cyrilzakka/clinical-trials huggingface dataset:
Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators hypothesize quality of PACU outcomes will correlate with preoperative demographic and behavioral characteristics as well as intraoperative and anesthetic procedures/techniques. This study will help the investigators improve post anesthetic care quality and create a higher level of satisfaction for patients, family, and health care providers.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30 years undergoing the following qualifying surgeries:

Genito-Urinary/Urology Department:

* Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and Ureteral Reimplants or Ureteral Stents.

Otolaryngology Department:

* Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy.

Orthopaedics Department:

* Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening.
* Plastic Surgery Department: Alveolar Cleft Repair.

Exclusion Criteria:

* English as a second language.
* \< 6 months, \> 21 or 30 (hip patients only).
* Resident of a residential facility or ward of state.
* Guardianship status unclear.
* Not headed to the PACU post-operatively.
* Day of: Projected to arrive in PACU after 3 PM.
* Duration of surgery well beyond ordinary for procedure type.
* Exceptionally complex medical history.
Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice

Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has chronic pain AND / OR chronic ankle instability
* The current condition of his/her ankle allows the subject to pursue a usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
* Subject is affiliated to the French social security regime

Non-inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (ankle brace or articulated orthosis) during sports sessions during the last month
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, elastane, polyester, synthetic rubber)
* Adult subject to a legal protection measure
Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block.

compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg

In cesarean section, under subarachnoid block the most common complication is hypotension with a reported incidence greater than 80%. Hypotension may occur even after left uterine displacement and preloading with crystalloid. The severity of hypotension depends on the degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of local anesthetic drugs administered. The most effective treatment of hypotension associated with cesarean section under subarachnoid block is the administration of vasopressor drugs.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists 1 and 2 patients
* Gestational amenorrhea of \> 32 weeks
* Elective cesarean section
* Patient willing for spinal anesthesia.
* Singleton pregnancy with cephalic presentation.
* Baseline systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 70-89 mmHg.

Exclusion Criteria:

* Any contraindication to spinal anesthesia, i.e., local infection at the site of injection
* valvular heat diseases
* bleeding tendency
* any co-morbidity like diabetes mellitus
* liver cirrhosis
* renal failure
* any obstetric complications like placenta previa
* pregnancy-induced hypertension or HELLP syndrome
* multiple gestations
* fetal malformation
* coagulopathies
* morbid obesity and spine deformity
* profound hypotension (total spinal) bradycardia and need atropine and severe bleeding
Reproductive and Mental Health of Patients With Aplastic Anemia

Aplastic anemia (AA) is a hematological disease characterized by bone marrow failure, leading to varying degrees of anemia, leukopenia, and thrombocytopenia. With the advancement of immunosuppressive therapy and hematopoietic stem cell transplantation, the survival of AA patients has significantly improved. However, these treatment approaches may result in reproductive system impairment.

Reproductive health has been a major concern among reproductive-age AA patients. In female patients, it often manifests as irregular menstruation, amenorrhea, and infertility; while in male patients, it may present as reduced sperm count and low sperm motility. The reproductive impairment observed in AA patients may be attributed to various factors, including the disease's underlying pathophysiology, side effects of used medications such as androgens and the toxicity conditioning agents during transplantation.

Notably, immunosuppressive agents (such as cyclosporine and antithymocyte globulin) and chemotherapeutic drugs (such as cyclophosphamide) can suppress hematopoiesis and directly damage the gonads, thereby impairing reproductive function. Furthermore, long-term use of these medications may disrupt the endocrine system, affecting the secretion of sex hormones and overall reproductive capacity. Additionally, chronic anemia in AA patients can lead to compensatory physiological changes in other body systems, which may also indirectly affect reproductive health.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AA
* Male or female, aged 18-40 years
* ECOG performance status ≤2
* Willing and able to comply with the requirements for this study and written informed consent

Exclusion Criteria:

* Diagnosis of inherited bone marrow failure syndromes
* Combined with other hematological diseases
* Chemotherapy-induced bone marrow failure
* Pregnant or breastfeeding women
* Subjects with a history of mental illness or severe psychological disorders
* Subjects with a history of reproductive system cancer (eg, penile cancer, testicular cancer, prostate cancer, ovarian cancer, cervical cancer, vaginal cancer, etc.)
* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 to 75 years of age
2. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
4. Willing to provide signed informed consent

Exclusion Criteria:

1. Treatment naïve acromegaly subjects
2. Prior treatment with paltusotine
3. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
7. History of alcohol or substance abuse in the past 12 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
10. Subjects with symptomatic cholelithiasis
11. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
12. Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg
13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
Effect of CI on Prognosis in the Elderly Patients With ACS

This study aims to investigate the incidence and characteristics of cognitive Impairment(CI) in the elderly patients with acute coronary syndrome (ACS), and to determine whether CI are predictive of the prognosis of major adverse cardiovascular events (MACE) and mortality.


Eligibility Criteria:
Inclusion Criteria:

* ≥65yr
* Confirmed ACS diagnosis （include unstable angina, ST-segment elevation myocardial infarction and Non ST-segment elevation myocardial infarction）
* fulfilled MMSE or MoCA
* patients agreed and provided informed consent

Exclusion Criteria:

* Type 2 myocardial infarction and Acute nonischemic myocardial injury
* past history of malignant tumors
* Past history of stroke or dementia
* Hepatic insufficiency (ALT\>8ULN or ALT\>3ULN and TBIL\>2ULN)
* Renal insufficiency (GFR\<15 ml/min/1.73m2)
A Study of Absorption, Metabolism, Excretion of [14C]-NS-580 in Healthy Male Subjects

The purpose of this study was to determine the absorption, metabolism, and excretion of radioactivity and to characterize and determine, where possible, the metabolites present in plasma, urine, and faeces in healthy male subjects following a single oral administration of \[14C\]-NS-580.


Eligibility Criteria:
Inclusion Criteria:

* Males of any race, between 35 and 60 years of age, inclusive.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* History of a minimum of 1 bowel movement per day.

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
Nonsurgical Periodontal Therapy on Banded First Molars

The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment.

A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and divided into two groups.

Group A comprised of 15 patients who were treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars.

Group B comprised of 15 patients who were treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Treatment for both the groups was performed at 3rd month, 6th month and 9th month.

Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month. The differences between the values were assessed and sent for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female patients within the age group 16 to 25 years.
2. Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.
3. Systemically healthy patients.

Exclusion Criteria:

1. Congenital malformations in the oral cavity.
2. Patients who had undergone periodontal therapy within the previous 6 months.
3. Patients using removable orthodontic appliances.
4. Patients who were administered antibiotics or other systemic or topical antimicrobial agents.
5. Smokers.
Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes

The purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.

Vildagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and inhibits glucagon secretion and stimulates insulin secretion. This improves glycemia in subjects with type 2 diabetes with a very low risk for hypoglycemia. If hypoglycemia nevertheless develops, it is important that vildagliptin under such conditions does not inhibit glucagon secretion, since that would aggravate the hypoglycemia. It was indeed previously demonstrated in type 2 diabetes that vildagliptin dos not inhibit glucagon secretion during hypoglycemia. This study explores whether vildagliptin affects glucagon counterregulation during hypoglycemia in insulin-treated patients of type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment. The hypoglycemia is induced bvy a standardized clamp procedure.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin treatment
* Age \>18 years
* HbA1c \<=8.5%

Exclusion Criteria:

* Pregnancy
* Lactation
* Acute infection
* Liver disease
* Treatment with cortisol
Elucidating How Physical Activity and Sleep Relate to Optimal Cognitive Ageing

Increased longevity is one of the greatest success stories in public health. However, ageing is accompanied by cognitive decline which affects people's daily functioning and, if it develops to dementia, their ability to live independently. By 2050, the number of people who develop dementia will triple to 152 million. The aim of this project is to precisely examine how physical activity (PA) and sleep, both modifiable lifestyle factors, are related to cognitive function and which role they can play in optimal cognitive ageing. To do so, a longitudinal study will be conducted, with objective measures of PA, sleep and cognition in midlife and older adults. This project will meet the current need for longitudinal studies with objective PA and sleep data, as well as provide, for the first time, in-depth information on associations of type of PA (aerobic vs muscle strengthening), characteristics of sleep (quality vs quantity) with specific cognitive domains (executive function and memory). Furthermore, although PA and sleep are related, the behavioural dynamics of combinations of PA and sleep on cognition has never been studied before. To fill this gap, these relationships will be examined with an innovative statistical approach, looking at data across a 24-hour period. The resulting deeper understanding of the precise relationship between PA, sleep and cognitive function will contribute to the development of preventive interventions for maintaining cognitive health at older age.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling, healthy adults aged 55 and above

Exclusion Criteria:

1. has a neurodegenerative disease such as Parkinson's, Alzheimer's, MS...; or
2. has a psychiatric illness such as bipolar disorder, OCD...; or
3. has had a serious brain injury in the past year or before that is still affecting them; or
4. has had a brain haemorrhage; or
5. is currently experiencing a depressive episode; or
6. has a history of addiction or excessive alcohol abuse; or
7. uses a sleeping device (for sleep apnoea); or
8. has chronic insomnia (diagnosed insomnia); or
9. is severely limited in performing daily activities (up and down stairs, walk ...)
10. has a first-degree dementia within the family
11. scores a 23 or lower on the Montreal Cognitive Assessment
Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging

Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under the pectoralis minor muscle in the infraclavicular region of the shoulder. The hypothesis is that ultrasound imaging can be used to visualize brachial plexus compression and distortion of the pectoralis muscle during arm activity, such as abduction, and that normal subjects will not demonstrate any plexus compression or muscle distortion.

Four patients with thoracic outlet syndrome (TOS) underwent clinical exam and nerve testing to prove that they had TOS and no other nerve abnormality. They subsequently had ultrasound imaging of the shoulder (infraclavicular region) at rest and during arm abduction stress testing. Two control subjects had similar clinical exams and nerve testing to prove they did not have TOS, and then underwent similar ultrasound stress testing. The TOS patients demonstrated brachial plexus compression and pectoralis minor muscle distortion during the stress tests, and the normal subjects showed no plexus compression or muscle distortion.

Eligibility Criteria:
INCLUSION CRITERIA:

Thoracic outlet patients must have:

* symptoms consistent with thoracic outlet syndrome, and
* no electrical testing abnormality, and
* positive arm abduction stress tests.

Normal subjects must have:

* no upper limb symptoms, or
* normal nerve testing, and
* negative arm abduction stress test

EXCLUSION CRITERIA:

Thoracic outlet patients excluded if they have:

* nerve test abnormalities, or
* negative arm abduction stress test

Normals excluded if they have:

* abnormalities on nerve testing, or
* positive arm abduction stress tests
Integrated Treatment for Smoking Cessation & Anxiety in People With HIV

During the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. During the two-year pilot RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for HIV+ smokers with interfering psychological distress.

This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The 1-year formative phase of the study will develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be conducted with a small group of individuals (N = up to 12). This phase will be used to establish feasibility of treatment delivery, and participant acceptability before conducting a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The pilot RCT phase of the study (years 2 and 3), will test the developed cognitive-behavioral intervention in a pilot randomized-controlled trial format. The outcomes for this trial will be to determine the acceptability and feasibility of the intervention and the potential for an effect on increasing point prevalence abstinence and deceasing psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Informed consent
* Daily smoker
* Motivated to quit smoking

Exclusion Criteria:

* Use of other tobacco products
* Untreated or unstable psychiatric disorders
* Current use of cognitive-behavioral therapy or medication for smoking cessation treatment
* Insufficient command of English