cyrilzakka/clinical-trials huggingface dataset:
Early Versus Delayed Pushing in the Second Stage of Labor

Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.

Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.

Oxytocin was allowed in both group and fetus was monitored with CTG.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Gestational age 36 to 40 weeks
* singleton pregnancy

Exclusion Criteria:

* women indicated for cesarean section
* Medical complications of pregnancy as hypertensive disorders or Diabetes Mellitus
* Fetal distress
* Epidural anaesthesia
A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement

This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement.

Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.

Patient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS).

Eligibility Criteria:
Inclusion Criteria:

* Sex: both sexes.
* Age: 18 years - 60 years.
* Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).
* Traumatic Labral tears

Exclusion Criteria:

* Previous hip surgery.
* Hip joint dysplasia, defined by both center edge (CE) angles \<25 degrees and Acetabular Index angle \>10 degrees.
* Osteoarthritis grade \>2 according to Tönnis classification.
Role of Positive Affect in Adjustment to HIV

The purpose of this study is to examine the role of emotion and mood in the context of HIV.

A growing body of literature indicates that positive affect may have a unique adaptive role in the process of adjustment to chronic stress, independent of the effects of negative affects like depression. The overarching goal of this research is to provide evidence and direction for the development of interventions for people with HIV that include a focus on positive affect. To this end, this study will document the occurrence, predictors, and consequences of positive affect during the 18 months post-notification of HIV+ serostatus.

Eligibility Criteria:
Inclusion Criteria:

* Have been informed they were HIV positive within the past two months
* Speak English
* Be 18 years or older
* Have the ability to provide informed consent to be a research participant

Exclusion Criteria:

* Severe cognitive impairment
* Active psychosis
Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services

Alcohol is a major modifiable risk factor for breast cancer in women, yet this is not widely understood by health practitioners or policy makers, let alone the general population. The investigators aim to test the effects of a targeted alcohol and lifestyle brief intervention for women attending breast screening services, to improve knowledge of alcohol as a risk factor for breast cancer and reduce harmful alcohol use.


Eligibility Criteria:
Inclusion Criteria:

* female
* attending breast screening service for a routine mammography
* 40-74 years
* English as a first language or fluent
* regular access to a telephone
* able to provide informed consent to participate
* any level of alcohol consumption (including non-drinkers)

Exclusion Criteria:

* hearing impairment sufficient to prohibit a telephone interview
* pregnancy
* not able to read or comprehend English to provide informed consent or receive the brief intervention
Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study

This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension) or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D. This may reduce the chances of developing diabetes or high blood pressure or both later in life.

Study visits will measure temperature, fasting glucose, resting blood pressure, respiratory rate, height, weight and waist circumference. A brief medical History will be taken, followed by an abbreviated physical exam. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will be completed.

Based on your fasting glucose and/or resting blood pressure you will be in one of the three arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and prehypertension (arm 3). After determining the arm of the study you are in, you will be randomly assigned to receive either a placebo or vitamin D supplementation.

If you are in the first arm with prediabetes (fasting glucose 100-125 mg/dL), the primary outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in the second arm with prehypertension (resting blood pressure 120-139/80-89 mm Hg), the primary outcome measure will change in resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in third arm with prediabetes and prehypertension, both these measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. A repeat blood test to check vitamin D levels will be done at 8 and 16 weeks (and periodically as necessary) during the study.

Other measures will be taken as are routine in your doctor's office.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or Female 18 years or older presenting to The America Family Practice, Physicians Care Center offices or Egan Wellness Clinic/Anti-Aging \& Skin Care Spa.
* Agreeable to treatment with placebo or vitamin D 1000IU twice a day with food.

Exclusion Criteria:

* Women who are pregnant or nursing
* Anyone with chronic medical conditions requiring regular intake of any prescription medications.
Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

If you are found to be eligible to take part in this study, you will first have your scheduled VIA and colposcopy. The study doctor will tell you more about this procedure.

You will then have proflavine hemisulfate solution (contrast dye) applied to your cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This should add about 10 minutes to the total procedure time.

The HRME images will be stored in an electronic database and used for research. The images will be deidentified and only the MD Anderson staff will have access. This data will be stored in the database indefinitely (forever).

Any abnormal areas found during the VIA and/or colposcopy will be biopsied as part of your standard of care using very small forceps (a medical tool that is like tongs). If the exam shows no abnormalities, a normal area will be biopsied.

The study doctor will talk to you about the results of the HRME imaging, colposcopy, and biopsy/ies.

There will be no change to the planned standard-of-care colposcopy and biopsy.

Researchers will also collect information from your medical record about the colposcopy, surgery, the status of the disease, and demographics (such as your age).

Follow-Up:

About 1 month after the study procedure, the study staff will contact you by phone to ask how you are doing. The call should last about 5 minutes.

Length of Study:

Your active participation in this study will be over after the biopsy.

This is an investigational study. Proflavine hemisulfate is not FDA approved or commercially available. The HRME device is not FDA approved or commercially available. Both are currently being used for research purposes only.

Up to 800 participants will be enrolled in this study. Up to 400 will take part at MD Anderson and up to 400 will take part at the Harris Health System.

Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS)
2. Women of childbearing potential must have a negative pregnancy test
3. Women who are at least 21 years of age or older
4. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

Exclusion Criteria:

1. Women \< 21 years of age
2. Women with a known allergy to proflavine or acriflavine
3. Women who are pregnant or nursing
4. Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.


Eligibility Criteria:
Inclusion Criteria:

Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.

Exclusion Criteria:

1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.
2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
3. Known or suspected impairment/alteration of immune function.
4. Individuals with a known bleeding diathesis.
5. History of Guillain-Barré syndrome.
6. Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).
7. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.
8. Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.
9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.
10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
11. Individuals with history of substance or alcohol abuse within the past 2 years.
12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.
13. Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.
14. Subjects from whom blood could not be drawn at visit 1.
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.


Eligibility Criteria:
Inclusion Criteria:

* Healthy;
* Body Mass Index (BMI) of 18 to 28 kg/m2;
* total body weight within the range of 50 to 100 kg

Exclusion Criteria:

* History of regular alcohol consumption exceeding 14 drinks/week
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day
Impact of Active and Healthy Families

The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.


Eligibility Criteria:
Inclusion Criteria:

* Aged 5-12 years
* Body mass index greater than or equal to the 85th percentile for age and sex
* Patients seen at Contra Costa County clinics participating in Active and Healthy Families
* Spanish speaking
* Parent of participant

Exclusion Criteria:

* Previous participation in Active and Healthy Families
Skillful Neglect Vs Repair For Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair.

The purpose of this study is to compare functional outcomes of Skillful Neglect \& arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)

patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ASES score

Eligibility Criteria:
Inclusion Criteria:

* Patients with combined upper subscapularis border tear in Lafosse type 1 and type 2.

Exclusion Criteria:

* Glenohumeral arthritis.
* Patients with other intra-articular pathology like SLAP lesions.
* Neural damage (Brachial plexus injury).
* Revision cases.
* Patient with subscapularis border tear type 3, type 4, and type 5.
Cohorts and Collections: Clinical and Genetic Study of Parkinson's Disease and Epilepsies

The DNA and Cell Bank of Instituts Federatifs de Recherche (IFR) of Neurosciences has been running for the last 15 years at the Institut National de la Santé Et de la Recherche Médicale (INSERM) Unit 679 (former unit 289). Since its creation, this structure has been the support of research projects in genetics for neurological and psychiatric disorders. The cohorts established have led to discoveries in monogenic disorders, such as cerebellar ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, Parkinson's and Alzheimer's disease, Charcot-Marie-Tooth disease and related entities. The research projects based on the study of the genetic bases in Parkinson's disease and epilepsies are especially developed for this grant.

Concerning Parkinson's disease, the project is based on the extension of the existing cohort throughout the French Parkinson's Disease Study Group network. Concerning epilepsies, this project is the occasion to build this network with the constitution of a new cohort.

The specific aims of the scientific projects are the following for Parkinson's disease:

* to evaluate the frequency, the nature and the phenotype associated with parkin mutations in familial or sporadic forms of the disease, according to the age at onset, and
* to identify the genetic susceptibility factors in Parkinson's disease with the study of affected sibpairs and with case/controls association studies.

For epilepsies, the aims are:

* to evaluate the frequency, the nature and the phenotype associated with SCN1A, SCNab and GABR2 gene mutations in familial or sporadic forms of the affection associated with febrile seizures, and
* to search for an intervention SCN1A, SCN1B and GABRG2 as susceptible genes in these forms of epilepsies.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with Parkinson's disease, with a family history or not,
* Minors presenting clinical signs of the disease,
* Controls (without signs of the disease), matched by sex and age with the patients,
* Relatives for the familial cases,
* Patients presenting with an epilepsy episode (myoclonic epilepsy of the newborn, with febrile seizures, of the frontal lobe)

Exclusion Criteria:

* Lack of signed informed consent
Adaptation Processes in School-based Substance Abuse Prevention

The purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.

The goals of the proposed study are to conduct an effectiveness trial of the keepin' it REAL (refuse, explain, avoid, leave) middle school substance use prevention curriculum among a new target audience in rural Pennsylvania and Ohio, describe how teachers adapt the curriculum when they present it, and develop, implement, and evaluate a Pennsylvania/Ohio-version of the curriculum to test whether an evidence-based universal curriculum can be improved by adapting it to local cultures. keepin' it REAL is recognized as a "model program" by SAMHSA's (Substance Abuse and Mental Health Services Administration's) National Registry of Effective programs and is one of the few that are multicultural. The study will evaluate the effectiveness of the original curriculum, grounded in the cultures of the southwest and compare that to a new version, "re-grounded" in the rural culture of Pennsylvania and Ohio, while studying how teachers adapt both versions. This proposal responds to NIDA (National Institute on Drug Abuse) PA-05-118 (Program Announcement), Drug Abuse Prevention Intervention Research that calls for investigations addressing, "1) the development of novel drug abuse prevention approaches; 2) the efficacy and effectiveness of newly developed and/or modified prevention programs; 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions." This proposal addresses all three points.

A randomized control trial will be conducted in middle schools to accomplish these goals. First, formative research will be conducted to develop a rural Pennsylvania/Ohio-version of the curriculum. Second, 39 rural schools will be randomly assigned to one of three conditions: teacher adaptation in which the original keepin' it REAL curriculum is implemented; researcher adaptation in which a new Pennsylvania-version of the curriculum is implemented, and a control group. We hypothesized the participation in either form of the curriculum will reduce drug use and that the researcher adaptation will produce better outcomes and less teacher adaptation than the teacher adaptation. A pretest will be administered followed by post-tests in 7-9th grades. Adaptation and fidelity will be measured in 3 ways: teachers completing a Program Quality and Adaptation online measure after each lesson, videotaped lessons, and attendance. The major hypothesis tests will be conducted using variants of the general linear model, taking into account the multilevel structure of the data, test of a mediation model, and growth modeling.

Eligibility Criteria:
Inclusion Criteria:

- all 7th grade students in implementation middle

Exclusion Criteria:

* lack of parental consent
* lack of student assent
Maternal Fetal Device Performance Singleton

Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed Corometrics 259cx. The fetal heart rate and will be collected during antenatal monitoring using standard of care Doppler ultrasound.

This study aims to compare a maternal fetal monitoring device to the currently marketed Corometrics 259cx. Fetal heart rate and Fetal Movement Detection data will be collected during antenatal monitoring using standard of care Doppler Ultrasound transducers.

The new Maternal/Fetal Monitor is capable of monitoring heart rates (maternal/ fetal), maternal uterine contractions, as well as maternal blood pressure and maternal pulse oximetry. This study will compare clinical data between the current and the new monitor on non-laboring singleton gestation women.

Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Singleton pregnancy.
3. Aged 18+.
4. Greater than or equal to 22 0/7 weeks gestation.
5. Patient has none of the exclusion criteria.

Exclusion Criteria:

1. Multiple pregnancy.
2. Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
3. Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
4. Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.