cyrilzakka/clinical-trials huggingface dataset:
Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation

The main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes 4 months following extraction and ridge preservation.

The null hypothesis for this study is that there is no difference in bone ridge width and height changes 4 months following extraction and alveolar ridge preservation at sites that undergo immediate post-extraction socket expansion or no immediate post-extraction ridge width change. Patients of the Graduate Periodontics Clinic at Marquette University School of Dentistry scheduled for extraction, bone graft and resorbable membrane will be recruited for this study.

After providing informed consent and prior to local anesthesia and extraction, the following parameters will be recorded: age, gender, race, medical history, medications, tooth site, reason for extraction and tooth mobility. Gingival width will be recorded prior to local anesthesia and extraction, and at 4 months. Gingival thickness will be recorded after local anesthesia and prior to extraction, and at 4 months. Buccolingual ridge width and ridge height will be recorded immediately before, immediately after extraction, and at 4 months. Immediately after extraction, the following measurements will be recorded: buccal bone thickness, number of roots, root length and width, instruments used for extraction, need for flap elevation, duration of extraction, anesthetic amount, type and approach, and operator experience.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-75 years)
* Good general health (controlled conditions)
* Controlled periodontal disease
* Scheduled for single tooth extraction with bone graft placement and resorbable membrane
* Tooth to be extracted must have adjacent teeth
* Socket wall integrity

Exclusion Criteria:

* Smoking
* Pregnancy
* Active periodontal disease
* Systemic conditions that affect healing
* Lack of socket wall integrity (bone loss ≥50 %) prior to extraction, teeth with severe infection requiring pre-extraction antibiotic treatment to control infection), and contraindications for tooth extraction.
Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo

A single group of pregnant women who was analyzed in the first and in the third trimesters of pregnancy

A single group of 120 pregnant women separated in smokers (n = 17) and nonsmokers (n = 103) and first pregnancy (n = 54) or multiparous (n = 66) who underwent pulmonary function test and used the individual passive sampler in the first and third trimesters of pregnancy

Eligibility Criteria:
Inclusion Criteria:

* prior informed consent;
* single pregnancy;
* topical and feasible;
* gestational age of less than 13.86 weeks at the first evaluation;
* absence of preexisting maternal diseases

Exclusion Criteria:

* withdrawal from the project;
* abortion;
* inadequate pulmonary function test
A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.


Eligibility Criteria:
Inclusion Criteria:

* Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-07
* Are 18 to 75 years of age
* Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
* Are able to provide written informed consent

Exclusion Criteria:

* Have a major medical problem
* Have a history of an allergic reaction to Corlux (C-1073, mifepristone)
Prognostic Value of Myosteatosis and Creatinine-to-cystatin C Ratio in Patients With Pancreatic Ductal Adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC) is a dismal disease with a 5-year survival rate as low as 6%. It causes body composition changes and many patients develop muscle loss with disease progression. Computed tomography (CT) is a common, noninvasive method of muscle assessment.Known as myoesteatosis,low muscle radiodensity is reflective of intermuscular adipose tissue that influences survival outcomes in patients with cancer.Serum creatinine (Scr) and cystatin C (CysC) are usually employed to estimate renal function in clinical practice. Scr is a metabolic waste product produced by creatine in skeletal muscle. CysC can be produced by all nucleated cells in the body at a constant production rate. CysC is used as an endogenous marker to reflect the glomerular filtration rate. Some studies have supported that the Scr/CysC ratio (CCR) is a simple and inexpensive measure that can be used to evaluate the skeletal muscle mass of patients with malignancies, such as gastric cancer. Therefore, the purpose of the present study is to explore the association between CCR and myosteatosis upon diagnosis of PDAC, specially whether the co-occurrence of these factors could predict survival outcomes.Preoperative assessment of muscle quality may be valuable for treatment planning and optimization of nutritional support.

This retrospective study enrolls patients who underwent surgery for PDAC, from January 2016 to December 2021. Patients will be divided into myosteatosis and non-myosteatosis groups. Clinical and imaging data are collected.The study does not have any intervention measures and harm to subjects.

Inclusion criteria:

a）aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.

Exclusion criteria:

* pancreatic malignant tumors of other pathological types or other malignant tumors;

  * received local or systemic radiotherapy and chemotherapy before operation; ③ with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data;

Eligibility Criteria:
Inclusion Criteria:

* a） aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.

Exclusion Criteria:

* ① pancreatic malignant tumors of other pathological types or other malignant tumors;

  * received local or systemic radiotherapy and chemotherapy before operation;

    * with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data; ⑤ Lost interviewers.
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 70 years of age
* Stage II or greater pelvic organ prolapse (POP)
* Individuals electing surgery to treat their POP
* Willing and able to comply with study procedures
* Willing and able to provide written informed consent

Exclusion Criteria:

* Contraindication for estrogen cream
* Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
* History of connective tissue disease
* Previous hysterectomy or pelvic organ prolapse surgery
* Known allergic reaction to any agent required by the protocol
* Use of hormone therapy in postmenopausal women in the last 90 days
* Pregnant or lactating females
* History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions
Investigation of the Relationship Between Blood Transfusion Volume and Development of Renal Failure in Pediatric Patients Undergoing Cardiovascular Surgery

Blood transfusion strategies in cardiac surgery are a research topic that has been studied more for adults. There is not enough data on this subject for children in studies. Investigators aim to examine the renal damage risk level of blood transfusion volume, which is one of the modifiable risk factors that can cause acute kidney injury in pediatric cases undergoing cardiac surgery.

The main question it aims to answer is:

What is the effect of blood transfusion volume on the risk of renal damage in pediatric cardiovascular surgery? The names of the patients who were operated on by the Department of Cardiovascular Surgery will be accessed from the system records and their files will be reviewed. The patients' demographic information, anesthesia management and postoperative renal function tests will be scanned.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing cardiovascular surgery

Exclusion Criteria:

* Being over 18 years old Weighting over 30 kg Preoperative acute kidney injury
Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.

Currently, it is established that the voltage-gated calcium channels modulate pain perception due to an influence on the neuronal transmission and excitability. In the past, attention has focused on the modulation of high voltage activated calcium channel. More recently, scientific interest has proven to the low voltage activated calcium channel, also called T-type channels. The data from the literature show significant involvement of these channels in the physiology of nociception and pathophysiology of acute and chronic pain. Moreover, in several animal pain models (acute, neuropathic, inflammatory), T-type channels inhibition alleviates painful behaviours.

Analgesics treatments available in clinic are ineffective in some patients with chronic pain (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical use of selective inhibitors of T-type channels could not only help the development of new therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a pharmaco-economic impact due to the low selling price of their inhibitor currently available: Zarontin®.

The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with peripheral neuropathic pain compared to a control group.

This is a multicentre, parallel-group, double-blind, randomised clinical trial comparing ethosuximide and inactive control for the treatment of peripheral neuropathic pain, assessed by numerical rating scale and quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Traumatic neuropathy or post-surgical (excluding amputations) with Neuropathic -Pain Diagnostic DN4 ≥ 4 positive and IASP criteria
* ENS pain ≥ 4
* ALT, AST, PAL, normal GGT, creatinine \<133μmol / L, hematocrit\> 38%, β-HCG
* Patients affiliated to the French Social Security
* Patients with free and informed consent has been obtained
* Peripheral neuropathic pain with Neuropathic Pain Diagnostic DN4 ≥ 4 positive

Exclusion Criteria:

* Pregnancy or breastfeeding
* Diabetic neuropathy, post-herpetic neuralgia, cancer or chemotherapy-induced,
* Patients with impaired glucose tolerance,
* Medical and surgical history incompatible with the study,
* History of renal disease and / or liver,
* Addiction to alcohol and / or drugs,
* Taking antiepileptic family carboxamides and ethosuximide
* Use of St. John's wort,
* Allergy succinimides (ethosuximide, methsuximide, phensuximide)
* Psychotic disorders,
* Patients with epilepsy,
* Patient exclusion period, or the total allowable compensation exceeded
* Patients undergoing a measure of legal protection (guardianship, supervision ...)
* Central neuropathic pain
* Other chronic pain (osteoarthritis, arthritis, fibromyalgia...) with intensity greater than neuropathic pain
Type 2 Diabetes and Bone Microarchitecture

Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences (post-operative complications, longer hospital stays, increased mortality rate).

Currently, the risk of fractures is estimated by the measure of areal bone mineral density (aBMD) and T-score. However, in diabetics aBMD is not decreased, and even paradoxically increased. Indeed, aBMD is 5-10% higher in type 2 diabetic patients compared to non-diabetic subjects, which suggests that the assessment of fracture risk in these patients is underestimated. The High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) 3D bone imaging technique has a resolution close to the size of the bone trabeculae. It is used to assess volumetric bone mineral density (vBMD) and bone microarchitecture at the tibia and distal radius, and enables a better estimation of the fracture risk compared to the measurement of aBMD. Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients, explaining the increased risk of fracture in this population compared to non-diabetics.

We propose to set up a descriptive case control study, nestled in 3 cohorts of men and women (QUALYOR, OFELY and STRAMBO), to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from the same cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
* Age- and sex-matched control patients from the same cohorts without type 2 diabetes ; two control were age- and sex-matched to one type 2 diabetes patient.

Exclusion Criteria:

-
Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）

Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg

Exclusion Criteria:

1. Patients cannot be followed up for any reasons.
2. Patients in critical condition may be die in one year.
3. Patients have been enrolled in this study.
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Enrollment of participants will occur in a sequential order of treatment initiation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' labeling
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques

This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients with Carotid Atherosclerosis.

This will be a 2-year, randomized, open-label, prospective, parallel-group study. It only be held in China-Japan Friendship Hospital. Subjects with Carotid Atherosclerosis Plaques who meet all inclusion and none of the exclusion criteria will be randomized in a 1:1 ratio to receive treatment of rosuvastatin (5 mg, 10mg, 20mg) dosing adjustment by LDL-c level or fixed dose 5 mg. The study will consist of two phases: the Screening/Baseline period（-1to week 0）and the Follow-up period(0 to month 24). The follow-up period will comprise seven visits.

Eligibility Criteria:
Inclusion Criteria:

* Subjects or legal guardian can understand and sign the written informed consent form;
* LDL-C≥100mg/dl（2.6mmol/l）.
* Subjects with carotid atherosclerotic non-calcified plaques determined by color Doppler ultrasound on carotid. ( Plaque defined as limited intima media thickness≥1.5mm, according to the procedure of vascular ultrasound examination in 2009 Chinese Journal of Ultrasonography )
* Subjects had not been treated with statins, or one had been treated with antihyperlipidemics no more than 3 months within 12 months prior to screening.

Exclusion Criteria:

* Subjects known to be allergic to the study medication, or any components .
* Uncontrolled hypothyroidism defined as the systolic blood pressure(SBP) \>180 mmHg or the diastolic blood pressure(DBP) \>100 mmHg.
* Concomitant with severe or frequent arrhythmia, such as Atrial Fibrillation, second or third degree Atrioventricular Block, Sick sinus Syndrome etc.
* Alanine aminotransaminase (ALT) and /or Aspartate aminotransferase (AST) \>1.5×ULN (upper limit of normal).
* Subjects with myopathies，or the value of Creatine kinase \>1.5×ULN (upper limit of normal).
* Concomitant with chronic wasting diseases, whose life span was anticipated no longer than 2 years.
* Pregnant or nursing woman, and subjects with a Pregnant plan during this study.
* Cognitive impairment, which may affect obtaining informed consent and participating in the study procedures.
* Unwilling to receive treatment or examinations outlined in protocol.
Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis

Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy

1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12 weeks after the beginning of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who signed Informed Consent Form；
2. Male or female subjects 18-65 years of age；
3. Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
4. Involved area 1-10% of the body surface area.

Exclusion Criteria:

1. Incompliance with the diagnosis of plaque psoriasis or plaque area \> 10% of the body surface area.
2. Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
3. Known allergy to any component of the test or control drug；
4. Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
5. Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
6. Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
7. Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
8. Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
9. Serious life-threatening condition that allows a life expectancy of less than 2 months；
10. Inability to guarantee taking medications and completing visits as scheduled during the study;
11. Serious infection that is not suitable for external treatment；
12. Any other condition that the investigator deems unsuitable for entering the study.