume

Eligibility Criteria:
Inclusion Criteria:

* Adults.
* Who have given their written consent.
* Affiliated to a social security system.
* Any patient hospitalized at the University Hospital of Angers in neurosurgical intensive care unit for supervision by ASL and DTC a subarachnoid hemorrhage from all etiologies (excluding traumatic).

Exclusion Criteria:

* Contraindications to MRI
* patient hospitalized at the University Hospital of Angers in surgical intensive care for monitoring a subarachnoid hemorrhage.
* patient hospitalized at the University Hospital of Angers for monitoring a subarachnoid hemorrhage traumatic.
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell cervical cancer
* Stages IB2-IIIB according to FIGO Staging System
* Age:18-75
* ECOG\<2
* Normal bone marrow function
* Initial assessed and considered not candidates for operation
* Signed study-specific consent form

Exclusion Criteria:

* Pregnant or lactating women
* Patients with other malignancies
* Patients who received radiotherapy or chemotherapy previously
* Presence of uncontrolled life-threatening illness
* Allergy to platinum or monoclonal antibody
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 20 to 45 years at screening
* BMI: 18 \~ 29.9kg/m\^2
* Body weight ≥ 50kg
* Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Exclusion Criteria:

* Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
* Subjects who have symptoms of an acute disease within 28 days before first administration
* Subjects who have clinically significant active, chronic disease
* Subjects who fall under the criteria below in laboratory test

  * AST/ALT \> UNL (upper normal limit) x 2
  * Total bilirubin \> UNL x 1.5
  * CrCL \< 50mL/min
  * CPK \> UNL x 2.5
* Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
* Subjects with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests
Modified Versus Conventional Serratus Anterior Plane Block

comparing preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

comparing the quality of postoperative analgesia and opioid consumption in patients undergoing Video-Assisted Thoracoscopic Surgery when using preemptive analgesia with ultrasound guided modified serratus anterior plane block versus ultrasound guided serratus anterior plane block

Eligibility Criteria:
Inclusion Criteria:

* Patient consent.
* both sex.
* Age: 21-70 years old.
* BMI: 18- 30 kg/m2
* ASA: I and II.
* Scheduled for elective unilateral Video-Assisted thoracoscopy under general anesthesia.

Exclusion Criteria:

* History of allergy to the local anesthesia agents used in this study,
* Skin lesion at needle insertion site,
* Those receiving anticoagulant therapy or having bleeding disorders
* Patients with history of chronic pain and taking analgesics,
* Patients with sepsis and Significant cardiac, liver or renal diseases
* Uncooperative patients or with psychiatric disorders.
ACY-7 Oral Administration of Acyline

We propose oral dosing of gastrointestinal permeation enhancement technology \[GIPET\] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.

The purpose of this study is to test how the body responds to a new oral form of acyline given for seven days and to also look at the safety of oral acyline.

Acyline temporarily blocks the production of the hormone testosterone in healthy men. It has been tested in over 100 men in an injection form. This study will be testing acyline in a pill form for seven days.

This study may help develop an oral form of testosterone-blocker which may be useful in the treatment of diseases such as prostate cancer, premature puberty and possibly in a male contraceptive.

This study will evaluate a single dose of oral acyline given once a day for seven days and subsequent effects on Testosterone, FSH and LH blood serum concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* 18-50 years of age
* Non-smoker
* Not taking any medications other than the study drug for the duration of the study.
* Must be willing to use an accepted method of contraception during the study.

Exclusion Criteria:

* BMI \> 35
* Abnormal evaluation on screening exam and labs
* Known history of alcohol abuse, illicit drugs or steroids and/or use of more that 3 alcoholic beverages/day
* History of current testosterone use or infertility
* History of testicular disease or severe testicular trauma
* History of major psychiatric disorder or sleep apnea
* History of bleeding disorder or need for anticoagulation
* Current smoker or utilizing nicotine patches or gum
* Participation in a hormonal drug study within past month.
Breathe for Hot Flashes Randomized Controlled Trial

Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence.

Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other menopausal symptoms.

Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), Midwestern city and surrounding area.

Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without cancer) recruited through community mailings and registries.

Interventions: Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment.

Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Reporting daily hot flashes and desirous of hot flash treatment
* Peri- or post menopausal
* Living within a 60-mile radius of Indianapolis or willing to drive to the center for all study visits
* Able to read, write, and speak English
* in good general health

In addition:

* Breast Cancer survivors will have a known diagnosis of non-metastatic disease
* No history of other cancers
* Be at least four weeks post-completion of surgery, radiation and chemotherapy

Exclusion Criteria:

* Known psychiatric disorders or cognitive impairments
* Participation in our previous pilot study evaluating our control condition
* Self-reported difficulties with normal everyday breathing
* Meet criteria at baseline for number of subjective and/or objective hot flashes
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
* Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
* Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

For Triplet combination MSS-CRC:

* Histologically confirmed adenocarcinoma of the colon/rectum
* Stage IV disease
* MSS-CRC status by an FDA approved test
* Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin

For Triplet combination ovarian cancer:

* Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
* Platinum resistant ovarian cancer (PROC) defined as disease recurrence \< 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
* Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
* Subjects who have received PARP inhibitor therapy are eligible

Key Exclusion Criteria:

* Prior treatment with a TIGIT inhibitor.
* Prior treatment with an inhibitor of PVRIG
* Symptomatic interstitial lung disease or inflammatory pneumonitis.
* History of immune-related events that required immunotherapy treatment discontinuation

For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.
Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms

Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour.

Several studies have reported that cannabis use worsen the prognosis of psychiatric pathologies in general and psychotic in particular.

Few or no studies have evaluated the impact of cannabis consumption on patients with psychotic symptoms during their hospitalization (duration, type of hospitalization, quality of relationship with staff hospital), and on the short-term prognosis.

The objective of this study will be to assess the impact of cannabis on the duration of the hospitalization and the short- and medium-term evolution of patients with a psychotic symptomatology and cannabis use. Making the hypothesis that these patients (compared to patients with symptomatology psychotic and not using cannabis) would be hospitalized longer, exposed at a higher risk of resistance to the usual therapies, to have a lack of alliance therapeutic and insight, relapses and more frequent hospitalizations and symptoms.

They would also be more likely to have lower quality. They would also be more likely to be impulsive, and have aggressive behaviours.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in psychiatry regardless of the mode of hospitalization
* With or without protective measures (guardianship or curatorship)
* Presenting psychotic symptoms (schizophrenia, schizo affective disorder, thymic disorder with psychotic characteristic, psychotic disorder substance-induced, brief psychotic disorder, schizophrenic disorders, delirious disorders)
* Members of the social security system
* Enlightened information

Exclusion Criteria:

* Degenerative neurological pathologies or mental retardation
* Psychotic disorders secondary to generalized medical conditions(epilepsy, delirium tremens, tumors, etc.)
* Other psychiatric pathologies
UK SMA Patient Registry

Spinal muscular atrophy (SMA) is a form of motor neuron disease, most commonly caused by a mutation in the survival motor neuron 1 gene (SMN1) which results in a wide disease spectrum affecting children and adults. It is an autosomal recessive disorder and is therefore caused by inheritance of a mutated gene from each parent. All forms of SMA have an estimated combined incidence of 1 in 6,000 to 1 in 10,000 live births, with a carrier frequency of 1/40 to 1/60.

The patient registry aims to facilitate a questionnaire-based research study in order to better characterise and understand the disease in the UK and in Ireland. Entry is via self-registration over a secure internet connection (https://www.sma-registry.org.uk/). Online, patients are asked to read an information sheet about the research project and then indicate their consent to demonstrate willingness to participate. Following online consent, subjects will be entered into the registry. This is an on-going database and all participants are invited to update their information on a biannual basis.

Participants are asked to provide information by completing online questionnaires. The medical questionnaire asks specific questions about their SMA diagnosis and their condition, including their motor function, requirement of assistance for feeding or breathing, scoliosis, contractures, hospitalisations, other illnesses, medications and participation in clinical trials. Additional short questionnaires collect information about patients' experience of daily life, their activities and quality of life, also known as patient-reported outcome measures or PROMs. Participants are asked to forward a copy of their genetic results to the registry.

The registry collaborates closely with the clinical networks SMA REACH UK (paediatric) and Adult SMA REACH and with TREAT-NMD Alliance.

The SMA REACH networks collect clinician-reported medical and functional assessment data from consented SMA patients who attend participating neuromuscular clinics in the UK. Links between the SMA REACH clinical databases and the UK SMA Patient Registry have been developed to enable the consented sharing of limited and specific data. Currently, linkage enables the sharing of patient-level PROMs data collected by the registry with each patient's SMA REACH clinic and with the SMA REACH coordination teams. At clinic level, the data informs patient care. At project coordination level, the data is aligned with clinical data collected by SMA REACH. It is then anonymised, analysed and reported to regulatory authorities as part of managed access agreements (MAA) for SMA therapies. Future linkage will enable patient registry participants to view elements of their own clinical data entered into the SMA REACH database by their doctor.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a confirmed SMA diagnosis (or pending diagnosis) are eligible for inclusion. Diagnosis will be confirmed via genetic testing results

Exclusion Criteria:

* There are no exclusion criteria for the registry
Phase II Study to Evaluate the Efficacy of AMG 317

A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 to 65 years of age at the time of screening
* Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening
* At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening
* If receiving allergen immunotherapy, a stable dose for \> 3 months before screening and anticipated to remain stable for the duration of the study
* Positive to skin prick or RAST
* Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points
* Nonsmoker or ex-smoker with \< 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago

Exclusion Criteria:

* Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months
* History of endotracheal intubation for asthma-related exacerbation within 3 years of screening
* Respiratory illness within 4 weeks of screening
* History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
* Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit.
* Leukotriene antagonists within 2 weeks before first run-in visit
* Oral or parenteral corticosteroids within 6 weeks before first run-in visit
* Live/attenuated vaccinations within 4 weeks of screening or during the study
* Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Moderate of severe diastolic dysfunction, E/Ea\>12
* Preserved systolic function
* NYHA Class I-II

Exclusion Criteria:

* QTc \>450 msec at enrollment
* Taking medications that prolong QT interval or are potent inhibitors of CYP3A
* Significant coronary artery disease
* Severe valvular disease
* Hepatic disease
* Severe kidney disease
* Women of childbearing age
* Prior serious ventricular arrhythmia
Ginglival Health Among Smokers Visiting Dental Hospital

The effect of different forms of nicotine intake on the gingival health of dental patients that visited a public sector in Islamabad. A total of 300 dental patients that visited School of Dentistry, Islamabad voluntarily participated in this study. The nicotine consuming participants involved in this study were Smoke-form users, E cigarette-form users, and Dual-form users whose Gingival Index (G-I) was inspected to demonstrate an association between their smoking type and duration of developing severe gingivitis.

A total of 300 dental patients who visited the School of Dentistry, Islamabad, participated voluntarily in this study. The nicotine-consuming participants involved in this study were Smoke-Form users (S-form), Electronic cigarette-form users (E-form), and Dual-Form users (D-form) whose Gingival Index (G-I) was inspected to demonstrate an association between their smoking type and duration of developing severe gingivitis. The G-I ranging between 0.5 - 2.00 was used to calculate the occurrence of severe gingival issues in participants with smoking habits where G-I between 0.50 1.00 displayed Light gingival inflammation, G-I between 1.10-2.00 revealed Moderate gingival inflammation and G-I \> 2.00 confirmed Severe gingival inflammation. A chi-Square test was used for the association by keeping significance p\< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Smokers with good general health status visiting dental hospital

Exclusion Criteria:

* Non-smoker dental patients