cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Diagnosis of Antibiotic Associated Diarrhea

The hypothesis is that there are unique sonographic characteristics of antibiotic-associated diarrhea. We will compare the ultrasound findings in patients who received antibiotics and developed diarrhea to toxin analysis for clostridium difficile in stool in order to find differences in the sonographic findings in the positive and negative cases.


Eligibility Criteria:
Inclusion Criteria:

* admitted patients who developed diarrhea in 72 hours since the beginning of admission
* patients age above 18 years.
* patients received antibiotics during admission

Exclusion Criteria:

* other reasons of diarrhea
* drugs induced diarrhea
* length of time since the beginning of diarrhea is shorter than 72 hours.
* patients had diarrhea during the first day of admission
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes
* Have HbA1c ≥7.5% to ≤10.5% at screening
* Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
* Have had a stable body weight for the three months prior to screening
* On stable treatment dose of one of the following incretins for at least three months:

  * Injectable semaglutide (1 and 2 milligram (mg))
  * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)

Exclusion Criteria:

* Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
* Have a prior or planned surgical treatment for obesity
* Have any of the following cardiovascular conditions within three months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure
* Have used insulin to control blood glucose within the past year (short-term use allowed)
* Current use of another oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the additional OAM treatment was discontinued at least 3 months prior to screening

  * If participant has been on stable doses (for at least three months) of up to three OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
* Have taken any medications or alternative remedies for weight loss within three months prior to screening
A Comparative Study of Supine Position and the Head Elevated Position on the Level of Sensory Block After Spinal Anesthesia in Morbidly Obese Parturient Undergoing Elective Cesarean Delivery

The sniffing position defined as neck flexion with upper cervical extension, is traditionally recommended for general anesthesia induction, as it improves laryngoscopic views. However, the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical,Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA)has been shown to not only increase respiratory reserve but also to improve laryngeal views in patients undergoing bariatric surgery. Additionally it helps in pre-oxygenating the patient more efficiently by keeping the airway patent and provides easier bag-mask ventilation.

It may also benefit the term parturient in a similar way by improving functional residual capacity (FRC), ventilation and comfort. However, this positon may affect the cephalad spread of the intrathecal local anesthetic.

Two earlier studies looked at the intrathecal local anesthetic spread in obstetric patients when placed in the head elevated laryngoscopy position, and both suggested poor cephalad spread, with patients requiring higher supplementation.

However, both studies excluded morbidly obese patients. The Investigators hypothesized that in obese parturients with BMI more than or equal 40, higher intra-abdominal pressures and possibly lower CSF volumes will counteract the poor cephalad spread associated with this position. The aim of this study is to determine the effect of a ramped position on intrathecal local anesthetic spread in the morbidly obese term parturients with BMI more than or equal 40 undergoing elective Cesarean delivery(CD).


Eligibility Criteria:
Inclusion Criteria:

* Age 18yrs of age or more
* BMI 40 or more and more than or equal 37 weeks of gestation
* elective CD
* consented for neuraxial anesthesia
* singleton fetus
* ASA class 3 (no co-morbidities except morbid obesity, gestational diabetes, and gestational hypothyroidism)

Exclusion Criteria:

* Age \<18 years
* BMI less than 39.9 and \<37 weeks of gestation
* parturient preference for general anesthesia or contraindication to neuraxial anesthesia
* Women with comorbidities other than obesity, gestational diabetes or gestational hypothyroidism.
* women in active labor (\>3 cm dilated with regular uterine contractions)
* emergency CD
* Possible uterine over-distension or under-distension (e.g. polyhydramnios, estimated fetal weight \>4 kg by ultrasound scan, or oligohydramnios or concern for fetal IUGR)
* maternal height \<150 cm or \>180 cm.
* Patients for which more than 2 minutes is taken in positioning after anesthesia induction (Time 0).
Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention

The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information , and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis.

Pregnant women were recruited in their 3rd trimester of pregnancy and were randomly assigned to either an intervention or control group.

Both groups received standard breastfeeding education at the maternity ward. Additionally, the intervention is based on informative and supportive videos and a whatsapp group for interpersonal support. Videos and whatsapp groups were created and moderated by Infant Feeding Helpers. These are women from the same socio-economical background as the subjects, and have previous history of breastfeeding a minimum of 6 months exclusive breastfeeding.

The aim of the intervention was to increase initiation and duration of breastfeeding by increasing comprehensibility, manageability and meaningfulness of the breastfeeding period and therefore by enhancing their sense of coherence.

Chi-squared tests were used for descriptive statistics, Wilcoxon test was used for pre- post results of SOC and (SE) within each group. The change in pre-post SOC, SOC parameters and SE scores between control and intervention groups was analyzed with Quade non parametric.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Singleton
* Healthy
* New born not admitted to Neonatal Intensive Care Unit
* Residing in Lebanon

Exclusion Criteria:

* Pregnant with more than 1 fetus
* Mothers with a health condition contraindicating breastfeeding
* Newborn admitted to NICU
Comparison of Transparent Retractable Extension Device and Narrow Band Imaging on Colorectal Adenoma Detection

The investigators previously reported that colonoscopy with a transparent retractable extension (TRE) device improved the adenoma detection rate without affecting intubation and withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE device on colorectal adenoma detection with those of NBI.


Eligibility Criteria:
Exclusion Criteria:

* Age less than 20 years old
* Pregnant
* American Society of Anesthesiologists class III and IV
* Overweight (body weight \> 100 kg)
* Allergic to the drugs used or its components (soybeans or eggs)
* Poor bowel preparation
* Previous colorectal surgical resection
Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm

Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm


Eligibility Criteria:
Inclusion Criteria:

stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

Exclusion Criteria:

stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
The Effect of Electrical Stimulation on Tear Production

The purpose of this study is to investigate whether electrical stimulation of the nerve innervating the tear gland results in tear production in subjects with severe Dry Eye.

A non-randomized, open-label study designed to investigate the feasibility of a novel treatment for severe Dry Eye Disease, which involves safe delivery of small electrical currents to the lacrimal nerve to induce tear production.

Eligibility Criteria:
Inclusion Criteria:

* Schirmer test with topical anesthesia of ≤ 5 mm/5 min in at least one eye
* Sum of corneal and interpalpebral conjunctival staining of \> +5 in the same eye where corneal staining is \> +2 using the CLEK criteria.

Exclusion Criteria:

* Individuals with the presence or history of any ocular disorder or condition (including ocular surgery, trauma, and disease) that could possibly interfere with the interpretation of the study results. Individuals who have had LASIK or other refractive surgeries are eligible. Excluded conditions include:

  * History of orbital trauma
  * History of orbital surgery
  * Orbital cancer
  * History of orbital cancer
* Within the 3 months before the Screening Visit, known history of ocular infection (viral, bacterial, fungal), inflammation not associated with dry eye, or active ocular herpes
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR

The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).

This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for TAVR through femoral artery access
* 1h ≤ Expected duration of surgery ≤ 3h
* Planned for general anesthesia without intubation
* 18 ≤ BMI ≤ 30
* ASA category Ⅱ～Ⅳ

Exclusion Criteria:

* Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
* Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
* Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
* Hemoglobin (HB) \< 10.0 g / dl (100 g / L)
* Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

NOTE: Biogen is the Sponsor of study 299AR301.

Eligibility Criteria:
Key Inclusion Criteria:

* Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
* Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
* Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 3 months prior to randomization.

Key Exclusion Criteria:

* Transplant: Blood type (ABO)-incompatible transplant.
* History of multiple organ transplants including en bloc and dual kidney transplants.
* Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.
* Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility:

  1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
  2. Complement system inhibitors (e.g., eculizumab).
  3. Proteasome inhibitors (e.g., bortezomib).
  4. Tocilizumab.
  5. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.

Other protocol-defined inclusion/exclusion criteria apply.
A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

This is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure.

The study hypothesis:

Which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?

The conservative control group will receive a special training program for abdominal muscle training for 3 months,and all groups wearing girdle for 3 months.

All patients examined with a CT scan before randomization and then a Biodex measurement of abdominal muscle strength.

All patients must also complete the SF-36 (scientifically tested instruments to measure self-reported physical and mental health) and VHPQ (ventral hernia Pain Questionnaire).

Two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.At 1 year of control, all go through a CT scan and a Biodex measurement of muscle strength.

The control group followed up after one and half months and 3 months. In the surgery group, patients may not know what reconstruction they received before the final assessment after 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Abdominal wall diastasis\> 3 cm
2. Discomfort or tenderness in the abdominal wall
3. Desire for abdominal wall reconstruction
4. Women have undergone at least one birth
5. Smoking cessation 1 month pre-and 3 months post-operatively

Exclusion Criteria:

1. \<18 years old
2. Ongoing pregnancy
3. Ongoing breastfeeding
4. Current immunosuppressive therapy
The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure

The aim of the present study is to evaluate differential lactate removal kinetics in heart failure patients that are trained according to 2 different exercise protocols:

(A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)

Introduction: Congestive heart failure (CHF) patients suffer from early fatigue and functional aerobic impairment. Their reduced cardiac output and O2 delivery to the peripheral muscles shifts those patients consistent anaerobic metabolism, thus, CHF patients rely on anaerobic metabolism even in everyday life activity. This metabolism leads to a shift of muscles fiber types from mainly slow twitch, oxidative type I fibers to fast twitch, glycolytic type IIb fibers. Monocarboxylate proteins MCT1 and MCT4 transport lactate crosses the membrane. MCT1 is responsible for the lactate uptake and MCT4 is responsible for efflux of excess lactate. Exercise training is known to improve the quality of life in CHF. We hypothesized that exercise training might change MCT1 and 4 expression and distribution. Accordingly, these changes may also affect lactate clearance during recovery, which may contribute to the beneficial effect of exercise training in CHF patients. Methods: New-York Heart association (NYHA) class II-III CHF patients will be assigned to the experiment. At baseline and upon training conclusion they will undergo the same tests battery. The test battery includes heart rate, blood pressure measurements, echocardiographic evaluation. All participants will fill out "Minnesota living with heart failure" questionnaire. Subsequently, after their basal blood lactate will be assessed they will undergo measurement which will be followed by lactate clearance-rate evaluation.

Randomly each patient will then be assigned to one of two experimental training groups: (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT). Each volunteer will be trained twice a week for 12 weeks, according to his/hers assigned training protocol and in accordance to exercise training guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute
* Age \> 21

Exclusion Criteria:

* Severe symptomatic heart failure
* Severe orthopedic limitations
* Unstable arrythmia
* Cognitive decline or substance abuse
* Unable to comply with exercise protocol
* Significant pulmonary disease
* NYHA 4 heart failure class
Renal Sympathetic Modification in Patients With Essential Hypertension

The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with essential hypertension, and evaluate safety and efficacy of the intervention.

Hypertension is a common cardiovascular disease, and is also an important risk factor for heart-brain-renal diseases, with relatively low controlled rate. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that sympathetic nerves activity contributed to development and perpetuation of hypertension. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of hypertension. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-hypertensive medications besides expectant intervention, and patients in control group will receive appropriate anti-hypertensive medications only. We aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with hypertension, and evaluate safety and efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old, and ≤ 75 years old of age
* more than half a year history of hypertension, except for valvular heart disease
* recently at least three times office blood pressure suggest systolic blood pressure of 140mmHg or more and/or a diastolic blood pressure of 90mmHg or more
* estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* secondary hypertension
* isolated systolic hypertension
* estimated glomerular filtration rate (eGFR) of \< 45mL/min
* has the history of renal restenosis or renal stents implantation
* has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
* patients with sick sinus syndrome
* pregnant women
* mental disorders
* patients that have allergy to contrast agent
* patients that do not go with follow-up
* others such as researcher considers it is not appropriate to be included into the study
Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo


Eligibility Criteria:
Inclusion Criteria:

* patient treated as out-patient
* score of 85 or greater in IQ-test (MWT-B)
* diagnosis of ADHD according ADHS-CL (DSM IV) and WRAADDS \> 35 points
* ADHD symptoms have existed since childhood (WURS-k \>= 30)
* Body Mass Index \>= 20 and body weight \< 130 kg
* willing to eat breakfast and lunch
* patient is willing and able to come to the observation appointments
* written consent of the patient to participate in the study

Exclusion Criteria:

* treatment with psychostimulants in the past two weeks before screening
* shift work or night work
* alcohol, medication or drug dependency in the past six months or manifest drug abuse
* diagnosis of a psychosis (SKID-I)
* epileptic attacks in the past
* EEG result which suggests epilepsy
* acute depressive episode according to ICD-10 F32.2 and ICD-10 F32.3 (Beck-Depression-Inventory \> 18)
* Illness with schizophrenic symptoms (SKID-I)
* acute manic episode, bipolar disorder(SKID-I)
* diagnosis of a tic disorder
* acute anorexia
* acute prominent panic disorder and generalised anxiety (SKID-I)
* clinically relevant kidney disorders
* creatinine \> 1,5 x upper norm-range
* clinically relevant liver disorder
* SGOT and/or SGPT \> 2 x upper norm-range
* pathological ECG-finding
* QTc \> 450 msec in male, QTc \> 470 msec in female
* high blood pressure (anamnesis or blood pressure \> 140/90 mm Hg at screening)
* known acclusive arterial disease
* angina pectoris (anamnesis or ECG-finding)
* cardiac arrhythmias (anamnesis or ECG-finding)
* KHK (anamnesis or ECG-finding)
* post heart-attack status (anamnesis or ECG-finding)
* post stroke status
* known elevated intra-ocular pressure
* known enlarged prostates
* latent and manifest hyperthyreosis
* TSH \< lower norm-range
* patient with a terminal disease (e.g. cancer)
* participation in a clinical study within the past 30 days
* participation in this study at an earlier point in time
* simultaneous participation in another clinical trial
* women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
* pregnancy (positive pregnancy test) or lactation period