cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Metformin for Treatment of Cytopenia in Children and Adolescents With Fanconi Anemia

Prospective interventional open-label non-randomized controlled trial to assess safety and efficacy of metformin in treating cytopenia in children and adolescents with Fanconi Anemia.

Fanconi anemia (FA) is a genetic disease characterized by bone marrow failure, cancer susceptibility, and developmental abnormalities. Allogeneic hematopoietic stem cell transplantation offers curative therapy for hematologic complications of FA.

Oxymetholone is commonly used in the management of FA as it improves blood counts, red cells, and platelets. However, its use is limited by its high toxicity profile.

Metformin is a potential agent that reduces levels of both chromosomal radials and breaks in FA cells and increases the size of the hematopoietic stem cell compartment thus reducing cytopenia in patients with FA.

Eligibility Criteria:
Inclusion Criteria:

* Age: 5 to 18 years
* Patients who are diagnosed with Fanconi anemia based on clinical features and confirmed by increased chromosomal breakage on diepoxybutane (DEB) stress testing.
* Presence of cytopenia (at least one of the following: hemoglobin (Hb) \< 10 g/dL, platelet count \< 100 x 109/L, or an absolute neutrophil count (ANC) \< 1.0 x 109/L
* Patients receiving other therapies e.g., androgens are eligible for enrollment after a one-month washout period before the start of metformin.

Exclusion Criteria:

* Patients who underwent bone marrow transplantation.
* Patients with evidence of myelodysplasia, leukemia, or other concurrent malignancy.
* Patients who have a history of allergic reactions to metformin or similar compounds.
* Patients with a history of symptomatic hypoglycemia over the past year or hypoglycemia \< 50 mg/dL on screening and baseline laboratory assessments.
* Patients with type 1 diabetes mellitus.
* Patients with vitamin B12 deficiency.
* Patients with Glucose-6-Phosphate Dehydrogenase deficiency.
* Patients with abnormal Kidney function tests including serum creatinine, elevated liver function tests including live enzymes (ALT or AST \> 135 U/L, total bilirubin \> 1.5 x upper limit of normal for age, and/or patients with metabolic acidosis (bicarbonate \< 17 meq/L on venous blood gases).
Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors

The purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors

A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants\&#39; pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* women between 18 and 65 years of age,
* women with oncologic treatment completed less than 3 months ago,
* women without metastasis,
* women without pathologies that contraindicate exercise,
* women who have agreed to sign the informed consent form

Exclusion Criteria:

* not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
* undergoing another type of therapy
* pregnancy patients.
Laughter Therapy and Mindfulness Practices

Nurses working by shifts under intense stress and pressure and using complicated technological products- undergo fatigue and attention deficit with the effect of the many negative factors caused by work setting. This threatens patient and staff safety as well as leads to communicational problems, work absenteeism, lowered motivation, inability to control stress and poor work performance and productivity among nurses as well. In this sense; laughter therapy and mindfulness practices may help nurses cope with these problems because some experimental studies proved that both methods showed many benefits in different samples. However; no studies in which these two methods were compared among nurses were encountered. Therefore; the study -being in experimental design and randomized controlled trial- will be undertaken with a total of 111 nurses employed at a university hospital -37 nurses allocated to the experimental 1 group, 37 nurses to the experimental 2 group and 37 nurses to the control group-. First; Computer-Based Sustained Attention Test, the Stroop Test Çapa Version, The Chalder Fatigue Scale (CFQ) and Individual Work Performance Questionnaire will be administered to the nurses of the experimental and control groups as a pre-test. Then; nurses of the experimental 1 group will join sessions of laughter therapy (30-45 minutes twice a week for 8 weeks) and nurses of the experimental 2 group will join sessions of mindfulness practices (45-60 minutes twice a week for 8 weeks) for two months. One month later when the sessions are started, a mid test will be administered and soon after the sessions are completed a post test will be administered to the nurses via Computer-Based Sustained Attention Test, the Stroop Test Çapa Version, The Chalder Fatigue Scale (CFQ) and Individual Work Performance Questionnaire. One month later after the post test; a follow-up will be performed using the same tools. As a result; the effects of both applications on fatigue, attention and performance will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* at least 6 months experience
* volunteering
* alternative work schedule

Exclusion Criteria:

* Not being a nurse,
* Pregnancy
* Diagnosis of colour blindness, cardiovascular, psychological diseases
* Meditating before
Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin

The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.

1. To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.
2. To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups.
3. To detect any side effects of the study medications in all patient groups.

Eligibility Criteria:
Inclusion Criteria:

* - Both gender.
* Age: 18- 65 years old.
* Body Mass Index 20-30 kg/m2
* American Society of Anesthesiologist (ASA) physical status I - II.
* Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .

Exclusion Criteria:

* - Allergy to study drugs.
* History of chronic headache and migraine.
* History of cerebrovascular accidents and neurological disorders.
* Systemic infection
* History of uncontrolled DM or hepatic disease or pregnant female
* Patient refusal or uncooperative patient.
Exploring the Impact of " ACP Board Game for Life" on Death Preparation and Anxiety in Patients With Stage 4 and 5 Chronic Kidney Diseases: A Pilot Study

This study was to explore the impacts of participating in "ACP board game for life" on death preparation, death anxiety, end-of-life care preferences, and intervention perception in stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center.

This study was to explore the impacts of participating in "ACP board game for life" on death preparation, death anxiety, end-of-life care preferences, and intervention perception in stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center. A nonrandomized two-arm pretest and posttest quasi-experimental design was used. Patients in the control group received routine care while patients in the experimental group received routine care and ACP board game for life. The ACP board game, death preparation subscale, Chinese Likert death anxiety scale, self-created questionnaires and brief interview were used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Stage 4-5 chronic kidney disease patients
* Chinese nationality
* Over 20 years old
* Consciousness clear, can communicate and express their opinions in Mandarin and Taiwanese

Exclusion Criteria:

* Patients express that talking about death makes them feel scared or cause anxiety
* The doctor assesses that the patient's condition is in the stage of septic shock, hemodynamic instability, asthma, pulmonary edema, hypoxemia or acute myocardial infarction
* Patients with contact or airborne precautions
* Patients without legal capacity
Sensory Changes Associated With Thoracic Surgery

Many patients experience chronic pain after thoracic surgery and this is caused by nerve damage during surgery. Changes in skin sensation (dysaesthesia) is typically associated with chronic nerve pain.

We hypothesise that thoracic surgery causes sensory changes. Another hypothesis is that minimally invasive thoracic surgery using video cameras results in less nerve damage and so a smaller area of altered skin sensation, when compared to the traditional method of chest surgery using a large surgical incision. A final hypothesis is that the extent of nerve damage during surgery is associated with the severity of pain early after surgery.

This study is designed to compare the total areas of sensory changes after thoracic surgery on the operated side of the chest with that on the non-operated side of the chest. We also aim to identify the type, pattern, location and area of sensory changes associated with thoracic surgery, comparing the operated with the non-operated side of the chest. In addition, we aim to compare the total area of sensory changes between the traditional method of chest surgery and the minimally invasive method of chest surgery. We would also like to determine whether the severity of pain early after surgery is associated with the area of sensory changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or older admitted for elective thoracic surgery

Exclusion Criteria:

* Emergency thoracic surgery
* Thoracic surgery involving sternotomy
* Damage to the spinal cord and/ or intercostal nerves prior to surgery
* Neurological diseases that may alter the skin sensation to the chest wall such as multiple sclerosis and neuropathies, previous surgery of chest wall, a history of chronic pain
SGB Reduces the Incidence and Severity of CSA-AKI

The incidence of acute kidney injury after cardiopulmonary bypass cardiac surgery is high, which increases postoperative mortality and is not conducive to the prognosis of patients. Stellate ganglion blocks increase renal blood flow, reduce inflammation and stress, and protect the heart muscle. In this study, stellate ganglion block was used to promote rapid recovery of kidney function after cardiopulmonary bypass cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of any gender were eligible provided they were between the ages of 18 and 80 years;
2. American Society of Anesthesiologists (ASA) class of Ⅲ or IV.

Exclusion Criteria:

1. emergency cardiac surgery；
2. major vascular surgery；
3. non-sinus rhythm, reoperation；
4. contraindications for TEE or SGB；
5. abnormal preoperative renal function；
6. severe preoperative heart failure with left ventricular ejection fraction \&lt; 30%, multi-organ dysfunction；
7. and severe infection requiring continuous antibiotic treatment;
8. enrolled in another clinical trial.

Elimination criteria:

1. incomplete follow-up data;
2. withdrawal during the procedure;
3. SGB failure or complications;
4. insufficient ultrasonographic imaging of the left renal artery on TEE;
5. repeated CPB during surgery;
6. need for cardiac assist devices (extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist devices) after CPB completion.
IgY Efficacy on Periodontitis Patients

Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8 weeks the patients were examined against. Parameters including probing depth (PD), bleeding on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared to the control group that had used placebo lozenges.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with chronic periodontitis
* had at least 2 interproximal site with pocket depth between 3 mm to 5 mm
* nonsmokers with at least 20 natural teeth
* bone loss and bleeding on probing
* had not undergone periodontal treatments within 6 weeks before the study

Exclusion Criteria:

* patients received medication such as antibiotics or anti-inflammatory drugs within the previous 3 months
* had allergy to egg proteins
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion
* Participants had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
* Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)
* Participant was ≤6 months postpartum at screening
* Participant was amenable to IV therapy

Key Exclusion Criteria:

* Active psychosis
* Attempted suicide associated with index case of postpartum depression
* Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

Note: Other protocol-defined inclusion/exclusion criteria applied.
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass

Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes. This study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI). The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further than the conventional food pre-operative diet.

The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will reassess at week 6.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing Roux-en-Y gastric bypass at Imperial Weight Centre
* aged 18 to 60 years
* boby mass index of 35 to 55 kg/m2

Exclusion Criteria:

* Claustrophobia
* Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging
* Current pregnancy or breast feeding for females (as determined by a pregnancy test)
* A full term pregnancy within the last year for females
* Treatment with any medication that might affect the study outcomes
* Haemorrhagic disorders and anticoagulant treatment
* History of cancer, excluding skin cancer
* History of severe or multiple allergies, severe adverse drug reaction or leucopenia
* Smokers
* Regular drinkers of more than three units of alcohol daily
* History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
* Regular intake of over-the-counter (OTC) medication (other than the occasional paracetamol/aspirin)
* Poor compliers or subjects unlikely to commit to the 26 week study duration
* Blood donation within the 12 week period before the initial study dose
* Use of monoamine oxidase inhibitors (MAOIs) as anti depressant
Documentation of Altered Mental Status

Altered mental status (AMS) is common in older patients. However there is a lack of standardization in the definition and documentation of this compliant. Different perception of AMS can cause negative impact on interpretation and obtaining scientific data. Although definition of AMS is so complicated, clinical documentation can be detected in these patients with AMS.

Basically, consciousness is the state of full awareness of the self and one's relationship to the environment. There are 2 related areas of neurologic function that are connected to consciousness: content (orientation and memory) and level (arousal and response to stimuli).

The mental changes are best looked for in terms of arousal, attention, alertness, orientation, cognition, memory, affect, and perception. Arousal (level of consciousness) can be detected by the Richmond Agitation and Sedation Scale. Others are related to content of consciousness and can be evaluated by cognitive tests. After one month pilot study, the investigators chose 5 features of content of consciousness due to easy applicable and detectable;

1. Attention (counting numbers backwards from 20) (\>1 error positive)
2. Cognition (disorganized thinking; meaningless speech, irrelevant explanations)
3. Perception (visual or auditory hallucinations)
4. Memory (3 items recall) (\>1 error positive)
5. Orientation (day of week, month and year) (\>1 error positive)

These features are also combination of six item screener test and delirium symptoms.

All elderly patients (65 aged and older) presented to the emergency department, will be assessed according to these two methods; content and level of consciousness. And also, every patient's baseline status of consciousness will be obtained from surrogates who knows the patient best. All changes from patient's baseline status will be recorded. The investigators will investigate how changes are reflected in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* All older ED patients

Exclusion Criteria:

* Unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (STE MI, severe dyspnea, etc)
Lung Cancer Screening in Family Members and Peers of Lung Cancer Patients: a Prospective Cohort Study

Lung cancer screening of active or former heavy smokers with yearly low-dose CT allows for earlier diagnosis and better lung cancer survival. Risk of developing lung cancer is higher among family members and close contacts of lung cancer patients, because of shared genetics, environment and life habits like smoking. The investigators want to engage lung cancer patients to refer their family members and close contacts for lung cancer screening, and evaluate if this referred population have higher risk of lung cancer than the population referred by their family doctors.


Eligibility Criteria:
Lung cancer patients:

Inclusion Criteria:

* \> 18 years old
* Current or former lung cancer patient

Exclusion Criteria: none

Referred participants Inclusion criteria: \>18 years old Exclusion criteria: Personal history of lung cancer.
Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

A phase II, randomized study of placebo versus metformin in association to chemotherapy with capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or TxN1-2M0) rectal carcinomas.

NEOMETRE is a randomized, double blind trial aiming to evaluate the efficacy and tolerability of metformin in association to chemoradiotherapy for the preoperative treatment of locally advanced (T3-4N0M0 or TxN1-2M0) rectal carcinomas.

Patients eligible for this study will be submitted to neoadjuvant 3D radiotherapy with 50,4 Gray (Gy) divided in 25 applications, in association to capecitabine, 825mg/m2 bid for five days every week. The participants will be randomized to daily metformin or placebo during the chemoradiotherapy period. The primary end-point is pathological complete response. The secondary end-points are recurrence-free survival (RFS), disease-free survival (DFS), overall survival (OS), local recurrence rate, overall response rate, sphincter preservation rate, quality of life (QoL) and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* biopsy proven poorly differentiated carcinoma or adenocarcinoma of the rectum;
* lesions located within 12 cm of the anal verge (from colonoscopy assessment);
* ability to tolerate oral treatment;
* locally advanced tumor, classified by the presence of positive regional lymph nodes or primary tumor invasion beyond the serosa (T3 or T4), assessed by MRI;
* eligibility for curative surgery (no distant metastasis or invasion of bony structures of the pelvis);
* Performance Status (PS) Eastern Cooperative Oncology Group (ECOG) 0-2;
* adequate hematologic functions (hemoglobin ≥ 10 g / dL \[5.6 mmol / L\]; neutrophil count ≥ 1,500 / mm3 and platelet count ≥ 100,000 / mm3), adequate renal function (serum creatinine less than 1.5 times the UNL) and adequate hepatic function (bilirubin less than 1.5 times the UNL; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the UNL);

Exclusion Criteria:

* known hypersensitivity to metformin or its excipients;
* squamous carcinomas of the rectum or anal canal;
* chronic treatment with corticosteroids or other immunosuppressive agents;
* treatment with oral antidiabetic products;
* distant metastasis at diagnosis or tumor invasion of pelvic bone structures that may proscribe curative intent surgery;
* chronic or acute infections;
* use of drugs under study up to four weeks prior to randomization;
* pregnant or nursing patients;
* prior radiotherapy to the pelvic region;
* myocardial infarction up to six months prior to randomization, or uncontrolled ischemic heart disease;
* congestive heart insufficiency New York Heart Association (NYHA) III-IV.
A Study to Investigate the Effects of Food and Morning Versus Evening on Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women

The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.

This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasian women aged between 55 to 75 years inclusive
* Subjects weighing at least 50 kg with mass index between 19 to 30 kg/m2 inclusive
* Subjects who have been amenorrhoeic for at least 5 years.
* Subjects who are confirmed at Screening Visit to have oestradiol and follicle stimulating hormone (FSH) levels consistent with menopause

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
* Subjects who have a clinically relevant history of insomnia or sleep disorders