cyrilzakka/clinical-trials huggingface dataset:
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age more than or equal to 18 years at the time of signing informed consent
* BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
* History of at least one self-reported unsuccessful dietary effort to lose body weight
* For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

Exclusion Criteria:

* A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
* For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 mL/min/1.73 m\^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations

This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.

Protocol has two cohorts. Cohort 1 will receive radiation to breast and chest wall. Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy x 15 fractions (40.50 Gy) with a concomitant boost of 0.50 (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

Cohort 2 patients will receive radiation to breast, chest wall and LevelII/SCV nodes.

In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy).

Patients will complete treatment in three weeks (15 fractions). All patients will be followed at 3 months after the completion of treatment then yearly for the next 5 years.

Eligibility Criteria:
The study will also include patients who because of COVID had undergone up to 3 months neoadjuvant hormonal therapy before surgery for clinical T1/T2 BC.

Inclusion Criteria:

* Age older than 18
* Pre- or post-menopausal women with Stage I-III breast cancer
* Status post neoadjuvant systemic therapy
* Status post-chemotherapy breast surgery
* Original biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm (patients with focally positive margin are not excluded).
* Status post segmental mastectomy or mastectomy, with either negative sentinel node biopsy and/or axillary node dissection (at least 6 nodes removed).
* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast and/or nodal area
* Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
* Pregnant or lactating women
* Concurrent chemotherapy, with the exception of anti HER2neu therapies
* Inadequate axillary dissection in a setting of positive sentinel node
* Patients with more than 5 nodes involved at axillary dissection will be excluded from this study since they will be eligible to receive radiotherapy to level I and II axilla.
Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

The objective of this study is to examine the impact of the "Doing What Matters in Times of Stress" guided self-help handbook, along with phone-based lay helpers sessions, on the psychological well-being, business performance, and incidence of intimate partner violence among women entrepreneurs in Ethiopia.

This study aims to evaluate the impact of the "Doing What Matters in Times of Stress Guided" self-help manual on mental distress, business performance, and intimate partner violence experienced by women entrepreneurs in Ethiopia. The study will be conducted in four cities - Addis Ababa, Hawassa, Bahir Dar, and Adama - using a randomized controlled trial (RCT) design. The investigators will screen 5000 potential participants via phone and enroll 1200 eligible women, who will be equally distributed across the four cities. After an in-person baseline survey, the women will be stratified by marital status and city and randomized into the intervention or waitlist control group using a computer-generated random assignment. The intervention group will receive seven phone-based sessions over ten weeks to review the self-help manual materials with a lay helper. Two follow-up surveys will be conducted after the intervention, the first one a month after the completion of the intervention, and the second one twelve months after completion.

This study is a continuation of a pilot study conducted between July 2021 and August 2022 (PRS registration ID - NCT05208723). The current study seeks to build on the pilot study in the following dimensions:

1. Increase the sample size to 1200 women entrepreneurs to improve the power of the study to detect the impact of the intervention on business performance outcomes,
2. Widen the geographical and contextual coverage,
3. Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them,
4. Capture the impact on intimate partner violence,
5. Introduce a short conflict module to capture the direct and indirect effects of conflict on mental health outcomes, business performance, and intimate partner violence.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18;
* Those who plan to live in the study city in the next six months;
* Those who can read and speak Amharic and can understand the study questionnaire;
* Those who have the capacity to provide informed consent;
* Score 8 or above on the Ethiopian adaptation of Kessler-6

Exclusion Criteria:

* Kessler 6 score \>20;
* Those who have recent or current suicidal thoughts or plans;
* Those who have limitations in understanding the study questionnaire;
* Those who do not have the capacity to provide informed consent;
* Do not have access to a phone;
* Not interested in receiving the intervention
A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease

This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

This is a double-blind, placebo-controlled, randomized, multiple-dose, parallel group, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. The study will be conducted in up to four sites. Within 28 days prior to study drug administration, subjects will be screened based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity Rating Scale (C-SSRS).

Subjects will be divided into two groups of 10 subjects each. In each group, 8 subjects will receive ABT-126 and two subjects will receive matching placebo. Group 1 will be administered Dose 1 of ABT-126 or placebo. Group 2 will be administered Dose 2 ABT-126 or placebo. All doses will be administered once daily in the morning for 10 days.

Eligibility Criteria:
Inclusion Criteria

1. Male or female and age between 55 and 90 years, inclusive.
2. The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease (AD).
3. The subject has a Mini-Mental State Examination (MMSE) total score of 16 to 26, inclusive, at Screening Visit.
4. The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit.
5. The subject must be on a stable dose of donepezil or rivastigmine for at least 1 month prior to study drug administration.
6. The subject has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization and after the subject met NINCDS/ADRDA diagnostic criteria for probable AD. The scan must not show evidence for an alternative etiology for dementia.

Exclusion Criteria

1. Receipt of an investigational product within 6 weeks prior to study drug administration.
2. History of significant sensitivity or allergy to any drug.
3. History of any significant neurological disease other than AD.
4. Significant current suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any history of suicide attempts.
The Effect of Breastfeeding Education Given to Fathers on Breastfeeding

The goal of this clinical trial is to determine the effect of breastfeeding education given to fathers via Whatsapp messaging application in the postpartum period on breastfeeding.

The main hypotheses it aims to answer are: ,

* Ho: There is no difference between the "Fathers' Effect on Breastfeeding" scale scores and the Breastfeeding Support Scale scores of the fathers who received breastfeeding training via Whatsapp messaging application in the postpartum period and the scale scores of the fathers who did not receive training.
* H1: There is a difference between the scale scores of the fathers who received breastfeeding training via Whatsapp messaging application in the postpartum period and the scale scores of the fathers who did not receive education.
* H2: There is a difference between the "Breastfeeding Support Scale" scores of fathers who received breastfeeding training via Whatsapp messaging application in the postpartum period and the scale scores of fathers who did not receive education.

Participants will be received breastfeeding training via Whatsapp messaging application in the postpartum period.

If there is a comparison group: Researchers will compare training group and control group to see if effect on breastfeeding.

Spousal and family support increases breastfeeding rates, has a positive effect on the mother-baby relationship, the decisions of mothers who receive emotional support from their spouses are positively affected, women experience less breastfeeding problems when they are consciously supported by their spouses and cope with these problems better, fathers' benefits of breastfeeding It has been reported that the state of knowledge about breastfeeding and its management affects the duration and frequency of breastfeeding. In a study, fathers stated that they wanted to investigate suggestions on how to help their spouses, but there were limited studies on these suggestions so this study was planned .

Eligibility Criteria:
Inclusion Criteria:

* Follow-up of the mother in the postpartum clinic of the hospital
* Feeding the baby with breast milk
* Being an only baby, being at a gestational age of 37 weeks and above, weighing 2500 g and over, not having a congenital disease
* The mother does not have any health problems that may prevent breastfeeding
* The mother and father do not have any barriers to filling out the questionnaire.
* Literacy of mother and father
* Availability of a phone and internet where messages can be read
* Mother and father living in the same house

Exclusion Criteria:

* The baby's inability to get breast milk
* Fathers or mothers have a disability in completing the questionnaire.
* Lack of a phone and internet where messages can be read
* Parents living in separate places
Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre


Eligibility Criteria:
Inclusion Criteria:

* newborn patients with complete unilateral cleft lip and palate

Exclusion Criteria:

* with associated syndrome
* previous lip/ palate repair
* previous presurgical orthopaedics other than passive palatal plate
Intraoperative Measurement Technique

This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.

Introduction: Restoration of limb length equality and femoral offset is critical for the success of THR. The purpose of this study was to investigate the efficacy of a novel intraoperative measurement technique in minimizing errors in leg length and offset in total hip replacement (THR).

Methods: This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.

Eligibility Criteria:
Inclusion Criteria:

\* patients that underwent THR due to primary osteoarthritis of the hip joint.

Exclusion Criteria:

* Patients who underwent THR for any other reasons
* patients that underwent revision surgery
Physiologic Assessment of Coronary Stenosis Following PCI

This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).

DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR\<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be \> 18 years old
2. Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)
3. Single vessel CAD with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm OR multi-vessel CAD, defined as at least 2 vessels with ≥40% stenosis
4. Pre-PCI iFR performed in all vessels intended for PCI
5. Pre-PCI iFR of \<0.90 of at least 1 stenosis
6. Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion Criteria:

1. Pregnant or planning to become pregnant for the duration of the study
2. Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
3. Cardiogenic shock (sustained (\>10 min) systolic blood pressure \< 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
4. Ionotropic or temporary pacing requirement
5. Sustained ventricular arrhythmias
6. Prior CABG (Coronary Artery Bypass Graft)
7. Known ejection fraction ≤30%
8. Chronic Total Occlusion (CTO)
9. Known severe mitral or aortic stenosis.
10. Any known medical comorbidity resulting in life expectancy \< 12 months.
11. Participation in any investigational study that has not yet reached its primary endpoint.
12. Known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2).
13. TIMI flow \<3 at baseline
14. Intra-coronary thrombus on baseline angiography
Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may require multiple drugs.

Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin treatment is limited by its systemic route of administration and a lot of adverse events. Amikacin inhalation treatment could overcome these limitations and also could be effective for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The purpose of this study is to determine whether amikacin inhalation treatment is effective in patients with MAC infection who experienced treatment failure after standard treatment for more than 6 months or with M. abscessus infection.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria.
2. MAC lung disease with persistent sputum culture positive after 6 months of standard treatment
3. M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment
4. New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment

Exclusion Criteria:

1. Subjects with negative sputum culture before starting of this study
2. Forced expiratory volume in 1 second (FEV1) \<30% of predicted at screening.
3. Positive in HIV test.
4. Subjects with chronic renal insufficient state (serum creatinine level is more than 2.0 mg/dL)
5. Subjects with decreased liver function (serum total bilirubin level is more than 2 mg/dL or AST or ALT are more than 1.5 times of upper normal limits)
6. Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening.
7. Subjects with history of allergy to amikacin.
8. Subjects with pregnant state or women of childbearing age with no appropriate contraception.
Types of Fixation of Vancouver B1 Periprosthetic Fractures

The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.


Eligibility Criteria:
Inclusion Criteria:

* Age: over 18, no upper limit
* Vancouver type B1 periprosthetic fracture
* Fracture is amenable to either treatment group
* Prosthesis is well fixed
* Provision of informed consent

Exclusion Criteria:

* Presence of an active infection around the fracture (soft tissue or bone)
* Loose prosthesis
* Trauma patients with an ISS \> 16 or associated major injuries of the lower extremities
* Known substance abuse
* Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)