cyrilzakka/clinical-trials huggingface dataset:
Prevention of Diabetes Mellitus Development in Women Who Had Already Experienced A Gestational Diabetes

Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.

The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.

Gestational diabetes mellitus (GDM) is one of the most frequent metabolic disorders occurring during pregnancy that complicates both, the course of pregnancy and the delivery and is also responsible for many fetal complications. Gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous GDM woman. Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. The incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years.

Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, a modification of the life style and pharmacotherapy. The use of metformin in patients with a impaired glucose tolerance, resulted in a ca. 30% reduction of the diabetes incidence rate.

The aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.

Eligibility Criteria:
Inclusion Criteria:

* GDM - experienced during pregnancy (diagnosis of GDM according to WHO-criteria)
* Breast-feeding of the newborn finished (lactation finished)
* Actual BMI \>= 25 kg/ m2
* Written consent for participation in the study
* A hitherto prevailing good cooperation with the patient

Exclusion Criteria:

* Cholestasis during the past pregnancy
* Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage,jaundice of unknown etiology)
* Serum ASPAT and/or ALAT level exceeding more than twice normal laboratory values
* Pregnancy planned during the coming two years
* Presence of contradictions for metformin administration according to demands of the Drug Admission Committee in Poland
Cigar Box Arthroscopy: A Study of Non-Anatomic Arthroscopy Training

Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy skills after receiving prior training with different simulation systems.

A non-anatomic set of training modules utilizing cigar boxes was developed at our institution to instruct residents in the basics of knee arthroscopy. Twenty-four medical students with no prior arthroscopic or laparoscopic experience were enrolled as subjects. Sixteen subjects were randomized to participate in four hours of either the cigar box arthroscopy trainer (CBAT) or a previously validated anatomic knee arthroscopy trainer (AKAT). The remaining eight subjects served as controls (CO). All subjects underwent a one-hour formalized training session provided by our orthopaedic sports faculty. Subjects' skills were assessed by one of two faculty members through repeated attempts at performing a diagnostic knee arthroscopy on a cadaveric specimen. Objective scores were given using the Basic Arthroscopic Knee Skill Scoring System. Total cost differences were also calculated.

Eligibility Criteria:
Inclusion Criteria:

* First or Second year medical student with no prior arthroscopy or laparoscopy training.

Exclusion Criteria:

* Having previously received education in arthroscopy or laparoscopy or handled these instruments.
DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic CD as determined by the enrolling investigator
* If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study
* Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews)
* Provision of written informed consent prior to enrollment

Exclusion Criteria:

* Contraindications to treatment with any BoNT-A or BoNT-B preparations
* Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction
* Anticipated concomitant treatment with BoNT for other than cervical dystonia
* Secondary cervical dystonia
Mental Health and Medication Adherence Among MSM in South Africa

The goal of this behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa.

Men who have sex with men (MSM) are at an increased risk of HIV infection and transmission, and MSM with depression or anxiety may have adherence to medication challenges. Development of an integrated mental health and adherence support intervention for MSM can be an effective strategy to improve both psychological outcomes and care continuum outcomes including adherence to Pre-Exposure prophylaxis (PrEP) and Anti Retroviral Therapy (ART).

The team proposes developing an intervention approach that responds to the unique social contexts of South African MSM living with or at risk for HIV, and that addresses the relationship between mental health and adherence to HIV prevention medication (daily PrEP) and ART. This intervention approach, WeCare, will adapt an evidence-based program entitled Friendship Bench (i.e., FB) - an empirically supported mental health program using problem-solving therapy (developed/validated in southern Africa) - to incorporate mental health and medication adherence concerns for MSM.

Eligibility Criteria:
Inclusion Criteria:

* Cis-gender male
* Reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
* Current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic
* Self-reported challenges adhering to daily ART (HIV-positive participants) or PrEP (HIV-negative participants)
* Interested in participating in a group discussion to discuss common mental health problems and medication adherence challenges
* Ability to understand and provide informed consent.

Exclusion Criteria:

* Presently engaged in mental health therapy.
* Participated as an intervention participant in a pilot mental health study (AUR6-8-403)
* Refuses audio recording of the focus group discussion
* Those who score over 20 on the PHQ-9 (i.e., indicating severe depression)
Cocaine Abuse and ADHD - 10

The purpose of this study is to evaluate the safety and efficacy of buproprion in treating individuals with adult attention-deficit hyperactivity disorder (ADHD) and cocaine dependence.


Eligibility Criteria:
Please contact site for information.
Pooling of Cohort Studies on Diet & Coronary Disease

To quantify the role of dietary factors in the etiology of coronary heart disease by pooling data from 10 major prospective studies on diet and coronary heart disease.

DESIGN NARRATIVE:

Specific hypotheses tested included an adverse effect of saturated fat and carotenoids (alpha-carotene, lutein, and lycopene), flavonoids, folic acid, and vitamin B6. Plausible biological interactions between nutrients, such as fatty acids of the n-6 and n-3 series were also explored. Each participating center sent data on tape to the coordinating unit at the Department of Nutrition, Harvard School of Public Health. The relations of dietary factors and coronary heart disease were first estimated within each study and compared for consistency. Data were then combined to obtain the best overall estimates, taking into account the validity of dietary data collected at each center. Members from study centers met annually to discuss the interpretation of findings. Over 6,000 cases of myocardial infarction or coronary death were anticipated, which should have provided excellent precision in measuring associations, and allowed the comparison of extreme intakes that were poorly represented in individual studies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening

Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective was to evaluate the sensitivity of FIT and the proportion of interval cancer.

Fecal immunochemical test (FIT) aims to detect pre-symptomatic lesions, i.e., early stage colorectal cancers (CRCs) or pre-cancerous lesions such as colonic adenomas in order to reduce CRC mortality. FIT was introduced in France late 2015, FIT has better diagnostic accuracy for CRCs than previous screening tests. Determining the incidence of post-test interval CRCs, diagnosed after a negative FIT and before the recommended date of the next test (2-year interval), allows assessment of the sensitivity of the test. The primary objective of this study was to evaluate the performance of FIT during the CRC screening campaign in the Finistère department (France) from January 1, 2016 to December 31, 2017. Its secondary objectives were the evaluation of diagnostic circumstances and their impact on treatment and survival, and risk factors for interval cancer (IC).

Eligibility Criteria:
Inclusion Criteria:

* All subjects between 50 and 77 years diagnosed with an in situ or an invasive CRC
* Inhabitants of the Finistère area
* Subjects were included by period:

  * from January 2016 to December 2017 for subjects with SD-CRC, non-responders and the excluded population
  * from January 2016 to December 2019 for subjects with FIT-ICs (2-year interval)
  * from January 2016 to December 2020 for subjects with post-colonoscopy IC
  * from January 2018 to December 2020 for subjects with delayed diagnosis

Exclusion Criteria:

* Subjects who refused to participate in the case of refusal of data collection
* Subject swith CRC other than adenocarcinoma were excluded.
Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design

compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 45 years
2. Patients who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

to. Primary or secondary osteoarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Moderate valgus, varus or flexion deformities (HKA within ±10°, flexion contracture \<10°) 3. Patients consenting and able to complete planned study procedures and follow-up assessments 4. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

Exclusion Criteria:

1. Patients aged \< 45 years;
2. Patients who have already undergone hip or knee arthroplasty ankle, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases. In this way, homogeneity of the investigated cohort will be guaranteed;
3. Pregnant women. -
An Aerobic Exercising Program on Respiratory Muscle Strength in Patients With Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis (AIS) can change the respiratory dynamics and performance of the inspiratory and expiratory muscles, affecting ventilatory capacity. This was a randomized, controlled, open study to test the impact of a physiotherapeutic program of aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic scoliosis. Patients with AIS were randomly assigned to the aerobic exercise-training program group or the no treatment group. There was a significant increase in Pimax and Pemax in the group which received physiotherapy.

Study Design: This was a randomized, controlled, open study to test the impact of a physiotherapeutic program of aerobic exercises on respiratory muscle strength, in patients with adolescent idiopathic scoliosis (AIS). Objective. To analyze, by means of maximum respiratory pressure measurements, the conditioning of the respiratory muscles after four months of aerobic exercise training. Summary of Background Data. AIS can change the respiratory dynamics and performance of the inspiratory and expiratory muscles, affecting ventilatory capacity.

Methods: Patients with AIS, aged between 10 and 20 years, were randomly assigned to the aerobic exercise-training program group or the no treatment group. They were evaluated for respiratory muscle strength before and after the treatment period, by means of a manometer, and radiographs of the chest and spine. The physical therapy exercise protocol consisted of three weekly sessions, including stretching, aerobic exercises (first mild and then accelerated) and relaxation techniques, for a period of four months.

Eligibility Criteria:
Inclusion Criteria:

* aged between 10 and 20 years
* diagnosed as having adolescent idiopathic scoliosis with a spinal angle of scoliotic deformity of at least 45º, and candidates for surgical correction
* sedentary

Exclusion Criteria:

* spinal angle deformities of less than 45º
* previous operation for spinal correction
* comorbidities (lung, heart or neurological diseases) that could interfere with the understanding of the procedures of this study (both diagnostic and interventional)
* regular physical activity
Calcitonin in the Treatment of Fibromyalgia

The purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.

Fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness. Fibromyalgia occurs in around 2% of the US general population, is more common in women and is associated with substantial morbidity and disability. Treatment of fibromyalgia has been disappointing; roughly one-third of patients have had a clinically important therapeutic response to medications or no-medicinal treatment, event with the newest drugs reported in the literature. Pathophysiology of fibromyalgia is unknown, but abnormalities in central neurotransmission might play a role. Some studies have shown that salmon calcitonin increases peripheral and central levels of endorphins. Increasing endorphins levels may decrease pain. Then, it is feasible that nasal administered salmon calcitonin may decrease several of the symptoms and signs of patients suffering fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Female patients between 18 and 50 years
* Fibromyalgia diagnosis (ACR criteria)
* Must be able to apply the nasal medication
* Must be able to comply with study visits
* Must be able to understand informed consent
* Must be able to answer self-administered questionnaires
* Must have an active disease(VAS \> 60mm)

Exclusion Criteria:

* Comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.)
* Any disturbance in the nasal tissue
* Use of concomitant opioid analgesics
* Contraindication to use salmon calcitonin (allergy, hypocalcemia, hypophosphatemia)
* Other rheumatic diseases
* Diagnosis of major depressive disorder
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2

This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.

The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females with a BMI between 19 and 30kg/m2
* No clinically significant abnormalities

Exclusion Criteria:

* Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2)
* Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry
* Significant history of depression or other psychiatric illness
* Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
* unable to swallow capsules
Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
* HbA1c between 7.0-11.0% if on OAD monotherapy
* HbA1c between 7.0-10.0% if on OAD combination therapy
* BMI less than or equal to 40 kg/m2

Exclusion Criteria:

* Current regular smoking or regular smoking within the last 6 months
* Current acute or chronic pulmonary disease (except for asthma)
* Proliferative retinopathy requiring treatment
* Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
* Pregnancy
The Effectiveness of Expressive Writing on a Sample of New Mothers

This pilot study aims to evaluate the effects of an expressive writing intervention on a sample of new mothers after the childbirth on the psychological health and on the healthcare costs. The mothers were evaluated also in a follow-up one month after the end of the expressive writing intervention.

Women are recruited starting from the sixth month of pregnancy; forty-one eventually agreed to participate and they were randomly assigned to two groups: an Experimental group (treated with the expressive writing task, one weeks-three months after childbirth) and a Control group (no intervention).

Psychological health is measured at three stages:

before intervention, at 8-9 months pregnant (T0); after intervention, from 1 week to 3 months after delivery (T1); and a follow-up after 1 to 3 months (T2). The assessment protocol consists of the Attachment Style Questionnaire (ASQ), the Prenatal Attachment Inventory (PAI), the Toronto Alexythimia Scale-20 (TAS-20), the Beck Depression Inventory (BDI-13), the State-Trait Anxiety Inventory (STAI-Y), the Rating Scale For Rapid Stress Assessment (VRS) and the 12-Item Short Form Survey (SF-12). The healthcare costs are collected at baseline (T0) and follow-up (T2) with a survey created ad hoc, in which participants reported the number and the type of the medical examinations, hospitalisations, prescribed drugs etc. Social and personal data are collected from the first survey.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* \> 6 months of pregnancy
* no medical complications during pregnancy

Exclusion Criteria:

* medical complication during pregnancy
* no comprehension of Italian language
Subsidence of Cementless Stem Following Arthroplasty for Fracture Neck of Femur

Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.

Neck of femur fractures are occurring at an increased incidence, Functionally independent patients without cognitive impairment can expect reasonable life expectancy, this indicates the need for a durable surgical option that optimises the chance to return to pre-injury functional status, with minimal risk of complications and reoperation. THA should be considered the gold standard producing better functional and quality of life outcomes lower reoperation rates and better cost effectiveness.

THA is associated with better functional outcomes and a lower risk of revision surgery in self-sufficient, physically active patients , Instability is the leading complication of conventional THA and occurs with a higher incidence ,THA remains the option of choice as it provides better functional outcomes.

Although the clinical outcomes of total hip arthroplasty (THA) in elderly patients with femoral neck fracture were reported to be better than hemiarthroplasty, hemiarthroplasty was frequently recommended in cases where the patient has a low functional level and/or osteoporosis and high rates of postoperative dislocation of total hip arthroplasty.

Hip joint replacement surgery is considered one of the most successful operations due to its high success and low complication rate , one possible risk factor for early failure of total hip arthroplasty (THA) is the subsidence of the femoral stem , Cementless THA in particular could be susceptible to subsidence.

Cementless femoral stems ideally achieve direct integration between the stem surface and endosteal bone with the aim of decreasing the incidence of aseptic loosening.

Subsidence is defined as a distalization of the femoral stem in reference to the greater trochanter.

Measurement of subsidence of uncemented femoral stems can be used to evaluate the likelihood of long term stem component loosening and therefore clinical failure .

Eligibility Criteria:
Inclusion Criteria:

* cases that underwent cementless hip arthroplasty for fracture neck of femur

Exclusion Criteria:

- 1- malignancy. 2- Previous plating. 3- Revision for infection. 4- dysplasia. 5- SLE and Rheumatoid Arthritis