cyrilzakka/clinical-trials huggingface dataset:
Comparing the Shape and Frequency of Uterine Contractions

Dystocia is the most common indication for primary cesarean section. The most common cause of dystocia is uterine dysfunction. In all cephalopelvic disproportion studies, more attention is usually paid on fetus and pelvic rather than on the role of uterine contraction in delivery. So we decided to determine the relationship between dystocia and uterine contraction patterns.


Eligibility Criteria:
Inclusion Criteria:

* age 18-35 years
* singleton pregnancy with cephalic term presentation
* tendency to do vaginal delivery
* having no medical or mental diseases
* having no pregnancy complications
* Intact membranes
* BMI\<26

Exclusion Criteria:

* using oxytocin before and during the monitoring of contractions
* performing cesarean section for any reason except arrested delivery or pelvic constriction
* the birth weight\< 2500 or \>4000
* using the analgesia such as epidural anesthesia morphine and pethidine during the study
A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)

The purpose of this research study is to see if tetrabenazine, which is commonly used to treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in patients with HD. Investigators will also see how the medicine affects aspects of thinking and mood.

This study is an open-label assessment of behavioral symptoms including depression, impulsivity, and suicidal ideations in patients prior to, and after, taking a stable dose of TBZ for Huntington's disease. All subjects will be evaluated with tests of depression (Beck Depression Scale), impulsivity (QUIP, BIS-11, and computerized impulsivity scales), and suicidal ideation (Columbia Suicide Scale) as a safety measure before they actually start taking TBZ. Since there is a significant lack of awareness of emotional and cognitive symptoms (anosagnosia) in patients with HD, collateral sources will be asked to fill out similar questionnaires based on their knowledge and observation of the patient. Patients and collaterals will be asked to return to the clinic for an identical evaluation plus adverse events, after they have been on a stable dose of TBZ for 4 weeks, which would be 8 ± 1 week after initiating TBZ. Patients will be titrated over 3-5 weeks to best dose as determined by the investigator, up to a maximum of 75 mg/day. As patients are titrating, there will be several telephone contacts conducted. The initial dose will be 12.5 mg BID. Best dose will be largely determined by adverse events and subjective efficacy. Determination of best dose will include two scheduled phone calls and others as needed. Other medications will remain stable between visits.

Eligibility Criteria:
Inclusion Criteria:

* For HUntington's Disease (HD) patients only--Definite HD as indicated by positive gene testing or typical symptoms in the context of family history of HD.
* A moderate degree of impulsivity as measured by the Barrat Impulsivity Scale (BIS). (\>65)
* Must be symptomatic in the opinion of the investigator. Standard clinical criteria for symptomatic HD will be employed, any motor signs c/w HD, usually chorea.
* Patient is cognitively alert and able to answer/understand.

Exclusion Criteria:

* Patient requires the assistance of another person to walk, or is non-ambulatory.
* Patient is severely impaired cognitively.
* Patients taking neuroleptic (dopamine blocking) medications within the past 14 days.
* patient is actively suicidal, has untreated or inadequately treated depression, has impaired hepatic function, is taking MAO inhibitors or is taking reserpine or has been off of reserpine for less than 20 days
Oral Ghrelin Agonist in Healthy Subjects

EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing activity after intravenous administration.It is an analogue of the natural compound ghrelin. Since an oral delivery system would be preferable in many of the possible therapeutic indications, the pharmacological profile and the GH-releasing activity of increasing single, oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the pharmacokinetics and pharmacological effects of EP01572 will be investigated after intraduodenal administration.

EP01572 willbe given orally to 36 male subjects; the treatment will consist of one oral dose of either EP01572 or placebo (0.005, 0.05 and 0.5 mg/kg body weight). Subjects will receive one dose of EP01572 and placebo. Six subjects will receive two additional oral doses of EP01572: 0.125 and 0.25 mg/kg body weight. In another part, 6 subjects will receive the following treatments in a randomized order: 1) administration of a bolus of saline (placebo) to the small intestine; 2) intraduodenal (ID) administration of a bolus of EP01572 at 0.2 mg/kg body weight; 3) ID perfusion of a bolus of EP01572 at 0.35 mg/kg body weight; 4) ID perfusion of a bolus of EP01572 at 0.5 mg/kg body weight.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Females
Effectiveness of TDCS Over Broca's Area in Verb Naming: a Randomized, Double-Blind, Crossover Study

This clinical trial investigated whether transcranial direct current stimulation (tDCS) over Broca's area (F5) could improve verb naming abilities in adults with aphasia. Additionally, the study evaluated the stability of the treatment response to tDCS over time.

The main questions this study sought to answer were:

* Does tDCS improve verb naming abilities compared to inactive (sham) stimulation?
* Are the observed effects stable over time?

Participants received 10 daily sessions of tDCS over two consecutive weeks (5 days per week). The study included two treatment conditions, separated by one-month washout period:

* Active tDCS: Stimulation over Broca's area at 2 mA;
* Sham tDCS: Stimulation mimicking the active condition without delivering electrical current.

During the treatment, participants were asked to name aloud videos of actions displayed on a computer screen. One month after each treatment condition, follow-up testing was conducted to evaluate the stability of the treatment response.


Eligibility Criteria:
Inclusion Criteria:

* native Italian proficiency;
* pre-morbid right-handedness;
* a single left hemispheric stroke at least 6 months before the investigation.

Exclusion Criteria:

* acute or chronic neurological symptoms requiring medication;
* attention and/or memory deficits.
Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.

The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects.
Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end. EOHS is intended for a caregiver to use to remove adherent plaque and food debris from the teeth of a consumer to reduce tooth decay. Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety is a first-in-human-use single arm clinical study to evaluate the safety of EOHS. This study has been designed to assess the safety of the device during self-brushing. The primary objective of the study is to evaluate the safety of the EOHS with able-bodied individuals during self-brushing. The primary endpoint for safety is 28 days. The primary endpoint of the study will be met if there are no device failures and no Adverse Device Effects (ADEs). Subjective assessment of cleaning using the EHOS during self-brushing will also be evaluated. A total of up to 12 subjects will be enrolled in the study.

Twelve subjects will be recruited to evaluate the Enable Oral Hygiene System (EOHS) for safety. Subjects will be asked to complete demographic information and a medical history. An oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed following standard of care procedures. Inclusion/exclusion criteria will be evaluated and eligibility for the study will be determined. Subjects who qualify for participation in the study will receive an EOHS toothbrush with the instructions for use accompanied within the product package. Subjects will then watch an instructional video demonstrating the use of the novel toothbrush. For 28 days, subjects will use the EOHS during normal (self) brushing twice daily. Subjects will be asked to record daily impressions of comfort, ease of use, and perceived cleanliness. At the conclusion of the study, subjects will record overall subjective impressions of comfort, ease of use, and perceived cleanliness. Any device related failures, adverse events, or safety concerns will be recorded. After 28 days, an oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed following standard of care procedures. Subjects will be asked to return daily and overall impression documents as well as the EOHS.

Eligibility Criteria:
Inclusion Criteria:

* Willing to attempt brushing 2 x daily.
* Write and read English.
* 18-65 years of age.

Exclusion Criteria:

* Individuals who identify as a dentist, dental student, or a dental professional.
* Any physical limitations that might compromise normal tooth brushing technique.
* Teeth with orthodontic appliances.
* Evidence of periodontal abscess or major hard or soft tissue lesions or trauma.
* Use of anti-inflammatory medications for three or more consecutive days in the previous 28 days.
* Not willing to comply.
Virtual Visits (Utilization of Virtual Care in Postoperative Patients to Improve the Patient Experience)

The purpose of this study is to implement and evaluate postoperative virtual care visits for patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy. The investigators aim to better understand whether postoperative virtual care visits will not result in a greater composite measure of the occurrence of hospital encounters within Atrium Health (AH) for the 30 days following surgery than standard in-person clinic care. The investigators also aim to better understand whether postoperative virtual care visits provide time and cost savings, and provide equal or improved patient satisfaction and convenience.

Participants will be randomized to complete either a postoperative follow-up visit using virtual care technology or by attending a standard in-person visit at the clinic. The virtual visit uses a camera-enabled device and internet access to provide live access to the medical professional. Surveys to assess patient satisfaction and convenience will be administered by email on the day of the postoperative follow-up visit. Additional information including demographics, hospital encounters within 30 days of surgery, length of time of the follow-up visit, travel cost and time, whether additional follow-up care is required, and complications after surgery will be collected to evaluate postoperative virtual care visits. Subject participation in the study will end after follow-up care is complete or at 30 days, whichever occurs last.

Eligibility Criteria:
Inclusion Criteria:

* Willing to comply with all study procedures and be available for the duration of the study
* English speaking
* Able to read
* Have an email address
* Scheduled to undergo a laparoscopic appendectomy, laparoscopic cholecystectomy or robotic cholecystectomy OR have undergone an unplanned (urgent or emergent) laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic cholecystectomy
* Have surgery performed by a surgeon at either Carolinas Medical Center-Main or Carolinas Medical Center- Mercy who provides emergency general surgery clinical coverage
* Live in North Carolina or South Carolina

Exclusion Criteria:

* Unable to complete a virtual visit (due to lack of appropriate technology, necessary technology skills, other);
* Medical condition, laboratory finding, or physical exam finding that precludes participation (patients at high risk for complications, particularly those with perforated appendicitis, patients with active cocaine abuse)
* Postoperative length of stay greater than or equal to 4 days
* Discharged with drains that need to be removed at a postoperative visit
* Admitted from or discharged to assisted living facility, skilled nursing facility, or location other than home
* Have chronic pain for which the participant takes narcotic medication
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss

This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.

Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.

Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).

The amount of drug in the blood will also be measured. It is expected that around 70 people (at least 35 in each arm) with age-related hearing loss may take part in the study. The study participants will be recruited at around 13 sites in the USA.

Eligibility Criteria:
* Be between ages 50-89 years old
* American-English speaking
* Have difficulty hearing speech in a noisy environment
* No recent history of middle ear disease
* No severe insomnia, major depressive disorders, severe anxiety or post-traumatic stress disorder
* Not a current or previous user of hearing aids. You are eligible if you were noncompliant and stopped wearing a hearing aid device \>6 months earlier for intermittent use or \>3 years if you were a full-time consistent user of hearing aid devices
* Not be dependent on alcohol or drugs
* Have not participated in another research study within 30-days
* If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile)
* If male, you must confirm to use a barrier method (condom)
* Not be a professional musician
* No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor

While you are in the study, you must:

* Follow the instructions you are given
* Come to the study centre for all visits with the study doctor or study staff
* Answer the telephone at the scheduled date and time for the 2 telephone calls
* Tell the study doctor or study staff about any changes in your health or the way you feel
* Tell the study doctor or study staff if you want to stop being in the study at any time
* Bring your Diary to each visit
* Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study
* Use sun screen if you plan to sunbathe
* Not use headphones or headsets at high volume
* Not use hearing aids or devices at any time during the study
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

Visit 1 (Screening Visit)

* Be willing and able to comply with all treatment and follow-up/study procedures.
* Be a candidate for routine, uncomplicated cataract surgery

Visit 3 (Postoperative Day 1)

* Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
* Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion Criteria:

* Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Have known hypersensitivity or contraindication to the study drug(s) or their components.
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
* Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
* Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant

Exclusion Criteria:

* Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments
Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients

To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain

Exclusion Criteria:

* under 18 years
* non-cancer pain
* allergy to ketamine
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant

The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.

* When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes will remain in place for 7-9 days following the surgery.
* The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.

Eligibility Criteria:
Inclusion Criteria:

* Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
* Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor \< 2cm, clinically negative nodes)
* Location of primary tumor is not immediately adjacent to the nipple of chest wall
* No evidence of two or more separate tumors within the breast
* All histologic types and pathologic grades of primary tumor
* No extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
* No lymphatic or vascular invasion
* Lymph node staging by sentinel node excision or axillary dissection confirms node negative status (If node positive, implant is used to deliver boost to tumor bed)
* Assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
* 18 years of age or older

Exclusion Criteria:

* Tumor is too close to the chest wall to allow placement of catheters
* Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation

1. To explore specific aspects of social adaptation such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT).
2. To investigate how social adaptation varies with time lapsed since BMT and with the life stage as determined by patient?s age. Understanding both the positive and negative aspects of cancer and cancer therapy leads to opportunities to promote adaptive strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Lymphoma patients treated with blood and marrow transplantation at Stanford University Medical Center
2. Age \> 18 years at the time of transplant
3. English speaking
4. Willingness to sign a written informed consent document