cyrilzakka/clinical-trials huggingface dataset:
Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls

The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB women ages 14-18 years, nation-wide. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is associated with increases in TPP behavior.

An estimated one in four teen women will become pregnant by the time she is 20 years of age. That said, significant disparity in rates exist for lesbian, gay, bisexual and other sexual minority women (LGB) versus non-LGB teen women: Research suggests that lesbian and bisexual teen women are between two and four times more likely to report having been pregnant than teen women who identified as exclusively heterosexual. Despite this compelling evidence that lesbian and bisexual adolescent women are at risk for teen pregnancy, programs tailored to the unique needs of adolescent LGB women are nonexistent. Evidence-based teen pregnancy prevention (TPP) programs targeting LGB teen women are urgently needed.

The Girl2Girl intervention text messaging-based TPP program designed specifically for LGB women ages 14-18 years, nation-wide. The investigators will test the intervention in a randomized control trial (RCT) of 840 LGB teenage women randomly assigned to either the intervention (n = 420) or control (n = 420) arms. Our primary efficacy outcome measures, measured at 12-months post-intervention, will be: (a) abstinence from penile-vaginal sex; (b) condom use during penile-vaginal sex, (c) use of other birth control methods during penile-vaginal sex, and (d) pregnancy.

If effective, Girl2Girl has promise to be quickly and cost-effectively implemented to scale to help to curb the spread of teenage pregnancy among women who identify as LGB.

Eligibility Criteria:
Inclusion Criteria:

* endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer, questioning, unsure);
* be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity);
* be aged 14-18;
* in high school or equivalent (including those who did not finish school/dropped out);
* be English speaking;
* be exclusive owners of a cell phone with an unlimited text messaging plan;
* have used text messaging for at least six months;
* intend to have the same cell number for the next six months; and,
* be able to provide informed assent, including an acceptable score for "capacity to consent" and the self-safety assessment.

Exclusion Criteria:

* not having the capacity to assent
* not passing the self-safety assessment
* previously participating in another study activity (with the exception of the baseline and intervention end survey pilot tests)
* knowing someone who is already enrolled in the program
* non-cisgender
Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures

The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery
* No medical contraindications that would limit the ability to exercise
* Having a caregiver who can supervise the exercise program after discharge
* To be able to understand simple commands and to have signed the consent form

Exclusion Criteria:

* Patients with pathological fractures and/or multiple fractures
* Those with serious early complications
* Terminally ill patients
* Circumstances that would interfere with conducting assessments or communicating
* Lack of cooperation during the study
* Scoring ≤14 on the Mini Mental State Examinatio
Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Participants are randomly assigned to the TRE or the non-fasting control group. The TRE group will consume calorie containing food and drink only over an 8 hour period and rest of the 16 hour would be fasting. Adherence to TRE and calorie intake are the primary outcomes. Motivators, facilitators and barriers to TRE, hunger and cravings levels, weight bias internalization, body composition (weight, body fat%, fat mass and muscle mass) , Healthy Eating Index (HEI) to assess diet quality, skin carotenoid levels, disordered eating risk, sleep quality, and perceptions of health and well-being are secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 65 years
* Owns a smartphone
* Apparently healthy
* BMI ( more than or equal to 25 kg/m2 ) and high body fat percent (BF%) (≥25% and ≥35% for males and females, respectively)
* Sedentary lifestyle (less than 150 minutes of self-reported moderate to vigorous activity per week)
* Self-reported eating interval of ≥12 h per day

Exclusion Criteria:

* Diagnosed diabetes mellitus (type I or II), coronary heart disease, heart failure, hypertension, hyperlipidemia, stroke, chronic lung diseases, liver or kidney disease, adrenal diseases, musculoskeletal disorders, uncontrolled thyroid disease (dose changes within the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness).
* Currently taking any medication that is meant for, or has a known effect on, appetite
* On anabolic steroid or hormone replacement therapy
* Participation in an exercise/nutrition/ weight-loss program within the last 6 months
* Any history of surgical intervention for weight management
* Having a ≥5% body weight change during the last 3 months
* Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation
* missing limbs, have a pacemaker or metal implants,
* eating disorders or EAT-26 score \>20
* Alcohol or drug addiction
* Current smoker
* Works night shifts
* Unable to commit to a 9-week study
* Not willing to follow study protocol and any other contraindications.
* Currently following any of the following restrictive diets - Keto/low carbohydrate/ Vegan/ Vegetarian/ Intermittent fasting/ Paleo/ Calorie restriction/ Any other restrictive diet
* Participating in another study
Performance of Safety of SILKAM® Suture Material in Oral Surgery

Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.

The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).

Exclusion Criteria:

* Patients taking medication that might affect wound healing
* Patients having a condition that might affect wound healing.
* Patients with hypersensitivity or allergy to the suture material.
* Participation in another (Randomized) Clinical Trial / Clinical Study.
* Non-compliance of patient (i.e. dementia).
Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence

Background: Using three-dimensional (3D) surface imaging, this study aims to understand the differences in perception between schoolchildren with and without cleft lip and palate (CLP), as well as to explore peer awareness and acceptance of children with craniofacial abnormalities post-surgery.

Methods: This cross-sectional study utilized three-dimensional surface images of early adolescent patients with CLP post-repair and without CLP for examination by schoolchildren (with CLP and without). Both groups assessed the images and responded to a questionnaire eliciting perceptions of facial appearance and social acceptance of children with craniofacial abnormalities, rating each question on a Likert scale of one to five. The results were presented using bar graphs, and the Item Response Theory-Graded Response Model was employed to estimate the latent ability (θ) of each participant. The reliability of the questionnaire was assessed with Cronbach's alpha test.


Eligibility Criteria:
Inclusion Criteria:

* Cleft patient received cleft surgical treatment including lip repair, palatoplasty, and alveolar bone grafting in our Craniofacial Center, based on our cleft surgical protocol

Exclusion Criteria:

* Unable to complete the questionnaire on their own for any reason were excluded to avoid bias in responses caused by the presence of a secondary observer
Pain Management in Laparoscopic Cholecystectomies

Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* aged \>18 years
* patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria:

* Did not provide informed consent,
* Had any psychiatric or mental problem that prevented understanding of the informed consent form
* They were planned to undergo emergency cholecystectomy,
* Had any allergy or hypersensitivity to local anaesthetic,
* Had an infection in the needle entry area
* History of coagulopathy or the use of anticoagulants
Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma

The clinical incidence of intrahepatic cholangiocarcinoma (ICC) is high and insidious, and the prognosis of advanced patients is poor. The clinical manifestations of traditional chemotherapy GC and emerging targeted therapy are different in most patients, and there is still no effective scheme to evaluate the differences in individual patient reactivity. Patient-derived tumor organoids (PDO) are 3D-cultured tissues based on tumor cell dryness that reproduce a variety of biological characteristics of parental tumors in vitro and have similar drug responsiveness to tumors in vivo. This project plans to use clinical cases and optimized organoid culture system to first construct relevant organoids from unresectable ICC patient puncture samples. Secondly, based on the organoid model of intrahepatic cholangiocarcinoma, the clinical efficacy of GC regimen was predicted, and in vitro and in vivo drug screening was conducted to explore the guidance of patient-derived tumor organoids for clinical treatment. Then, multi-omics data of organoids and in vitro and in vivo drug efficacy evaluation model were used to explore the drug resistance genes of intrahepatic cholangiocarcinoma, providing the basis for personalized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

- Histologically confirmed intrahepatic cholangiocarcinoma They are between 18 and 80 years old Written informed and signed consent form Biopsy sample of the intrahepatic bile duct

Exclusion Criteria:

- Under 18, over 80 Informed consent cannot be given Biopsy samples were not available
A Danish Audit of Small Bowel Obstruction

Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.

This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.

This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.

Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Radiological or clinical diagnosis of mechanical SBO
* Admitted to one of the 6 participating centres

Exclusion Criteria:

* SBO presenting within 30 days of a previous abdominal operation
A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot

A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot


Eligibility Criteria:
Inclusion Criteria:

* An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
* An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
* Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter

Exclusion Criteria:

* Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
* Evidence of VTE(VTE event)during 6-month period preceding index encounter
* Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy

Other protocol defined inclusion/exclusion criteria could apply
Treadmill Training for Spinal Cord Injury

This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study will be randomly assigned to either the experimental group, which receives 12 weeks of this specialized treadmill training with regular physical therapy, or to the control group, which receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be measured before and after treatment as well as 6 and 12 months later, using standard tests that examine mobility independence and speed of ambulation. The trial takes place across five sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.

This is a 5-site randomized clinical trial of a task-oriented locomotor intervention for acute spinal cord injury (SCI). The intervention, body weight-supported treadmill training (BWSTT), partially supports the weight of the patient via an overhead lift attached to a harness. Therapists train the patient to walk on a treadmill by correcting gait deviations and manipulating sensory input that enhance control of the stance and swing phases of walking at increasingly higher speeds and less weight support. 100 patients with incomplete SCI (from below C4 to T10/11) and 100 patients with lesions at T12 to L3 will be randomly assigned to 12 weeks of conventional therapy programs for mobility versus the same intensity and duration of a combination of conventional therapy plus BWSTT. The primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet. Patients will be tested by masked examiners before and after the 12 weeks of therapy, and 6 and 12 months after entry into the study.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury (within 56 days)
* Incomplete lesion: - ASIA C or D, from below C4 to L3 - ASIA B at or below C7
* Unable to ambulate over ground without at least moderate assistance (FIM locomotor 3 or less)
* Able to offer at least 3/5 strength in elbow extensors
* No clinically-significant cognitive impairment

Exclusion Criteria:

* Symptomatic fall in blood pressure greater than 30 mm Hg when upright
* Halo or other cervical brace or TLSO (unless primary surgeon agrees)
* Contraindication to weight bearing on lower extremities
* Pressure sore with any skin breakdown below level of the SCI
* Any debilitating disease prior to the acute SCI that would cause exercise intolerance
* Premorbid, ongoing major depression or psychosis
* Required use of anti-spasticity medication
* Subject unlikely to complete intervention or return for follow-up
Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms

The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk.

This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC). Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.

Objectives

1. Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases
2. Show pre-post BE-SMART-DR improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vPFC), (HAV), system)

Eligibility Criteria:
Inclusion Criteria:

* with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD)
* have a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI

Exclusion Criteria:

* Significant medical or neurologic illness (especially if related to cerebral tissue)
* MRI contraindication,
* pregnancy by urine test
* current moderate or severe alcohol/other substance use disorders except caffeine/nicotine
* positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month
* current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest e.g. transcranial magnetic stimulation or electro-convulsive therapy,
* current psychosis
* inability to provide informed consent, including IQ\<70, Young Mania Rating Scale (YMRS) \>25, or too symptomatic by PI's judgment
* active suicidal plan or intent or Columbia Suicide Severity Rating Scale (C-SSRS) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician.
* homicidal ideation
Decision Aid and Thyroid Nodules Management

Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)
* Thyroid nodule size less or equal to 2cm

Exclusion Criteria:

* History of thyroid surgery
* History of thyroid cancer