cyrilzakka/clinical-trials huggingface dataset:
Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy

Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes .

So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other.

Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis .

Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy. Severe hypothyroidism (biochemically) may be completely asymptomatic. Though our patient had throid stimulating hormone level more than 100 mIU/L, he did not have any symptoms of hypothyroidism.so diagnosis of hypothyroidism depends on laboratory parameters rather than clinical findings Recognition and treatment of hypothyroidism in diabetic patients will benefit glycemic control and improve general well-being ). Diabetic nephropathy, a major micro-vascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors .

Eligibility Criteria:
Inclusion Criteria:

* All patients with Type 2 diabetes mellitus and with diabetic nephropathy.
* All diabetics irrespective of glucose control.
* All diabetics irrespective of treatment (oral hypoglycemic drugs/insulin)

Exclusion Criteria:

* 1) Type 1 diabetes mellitus 2) Patients with:

  * Gestational diabetes mellitus.
  * Pancreatitis.
  * Steroid induced Diabetes.
  * hepatobiliary disease
  * on systemic drug therapy such glucocorticoids and oral contraceptives.
EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders

The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score.


Eligibility Criteria:
Inclusion Criteria:

* Patients who signed the Informed Consent for participation in the observational study before collection of any information
* Patients who complain of psycho-emotional disturbance (of any intensity)
* Men and women aged 18-45 years, who prescribed to receive Tanakan® for cognitive disorders

Exclusion Criteria:

* Presence of any contraindications listed in the Tanakan® local SmPC (hypersensitivity to any of the components of Tanakan®, pregnancy, lactation, erosive gastritis in acute phase, gastric ulcer and duodenum ulcer in acute phase, acute cerebrovascular accident, acute myocardial infarction, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption, haemolysis)
* Presence of dementia (according to Diagnostic and Statistical Manual of Mental Disorders \[DSM IV\])
* Disturbance of usual activities of daily living (e.g. self-care)
* Patients taking antipsychotic drugs, antidepressants, tranquillisers and nootropic agents
* Presence of any severe disease or condition which could affect cognitive function (e.g. Parkinson disease, epilepsy, brain inflammatory disease, major depression, recent post-stroke condition, recent brain-trauma etc.);
* Presence of anxiety or depression according to the Hospital Anxiety and Depression Scale (11 points and more).
Effect of Low Level Laser Therapy on Orthodontic Miniscrew Displacement

EFFECT OF LOW LEVEL LASER THERAPY ON ORTHODONTIC MINISCREW DISPLACEMENT

Miniscrews can achieve good anchorage for different types of tooth movements, as intrusion, retraction, and protraction. However, obtaining primary stability is a challenge in their clinical application.Low Level Laser Therapy is suggested to prevent miniscrew displacement. Also previous studies concluded that Low Level Laser Therapy has an effect in stabilizing miniscrew after direct application.

So the aim of this study is to assess the effect of Low Level Laser Therapy on displacement of miniscrews during canine retraction.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 22 years old.
* Permanent dentition.
* Class I Bimaxillary protrusion and class II devision 1 patients.
* Good oral hygiene.

Exclusion Criteria:

* Medically compromised patients.
* Chronic renal failure and hormonal disorders as thyroid and parathyroid.
* Regular use of steroids, barbiturates, anticonvulsants drugs, and thyroid hormone replacements.
* Tobacco smoking.
* Any disease or metabolic disorder that can affect bone physiology
PROVIDENCE-1: Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients

The objective of this study is to determine whether rifalazil can significantly increase peak walking time (PWT) in patients with peripheral arterial disease (PAD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 40 and 80 years of age, inclusive.
* The patient has seropositive evidence of Chlamydia pneumoniae defined by immunoglobulin G antibody titers.
* The patient has a diagnosis of intermittent claudication due to PAD at screening.
* The patient's maximal effort PWT is limited only by severe claudication symptoms.
* If the patient is taking cilostazol or pentoxifylline and has been on a stable dose of the medication for at least 6 months prior to screening. Patients who have recently discontinued medications for PAD and/or intermittent claudication must "wash-out" for at least one month prior to screening.
* The patient has been on a stable dose of statin therapy for at least 6 months prior to screening.Patients who have recently discontinued statin therapy must "wash-out" for at least one month prior to screening.
* Male and female patients must agree to use an effective form of birth control throughout the study period.

Exclusion Criteria:

* The patient has critical limb ischemia as evidenced by ischemic rest pain, ulceration, or gangrene.
* The patient has had a major amputation of the leg or any other amputation that limits walking ability.
* The patient is planned for surgical/endovascular intervention for PAD during the course of the study.
* The patient has or is being treated or evaluated for tuberculosis.
* The patient has a known immunodeficient state (e.g., positive for human immunodeficiency virus) or is being treated with immunosuppressive drugs including high dose steroids or cyclosporine.
* The patient has an active infection requiring systemic or oral antibiotics.
* The patient has an uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis. Patients who develop autoimmune disease during the course of the study must be withdrawn.
* The patient's PWT is limited by symptoms other than claudication (shortness of breath, fatigue, angina, or arthritis).
* The patient has a history of alcohol abuse, illicit drug use or drug abuse or significant mental illness.
* The patient has a known or suspected allergy to the study medication(s) or class of study medication (rifamycins) to be administered.
* The patient chronically uses antibacterials or has previously received rifalazil or any rifamycin (e.g. rifampin).
* The patient has uncontrolled hypertension (resting blood pressure \> 160/100 mm Hg), uncontrolled moderate to severe congestive heart failure (CHF), or uncontrolled arrhythmic disorders.
Effectiveness of Ultrasound (US) Guided Supraclavicular Block

This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-64,
* Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.

Exclusion Criteria:

* Emergency surgery,
* Patient or surgeon refusal
* Patients for which peripheral nerve block or study medications are contraindicated,
* Patients on chronic analgesic therapy at home,
* History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).
Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1

The purpose of this study is to determine whether MYODM (formulated composition containing Theobroma cacao supplemented with caffeine (caffeine/theobromine ratio1/1.85, w/w) is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1) and improves the quality of life of these patients.

Detailed Description:

Myotonic Dystrophy type I (DM1) is the most common form of adult muscular dystrophy, affecting 1 in 8000 individuals. It is an autosomal dominant disorder with multisystemic involvement of multiple organs and tissues, mainly brain, heart, endocrine system, eyes and both smooth and skeletal muscles.

Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities. The present project is a 6 month randomized study to assess the effect of MYODM on fatigue, hypersomnia and quality of life in DM1 patients.The patients will be randomized to one of the two study arms. The active arm will receive the MYODM treatment and the control arm will not but both will follow the same evaluation program.

Patients will come to the center every 3 months for evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Genetically proven DM1
* Able to walk independently

Exclusion Criteria:

* Regular intake of plant stanols or other nutritional supplement
* Co-morbidity interfering with the interventions or possibly influencing outcomes.
* Participation in another clinical trial at the same time
* Unable to complete study questionnaires.
AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer

The goal of our project is building a predictive response algorithm for patients with metastatic lung cancer, exploiting an artificial intelligence platform. It will collect patient information from all areas (clinical, laboratory, radiological, pathological) and analyse them, understanding connections and correlations, both at baseline and at pre-specified timepoints. It would lead to the development of a reliable and constantly evolving predictive score, able to continuously re-weight the importance of each variable as new data come in.

Since the greatest clinical need is identifying non-responders to immunotherapy and chemo-immunotherapy combination (30% of all treated patients), these two populations are defined as the starting cohorts (Cohort A, immunotherapy alone, Cohort B, chemo-immunotherapy combinations).

For each cohort, three main questions are to be answered:

Q1) Early progressors (defined as progressive disease or death within three months of treatment or at first radiological restaging) Q2) Toxicity (with a special focus on severe toxicities G≥3) Q3) Long survivors (defined as patients reaching an overall survival of at least 1.5x median overall survival in registrative trials)

The early identification of non-responders, high-risk patients (or on the other hand, long survivors) would help their healthcare planning, providing individualised follow-up strategies or prompting their inclusion in alternative treatments (eg clinical trials).

For all cohorts, first data entry will be retrospective and second data entry will be prospective (as validation set).


Eligibility Criteria:
Inclusion criteria:

* Patients with histological or cytological diagnosis of NSCLC
* Stage IV according to investigator's staging procedures (or any locally advanced tumour not feasible for local radical treatment)
* Treatment with at least 1 cycle of mono-immunotherapy or chemo-immunotherapy (as per clinical practice)
* Availability of follow-up

Exclusion criteria:

* Patients with other thoracic tumours non-NSCLC (i.e. SCLC)
* Stage other than IV or feasible for radical treatment upfront
* Treatment within clinical trials (with combination regimens different from the aforementioned combinations)
* Lost to follow-up
Study Evaluating Bifeprunox in Patients With Schizophrenia.

An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients who have successfully completed Wyeth study 3168A1-313.
2. A signed and dated informed consent form for this study.
3. No major protocol violations in the previous study.

Exclusion Criteria:

1. Clinically important abnormalities in the preceding short-term study that have not resolved.
2. Use of prohibited treatments in the preceding short-term study.
3. Meeting any exclusion criteria in the preceding short-term study
Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions

The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to:

* Group A: single BMS restenosis (\> 50% of luminal diameter)
* Group B: single de-novo lesion (\> 50% of luminal diameter)

Exclusion Criteria:

* contraindications to dual antiplatelet therapy
* acute myocardial infarction within the previous 48 hours
* significant left main coronary artery disease
* reference vessel diameter \< 2.5 mm,
* hemodynamic instability
* chronic kidney disease with serum creatinine \> 2 mg/dl
* pregnancy
* allergy to contrast agent, everolimus, aspirin, clopidogrel
* life expectancy \< 24 months
* patients with possible low adherence to medical therapy
Waiting Time. Wasting Time

Our study's principle purpose is to determine whether decreasing waiting time before being seen for antenatal care increases demand for and use of antenatal care services in Mozambique.

This protocol describes a pilot study that will test the impact of a scheduling intervention intended to reduce waiting times for antenatal care. The study will include one intervention health clinic and one control clinic in Maputo, Mozambique. In the intervention facility women attending antenatal care will be informed that if they return at their scheduled date and time they will be seen within one hour by clinic staff rather than having to wait for an indefinite amount of time before being seen for care. Appointment cards will be clipped into ANC cards, which collect routine health data and are kept by women at the end of their ANC visit. Health facility staff will be trained to identify women who return at their scheduled time and to manage patient flow such that scheduled women are received quickly. After the start date of the intervention, all women attending ANC at the health facility will be provided a scheduled return date and time window. Baseline and endline exit interview surveys will be conducted in both intervention and control facilities to compare changes in waiting time, number of ANC visits, and provider satisfaction over the course the study period between clinics.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for individual study participants enrolled after delivery:

1. Women who delivered at the health facility during the weeks of recruitment

Inclusion criteria for women whose waiting time is measured:

1. Women at the health facility to seek care for antenatal care or another reproductive health service (anticipate total enrollment of 800 women)

Inclusion criteria for the health care provider survey is that the provider

1. Have worked in the health facility for at least 6 months
2. The health care worker provides ANC as part of their routine duties (anticipate total enrollment of 4 health care workers)

Exclusion Criteria:

Exclusion criteria for individual study participants enrolled after delivery:

1. Women under 18 years of age will be excluded
2. Women whose babies die during labor or childbirth from the delivery exit interviews

There are no exclusion criteria for the sample of women whose waiting time will be measured There are no exclusion criteria for the health care provider survey
Cytogenetic Study of Ocular Melanoma

Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation surgery consent to participate in the study. A tumor sample taken during surgery is studied in the lab for genetic features. These features and features of subjects' clinical course are recorded. Analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.

The Jules Stein Eye Institute Ocular Melanoma Research Group is conducting cytogenetic studies of choroidal melanoma to improve the screening of biopsy samples of choroidal melanoma through cytogenetic analysis. Our goal is to identify molecular probes that specifically target regions of chromosomes that undergo changes characteristic of metastatic choroidal melanoma.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with diagnosis of ocular melanoma
2. Patient with local treatment plan for ocular melanoma- plaque brachytherapy or enucleation
3. Patient 18 years of age or older
4. Archival enucleation specimens with diagnosis of ocular melanoma

Exclusion Criteria:

1. Patient who refuses local melanoma treatment
2. Patient who refuses to participate in this study
Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction

One of the important factors in obtaining successful outcomes when treating severe meibomian gland dysfunction (MGD) is to control the existing ocular and eyelid inflammation. Thus, in previous studies, topical and systemic antibiotics with anti-inflammatory function, such as topical azithromycin, systemic tetracycline, doxycycline and minocycline, have been used to treat severe MGD. In this study, minocycline which had the fewest side effects was used to evaluate the effect on cytokine levels in severe MGD. At study initiation, all patients completed an Ocular Surface Disease Index (OSDI) questionnaire and had an ocular surface, tear, and meibomian gland evaluation that consisted of fluorescein tear break-up time (TBUT), Schirmer test, corneal and conjunctival fluorescein staining, microscopic examination of lid margins and meibomian glands, and tear cytokine levels. All measurements except tear cytokine levels were conducted in the same manner before treatment, after 1 month, and after 2 months of treatment. Tear cytokine levels were evaluated before treatment and after 2 months of treatment. The aim of this research was to determine the concentration of inflammatory cytokines in the tears of patients with MGD and to compare the cytokine levels, corresponding clinical responses, and ocular symptoms before and after 2 months of treatment with oral minocycline.


Eligibility Criteria:
Inclusion Criteria:

* patients with stage 3 or 4 meibomian gland dysfunction
* moderate or marked symptoms of ocular discomfort, itching, or photophobia with limitations of activities
* moderate or severe meibomian gland dysfunction clinical signs
* mild to moderate conjunctival and peripheral corneal staining or increased conjunctival and corneal staining, including central staining
* increased signs of inflammation : moderate or severe conjunctival hyperemia, phlyctenulae

Exclusion Criteria:

* history of previous ocular or intraocular surgery
* evidence of acute or chronic infections or inflammation of the cornea and conjunctiva
* ocular allergy
* autoimmune disease
* history of intolerance or hypersensitivity to any component of the study medications
* use of topical ocular medications
* wearing contact lenses during the study period
* presence of current punctal occlusion
* pregnancy
* lactating women
* children
Innovative Ultrasound Technology in Neuromuscular Disease

This study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.


Eligibility Criteria:
Inclusion Criteria:

* History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.

Exclusion Criteria:

* Multiple generalized neuromuscular conditions.
Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation

This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Scheduled for CS on the following day or later, including coronary artery bypass, valve surgery, any other open cardiac surgery (i.e., that includes opening of the pericardium), or any combination.
* Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, and ectopy are acceptable).

Exclusion Criteria:

* Regular use (3 or more days/week) of fish oil within the past 4 weeks.
* Known allergy or intolerance to fish oil or corn oil.
* Currently pregnant.
* Unable to provide informed written consent.
* Current or planned cardiac transplant or LVAD