cyrilzakka/clinical-trials huggingface dataset:
Fatigue Levels in Fibromyalgia Syndrome

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease. The Fatigue Severity Scale (FSS) assessed the level and severity of fatigue. The short form of the International Physical Activity Questionnaire (IPAQ-SF) used to asess physical activity levels.The kinesiophobia level was assessed by using the Tampa Scale for Kinesiophobia.

Our study consists of 180 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between April 2021 and August 2021. This case-control study was conducted according to the Declaration of Helsinki. Participants gave written voluntary consent and enrolled in this case-control study.

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. Fibromyalgia Impact Questionnaire, Tampa Kinesiophobia Scale, Fatigue Severity Scale and The short form of İnternational Physical Activity Questionnaire (IPAQ-SF) were completed. All scales were filled in face to face for the participants. In addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis were recorded.

Exclusion criteria for both groups; The presence of health problems that affect the level of physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery history) and cognitive impairment that prevents answer questions

Eligibility Criteria:
Inclusion Criteria:

* Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
* Ninety (90) healthy volunteers

Exclusion Criteria:

* The presence of health problems that affect the level of physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery history)
* Cognitive impairment that prevents answer questions
Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project

The purpose of this study is to determine whether the use of Near-Infrared Technology can guide the laparoscopic resection of hypervascular neoplasms of the pancreas.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80
* diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery

Exclusion Criteria:

* allergy to indocyanine green or other vital stains, indium, shellfish
* chronic kidney insufficiency
* chronic hepatopathy
* hyperthyroidism, thyroid adenomas
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)

Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with prior VTE are based primarily on expert opinion and the optimal clinical management strategy remains unclear.

This multicentre, prospective cohort study aims to test the following hypotheses:

1. Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort)
2. Withholding antepartum prophylaxis is safe (recurrence risk \<1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)

All study patients will receive 6 weeks of postpartum prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed pregnancy (positive serum or urine)
* At least 18 years of age
* History of one prior episode of VTE consisting of DVT (diagnosed by compression ultrasonography \[CUS\] or venography) and/or PE (diagnosed by ventilation-perfusion \[V/Q\] lung scintigraphy, computed tomographic pulmonary angiography \[CTPA\], or traditional pulmonary angiography)

Exclusion Criteria:

* Ongoing need for therapeutic anticoagulation for prevention or treatment of cardioembolic stroke
* Known high-risk thrombophilia (specifically antithrombin deficiency, protein S deficiency, protein C deficiency, homozygosity for the factor V Leiden or prothrombin G20210A mutations, antiphospholipid antibody or compound abnormalities)
* VTE within 3 months of the current pregnancy
* Clinical risk factor for initial episode of VTE, if present, not resolved (excluding pregnancy)
* Known contraindication to anticoagulation (including active, uncontrolled bleeding or major bleed within the previous 4 weeks)
* For patients with prior unprovoked VTE, contraindication to LMWH (including allergy, HIT, impaired renal function, osteoporosis)
* Geographic or social factors precluding follow-up
* Inability or unwillingness to provide informed consent
Determination of Teeth Size in a Group of Egyptian Children. A Cross Sectional Study

Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in Rural Areas of Sohag Governorate: A Cross Sectional Study

Study Settings:

* Students will be randomly selected from preparatory schools in rural areas of Sohag governorate, seated in the school lap or an empty classroom.
* Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.
* Operator: Master degree's student in Pediatric Dentistry and Dental Public Health.
* Full mouth alginate impression will be taken and study models will be poured within one hour with hard dental stone for each subject.
* Mesio-distal widths of both maxillary and mandibular permanent incisors, canines, first and second premolars will be measured from the study models using digital caliper according to the method described by(Moorrees \& Reed, 1964) by measuring the greatest distance between the contact points on the proximal surfaces holding the caliper parallel to both occlusal and vestibular surfaces of the tooth.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are apparently medically free from any systemic disease.
2. Patients aged between 12-15 years.
3. Full set of fully erupted permanent dentition from left 1st permanent molar to right 1st permanent molar.
4. No apparent orthodontics problem.

Exclusion Criteria:

1. Patients with craniofacial developmental abnormality.
2. Any sensitivity or adverse reactions to any of used materials.
3. Patients who refused to participate in the study.
4. Teeth with severe malalignment or rotation.
5. Teeth with any inaccuracy caused by impression taking, pouring impressions with dental stone or any damage or breakage while the dental casts had been stored.
6. Teethwith notable wear, proximal decay, restorations, enamel hypoplasia or crown fracture.
7. Teeth with developmental anomalies such as microdont teeth, teeth with extra cusps or big talon cusps, or peg or conical shaped teeth.
8. Supernumerary or supplemental teeth (if present)
Gynaecological Speculum Examination: Straight Horizontal Insertion Versus Vertical Insertion and Rotation.

This study compares two different types of speculum insertion to determine the level of discomfort they might cause. This study compares the straight horizontal insertion (SHI) of the speculum and the vertical insertion and rotation (VIR).

Participants are randomly assigned to one of the two insertion groups and are not told which group they are in until the examination is over. Participants rate their level of discomfort immediately after insertion of the speculum.

Basic demographic information (e.g., age, ethnicity, number of vaginal deliveries, menopausal status, etc.) and clinical information are also collected to determine if other factors influence the level of discomfort experienced.

\*NOTE\* This is NOT a paid study.

In most medical schools around the world, speculum examination is taught using a bivalved speculum, since this is the type of speculum most commonly used in clinical practice. Due to the oval shape of the vulva, and the alignment of the labia majora and minora, the aperture of vaginal introitus is commonly perceived to have a vertical orientation. In reality however, the vaginal introitus is round and the vagina itself has more of a horizontal orientation: the anterior and posterior vaginal walls are opposed, and the sidewalls only become apparent once the anterior and posterior walls are separated. Nevertheless, the most common way of teaching the speculum examination worldwide is to introduce the speculum in a vertical orientation and then once it is successfully inserted into the vagina to rotate it 90° into a horizontal position. Once it is correctly positioned, it is slowly opened to visualize the vaginal epithelium and the cervix. However, in clinical practice, the rotation of the speculum in the vagina may cause pain and discomfort. Introduction of the speculum initially in a horizontal orientation, without rotation in the vagina, seems more appropriate and could potentially be associated with less discomfort or pain for women undergoing this exam. In practice, a minority of clinicians separate the labia first, introduce the speculum in a direct horizontal fashion, and thus avoid the potentially uncomfortable twisting part of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Women who are 18 years of age or older
* Undergoing a speculum examination as part of their regular clinical care
* Proficient knowledge of the English language and able to sign the informed consent form

Exclusion Criteria:

* Younger than 18 years of age
* Women with a history of vulvodynia, vaginismus, or dyspareunia
* No prior sexual activity or intercourse
* Active vaginal, cervical, uterine or adnexal infection
* Active pregnancy or within 6 weeks postpartum
* Vulvar or vaginal surgery within three months
* Psychiatric conditions
Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness

The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.

Migraine is a common disorder, often associated with dizziness symptoms. In many cases, dizziness is one of the only manifestations of migraine headaches. Various classes of drugs have been advocated as treatment for migraine-associated dizziness, though none has been shown to be superior over the others.

Topiramate is a drug approved for migraine prophylaxis. This study is designed to assess if there are significant changes in dizziness frequency and severity in patients diagnosed with migraine-associated dizziness treated with topiramate. Demonstrating benefit of topiramate with a placebo-controlled study to alleviate symptoms of dizziness would serve to clarify effective treatment options for patients with migraine-associated dizziness.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of migraine-associated dizziness.

Exclusion Criteria:

* Previous or current use of topiramate prior to study enrollment.
* Need for continued use of the following medications for any medical reason during the study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local anesthetics, botulinum toxin, or herbal preparations.
* History of nephrolithiasis.
* Women whom are pregnant or breastfeeding.
* Patients with known sensitivity to topiramate.
* Patients with a history of glaucoma.
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.

All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics. Immediately prior to each CBIT session, participants will undergo TMS targeting the SMA. The specific type of TMS procedure will be randomly assigned between subjects and be either: 1 Hz repetitive TMS (rTMS), continuous theta burst stimulation (cTBS), or sham stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
* At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
* Full scale IQ greater than or equal to 70
* English fluency to ensure comprehension of study measures and instructions.
* Right-handed

Exclusion Criteria:

* Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician
* Inability to undergo MRI.
* Left handedness.
* Active suicidality.
* Previous diagnosis of psychosis or cognitive disability.
* Substance abuse or dependence within the past year.
* Concurrent psychotherapy focused on tics.
* Neuroleptic/antipsychotic medications.
* Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
Online Cognitive Behavioral Therapy (CBT) Workbook

This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability and pain severity.

This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). The Wellness Workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (CBT) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the Wellness Workbook or alternative self-help materials for 10 weeks. Participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.

Eligibility Criteria:
Inclusion Criteria:

* currently experiencing chronic non-cancer pain in the lower back

Exclusion Criteria:

* has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer)
* does not have regular Internet access
Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis (SPRIMACC)

The SPRIMACC study is a prospective multicenter observational study with the primary endpoint to prospectively validate the Chole-Risk score in predicting a complicated postoperative course (post-operative major complications (Clavien-Dindo\>=3a), length of stay (LOS) \> 10 days or need of readmission within 30 days from the discharge) in patients undergoing Early Cholecystectomy (EC) for Acute Calculous Cholecystitis (ACC). The secondary endpoints of the study are to prospectively validate and compare other wellknown risk prediction models (the POSSUM/P-POSSUM score, the Modified Frailty Index (mFI), the Charlson Comorbidity Index (CCI), the American Society of Anesthesiologists (ASA) score and the APACHE II score) in predicting a complicated post-operative course in patients undergoing EC.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of Acute Calculous Cholecystitis (ACC) as defined by Tokyo Guidelines 2018 criteria
* be candidate to Early Cholecystectomy (EC) during the index admission\*
* be ≥ 18 years old
* be stratified for the risk of Common Bile Duct Stones (CBDS) according to the Israelian Score, and, in case of confirmation of CBDS receive pre-operative Endoscopic Retrograde Cholangiopancreatography (ERCP).
* provide signed and dated informed consent form
* willing to comply with all study procedures and be available for the duration of the study.

  * All the patients treated with initial open cholecystectomy, those who undergo Early Laparoscopic Cholecystectomy (ELC), those with conversion from laparoscopic to open cholecystectomy or those who undergo bail out procedures (e.g. subtotal cholecystectomy) will be included.

Exclusion Criteria:

* pregnancy or lactation
* acute cholecystitis not related to a gallstone etiology
* onset of symptoms \>10 days before cholecystectomy\*\*
* concomitant cholangitis or pancreatitis
* intraoperative treatment of common bile duct stones
* anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

  * Patients with ACC associated with common bile duct stones who underwent pre-operative ERCP could be included if they receive EC within 10 days from onset of symptoms
Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy

Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis


Eligibility Criteria:
Inclusion Criteria:

1. Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of \>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.
2. ≤14 weeks gestation,
3. age ≥18 years
4. Willingness to use the study devices a minimum of 10 days per trimester
5. Able to provide informed consent
6. Have access to email

Exclusion Criteria:

1. Non-type 2 diabetes
2. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
3. Known or suspected allergy against insulin
4. Women with nephropathy (eGFR\<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results
5. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
6. Unable to communicate effectively in English as judged by the investigator
7. Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
Dissemination and Implementation of Faith, Activity, and Nutrition

This dissemination and implementation study will examine the impact of the Faith, Activity, and Nutrition (FAN) program on both church practices and member behaviors in both a countywide (randomized trial) and statewide (quasi-experimental) study. Guided by two theoretical frameworks, the specific aims of the applied research project are to: 1) examine the adoption and reach of FAN in churches and organizational factors associated with adoption; 2) characterize implementation fidelity and multilevel factors associated with implementation; 3) describe organizational maintenance of FAN and factors associated with maintenance; and 4) study the effectiveness of FAN.

The USC PRC's applied research project will study the dissemination and implementation of an evidence-based program shown previously to significantly increase physical activity and fruit and vegetable intake in churches in South Carolina (Faith, Activity, and Nutrition; FAN). Guided by two theoretical frameworks, the specific aims of the applied research project are to: 1) examine the adoption and reach of FAN in churches and organizational factors associated with adoption; 2) characterize implementation fidelity and multilevel factors associated with implementation; 3) describe organizational maintenance of FAN and factors associated with maintenance; and 4) study the effectiveness of FAN. In Phase 1, churches in a rural county with a high proportion of African American residents will be randomized to receive training in FAN from a community health advisor (n=40) or to be part of a delayed intervention control group (n=20). In Phase 2, a quasi-experimental study will be done with a large religious denomination in SC (churches are not randomized).

Eligibility Criteria:
Inclusion Criteria:

* Phase 1 churches: church in Fairfield County, SC with at least 20 members who regularly attend worship service
* Phase 2 churches: church in the SC Conference of the United Methodist Church
* Members (phase 1): adult who regularly attends church participating in the study

Exclusion Criteria:

* Members (phase 1): under the age of 18
* Members (phase 1): does not regularly attend church participating in the study
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine

The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h


Eligibility Criteria:
Inclusion Criteria:

* pregnant patients
* live singleton pregnancy

Exclusion Criteria:

* BMI \>40
* obstructive sleep apnea
* drug abuse
* chronic pain
* chronic opioid use
* nonfunctioning epidural
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.

The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.


Eligibility Criteria:
Inclusion Criteria:

* ages 4-10 years old
* undergoing elective umbilical or inguinal hernia repair surgery
* ASA Physical Status = 1

Exclusion Criteria:

* None