cyrilzakka/clinical-trials huggingface dataset:
Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III)

The purpose of the study is to assess the efficacy and safety of electroacupuncture among women with pelvic organ prolapse(Level II - III), compared with sham electroacupuncture.

After being informed about the study and potential risk, all patients giving written informed consent form will be undergo a 1-week screening period to determine eligibility for study entry. Eligible patients will be randomly assigned to one of the two groups 1) electroacupuncture group: electroacupuncture will be provided to patients at BL33, BL35 and SP6 for 3 time per week for the first 4 weeks, then twice a week for 4 weeks, and once a week for the last 4 weeks. There will be 24 times of treatment in total in 3 month; 2) sham electroacupuncture group: sham electroacupuncture will be provided to patients at sham acupoints to BL33, BL35 and SP6 with the same schedule as electroacupuncture group.The follow-up time for the two groups are 6 months after treatment. Primary and secondary outcome will be measured at 3, 6, and 9 months from the start of the treatment, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. female patients with pelvic organ prolapse at level 2-3 via POP-Q examination;
2. patients at the age of 35 years or older;
3. patients who have a sensation of bulging or protrusion from virginal area, with or without urinary, bowel, and sexual disorders;
4. patients who have a score of PFDI-20 \> 24.
5. Patients who have signed informed consent form and are willing to participate the study voluntarily.

Patients will be included if all above 5 items are met.

Exclusion Criteria:

1. Patients who have cognitive disorders and cannot understand the content of questionnaires;
2. Patients who have severe heart, lung, brain, liver, kidney, hematopoietic system, and immune system diseases, or severe malnutrition;
3. Patients who have cancer or are at terminal stage of severe diseases;
4. Patients who need finger assistance for defecation, or have severe prolapse of rectum, sigmoid colon or small intestine;
5. Patients who have received(or are receiving) treatments for pelvic floor disorders , including pelvic organ prolapse, stress urinary incontinence, and etc in the past one month;
6. Patients who are receiving any treatment for other gynecological diseases;
7. Patients who have symptomatic urinary tract infection with urinary pain and urge, or have residual urine volume ≥ 100ml;
8. Patients who have diseases affecting the neurological function of pelvic organ, e.g. spinal cord injury, or peripheral nerve injury caused by surgery at lumbosacral area or pelvic floor .

Patients will be excluded if they meet any of the above criteria.
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.

This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence. The immediate release form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of schizophrenia and acute manic episodes associated with bipolar disorder. The extended release formulation (SEROQUEL XR®) is also approved by the FDA and is undergoing clinical investigation for the treatment of major depressive disorders, schizophrenia, generalized anxiety disorder, and alcohol dependence.

Treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric diagnoses. Quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol use among alcoholics and drug dependent patients with co-morbid psychiatric illness.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65 years old
* DSM-IV diagnosis of current alcohol dependence as supported by SCID Module E
* Report "very heavy" drinking (10 or more drinks per drinking day for men or 8 or more drinks per drinking day for women) at least 40% of the days during the interval from day 31 to 90 prior to the initial screening visit (i.e. a total of 24 days of this 60-day period), with at least one day of "very heavy" drinking occurring within the last 2 weeks before screening
* Seeking treatment for alcohol dependence and desire reduction or cessation of drinking
* Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
* Females of child bearing potential must agree to use of at least one approved method of birth control, or must be surgically sterile or postmenopausal
* Able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits
* Able to understand written and oral instructions in English and to complete the questionnaires required by the protocol
* Can complete all psychological assessments required at screening and baseline
* Able to provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to study site, and have no plans to move within the next 3 months or unresolved legal problems; must provide contact information of family member, spouse, or significant other who can contact subject in case of missed appointment
* Breath alcohol concentration (BAC) equal to 0.00 when s/he signed the informed consent document
* Must have an absolute neutrophil count of 1.5 x 109/L or greater.

Exclusion Criteria:

Please contact site for additional information.
Insertion of an Intrauterine Device (IUD) After Medical Abortion

The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion.

Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).

Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an intreatuereine device (IUD) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.

Eligibility Criteria:
Inclusion Criteria:

* Women who completed a medical abortion in the last 14 days
* At least 18 years old.
* Desiring long-term contraception with an IUD.
* Able and willing to give consent for participation in research.
* Gonorrhea and chlamydia screen negative within 60 days of entry to study.
* Willing to comply with the study requirements.
* Accessible by telephone.

Exclusion Criteria:

* Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days.
* Allergy to copper, or Wilson's disease (for Paragard; may have Mirena)
* Intracavitary of symptomatic uterine fibroids.
* Ovarian, cervical or endometrial cancer.
* Severe anemia (defined as hgb \< 8).
Sugammadex Hypersensitivity Study (Study P06042)

This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period.

In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.

All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* Serum tryptase \<=11.4 mcg/L and fasting triglyceride levels within normal limits
* Safety laboratory tests and vital signs must have been within normal limits
* Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
* Body Mass Index between 19 and 32 kg/m\^2
* Females must have agreed to use contraceptives
* Other certain administrative criteria as described in the protocol

Exclusion Criteria:

* Females who were pregnant or intending to become pregnant
* Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
* Certain surgical or medical conditions, recent infections, or mental instability
* Positive test for certain drugs or history of alcohol or drug abuse
* Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
* Blood donation in the past 60 days
* A history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia
* History of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities
* Heavy smoker
* Received certain medications in the past
* History of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration
* Other certain administrative criteria as described in the protocol
Impact of the Postponement of Surgery on Postoperative Morbidity After Sars-cov-2 Infection

The deployment of vaccination against SARS-CoV-2 from 2021 led to a modification in June 2021of previous recommendations concerning the postponing scheduled surgery suggesting local adaptations of this delay if epidemic developments appear. Today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. Among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand

Previous studies performed during the first COVID-19 epidemic wave in the first half of 2020 led to the recommendation, after taking into account the individual risk-benefit balance, of postponing scheduled surgery for ideally at least 6 completed weeks in a patient with a positive preoperative SARS-CoV-2 PCR.

The deployment of vaccination against SARS-CoV-2 from 2021 led to a modification of these recommendations in June 2021 suggesting local adaptations of this delay if epidemic developments appear. Today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. Among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand

Eligibility Criteria:
Inclusion Criteria:

* Adult patients,
* Surgery performed in the operating room under general or locoregional anesthesia.
* Result of the preoperative SARS-COV-2 diagnostic test available on the day of the procedure or within 48 hours of the surgery.
* Emergency or scheduled surgery
* All surgical indications will be eligible with the exception of certain surgeries

Exclusion Criteria:

* Minor patient
* Pregnant patient
* Surgery or an intervention performed outside the operating room
* Patient operated under sedation alone,
* Patient under guardianship or curatorship
* Patient without social protection
* Patient previously included in this study
* Patient without preoperative COVID-19 status on day of surgery and not diagnosable within 48 postoperative hours
* Patient whose immediate postoperative follow-up is planned in a structure other than those where the inclusion was made
TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

The primary objective of this study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with refractory or relapsed multiple myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma
* Evidence of relapsed or refractory disease

Exclusion Criteria:

* Intracranial disease or epidural disease
* Clinically significant cardiac disease
* Diabetes mellitus
Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler

Open randomized non-inferiority controlled trial to examine the use of angiogenic factors (instead of feto-placental Doppler) for fetal growth restriction at term to reduce the rate of labor inductions, without worsening perinatal outcomes.

Pregnant women with estimated fetal weight (EFW) \< 10th centile between 36+0 and 37+6 weeks of gestation (WG) will receive complete ultrasonographic assessment consisting of feto-placental Doppler, amniotic fluid measurement and biophysical profile assessment. The cases not meeting any exclusion criteria will be offered to participate in this trial. After giving their informed consent a blood sample will be drawn in all of them and they will undergo randomization into two arms.

1. Intervention arm: In women allocated to the intervention group, the soluble fms-like tyrosine kinase/placental growth factor (sFlt-1/PlGF) result will be revealed to the investigators that will act according to the results of sFlt/PlGF:

   * Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended at ≥37 weeks.
   * Fetuses with sFlt-1/PlGF \<38, weekly follow up will be recommended until delivery (at ≥40 weeks).
2. Control arm: In women allocated to the control group, the sFlt-1/PlGF result will be blinded to caregivers. Routine Doppler-based clinical care will be used to counsel women. Following the Doppler classification:

   * Fetuses with EFW below the 3rd centile or below the 10th centile accompanied by any impaired fetoplacental Doppler, elective delivery will be recommended at at ≥37 weeks.
   * Fetuses with EFW above the 3rd centile without any fetoplacental Doppler abnormality, elective delivery will be recommended at at ≥40 weeks.

In both arms, fetuses will receive weekly follow-up from randomization to delivery consisting on feto-placental Doppler sFlt-1/PlGF and CTG. If any of the following is present at any time, earlier delivery will be recommended:

* sFlt-1/PlGF ≥38 (only in the intervention group),
* absent or reverse end-diastolic flow at the umbilical artery Doppler or DV PI\>95th centile
* non-reassuring CTG
* preeclampsia
* diminished fetal movements
* biophysical profile ≤ 6 or oligohydramnios (deepest pocket \<2 cm).

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women ≥ 16 years of age.
2. Singleton pregnancy.
3. Ultrasonographic estimated fetal weight \<10th centile.
4. Gestational age between 36+0 and 37+6 weeks.

Exclusion Criteria:

1. Major fetal malformations or genetic disorders.
2. Fetal death.
3. Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI\>95th centile.
4. Non-reassuring cardiotocography (CTG).
5. Preeclampsia.
6. Diminished fetal movements.
7. Biophysical profile ≤ 6.
8. Oligohydramnios
9. Refusal to give informed consent.
QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo

Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide a signed, executed written informed consent
2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
3. Female subjects who are practicing adequate contraception (see section 4.4) or who are sterile
4. No known cardiac disease
5. Normal hemoglobin values
6. Normal or not clinically significant 12-lead Electrocardiogram

   * Heart rate ≥ 40 and ≤ 100 at Visit 1 vital signs assessment (resting)
   * Subjects with QTcF interval duration \<430 msec for males and \<450 msec for females obtained from the ECG recorder's measurements on the screening ECG taken after at least 5 minutes of quiet rest in supine position
7. Demonstrated ability to properly use the Tempo® Inhaler
8. Subject has not donated blood in the last 56 days

Exclusion Criteria:

1. Contraindication to dihydroergotamine mesylate (DHE)
2. History of hemiplegic or basilar migraine
3. Family history of long QT syndrome
4. Participation in another investigational trial during the 30 days prior to Visit 1
Effects of Fat and Carbohydrates in Obese Men

Obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. The disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage capacity and increased exchange of lipids between adipose tissue and blood, and increased secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.

The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for the body's energy storages. The central role of the liver in energy supply, fat storage and normalization of blood values implies the importance of investigating the interaction between adipose tissue and liver to increase knowledge about the morbidity of obesity. Central obesity and insulin resistance are clear risk factors for the development of fatty liver, but the importance of diet is unclear. The common perception is that fatty liver condition can be improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and contradictory findings occur in epidemiological studies. It is therefore necessary to better understand the impact of the different macro-nutrients.

The purpose of this study is to determine whether two weight reducing diets with equal calorie levels that contain high or low fat differentially affects the adipose tissue function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory markers, lipids, vitamins, hormones and other substances that may be related to metabolically health.


Eligibility Criteria:
Inclusion Criteria.

* Healthy men.
* BMI 30-40.
* Fasting blood glucose \< 7 mM.
* Stable body weight last 2 months.

Exclusion Criteria.

* High intake of alcohol.
* Medication affecting glucose or lipid metabolism.
* Allergy towards important food items in the diet.
* Inflammatory bowel disease.
* Surgery or use of antibiotics last 2 months.
Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure

The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.

Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Have a viral load of 1,000 or more copies/ml.
* Have taken protease inhibitors (PIs).
* Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
* Are now taking antiretroviral therapy.
* Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.
* Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken APV or LPV for more than 1 week.
* Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
* Have taken more than 2 PIs.
* Are unable to take 2 active RTIs, as specified by the study.
* Have an active CDC Category C disease.
* Have certain abnormal laboratory tests.
* Are pregnant or breast-feeding.
* Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.
* Have a history of significant kidney or bone disease.
* Are not able to take drugs by mouth and cannot absorb them.
* Have had pancreatitis or hepatitis within the previous 6 months.
* Have a drug allergy or other allergy which might cause a problem during the study.
* Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.
* Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.
* Have had any HIV vaccine within 3 months before taking the study drug.
* Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.
* Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.
* Are not able to take the study drugs.
* Have inadequate kidney function.
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction

Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency department before casting. Standard of care currently requires that x-rays be performed before and after fracture reduction, and inadequate reductions may be subject to repeat attempts and are at a higher risk to require surgery. This study will assess the use of point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the angulation at the fracture site after a reduction is performed. If this angulation is decreased, it would suggest that POCUS for distal radius fracture reduction could decrease the number of failed reduction attempts and therefore the number of repeated reduction attempts.


Eligibility Criteria:
Inclusion Criteria:

* radiographically confirmed distal radius fracture

Exclusion Criteria:

* patients who do not consent
* patients with multiple acute injuries, open fractures, or other local fractures evident (a simple ulnar styloid fracture will not be considered an exclusion criterion)
* patients with neurovascular compromise
* patients with bilateral distal radius fractures
* patients with minimally displaced distal radius fractures that do not require closed reduction before casting