cyrilzakka/clinical-trials huggingface dataset:
Maternal Acupuncture for Substance Abuse

To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..

Potential study subjects will be recruited from the Chemical Dependency Unit by a trial coordinator. After obtaining written informed consent, the coordinator will take a sequentially numbered opaque envelope from a box on the unit. This envelope will contain a card indicating the treatment group to which the woman is allocated. Women participating in the treatment group of our study will have access to a quiet room furnished with comfortable reclining chairs. The acupuncturist will swab the ears with alcohol and insert sterile, disposable needles. Following the treatment, which is 45-minutes in length, participants will remove the needles themselves and place them in protective sharps boxes. A sham acupuncture procedure will not be used. Chinese traditional medicine does not include the concept of a placebo. Those who argue that auricular acupuncture stimulates the vagus nerve, which innervates the ear concha state that needles placed anywhere in the concha should produce the same effects. 58 Studies utilizing sham procedures have failed to show a difference between the control and active experimental conditions.

In this unit, morphine is prescribed for the neonate by pediatricians (11 in total) if there is a constellation of symptoms unresponsive to environmental control including: 1) convulsions, 2) inconsolability or crying continuously for 3 hours, 3) persistent tremors or jitteriness when undisturbed, 4) continuous central nervous system irritability including hyperactive Moro reflex, tremors, jitteriness, increased muscle tone and unprovoked muscle jerks, 5) persistent vomiting or projectile vomiting over a 12 hour period; or 6) explosive diarrhea for 2-3 consecutive episodes. Additional clinical signs such as tachycardia, tachypnea, watery stools, fever, or weight loss \> 10% may justify use of morphine after consideration of differential diagnoses. Morphine 1mg/ml is started at a rate of 0.03 mg/kg/dose every 3 hours. The dose is reviewed daily and titrated based on daily weights and ongoing symptoms.

Eligibility Criteria:
Inclusion Criteria:

Women admitted to the chemical dependency unit at BC Women's Hospital, Vancouver, B.C.

Exclusion Criteria:

* Women who neither read nor write English
* Having a pacemaker or any other electrical implants
* Bleeding disorder or on anti-coagulants
* Conditions putting someone at particular risk for infection including damaged heart valves or prior heart valve surgery, history of myocardiopathy, diabetes requiring insulin, history of knee or hip replacements, immunosuppressive drug therapy, open wounds.
CavatermTM vs TCRE in Women With DUB

The purpose of study is to compare the treatment success in the study groups.

Study success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC\<75.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and adequate mental capacity to sign written, informed consent
* Willingness to adhere to study plan regarding control visits and recording of PBLAC
* \> 30 years old
* Pre-menopausal as determined by FSH ≤30
* Agree not to use hormonal contraception or any other intervention for bleeding during study
* Suitable for local and/or general anesthesia
* A minimum PBLAC score of ≥ 150 for three months prior to study enrollment; OR PBLAC score 150 for one month for women who 1) had at least 3 (documented) prior months of failed medical therapy; 2) had a contraindication to medical therapy; or 3) refused medical therapy
* Uterine cavity sound measurement ≥ 4 cm and ≤ 10 cm.

Exclusion Criteria:

* Presence of bacteriaemia, sepsis, or other active systemic infection
* Active pelvic inflammatory disease
* Clotting defects or bleeding disorders
* Unwillingness to use a non-hormonal birth control post-ablation
* Desire for future fertility
* Abnormal cavity as confirmed by hysteroscopy, transvaginal ultrasound or HSG e.g. large fibroids, septum etc. Small submucosal fibroids defined as \< 2 cm are in this context not considered abnormal.
* Any condition leading to possible uterine wall weakness with total wall thickness \< 15 mm e.g. at c.section, postmyomectomy scars etc. In case of uniform uterine wall the wall thickness at the fundus should be measured.
* Premalignant or malignant uterine condition within the last five years as confirmed by histology
* Pregnancy
* Cervical length \> 6 cm.
* Uterine cavity \>30 ml defined as balloon can be filled with 30ml glucose solution without reaching the target pressure of 240 mmHg. (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately. The patients will be recorded as screening failures).
* Previous ablation or subtotal hysterectomy
A Study of Merestinib (LY2801653) in Healthy Participants

The purpose of this study is to evaluate the effect of food on merestinib (standard meal and high-fat meal) compared to the fasted state. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In addition, the tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last approximately 28 days. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy sterile male and female participants
* Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Are willing and able to eat the protocol specified high-fat breakfast

Exclusion Criteria:

* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have donated blood of more than 500 milliliters (mL) within the last month
* Cannot stop taking over-the-counter (OTC) or prescription medications that alter gastric pH, at least 14 days prior to first dosing
* Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product
Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study

Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.

The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:

* predict the severity of pain;
* select most suitable pain relief therapy for the patient.

The day after surgery, some serum markers are determined by a blood sample.

The markers analyzed are:

* Leukocytes;
* C-reactive protein (CRP);
* D-dimer;
* Fibrinogen;
* Neutrophil-to-Lymphocyte Ratio (NLR).

Pain level is assessed using the NRS scale at different times:

* 1st post-operative day;
* 7th post-operative day;
* One month after surgery;
* Three months after surgery;
* Six months after surgery.

Other data collected for the study are: gender, age, BMI.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing Open Tension-free Inguinal Hernia Repair

Exclusion Criteria:

* children
SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)

The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease.

SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses neurochemical and psychopharmacologic features that suggest it could improve memory and cognition in humans. The primary objective of the SGS742 clinical trial will be to determine the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* 55 to 90 years of age
* Diagnosed with mild to moderate Alzheimer's disease
* Willing caregiver
* In general good health

Exclusion Criteria:

* Call 1-877-MY-MEMORY and ask to be referred to a study center located near you for entry criteria information.

Prohibited Meds:

* Alzheimer's medications (Aricept, Exelon, Remydl, Nemenda)
A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)

This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. women aged 18-70 years old;
2. ECOG score: 0-2 points;
3. the expected life period is more than 3 months;
4. Histologically confirmed metastatic breast cancer: locations include central lung lesions, peripheral lung lesions or liver metastases;
5. PET-CT or other imaging showed patients with ≤3 metastastatic sites, involving 1-2 organs mentioned above, single lesion ≤5cm;
6. according to the RECIST 1.1 edition, there is at least one measurable lesion;
7. the main organs are functioning normally, meeting the following criteria: Blood routine: Hb \> 90g/L (no blood transfusion within 14 days); ANC \> 1.5 x 109/L; PLT \> 75 \* 109/L;Liver function: total bilirubin TBIL is less than 1.5 x ULN (upper limit of normal value); ALT and AST are less than 3 x ULN; if there is liver metastasis, ALT and AST are less than 5 x ULN;Renal function: serum creatinine \< 1 x ULN;
8. participants voluntarily joined the study, signed informed consent, and followed up.

Exclusion Criteria:

1. the number of metastastatic sites ≥ 3, or the surgeon determines that the R0 resection cannot be achieved;
2. with metastatic lesions other than liver or lung
3. patients with local recurrence
4. palliative radiation therapy or interventional therapy have been performed previously for metastatic lesions
5. has received systemic treatment for metastatic disease, such as chemotherapy, targeted therapy, endocrine therapy, immunotherapy, etc.
6. pregnant or lactating women, women of childbearing age who cannot practice effective contraceptives;
7. involvement in clinical trials of unlisted drugs within 4 weeks before the start of this study;
8. severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;
Effects of Resistance Exercise Compared to Whole-body Electromyostimulation in Young Female Dentists.

Due to their high workload and unfavorable working position, young female dentists are particularly at risk of cardiometabolic diseases and an early reduction in bone mineral density (BMD). With focus on the latter issue, short bouts of resistance exercise with high strain magnitude and velocity are commonly considered to be a feasible option to prevent bone loss in the early years of young adulthood. In parallel, whole-body electromyostimulation (WB-EMS) a trainings technology able address all main muscle groups simultaneously, however with dedicated exercise intensity might be a time-effective, joint friendly and safe option to maintain BMD in people unable or unmotivated to exercise conventionally. In the present study, we aim to compare the effects of a single session of WB-EMS versus high intensity, high velocity resistance exercise on biomarkers of bone formation (Procollagen type 1 N propeptide, P1NP) and resorption (C-terminal telopeptide of type I collagen, CTX-I). We hypothesize that no clinically relevant different effects on P1NP and CTX-I were determined.


Eligibility Criteria:
Inclusion Criteria:

* female dental students (\>3rd semester) or licensed dentists
* no competitive sports background for \>2 years
* normal body mass (BMI\>18,5 and \<25 kg/m2)

Exclusion Criteria:

* more than one resistance exercise session per week (last 12 month)
* whole-body electromyostimulation during the last 12 month
* amenorrhea, oligomenorrhea
Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics

The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.

The currently available therapy for radionuclide internal contamination is suboptimal. Pharmacological and toxicological data support the clinical development of HOPO 14-1 for decorporation of radionuclides.

Eligibility Criteria:
Inclusion Criteria:

* Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements
* Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential.
* In good general health based on medical history, physical examination (PE), and screening evaluations.
* Negative urine or blood screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen).
* Body weight ≥ 50 kilogram (kg) and ≤ 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be ≤ 40 kg/m\^2.

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher.
* Any clinically significant electrocardiogram (ECG) abnormality
* Pregnant or breastfeeding
* Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol.
* Received an organ transplant (solid or bone marrow).
* Received a blood transfusion within 3 months of dosing.
* Difficulty swallowing tablets or capsules.
* Febrile illness or significant infection within 7 days of dosing.
* Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing.
* Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
* Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing.
* Chelation therapy (e.g., ethylenediaminetetraacetic acid \[EDTA\], diethylenetriamine pentaacetate \[DTPA\]) in the past year.
* Use of laxatives, antibiotics, and/or antacids within 7 days of dosing.
* Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer.
* Received a vaccination within 30 days of dosing.
* Potential allergic reaction to product (oleic acid or HOPO 14-1 product).
* Past or current medical problems or findings from physical examination (PE) or laboratory testing
Young Adult Infusion Space Experience Satisfaction Survey

The purpose of this study is to compare the satisfaction of Adolescent and Young Adults (AYA) receiving treatment in two different infusion spaces at the North Carolina Basnight Cancer Hospital (NCBCH). A survey and semi-structured interviews will be administered to participants to compare the experience with the built environment, with mental health staff, and between outpatient infusion spaces at NCBCH.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age 18-39 years old at enrollment.
4. Receiving treatment for a cancer diagnosis in Adult Infusion Center or the Adolescent and Young Adult Infusion Center
5. English speaking.

Exclusion Criteria:

1. Dementia, altered mental status, or any psychiatric condition as determined by the clinical or study team that would prohibit the understanding or rendering of informed consent.
2. Current incarceration.
Bioequivalence Minocycline Bioequivalence

The aim of the study is to compare the bioavailability of two medications containing 100 mg of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is randomized, open, cross-over with two single administrations with two periods and two sequences with a wash-out period of 7 days between the periods. Subjects in the study will be 25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours after medication administration in each period. Plasma minocycline levels will be determined by HPLC method with UV detection with previously validated method. Minocycline concentration data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The log transformed pharmacokinetics parameters of test and reference medications will be compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.


Eligibility Criteria:
Inclusion Criteria:

Males 18-55 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent.

Exclusion Criteria:

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation ≥ 450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.
Optimization of Oral Diet in Critically Ill Patients

The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.

This is a prospective randomized controlled single center clinical trial. This trial include patient over 18 year hospitalized in ICU and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress. The randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure The day of the resumption of the oral feeding (J0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group

Control group:

* Nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients
* Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
* Nutritional evaluation before the release of resuscitation.

Intervention group:

* NAP: "Customized Adapted Nutrition"
* Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
* Therapeutic education.
* Nutritional evaluation before the release of resuscitation.
* Creation at the exit of resuscitation of a nutritional linkage sheet with instructions food

The prospects for optimizing oral replenishment are multiple:

* reduce morbidity and mortality within 3 months after a stay in intensive care unit.
* improve autonomy and quality of life after a stay in intensive care.
* improve the privileged relationship with the patients' families.
* strengthen links within the resuscitation team and with downstream services.
* Educate patients on a nutritional level.

Eligibility Criteria:
Inclusion Criteria:

- patient 18 yo or above hospitalized in ICU and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress

Exclusion Criteria:

* age under 18 yo, pregnancy,
* protected patients
* moribund patient (life expectancy of 48h or below),
* patient with disorders of swallowing
* tracheostomy
* patient with shock and/or respiratory distress
The Effect of Virtual Reality-Mediated Rehabilitation in Ischemic Stroke Patients

The aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke.

This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PMR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group). Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (total 450 minutes). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.

After the intervention, patients will be evaluated in terms of upper extremity functions, quality of life, range of motion and spasticity.

All evaluations will be repeated before, after and 3 months after the intervention. Routine 3-month PMR outpatient clinic control is recommended for patients with stroke. Therefore, no additional hospital visit is requested from the patients due to the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age,
* History of Ischemic Stroke
* Accept to participate in the study,

Exclusion Criteria:

* Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurologic deficit,
* Uncontrolled hypertension, diabetes, cardiovascular disease etc.
* Cognitive impairment causing difficulty in executing simple commands
* Epilepsy
* Botulinum toxin application to the upper extremity in the last 6 months
* Change in the medical treatment used for spasticity in the last 6 months
* Pregnancy.