cyrilzakka/clinical-trials huggingface dataset:
Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial

The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.

Excessive gestational weight gain is common with about one third of women gaining more weight in pregnancy than is recommended. Unfortunately, the prevalence of excessive gestational weight gain is increasing. Gestational weight gain greater than that recommended by the Institute of Medicine (IOM) is associated with increased risk of gestational complications (hypertension, diabetes, and preeclampsia), infant macrosomia, and complications in delivery including increased risk of cesarean delivery. Currently, there is no evidence-based prenatal counseling protocol available to prevent excessive gestational weight gain. We hypothesize that consistent counseling on appropriate pregnancy diet, weight gain, and the potential complications of excessive gestational weight gain will result in fewer women gaining above the IOM recommendations.

Eligibility Criteria:
Inclusion Criteria:

1. Establish prenatal care at 6 - 16 weeks gestation
2. 18-49 years of age
3. Receive their entire prenatal care at the Resident Obstetrics Clinic
4. English and/or Spanish speaking
5. Singleton gestation.

Exclusion Criteria:

1. Establish prenatal care \>16 weeks gestation
2. Non-English or non-Spanish speaking
3. Multiple gestation pregnancy
4. BMI \> 40
5. Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
6. Delivery at institution other than CMC-Main
7. Pregnancy ending in a premature delivery (\< 37 weeks)
8. Limited prenatal care (\<4 visits)
Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis

The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.


Eligibility Criteria:
Inclusion Criteria:

* Must be of Chinese ancestry and living in China.
* Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
* Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.

Exclusion Criteria:

* Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).
Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression

Among antidepressant treatments, Electroconvulsive therapy (ECT) stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). The investigators' current study of tDCS as a treatment for depression suggests that this technique has antidepressant effects and is safe, painless and well tolerated. However, not all patients may respond to this treatment and the concern of possible relapse in some patients who respond to tDCS has raised interest in finding treatments that may enhance and prolong the antidepressant effects of tDCS. This study will investigate whether D-Cycloserine, a medication shown to lengthen the effects of tDCS on brain activity, can also enhance/prolong the antidepressant effects of tDCS in people suffering from depression.


Eligibility Criteria:
Inclusion Criteria:

1. Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
2. Subject completed study HREC 07305.
3. Subject either did not reach remission at the end of trial (defined as MADRS score of ≤ 10) or suffered an early relapse (within a month of finishing the trial).

Exclusion Criteria:

1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder current or within the past year); mental retardation.
2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
3. Inadequate response to ECT in the current episode of depression.
4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used)
Is There Any Differences in Motor and Cognitive Development Between Preterm and Early Preterm Infants?

Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in extremely- very preterm (\<32 weeks) and moderate- late preterm (\>32 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates long term follow up motor and cognitive development in subgroups of preterm infants . Hence the aim of this study is to evaluate the differences in motor and cognitive development in moderate-late (\>32 weeks) and extremely-very preterm infants.

A convenience of infants with premature birth recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Babies divide into two groups according to the gestational ages. Babies with gestational ages between 32-36 weeks and 6 days (including the given days) are categorized as moderate-late preterm, while those born before 32 weeks are grouped as extremely and very preterm. Each group contains 20 babies. First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. It evaluates the baby at prone, supine, sitting, and standing positions. Bayley Scales of Infant and Toddler Development scales screen for cognitive, language, and motor development in babies. All infants will be testing in 3-6-9-12-15-18-24 months of ages.

Eligibility Criteria:
Inclusion Criteria:

* adjusted age of 24 months or less, born with a gestational age of 36 weeks and 6 days or earlier, not having any systemic disease, and accepting to join the study

Exclusion Criteria:

* age greater than 24 months and born with a gestational age of 37 weeks or more
* having major risk factor
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years of age, at the time of signing the informed consent.
* Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen.
* Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
* WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose.
* Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, in accordance with applicable laws.

Exclusion Criteria:

* Known active hepatic disease, End-Stage Renal Disease (ESRD) or known case of serious, uncontrolled medical disorder/active infections which precludes participant's inclusion in the study as per the investigator's judgement.
* Either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug.
* Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Received a live vaccine within 14 days of planned start of study therapy.
* Participation in another clinical study with a study drug administered in the last 3 months.
* Pregnant, breastfeeding, or expecting to conceive while receiving study treatment and for up to 120 days after the last dose of study treatment.
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Evaluation of Buffered Local Anesthesia in Dental Extraction.

To compare pain during injection, onset of anesthesia and effectiveness of anesthesia using buffered versus non- buffered 2% lidocaine with 1:80,000 adrenaline in dental extraction.

The investigators will conduct a prospective, randomized, single-blinded study, the sample will include 100 patients (extraction) who need dental extraction of upper teeth (premolar and molar teeth). The predictor variable is the use of buffered 2% lidocaine with 1:80,000 adrenaline and non-buffered 2% lidocaine with 1:80,000 adrenaline. The patients will be randomly assigned into two groups of 50 patients each using Microsoft Excel 2016; the first group (study group) will undergo dental extraction after receiving buffered 2% lidocaine with 1:80,000 adrenaline, the second group (control group) will undergo dental extraction after receiving non-buffered 2% lidocaine with 1:80,000 adrenaline. The outcome variables include pain during injection, onset of anesthesia and effectiveness of anesthesia on buffered and non-buffered group.

Eligibility Criteria:
Inclusion Criteria:

1. Give written, informed consent (both the subject and the legal guardian).
2. Be 18-65 years of age. 3.Be able to comprehend the visual analog scale (instructions given to ascertain this).

4.Be able to comprehend the verbal rating scale (instructions given to ascertain this).

5.upper premolars and molars extraction.

Exclusion Criteria:

1. Patient under 18 years.
2. pregnant women.
3. patient with uncontrolled systemic disease that are contraindicated for dental extraction. 4- patient taking medication that interfere with the assessment of local anesthetic such as narcotics and antidepressants .
Prophylactic Treatment of Episodic Cluster Headache

The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache

Cluster headache is an unilateral headache with periodic attacks, that usually lasts for 6 to 12 weeks. The pain is usually unbearable. The attacks are treated with injections of sumatriptan (migraine medication)and inhalation of oxygen.

The most common prophylactics today has limited effect and a risk of side effects.

Candesartan has in one study shown a clinically significant effect in migraine prophylaxis.

The angiotensin II receptor blocker, candesartan is well tolerated with side-effects not significantly different from placebo and with few drug interactions. We therefore wish to investigate the prophylactic effect in treatment of cluster in headache patients.

This will be a multicenter, double-blind, randomized, parallel study where the prophylactic effect of candesartan is compared to placebo in a period of 3 weeks. First week 16 mg and the following 2 weeks 32 mg.

Eligibility Criteria:
Inclusion Criteria:

* The episodic cluster headache must be diagnosed according to the IHS classification. Had at least one episode with cluster headache before inclusion. Previously had at least one cluster headache episode lasting one month or more. At the time of inclusion, the cluster headache period shall not have lasted more than 3 weeks

Exclusion Criteria:

* Pregnancy, nursing, decreased hepatic og renal function, psychiatric illness, cardiac problems, hypersensitivity to candesartan, previous serious allergic reaction to medication, chronic cluster headache, drug/alcohol abuse, use of antipsychotic,antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion, systolic blood pressure below 110 mmHg, use of other hypertensive medication, use og other specific attack medication than sumatriptan injection or oxygen 7-10l/min and inability to change medication, use of other triptans than sumatriptan during the study
Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population

The King's Sarcoidosis Questionnaire (KSQ) is a brief questionnaire assessing health status in patients with sarcoidosis. The KSQ was previously validated in English German and Dutch.

KSQ will be translated into Danish and validated in a Danish sarcoidosis population.

KSQ will be linguistic validated according to existing guidelines. Consecutive patients with sarcoidosis will complete KSQ and other health questionnaires at baseline, after two weeks and 12 months. Concurrent validity, reliability, and responsiveness will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent
A Multi-center Prospective Study of Branch Atheromatous Disease in China

Branch atheromatous disease (BAD), is regarded as one of the important etiologies for acute isolated subcortical infarction, especially in Asian population. However, due to the fact that the existing imaging techniques cannot depict small vessel changes, the clinical diagnosis, therapy and research of BAD are facing challenges. We have started a multi-center prospective observational study of BAD in China, aiming at establishing a large-sample clinical-radiological cohort of BAD, analyzing predictors for functional outcome, and exploring the efficacy of tirofiban on BAD. A standardized Case Report Form (and eCRF on website) is used to collect baseline and follow-up information on epidemiological, clinical, radiological（MRI, SWI, MRA, HRMRI,3TVWI）and blood test. The primary outcome was mRS on 90 days with blind evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18-80years
2. Acute cerebral infarction:if the clinical manifestations are TIA, new infarct lesions should be found on DWI at the same time.
3. The time from onset to enrollment is less than 72 hours. If the onset time was unknown, the time of last known free of new ischemic symptoms to enrollment is less than 72h.
4. Meet the following radiological criterial： 1) DWI infarct: single (isolated) deep (subcortical) infarct. 2) The culprit vessels are the lenticulostriate artery or the para-pontine median artery, and the infarct lesion on DWI conforms to one of the following characteri stics(A/B): A. Lenticulostriate artery: ① "comma-like" infarct lesions with "fan-shaped" extension from bottom to top in the coronary position; OR ② ≥3 layers (layer thickness 5-7 mm) on axial DWI images of the head; B. Para-pontine median artery: the infarct lesion extends from the deep pons to the ventral pons on the axial DWI of the head.

3) No ≥50% stenosis on the parent artery of the criminal vessel (i.e. corresponding basilar or middle cerebral artery) (confirmed by MRA or CTA or DSA).

5.Signed informed consent by the patient or legally authorised representatives

Exclusion Criteria:

1. Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions observed by baseline head CT and MRI, MRA/CTA/DSA;
2. There was ≥50% stenosis of extracranial vessels with ipsally serial relationship
3. Cardiogenic embolism: atrial fibrillation, myocardial infarction, valvular heart disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats /min
4. Have received or plan to receive acute endovascular treatment after onset of the disease
5. stroke caused by other clear causes, such as moyamoya disease, arterial dissection, vasculitis, etc
6. mRS score prior to the onset of the disease was ≥2 points
7. Known malignant tumor
8. Life expectancy ≤6 months
9. Can not tolerate 3T MRI examination
10. Pregnant or lactating women
11. Participation in another clinical within 3 months before enrollment, or taking part in another ongoing study.
Using Ultrasonography to Predict Clinical Response to Intraarticular Corticosteroids in Knee Osteoarthritis

The primary purposes of this study are the following:

1. To evaluate whether the presence of inflammatory knee osteoarthritis as determined by ultrasonography can be used as a clinical predictor of patient response to intra-articular corticosteroids.
2. To prospectively evaluate clinical responsiveness of intraarticular corticosteroids with the inflammatory phenotype of knee OA using a randomized, placebo controlled clinical design.
3. To evaluate whether lower extremity strength is improved with intraarticular corticosteroid injection.

The investigators hypothesize that patients with signs of inflammation by ultrasonography such as synovitis and effusion will respond better to intraarticular corticosteroid injection.

Osteoarthritis (OA) has previously been thought to be a non-inflammatory condition whose pathologic hallmark is destruction of hyaline cartilage. It is now realized that OA results from a complex interplay of multiple factors, including local inflammatory processes. Evidence suggests that synovitis which is the usual presenting sign of inflammatory arthritis is also frequently present in OA.

The presence of inflammation in knee OA may explain why intra-articular (IA) corticosteroid injections have been shown to result in clinically and statistically significant reduction in osteoarthritic knee pain. Randomized controlled trials have shown that treated patients were less likely to have continuing pain and had significantly lower scores on a visual analogue scale (VAS) for pain. However, studies have failed to determine clinical predictors of response to IA steroid injection, including traditional indices of inflammation (heat, fluid, stiffness). One possibility is that local corticosteroids do no act to relieve pain by reducing synovitis. These putative mechanisms have yet to be elucidated. Perhaps a more plausible explanation is that current methods of assessing local inflammation in OA are inadequate.

Recent studies involving ultrasonography (US) demonstrate that US is a valid and reproducible tool for the detection of synovitis in the knee. It has been shown to be more sensitive than clinical examination and is relatively inexpensive and noninvasive.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients are eligible for the study if they are between 40 and 80 years old, have symptomatic knee OA requiring treatment, and have not responded adequately to treatment with acetominophen or NSAIDs.

Exclusion Criteria:

* Severe OA as defined by radiographic Kellgren and Lawrence Grade IV
* The patient being wheel-chair bound
* Previous knee operation on the affected side within the past year or history of total knee arthroplasty (affected side)
* Any IA steroid or injections in the last 3 months or viscosupplementation in the last 6 months
* Local sepsis
* Local skin conditions
* Serious concomitant medical illness.
Influence of the Time of Day in the Effect of Caffeine on Maximal Fat Oxidation During Exercise in Women

Caffeine is a natural stimulant with well-recognized metabolic benefits, however, there is a lack of studies investigating the time-of-day caffeine influence to enhance fat oxidation in women. The aim of this study was to evaluate the influence of the time of the day on the effect of caffeine on maximal rate of fat oxidation during aerobic exercise in women.

Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge. Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs. Maximal fat oxidation rate (MFO) during exercise is a remarkable physiological indicator associated with metabolic flexibility/body weight loss and endurance performance To date, it is unknown if caffeine increases MFO in the same proportion during morning and evening exercise trials in women. For this reason, the aim of the present study was to evaluate the influence of the time of the day on the effect of caffeine on MFO in women. We hypothesised that caffeine would increase MFO during morning and evening exercise and this effect would be of similar magnitude at both times of day.

Eligibility Criteria:
Inclusion Criteria:

* To be non-smokers.
* To have low caffeine intake (i.e., \< 50 mg of caffeine per day in the previous 2 months)
* To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
* To have a regular duration of their menstrual cycle for the previous 6 months.
* To confirm no existence of any type of menstrual disorders such as dysmenorrhea, amenorrhea, or strong symptoms associated with pre-menstrual syndrome.

Exclusion Criteria:

-