cyrilzakka/clinical-trials huggingface dataset:
Maxillary Expansion Effects in Children With Upper Airway Obstruction

The most frequent causes of mouth breathers are the adenotonsillar hypertrophy. Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this surgical treatment does not have its effect well elucidated and apnea has been cited in the literature as a residual outcome. Other types of supporting treatment may also been involved such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among them rapid maxillary expansion (RME).

RME corrects the morphological constriction of the upper arch caused by buccal breathing and also reduce the airway resistance. Despite reports of RME influencing volume enhancement in pharyngeal airway, there are still few three-dimensional studies following the post-expansion effects. In addition, these changes are doubtful due postural changes of the tongue during the tomography exam. Conflicts of results are also present for changes in the nasal septum of children. The main alteration mentioned is the increase in the length of the lower third of the septum.

The investigators propose a randomized, prospective, controlled clinical trial in patients with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is elucidate if there is different outcomes considering the moment of RME treatment before or after the adenotonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

* Children (boys and girls) between 5 and 9 years of age.
* Atresic maxilla.
* Skeletal Class I
* With or without Adenotonsillar hypertrophy
* Parents or tutors sign Informed Consent.

Exclusion Criteria:

* Craniofacial syndromes or neurologic disease diagnosis.
* History of adenotonsillectomy and orthodontic treatment
* History of facial trauma
* Morbid obesity
* Premature loss of posterior teeth
Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful?

This is a randomized, single-blind study using oxytocin 5U i.v. during surgical abortion in one arm of the study, and no medication in the other arm of the study. Comparison is done between the two groups measuring the following outcomes: pain, nausea and blood loss. The investigators' hypothesis is that there will be no significant differences between the two groups.

All women seeking surgical abortion before 12 weeks of pregnancy will be invited to participate in the study. We will include 400 patients. Written consent is given. Pain is measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively. Nausea is categorized in 4 groups, from 1 (no nausea) to 4 (pronounced nausea with vomiting)and is registered together with bloodloss also during the hospital stay (2 hours) and 2 days postoperatively. The two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* seeking legal abortion
* first trimester
* surgical intervention
* no current medication
* fluent in norwegian language

Exclusion Criteria:

* current medication
* medical condition with coagulopathy
Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.


Eligibility Criteria:
Inclusion Criteria:

* IVH grade 3-4
* age : within postnatal day 28
* gestational age: 23-\<34 weeks

Exclusion Criteria:

* Patient with severe congenital abnormalities
* Patient with antenatal brain hemorrhage
* Patient with asphyxia or Hypoxic ischemic encepalophathy
* Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
* Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
* Patient withCRP \> 30 mg/dL; Severe sepsis or shock
* Patient with a history of participating in other clinical studies
* Patient who is considered inappropriate to participate in the study by the investigator
A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers

The project's primary aim is to evaluate the effectiveness of a multi-level heat prevention approach in reducing adverse heat health effects in outdoor agricultural workers

The secondary aims are to:

* Test the effectiveness of an individual-level training component designed to reduce adverse heat health effects in outdoor agricultural workers
* Evaluate the effectiveness of a workplace supervisor-level heat awareness application intended to support supervisor decisions to reduce the risk of workers experiencing adverse heat health effects


Eligibility Criteria:
Inclusion Criteria:

* Speak English or Spanish, live in same dwelling and work at same farm for the season, farm where participant works must agree to collaborate

Exclusion Criteria:
Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening

The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (PSA) screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.

Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.

In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men's ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.

Eligibility Criteria:
Inclusion Criteria:

* Worksites employing at least 100 men in target age group (45-65 years old)

Exclusion Criteria:

* Worksites with high turnover
* Non-English speaking workers
* Temporary or contract workers
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.

An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥18 years.
2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
3. Eastern Cooperative Oncology Group performance status 0 or 1.
4. Adequate renal, liver, cardiac and pulmonary organ function.
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX131 infusion.

Key Exclusion Criteria:

1. Prior treatment with anti-CD70 targeting agents
2. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
3. Presence of uncontrolled bacterial, viral, or fungal infection.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
6. Women who are pregnant or breastfeeding.
Effects of Black Cohosh on Menopausal Hot Flashes

This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.

Most American women will spend the last third of their lives post-menopause. During this time, chronically low levels of steroidal estrogens may lead to a number of short and long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of hormone therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT) and are increasingly exploring alternative approaches to ERT.

For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health. Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part because of lack in study design rigor and the short duration of studies to date. The primary aim of this study is to correct past shortcomings in study design to determine whether treatment with black cohosh is effective in treating menopausal symptoms.

Participants in this study will be given black cohosh for a 12-month period. Potential mechanisms of action of black cohosh will be examined by quantifying the levels of sex hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring the incidence of adverse events and compliance with the study.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the New York Metro Area
* Postmenopausal
* Weight within 90% to 120% of ideal body weight
ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke with zero to six weeks of evolution.
* Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction or finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).

Exclusion Criteria:

* Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA \< 18).
* Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS \> 6) or having limited reach ranges.
* Have severe visual impairment that does not allow to carry out the activities associated with the task.
* Previous stroke with neurological sequelae in the upper extremity.
* Present bilateral sensorimotor alterations.
* Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)
Diabetes Management Intervention For South Asians

The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.


Eligibility Criteria:
Inclusion Criteria:

* South Asian ethnicity (identified through a race and language code available in the EHR);
* an appointment with a physician for routine non-emergent primary care in the last 12 months
* diagnosis of diabetes
* an HbA1c reading of \>7 in the last 12 months

Exclusion Criteria:

* Pregnant women and visits to obstetrician/gynecologist are excluded from the study
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Hemophilia A or B
* ages 2-21 years

Exclusion Criteria:

* therapeutic vitamin D or calcium supplementation within 3 months of study entry
Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

The goal of this clinical trial is to test whether an oral medication (lamivudine) enters the eye and reduces blood markers of inflammation in people who undergo retinal detachment surgery (pars plana vitrectomy).

Participants will take the study medication or placebo, and the researchers will measure blood markers of inflammation before and after surgery. The researchers will also measure the amount of medication in the blood and fluid inside the participant's eye (which is collected during surgery).

Lamivudine is an anti-viral medication that has intrinsic anti-inflammatory properties that could be useful in the treatment of vitreoretinal disease. It is not known whether lamivudine enters the eye after oral administration. The purpose of this study is to measure the intra-ocular concentration of lamivudine after oral administration in participants that require pars plana vitrectomy surgery for repair of rhegmatogenous retinal detachment. Participants undergoing retinal detachment surgery will receive oral lamivudine for three days prior to surgery; lamivudine will be measured intra-operatively (vitreous and aqueous humor) and pre-operatively (plasma). Plasma markers of inflammation will be measured before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 or ≤ 75 years
* Patients with rhegmatogenous retinal detachment that require vitrectomy surgery

Exclusion Criteria:

* Previous pars plana vitrectomy in the affected eye
* Positive for Hepatitis B surface antigen or HIV antibodies, or history of Hepatitis B/HIV
* Pregnant or breast-feeding
* Liver disease or abnormal AST/ALT
* Renal impairment (Creatinine clearance \< 50)
* Diabetes with current use of insulin
* Anemia (Hemoglobin \<13.2 g/dL (male) or \< 11.6 g/dL (female))
* Unwilling to hold concurrent use of sorbitol or sorbitol-containing medications or products while taking study medication(including, but not limited to: blackberries, raspberries, strawberries, stone fruits, apples, avocados, sugar-free items such as chewing gum, hard candies, snack bars, frozen desserts, and chocolates, liquid and capsule/caplet analgesics, cough/cold/flu syrup, liquid and capsule/caplet pseudoephedrine, chewable antacid tablets, liquid and capsule allergy medications, motion sickness and nausea medications)
* Current use of trimethoprim-sulfamethoxazole
* Pancreatitis or history of pancreatitis
* Uncontrolled blood pressure (\> 160 mm Hg systolic or \>100 mm Hg diastolic) within the last 3 months, or current use of more than one anti-hypertensive medication
* History of stroke, myocardial infarction, or congestive heart failure
* Current vitreous hemorrhage that obscures view of retinal details
* Patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe
IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

Eligibility Criteria:
Inclusion Criteria:

* All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

Exclusion Criteria: Women who are:

* Planned or transferred for delivery via Cesarean section
* Not delivering a live birth
* Unable to provide informed consent due to mental impairment, distress during labor or other reason
* Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke

The purpose of this study is to examine the effects of a combination of "Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation" compared to "BT only" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* at least 4 months post stroke
* present with UL spasticity (MAS \>1 in elbow and/or spasticity of the hand, wrist or shoulder)
* present with at lease a stage 3 of CMSA
* able to comply with the requirements of the protocol and UL therapy programme.

Exclusion Criteria:

* significant cognitive and speech impairments
* other upper limb impairments such as frozen shoulder
* another diagnosis which could contribute to upper limb spasticity .
Prevention of Hypertension: A Randomized Trial

To determine whether improved nutrition to correct overweight and high sodium intake, and regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow heart rate could lower blood pressure and prevent development of hypertension in hypertension-prone individuals.

BACKGROUND:

Diet modification is one of the strategies in the primary prevention of hypertension. Studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures. The factors include overweight, alcohol consumption and high sodium intake. Heart rate is also an independent predictor of risk of hypertension. Diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension.

DESIGN NARRATIVE:

In the first phase of the trial participants were randomized to a Monitored (Control) Group or to an Intervention Group receiving individualized intervention to achieve changes in diet and physical activity. The goals of the Intervention Group were: a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight; a reduction in daily sodium intake to 1800 mg; a modification of alcohol intake to no more than two drinks per day; and an increase in regular, moderate physical activity. The primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the Intervention Group versus the Monitored Group. In the second phase of the trial, all randomized participants were followed for a minimum of five years. The primary endpoints in the second phase were the incidence of high blood pressure and/or hypertension.

Eligibility Criteria:
Men and women, ages 30 to 44. Normal high blood pressure of 80-89 mm Hg.