cyrilzakka/clinical-trials huggingface dataset:
How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn

"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. The World Health Organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. The tool guide the use of care interventions intended to mitigate any perceived risks. The partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. Normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.The purpose of this research project is to increase person-centred care during labor. Specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period.


Eligibility Criteria:
Inclusion Criteria:

All births with labor duration

Exclusion Criteria:

Elective Cesarean birth
SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.

In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.

28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma.
* Age:18-75 years, male or female.
* The estimated survival period is more than 3 months.
* ECOG 0-1.
* There is at least one measurable lesion, according to the RECIST 1.1 standard.
* Patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody.
* Patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected.

Exclusion Criteria:

* There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ.
* Other drug clinical trials have been taken in four weeks.
* Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening.
* Patients with a history of unstable angina.
* The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification \>1.0 g.
* Have used immune-targeted therapy drugs.
* The patient had received a liver transplant.
* Having a history of chronic autoimmune diseases such as systemic lupus erythematosus.
* Having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening
* Have hemoglobin A1c (HbA1c) greater than or equal to (≥) 7.5 percent (%) and less than or equal to (≤) 11.5%, both inclusive, at screening
* Have body mass index (BMI) ≥ 23 kilogram/square meter (kg/m²)

Exclusion Criteria:

* A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM
* Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening or estimated glomerular filtration rate (eGFR) \<15 milliliter/minute (ml/min)/1.73 square meter (m²)
* Participants have known hypersensitivity or allergy to dulaglutide or its excipients
* Participants are on systemic steroids for any period of more than 14 days
* Participants have severe gastrointestinal (GI) disease, including severe gastroparesis
* Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma
Effect of Glucose on Ocular Blood Flow

The primary objective is to assess the effect of glucose on retinal vascular diameter in otherwise healthy vasospastic subjects compared to non-vasospastic controls.

The secondary objective is to compare the effect of glucose also on choroidal blood flow in otherwise healthy vasospastic subjects with non-vasospastic controls.

It is known that a glucose load can induce an increase in ocular blood flow. Acute hyperglycemia increases retinal vessel diameters in animals and humans. The purpose of this study is to compare the effect of glucose on the ocular blood flow in vasospastics and nonvasospastics. Body core temperature depends on basal metabolism. Peripheral vasoconstriction is a physiological way to preserve core temperature of the body. The etiology of primary vasospastic syndrome is unknown and potentially represents simply a reaction to a defective metabolism. Based on this hypothesis, vasospastics are expected to show a different vascular reaction to glucose.

On both study days, after an overnight fast, the subjects will be seated for 30 minutes in the Lab and local tropicamide will be applied for pupil dilatation. After stabilisation of blood pressure Retinal vessel diameter and choroidal blood flow will be assessed. Baseline blood glucose levels will be measured. Afterwards study substance (75 gram of Glucose or Aspartate) will be applied in 3 dl of water. One and a half hour later, the vascular measurements will be repeated. Ath the end of hemodynamic assessments, blood sugar level will be measured again.

Eligibility Criteria:
Inclusion Criteria:

* No history of the following problems: ocular or systemic disease; chronic or current systemic or topical medication; or of drug or alcohol abuse
* normal blood pressure (100-140 / 60-90 mmhg)
* best corrected visual acuity above 20/25 in both eyes
* no pathological findings upon a slit-lamp examination and indirect fundoscopy
* ametropia within -3 to +3 diopters of spherical equivalent
* less than 1 diopter astigmatism
* IOP \< 20 mmHg in both eyes
* Subjects will be classified as vasospastic if they relate a clear history of frequent cold hands (answering yes to the questions: "do you have always cold hands, even during summer time?" and "do other people tell you that you have cold hands?") and as normals if they deny such a history
* Vasospastic propensity will also be assessed by capillaroscopy

Exclusion Criteria:

* Subjects describing "sometimes cold hands"
* if the test substance cannot be ingested
* not obtainable ocular blood flow measurements
* abnormally high levels of glucose at any point in time
Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss

Randomized trial comparing internet-delivered ACT with therapist support against waiting list for persons with hearing loss and comorbid psychological distress

Hearing loss is the most common sensory disability in the world. Hearing loss is an auditory disability which affects not only speech recognition, but also the ability to recognize, locate and identify sounds in one's environment. Today there are a variety of studies investigating the relationship between hearing loss and mental health. For example, there are studies showing that hearing loss can lead to depression, somatization, social isolation, worrying or anxiety, loneliness, smaller social networks, lower self-efficacy, sensitivity to stress, burnout, and impaired sleep quality and quality of life in comparison with people with normal hearing. Initial results from other studies indicate that acceptance may be of importance, as it in turn can lead to increased help-seeking.To avoid prolonged stress and a healthy self-efficacy could contribute to greater well-being of people with hearing loss. This is the first study to use ACT to improve psychological health in people with hearing loss through the process of psychological flexibility. The treatment is eight weeks long and internet delivered through self-help texts with weekly therapist support.

Eligibility Criteria:
Inclusion Criteria:

* HHIE-S score over 8
* Indication of comorbid psychological suffering/distress (defined as total score above 0 on PHQ9/GAD7 or below 1sd on QOLI)

Exclusion Criteria:

* No computer with internet connection
* Unability to understand written content
* Incomplete screening procedure
* A health condition that needs immediate care
Mobile Intervention to Improve Adherence of Oral Anti-cancer Medications Among Acute Myeloid Leukemia Patients, the txt4AML Study

This clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication reminders works to improve adherence to oral anti-cancer medications among patients with acute myeloid leukemia (AML). Medication adherence is how well patients take medications as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a barrier to effective treatment. Collecting feedback on patient experiences using the mobile intervention may help doctors design new methods and material for providing educational information to AML patients who are taking oral anti-cancer medications.

PRIMARY OBJECTIVE:

I. To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.

SECONDARY OBJECTIVE:

I. To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.

EXPLORATORY OBJECTIVE:

I. To summarize and assess other patient-reported outcomes, collected either as patient chart review or through self-reported survey, as well as the patient post-intervention interviews.

OUTLINE:

Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute myeloid leukemia (AML)
* Patients will be or is taking venetoclax (or any other oral anticancer medication) as part of their first line therapy
* Has a phone with text capabilities
* Among patients aged 18 and older we will enroll participants regardless of race or ethnicity

Exclusion Criteria:

* Individuals who are terminally ill (defined as having less than 2 months to live)
* Individuals for whom there is documentation of inability to provide consent in the medical record
* Do not speak/read English
* This study will exclude pediatric patients (defined as individuals under age 18 years)
The Impact of Chewing Gum on Postoperative Bowel Activity and Postoperative Pain After Total Laparoscopic Hysterectomy

Surgical interventions, such as restoring the health of patients and eliminating their existing symptoms, the surgical process can have many negative effects on the patient. In order to minimize these complications, the Accelerated Recovery Protocol After Surgery (ERAS) has also found widespread use in obstetric surgery. The ERAS protocol consists of different evidence-based practices at each stage, before, during, and after surgery. Stool and gas extraction, especially colorectal reported that chewing gum has a positive impact on the time/ can be used after pelvic surgical procedures, perioperative care guide contains reported in ERAS protocols, evidence-based, inexpensive, easily applied, and easily tolerated a practice that is emphasized.

Surgical interventions, such as restoring the health of patients and eliminating their existing symptoms, the surgical process can have many negative effects on the patient. In order to minimize these complications, the Accelerated Recovery Protocol After Surgery (ERAS) has also found widespread use in obstetric surgery. The ERAS protocol consists of different evidence-based practices at each stage, before, during, and after surgery. Stool and gas extraction, especially colorectal reported that chewing gum has a positive impact on the time/ can be used after pelvic surgical procedures, perioperative care guide contains reported in ERAS protocols, evidence-based, inexpensive, easily applied, and easily tolerated a practice that is emphasized. Different studies have been conducted to determine the effect of chewing gum on intestinal peristalsis. Intestinal sounds and defecation of chewing gum after cesarean section surgery. A limited number of studies on patients with total laparoscopic hysterectomy exist on this topic.

Eligibility Criteria:
Inclusion Criteria:

* Total laparoscopic hysterectomy is the most common type of hysterectomy.,

  * Who is literate,
  * over 18 years old,
  * The body mass index is dec 18.50-24.99 kg/m2,
  * Able to communicate, no language problems.
  * No history of allergies,
  * Who volunteered to participate in the study and received my approval,
  * No complications during the operation,
  * With a patient who is not diagnosed with a mental and psychiatric illness

Exclusion Criteria:

* Who can not adapt to the treatment process,

  * Developing postoperative complications,
  * Chemotherapy - receiving radiation therapy therapy,
  * With epilepsy disease,
  * With any history of allergies,
  * A history of dental and gum diseases, with difficulty chewing,
  * With a problem of the mucous membrane inside the mouth,
  * Using drugs that can affect bowel function due to systemic diseases,
  * Patients with a mental disability or a perception problem
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs

Exclusion Criteria:

* Type 1 Diabetes
* Treatment with more than two additional oral antidiabetic drugs
* Moderate and severe renal (kidney) failure or dysfunction
Deep Brain Stimulation for Parkinson's Disease Trial

The purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and psychiatric function, and quality of life in patients with Parkinson's disease.

Medical therapy is the mainstay of treatment for patients with Parkinson's disease (PD). After several years of drug therapy, however, a large proportion of patients experience worsening of their parkinsonism and develop incapacitating motor fluctuations and dyskinesias. To deal with this, attention has been directed to surgical procedures, such as deep brain stimulation (DBS). Recently, stimulating the areas of the brain that control movement, the globus pallidus (Gpi) and subthalamic nucleus (STN), has been proposed as a therapy for treating many of the disabling symptoms associated with PD and drug-induced side effects.

The major aim of this 5-year study is to carry out a prospective, double blinded, randomized, clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life in patients with PD. The study also will address two key issues: 1) whether there are differences between unilateral Gpi-DBS and STN-DBS and 2) which patients are the best candidates for bilateral DBS.

Eligibility Criteria:
INCLUSION:

* Clinical diagnosis of Idiopathic Parkinson's Disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to levodopa therapy.
* Hoeh \& Yahr staging III or worse "off " medication periods.
* Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes.
* Unsatisfactory clinical response to maximal medical management or previous surgical treatment.
* Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence varying no more than +/- twenty percent during the 30 day period.
* Absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form.

EXCLUSION:

* Clinically significant medical history that increases pre- / post operative complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes...).
* Secondary or atypical parkinsonism as suggested by: i. History of stroke, encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen.
* Dementia as indicated by a Mattis Dementia Rating Scale (DRS) less than 116 or DSM-IV criterion for dementia.
* Clinically significant psychiatric disorder meeting Structured Clinical Interview for the DSM-IV criteria for an active anxiety, depressive, or psychotic disorder.
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia

This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia

This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of ADHD in participants with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of participants with ADHD only and dyslexia only to determine to what extent symptomatic change in the comorbid ADHD \& dyslexia is achieved independently by atomoxetine effects on either condition. A healthy control group of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects \& effects of treatment that may be interpreted as normal maturation. The healthy control group will not be treated with any study medications.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD
* Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia
* Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient
* Child or adolescent participants must be 10 to 16 years old
* Must be able to communicate in English
* Must be able to swallow capsules
* Be reliable to keep appointments for clinic visits \& all related tests
* Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or dyslexia
* Participants for healthy control group must achieve a score of at least 80 but not \>120 on the Full Scale Intelligence Quotient

Exclusion Criteria:

* Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.
* Participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions
* Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis
* Participants with documented history of autism, Asperger's syndrome, or pervasive developmental disorder
* Females who are pregnant or breastfeeding
* Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks
Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer

RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life.

PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II, stage III, or stage IV breast cancer.

OBJECTIVES:

* Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II, III, or IV breast cancer.
* Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients.
* Determine baseline variables that contribute to predicting survival time in these patients.

OUTLINE: This is a randomized, single blind (to medical staff), multicenter study. Patients are stratified according to age and participation in support groups. Patients with stage IV disease are also stratified according to type of metastases (visceral vs non-visceral) and timing of metastases (first diagnosis vs recurrence). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive usual medical care and instruction on stress reduction using transcendental meditation (TM), which involves a standard 7-step course. Patients attend training for approximately 1-1.5 hours per session for a total of 6 sessions over 1 week, while receiving usual medical care. Patients then practice TM twice a day for 20 minutes. Patients attend group meetings for approximately 90 minutes once or twice monthly for 6 months to ensure proper technique and understanding.
* Arm II: Patients receive usual medical care and basic literature on breast cancer.

Quality of life is assessed at baseline and then every 6 months for up to 3 years.

Patients are followed monthly for up to 2.5 years.

PROJECTED ACCRUAL: Approximately 166 patients (83 per treatment arm) will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage II, III, or IV breast cancer
* No brain or CNS metastases
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 55 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-2

Life expectancy:

* More than 3 months

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No non-cancer life-threatening illness
* No history of major psychiatric disorders
* No drug abuse dependency disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified