cyrilzakka/clinical-trials huggingface dataset:
Social Support Intervention for Self-management of Type 2 Diabetes Mellitus

This study will assess the effect of a social support intervention for self-management of type 2 diabetes mellitus (DM2) in adults. This intervention is based on a medium-range nursing theory of individual and family self-management. Findings will be evaluated using the nursing outcomes "self-management: diabetes" and "social support" from the Nursing Outcomes Classification (NOC).

Diabetes mellitus is responsible for 1.6 million deaths a year, becoming one of the world's 21st century health emergencies.

DM2 is the most frequent form of diabetes, accounting for 90% of all cases of this chronic condition. If this trend continues, by 2045 about 693 million people will have diabetes.

People with chronic diseases have changing perspectives, in addition to suffering physical alterations, their psychological, emotional and social state is also compromised, presenting themselves as a need to modify lifestyle to improve prognosis, facing alterations in the ability to socialize and with death or a great loss. Few studies comprehensively address these dimensions.

The literature reports that DM2 self-control has a direct effect in improving clinical results, reducing complications and quality of life. Therefore, the patient must make multiple decisions every day regarding diet, physical activity, glucose control, and medication compliance.

However, intervention studies that seek to improve self-management behaviors in people with DM2 are characterized by emphasizing the transmission of knowledge and establishing compliance with prescribed treatments, but they do not address social and emotional elements such as social support. Additionally, most of these interventions do not show the use of theoretical models that provide explanations of human responses to disease and other phenomena important to practice.

Studies using the Nursing Outcomes Classification to assess the effect of social support interventions are scarce.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years with a diagnosis of DM2, attending the outpatient diabetes consultation at the health care institution.
* Initial score less than or equal to 3 on the NOC outcomes: self-management: diabetes and social support.

Exclusion Criteria:

* People with a score \<30 on the cognitive mini mental test.
* Other comorbidities reported by the patient or in the medical history that limit receiving the intervention (example: hearing loss, deafness, Alzheimer's disease).
Reducing Alcohol Use Post-Bariatric Surgery

Despite bariatric surgery being the most effective weight loss intervention for patients who are severely obese, as many as 1 in 5 patients will develop an alcohol use disorder after their surgery. Changes in metabolism, hormone levels, and behavior as a result of bariatric surgery alter the rewarding effects of alcohol while concurrently changing its absorption rate, putting patients at significantly elevated risk of hazardous drinking. Simply providing education to this vulnerable patient population about post-surgical risks has not been sufficient to reduce alcohol use, yet comprehensive in-person interventions are met with significant challenges, including hours-long distances between patients and their bariatric surgery programs. Thus, the long-term goal is to increase access to an empirically-supported intervention for reducing alcohol use among patients who undergo bariatric surgery by leveraging technology. This intervention, rooted in motivational interviewing and the transtheoretical model, is a two-session computerized brief intervention CBI, supplemented by six months of tailored text messaging based on participants CBI results and subsequent fluctuations in their readiness to change. The purpose of the proposed study is to optimize this technology-based intervention for patients who undergo bariatric surgery and to examine feasibility and acceptability of the intervention. In the first phase, patient interviews will be utilized to identify preferences for intervention content and treatment delivery. Ten patients will then participate in an open trial of the intervention, which will be subsequently revised based on feedback from these patients. In Phase 2, patients will be recruited between 3 and 6 months following bariatric surgery and randomized to the intervention or treatment as usual control group. All patients will complete baseline questionnaires and at 1, 3, 6, and 9 month post-assessments. The investigators expect that this intervention will be both feasible and acceptable to patients. Results will be used as preliminary data to inform a large, fully-powered clinical trial to test the larger efficacy of this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date
* Has not consumed alcohol since undergoing bariatric surgery

Exclusion Criteria:

* History of an alcohol use disorder
* Never consumed alcohol prior to surgery
* Does not have a cellular phone that can receive and send text messages
* No access to internet to complete the computerized brief intervention (CBI)
Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia

This study hypothesizes that an automated device using small electronic impulses can detect nerve impairment in unconscious patients.

Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1) bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3) on forehead will permit microvolt current to to be detected and analyzed against a proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in received SSEP signals.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* neuromuscular disease stroke
The Short-term Impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on Respiratory Function in Patients With Lung Cancer

The purpose of this study is to examine the short-term impact of Vocal Intonation Therapy (VIT) and Therapeutic Singing (TS) on respiratory function in patients with lung cancer. As a secondary outcome, this research will evaluate the effect of the music intervention on respiratory quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Participants will include three patients diagnosed with lung cancer, stages I-III, who have undergone a thoracentesis or thoracotomy in the last 12 months. Thoracic surgical procedures include pulmonary lobectomy or cancer-related surgical procedure (e.g., pneumonectomy). This diagnosis must be made by the patient's oncologist and medical team.
* The age range will be 40 to 80 years old. Both female and male participants from any race and ethnicity will be included in the study.
* The study will include English and Spanish speakers only.
* Patients must have less than five years of voice training experience (e.g., choir, private voice lessons).

Exclusion Criteria:

* Patients in respiratory failure
* Individuals with severe neurological and hearing impairments.
* Patients with diagnosed dysphonia and individuals who have undergone a laryngectomy
* Participants that do not have access to an electronic device, either an iPad, tablet, or laptop, as well as reliable internet access. They will also need to have adequate knowledge of technology or participate with a caregiver who knows how to navigate Zoom.
* Participants who do not have access to a quiet space. Headphones are optional for this study.
* Prisoners
* Persons under the age of 40 or over the age of 80.
Temporally Splitting Ovarian Stimulation and Embryo Transfer

The purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* Indication for IVF/ICSI
* Age 18-36 years
* \<= three earlier unsuccessful IVF/ICSI treatments with embryo transfer
* BMI 20-30
* Regular cycle with ovulation (28-35 days)
* Progesterone \>7ng/ml at the beginning of stimulation
* Informed consents

Exclusion Criteria:

* PCOS (polycystic ovarian syndrome
* Endometrioses \>= grade 3
* Known poor response syndrome
* History of ovariectomy
* Severe endocrinopathie
Dopamine in Orthostatic Tolerance

One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).


Eligibility Criteria:
Inclusion Criteria:

* Upright plasma norepinephrine \> 600 pg/ml, or
* An increase in heart rate of \> 30 beats per minute upon standing, and
* Withdrawal of all medications for at least 3 days, and
* No associated medical illness, and
* Age 18 - 60 years old.

Exclusion Criteria:

* Older than 60 years of age
* Routinely taking medications affecting the autonomic nervous system
* Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS
* Anemia (Hct \< 30)
* Women of childbearing age who are pregnant or nursing
* Unable to give informed consent
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents

Social media based intervention to support teens in their efforts to quit vaping.

This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.

Eligibility Criteria:
Inclusion Criteria:

1. English literacy
2. Age between 13-21 years
3. Indicate they use social media "most" (\>= 4) days per week
4. Have vaped at least once per week in the past 30 days (90 percent of participants)
5. Access to a computer or mobile phone with photo capability to verify abstinence from vaping
6. Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
7. Currently reside in California

Exclusion Criteria:

1. No English literacy
2. Age under 13 or over 21
3. Insufficient social media use (3 or fewer days per week)
4. Have not vaped at least once per week in past 30 days
5. No access to computer or mobile phone with photo capability to verify abstinence from vaping
6. Not considering or interested in quitting vaping in the next 30 days or 6 months;
7. Not a California resident
Class IV Laser Therapy on Ejection Fraction, Cardio Biomarkers and Functional Outcomes

A total of 60 Individuals with Acute coronary Syndrome who underwent angioplasty with or without stent will be recruited by purposive sampling method in a randomized double-blinded sham controlled trial. Recruited participants will be divided into two group of equal size (n = 30): Sham control group and experimental group by block randomization. The experimental group will subject to Class IV laser therapy along with the standard treatment regime at three spot(s) over the pericardium (left parasternal 2nd, 3rd intercostal space and apex) for a duration of 60 seconds at each point.; immediately after the angioplasty and subsequent two days. Left ventricular ejection fraction will be assessed at base line and after 3 days post-interventions. Cardiac biomarker (Troponin I) will be assessed at base line, peak hours (at 10 hour after revascularization) and on third day post intervention. Function outcomes will be assessed at baseline and at one month follow up.

Individuals with acute coronary syndrome admitted in the Cardiac Care Unit of MMIMSR, Mullana, Ambala, Haryana who underwent angioplasty with or without stent during the study period will be screened according to selection criteria. Then the invited participants will be asked to sign a written informed consent for voluntarily participation in the study. Participants will be divided into two group of equal size (n = 30): Sham control group and experimental group by block randomization. The researcher will be divided into therapist and evaluator or assessor. The therapist will responsible for conducting the therapy and evaluator or assessor will responsible for assessment of outcome measures both pre and post intervention. All the assessor or evaluator (lab technicians who assess cardiac biomarkers, Cardiologist who perform echocardiography and assess ECG) will be blinded from the grouping of the participants. The participants will also be blinded to the study by use of laser protected eye wears. Left ventricular ejection fraction, cardiac biomarker (Troponin I) and functional outcomes will be assessed at base line. The experimental group will subject to Class IV laser therapy along with the standard treatment regime at three spot(s) over the pericardium (left parasternal 2nd, 3rd intercostal space and apex) for a duration of 60 seconds at each point.; immediately after the angioplasty and subsequent two days. The sham group will subject to irradiation but the equipment will be kept off. All the outcomes measures will be reassess after 3 days post-interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with Acute Coronary Syndrome (ACS) who underwent angioplasty with drug eluting implant
2. Both male and female above 18 years of age,
3. Hemodynamically stable,
4. Who voluntarily signed the informed consent.

Exclusion Criteria:

1. Tumor or growth around mediastinum,
2. Temporary or permanent pacemaker,
3. Receiving steroids or photosensitive drugs,
4. Pregnancy,
5. Epilepsy,
6. LVEF ≤ 30%
Effects of HICT and Intermittent Fasting on PCOS

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.


Eligibility Criteria:
Inclusion Criteria:

* Unmarried females
* Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:

  * PCOM on US
  * Ovulatory dysfunction
  * Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)
* Not engaged in any regular lifestyle intervention for \&lt;3 Months prior to inclusion

Exclusion Criteria:

* Use of Estrogen, Progestin or combination.
* Taking medications or supplements for Insulin resistance \&lt; 3 months prior to the inclusion
* Type I or II DM
* Hypo/hyperthyroidism
* BMI ≥27 (Obese according to BMI Asia)
Asia Study Group of Prostate Cancer (A-CaP Study)

This study will target patients who have received a histopathological diagnosis of prostate cancer and who are undergoing treatment in various forms, including active PSA surveillance, surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. The study will survey information about the patient at time of diagnosis, clinical staging, details of initial treatment, status of disease progression, and prognosis at the end point of the study. The purpose of the study is to clarify distribution of staging, the actual status of treatment choices and treatment outcomes.

The A-CaP will collect information in a linkable anonymized format from all medical institutions in Asian countries participating in the study and will engage in data analysis. J-CaP which has previous experience of engaging in a similar study in 2010 wll be a sponsor for A-CaP study, the aggregated results of which have been reported. The registration period for this study will be three years followed by 7 years of follow-up study, and research will be implemented across a wider range of Asian countries, with new institutions participating for the purposes of this study. As this study will be an observational study the acquisition of data will be relatively simple, and as the content of the study will be almost identical to the study conducted by J-CaP in 2010, a system for research implementation is already established at J-CaP.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received a histopathological diagnosis of prostate cancer between January 1,2016,and December 31,2018.
* Patients who, having received a diagnosis within the abovementioned period, began initial treatment for prostate cancer(including active surveillance).
* Patients who are either hospitalized as outpatients.

Exclusion Criteria:

• Patients for whom information about the time of diagnosis, including histopathological diagnosis, cannot be acquired.
Safety and Tolerability of NN9068 in Healthy Male Volunteers

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.

The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
* Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
* Body weight between 60 kg and 90 kg (both inclusive)

Exclusion Criteria:

* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator
The Effect of Pranayamic Techniques on Obstructive Sleep Apnea Syndrome

Study was planned to investigate the effect of pranayama on dyspnea, daytime sleepiness, cognitive function, quality of life, activities of daily living, functional exercise capacity, physical activity level, sleep quality, fatigue, musculoskeletal pain, depression and anxiety in OSAS.

Thirty-four OSAS patients meeting the inclusion criteria will be randomized into 2 groups as pranayama and control groups. The pranayama group will practice pranayama on their own for 8 weeks, 7 days a week, 3 times a day for 15 minutes. In addition, he will perform a single 15-minute session 3 days a week online under the supervision of a physiotherapist. The control group will not receive any intervention. Dyspnea sensation before and after the training Modified Medical Research Council dyspnea scale, daytime sleepiness Epworth Sleepiness Scale, cognitive function Montreal Cognitive Assessment Scale, quality of life Short Form-36, Turkish Adaptation of Nottingham Health Profile Questionnaire and Functional Outcomes of Sleep Questionnaire, activities of daily living London Chest Activities of Daily Living Scale, functional exercise capacity 30 seconds sit and stand test, physical activity level International Physical Activity Questionnaire-Short Form, sleep quality Pittsburgh Sleep Quality Index, fatigue status Fatigue Severity Scale, depression and anxiety Hospital Anxiety and Depression Scale, musculoskeletal system pain will be assessed with the Nordic Musculoskeletal Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mild to moderate obstructive sleep apnea syndrome.

Exclusion Criteria:

* Using a mandibular advancement device
* Regularly using hypnotic drugs
* Have a metabolic disease (eg diabetes, hypothyroidism, obesity)
* Have Hypertension
* Have Malignancy
* Have Epilepsy
* Have Heart failure
* Have COPD
* Have asthma
* Neurological, psychological, cooperative problems
* Having a history of maxillofacial surgery
Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).

Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.


Eligibility Criteria:
Inclusion Criteria:

* Age from over 20 to under 60 years;
* Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
* Mid-low rectal cancer (distance from anal edge≤12cm);
* cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
* Expected curative resection through both L-PANP-TME and O-PANP-TME;
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
* ASA (American Society of Anesthesiology) score class I, II, or III;
* Written informed consent;
* Urinary and sexual function normal preoperatively

Exclusion Criteria:

* Women during pregnancy or breast-feeding;
* Severe mental disorder;
* History of previous pelvic surgery;
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
* History of other malignant disease within past five years;
* History of unstable angina or myocardial infarction within past six months;
* History of cerebrovascular accident within past six months;
* History of continuous systematic administration of corticosteroids within one month;
* Contraindication of heart, brain, lung, etc dysfunction;
* Requirement of simultaneous surgery for other disease;
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
* Rectal cancer invades surrounding tissues;
* Existence of genuine incontinence or severe stress incontinence preoperatively
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial

66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data


Eligibility Criteria:
Inclusion Criteria:

* Age range 20-50 years
* High caries risk patients defined according to cariogram caries risk assessment model
* On non-cariogenic diet
* High plaque index
* Systematically healthy
* No orthodontic or prosthodontic appliance

Exclusion Criteria:

* Age range less than 20 or more than 50 years
* Low or moderate caries risk patients according to cariogram
* Patients with a compromised medical history
* Cariogenic diet patient
* Participants with a history of allergy to any of the drugs or chemicals used in the study
* Patients on any antibiotics during the past month