cyrilzakka/clinical-trials huggingface dataset:
Posturography Changes During Pregnancy

Determine balance changes during pregnancy

The subjects will be tested at enrollment and during weeks 20, 24, 28, 32, 36, 40 of their pregnancy, as well every 4 weeks postpartum up to 6 months. The following protocol will be used:

1. Subjects will also be asked to answer a short health questionnaire.
2. The following data will be recorded each time: height, minimum stance width, circumference measurements of the chest, abdomen, hip and each thigh as well as a supine fundal height. A full body side-profile photo was also taken to determine the curvature of the spine.
3. A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity.
4. In a seated position, the following measurements will be recorded: 1-minute heart rate variability (HRV) with paced breathing, temporal scan body temperature, respiration rate, heart rate, blood pressure and SpO2 (these last three will be measured bilaterally).
5. Subject will undergo posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: four 30 s tests in the following conditions: eyes open on a rigid surface (NSEO), eyes closed on a rigid surface (NSEC), eyes open on a compliant surface (PSEO), and eyes closed on a compliant surface (PSEC).
6. At the end of the posturography testing, heart rate, blood pressure and SpO2 will be re-measured bilaterally in the standing and then seated positions, as will be the seated HRV.

Eligibility Criteria:
Inclusion Criteria:

* healthy women less than 20 weeks pregnant

Exclusion Criteria:

* women affected by any pathology and/or more than 20 weeks pregnant
Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lower respiratory tract infection.
* Patient is male or female \> 6 months and \< 12 years of age.
* Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
* Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information

Exclusion Criteria:

* Known hypersensitivity to or previously intolerant of macrolides.
* Illness severe enough to warrant hospitalization or parenteral therapy.
* Concomitant use of any of the following medications:

  * Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
  * Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
  * Colchicine
  * Digoxin
  * Ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment.
Prospective Study on Cesarean Wound Outcomes

This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads.

The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver impregnated dressing.

The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Elective and emergent cesarean deliveries
* Primary and repeat cesarean sections
* Transverse skin incisions (Pfannenstiel)
* Low transverse uterine incisions
* Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby
* Single and multiple gestations
* Able and willing to provide written informed consent

Exclusion Criteria:

* Patients that did not receive routine prophylactic dose of antibiotics in the operating room.
* Skin incisions other than Pfannenstiel
* Uterine incisions other than low transverse
* Patients with known or discovered allergy to silver or nylon
Aminoacidemia and Protein Kinetics in Response to the Ingestion of Plant-based Protein Blends

The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate.

Whey protein is considered the 'gold standard' to maintain body proteins (muscle, skin, bone). When isolated from milk, whey protein isolate (WPI) contains all nine essential amino acids (EAA) which are 'building blocks' that are needed to support the maintenance of body proteins. To date, there is no plant-based protein (PBP) isolate that compares to the recommended WPI towards how our body builds or supports our muscles. WPI is considered the 'gold standard' because it contains all of the EAA which provide the right amount of 'building blocks' to support our muscles. Current PBP isolates available contain insufficient amounts of EAA, and are less digestible, resulting in less 'building blocks' available to support our muscles. Recently, plant protein combinations have been designed to provide the right amounts of all the EAAs. Therefore, the aim of the present study is to determine the effects of a novel PBP blend on muscle protein synthesis responses by comparing it to WPI.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, between the ages of 18 - 30 years (inclusive)
2. Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
3. Be in general good health as assessed by a general health questionnaire
4. Non-smoking
5. Regular menstrual cycle and not using hormonal contraceptives
6. Willing and able to provide informed consent

Exclusion Criteria:

1. Currently using analgesic or anti-inflammatory drugs
2. A history of neuromuscular problems or muscle and/or bone wasting diseases
3. Any acute or chronic illness, metabolic disorders
4. Currently using corticosteroids
5. Use of hormonal contraceptives or anabolic steroids (e.g. testosterone)
Perceptions of Cigarette Smoking in Young Adults

This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).

The study will occur in three phases.

In session 1 of Phase 1, participants will engage in ad libitum smoking session of one's preferred cigarette brand (menthol or non-menthol). In session 2, participants will take several puffs each of a commercially available menthol and non-menthol cigarette (i.e., Camel Crush) and complete a complete a series of pre-post smoking questionnaires, and in Session 3 participants will complete a computerized task to measure perceptions of cigarette smoking. For the computerized task, participants will be able to "win" points toward earning puffs of a cigarette and will be able to smoke puffs earned. Participants will be asked to abstain from smoking for at least 12 hours before each in-person visit.

Phase 2 participants will engage in 14 days of surveys they will complete on their cell to measure different aspects of smoking behavior. These surveys will happen twice a day at random times.

For phase 3, participants will complete an assessment of smoking behavior and related factors 6-months after the baseline assessment either in-person, in the laboratory, or via telephone or online (if in-person follow-up is not viable).

The order in which phases occur differed was a result of COVID-19 restrictions on data collection. For some participants, they started EMA first and then began laboratory data collection when in-person was allowed. For others, they started laboratory data collection when COVID restrictions were lifted. Thus, the participant flow may appear unbalanced.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-26
* Currently smoke cigarettes "everyday" or "somedays"
* A strong preference for menthol or non-menthol cigarettes
* able to read and understand the consent form
* willingness to abstain from nicotine or tobacco products for at least 12 hours prior to smoking sessions

Exclusion Criteria:

* Current use of nicotine replacement therapy
* Pregnant or planning to become pregnant; or breastfeeding
* self-reported diagnosis of lung disease, including asthma, cystic fibrosis, or chronic obstructive pulmonary disease; or
* self-reported history of cardiac event or distress within the past 3-months
The Effect of Periodontal Treatment on the Level of Free Radicals in the Saliva

This study will examine the relationship between free radicals in the saliva and periodontitis. 30 adults, 15 with periodontitis and 15 as a control group will give a sample of saliva before treatment and after treatment. The investigators will examine the free radicals in both groups.

Periodontal disease is a chronic adult condition. Bacteria implicated in the etiology of this disease causes destruction of connective tissue and bone. As a result of stimulation by bacterial antigen PMN produces free radicals via respiratory burst as a part of host response to infection.

Free radicals can be defined as molecules or molecular fragments with an unpaired electron which imparts certain characteristics to the free radicals such as reactivity . Reactive free radicals are able to produce chemical modifications and to damage proteins, lipids, carbohydrates and nucleotides in the tissues.

Eligibility Criteria:
Inclusion Criteria:

* older than 18
* no medical problems

Exclusion Criteria:

* medical problems
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.


Eligibility Criteria:
Inclusion Criteria:

* 1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 3. Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer. 4.Cohort 1: patients had received ≤1 line of treatment. 5.Cohort 2: patients had not previously received systemic antitumor therapy. 6.Has at least one measurable lesion according to RECIST1.1 criteria. 7.Adequate laboratory indicators.

Exclusion Criteria:

* 1. Concomitant disease and medical history:

  1. Has other malignant tumors within 3 years;
  2. Has multiple factors affecting oral medication;
  3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
  4. Has active or uncontrolled severe infections before the first dose;
  5. Cirrhosis, active hepatitis#
  6. Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:

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  1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
  2. Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose;
  3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

     3. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.

     4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Preterm Infant Multicentre Growth Study

The purpose of this study is to improve health professionals understanding of preterm infant growth patterns, and to determine if early growth patterns predict risks of adverse metabolic and cognitive outcomes.

The purpose of this study is:

To improve health professionals understanding of preterm infant growth patterns, and to determine if growth patterns (rapid early growth in the first 2 weeks of life, weight less than the 10th percentile at the time of discharge) predict risks of adverse metabolic outcomes (measured as overweight at age 3) once the following variables are controlled for: size at birth (z-score), neonatal morbidities, social determinants of health, and nutritional adequacy in the neonatal intensive care unit (NICU).

To assess diagnostic accuracy of 36-week anthropometric weight, length and head circumference \<10th and \<3rd percentiles to predict preterm infant cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* \< 32 weeks gestational age at birth

Exclusion Criteria:

* infants who had congenital anomalies or those who died prior to discharge
Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.

This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.

Previous studies showed abnormal vestibular activity in major depression patients using caloric vestibular tests. The present study investigates the vestibular response to vestibular rotatory tests in major depression subjects and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* male and females adults (18 years or older)
* met the Diagnosing and Statistical Manual of Mental Disorders (DSM-IV-R, American Psychiatric Association, 2000) criterion.
* had a score of 12 or more in the Hamilton Rating Scale, 21 items for Depression.
* with or without actual pharmacological treatment, except benzodiazepines that were suspended 24 hours before the rotary test when corresponding.

Exclusion Criteria:

* pregnant women
* neurologic disorders.
German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q)

The SCD-Q (Subjective Cognitive Decline-Questionnaire) is an established instrument to quantify self-perceived cognitive decline. Both self- and informant-rated versions of the SCD-Q are available. However, the SCD-Q has not been validated in the German language yet. Hence, the investigators aim to validate the self-reported SCD-Q in a clinical sample in Germany.

The SCD-Q is a well-established screening instrument to quantify perceived subjective cognitive decline. In addition to self-perceived cognitive complaints, a 24-item questionnaire for informants is part of the SCD-Q. It demonstrates high sensitivity and lower specificity for detecting dementia and early cognitive changes associated with dementia. However, the questionnaire has not been translated into German or validated. Plasma biomarkers for amyloid and tau pathology, as well as for neurodegeneration and astrocytic activation, have been developed and show promising sensitivity and specificity for detecting Alzheimer's disease (AD). A relevant proportion of biomarker-positive patients does not convert to mild cognitive impairment or Alzheimer's disease dementia during the disease course. Currently, the predictive value of blood biomarkers remains to be clarified, particularly in conjunction with SCD. This study aims to validate the SCD-Q in German and analyze possible connections with biomarkers and (digital) cognitive tests. Follow-up visits are planned.

Eligibility Criteria:
Inclusion Criteria:

* Medical appointment for dementia diagnostics at the Alzheimer Therapie- und Forschungszentrum
* Provision of signed, written and dated informed consent
* Capacity to give informed consent

Exclusion Criteria:

* dementia in a very advance stage
* Illiteracy
Study of Memantine to Treat Huntington's Disease

To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).

Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 or older.
* Diagnosis of HD with current complaints of memory or concentration difficulties.
* Dementia Rating Scale score of \<129, to ensure that patients have sufficient cognitive impairment.
* Adequate visual and auditory acuity to allow neuropsychological testing.
* Good general health with no additional diseases expected to interfere with the study.
* Patient is not institutionalized.
* Sufficient English skills to complete all testing without assistance of an English language interpreter.
* Availability of a responsible caregiver who agrees to supervise administration of study drug, monitor the patient's compliance and adverse events, and accompany the patient to all clinic visits.

Exclusion Criteria:

* 1. Any significant neurologic disease other than HD.
* Severe psychotic features or other severe psychiatric problems within the last three months which could lead to difficulty complying with the protocol.
* History of alcohol or substance abuse within the past two years (DSM IV criteria).
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
* History of MI in the past year or head trauma with loss of consciousness greater than 20 minutes.
* Insulin-requiring diabetes.
* Use of any FDA approved cognitive enhancing prescription medications or investigational drugs within 30 days.
* Use of ginkgo biloba or DHEA within four weeks prior to baseline.
* Use of narcotic analgesics within 4 weeks prior to baseline.
* Patients who, in the investigator's opinion, would not comply with study procedures.
Spontaneous Haematomas of Psoas Occurring in Intensive Care

Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Psoas hematoma diagnosed during hospitalization

Exclusion Criteria:

* Refusal to participate in the study
The Periviable Birth Plan

Pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over their own pregnancy. There is some evidence that more counseling and planning can help reduce maternal stress and anxiety. Patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old.
* Currently Pregnant
* High risk of pre-term birth in the periviable period 20+0 to 25+6 wga

Exclusion Criteria:

* Intrauterine Fetal Demise (prior to admission)
* Inability to read or communicate in english
Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department

The purpose of this study is to determine the incidence of recall in patients managed in emergency department with a procedural sedation protocol using propofol in a population of 250 .

After procedural sedation for fracture or joint dislocation reduction using propofol, adult patients recall will be assessed with a standardised form. This recall assessment will be realised 2 hours (+/- 15 minutes) after the procedural sedation and the day after.

The primary outcome measure will be the recall incidence 2 hours (+/- 15 minutes) after a procedural sedation. A secondary outcome will be the recall incidence one day after the procedural sedation.

The recall will be defined by a positive answer to the third question of the Sandin form (Lancet. 2000;355(9205):707-11).

Eligibility Criteria:
Inclusion Criteria:

* Adults patients (\> 18 years old) who had a procedural sedation in emergency department using propofol for fracture or joint dislocation reduction
* Patients who received an initial injection of Propofol by slow intravenous injection of 1 mg/kg in 20 seconds
* Inclusion less than 2 hours from the injection of Propofol
* Patients who have signed a consent to participate in the study
* Patients covered by social security.

Exclusion Criteria:

* Patients under 18 years old
* Patients who cannot signed the informed consent
* Patients who had procedural sedation using other drugs that propofol
* Participation in another study type biomedical research
Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block

Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.

Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia.
* Surgery confined to the foot and ankle.
* Patients aged 18-70 years.

Exclusion Criteria:

* ASA Classification of 4 or higher.
* Pre-existing neuropathy
* Coagulopathy
* Infection at the site
* Diabetes
* Non-English speaking or reading patients
* Systemic use of corticosteroids within 6 months of surgery
* Chronic opioid use
* Pregnancy
* Large (\>3cm) skin incision around the medial aspect of the foot
* Any other contra-indication to regional anesthesia