cyrilzakka/clinical-trials huggingface dataset:
Low Dose Spinal Anesthesia in Cesarean Surgery

Anesthesia for cesarean section requires special importance because it may affect both mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. Even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. Many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement There are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients

Exclusion Criteria:

* Spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.

A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 50 years or older
* self reported foot pain including heel, arch, or ball of foot

Exclusion Criteria:

* Plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus)
* Lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g. corns, calluses)
* unstable conditions such as recent stroke, anticipated changes in medication regime
* Acute fractures of the foot
* Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.
* major cognitive impairment or major depression
Human Vasodilatory Effect of GLP-1

Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary arteries


Eligibility Criteria:
Inclusion Criteria:

* Waiting list for elective PCI to LAD Able to give informed consent Over 18

Exclusion Criteria:

* GLP-1 based therapy Insulin Calcium channel blockers Nicorandil Nitrates
Intraocular Pressure (IOP) and Isometric Exercise

The purpose of this study is to investigate changes in intraocular pressure measured continuously during isometric exercise.


Eligibility Criteria:
Inclusion Criteria:

* Young, healthy subjects

Exclusion Criteria:

* Known ocular diseases
* Previous ocular trauma
Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients.

The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the flow rate and pH of saliva, as one of the potential etiological factors, will be assessed.

Dental patients will be recruited from diagnostic central clinic at the Cairo University Dental Educational Hospital. Oral examination will be done, the full aim of the study will be explained to the patient, and patient acceptance is a must. The questionnaire will be filled by patients including age, gender, occupation, education, place of residence, toothbrushing: included frequency, method, intensity, hardness and duration, biting and chewing habits, medical history \[related to gastrointestinal problems such as belching, heartburn, vomiting, gastro-oesophageal reflux (GER), peptic ulcer disease\], eating disorders (anorexia, bulimia), medication list, frequency of consuming acidic food and fruits, carbonated beverages and alcohol and smoking status. Salivary assessment regarding flow rate and pH for a subgroup diagnosed with non-carious cervical lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age between 41-60 years old.
2. Patient consulting in the outpatient clinic
3. Provide informed consent.
4. Males \& Females
5. Egyptian

Exclusion Criteria:

1. Patients under or over this age group.
2. Refuse to participate in the study.
3. Wearing orthodontic appliance.
4. The presence of trismus.
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle

Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle , A Prospective Study.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot in HaEmek medical center, and have sufficient data/follow-up about them in medical records /

Exclusion Criteria:

* patients aged\< 5 years
* Neurological Clubfoot
* patients with insufficient data in medical records
* clubfoot caused by arthrogryposis , connective tissue diseases and congenital fibular hemimelia
Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?

Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days. Food insecurity has been associated with decreased academic performance. Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population. As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.


Eligibility Criteria:
Inclusion Criteria:

* Age: 13-19 years.
* Household has food security status of low or very low as designated by scoring 2-6 raw score using the U.S. Household Food Security Survey Module: Six-Item Short Form.

Exclusion Criteria:

* Participants unable or unwilling to provide informed consent.
* Participants with motor, visual or hearing impairment.
* Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression)
* Participants with history of psychiatric hospitalization.
* Participants with habitual egg consumption (past 3 months) of 4 eggs per week or more
* Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
* History of liver or kidney disease, cardiovascular disease, hematologic disease, metabolic disease, Epilepsy (or other seizure disorder) or malignant tumor
* Currently taking (or have taken in the past 4 weeks) any anti-anxiolytic, anti-epileptic, or anti-depression medications
* Currently taking (or have taken in the past 4 weeks) any proton pump inhibitor medications
* History of any cognitive disorder, medical and/or psychological conditions and/or medications affecting cognition
* Participants with contraindications for MRI scanning.

  1. aneurism clips
  2. any implanted medical devices (pacemaker, neurostimulator)
  3. known pregnancy
  4. shrapnel in body or any injury to eye involving metal
  5. any ferrous metal in body
Limitation of the Ventilatory Response to Exercise in the Master Athlete

It is generally accepted that the ventilatory system is not a limiting factor in physical exercise in terms of performance or exercise tolerance in healthy subjects. The ventilatory system would be oversized in relation to the stresses it has to cope with, even during maximum intensity exercise. However, some highly trained endurance athletes may be exceptions to this rule. A limitation of the expiratory flow is indeed sometimes found in these athletes, whose maximum values of ventilation can confront the mechanical limits of their ventilatory system. This phenomenon could be accentuated in elderly athletes (known as "master athletes") under the effect of structural and functional pulmonary alterations that accompany aging. Our hypothesis : What is the prevalence of exercise expiratory flow limitation in the master athlete and does it cause a decrease in physical performance via an acceleration of locomotor muscle fatigue?


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker (active or passive) or ex-smoker of less than 5 pack-years and stopped for more than 10 years.
* No known significant chronic pathology.
* No symptoms suggesting a progressive pathology.
* No contraindication to physical exercise. Normal Pulmonary Functional Test (PFT).
* Participants affiliated to the social security system

Exclusion Criteria:

* Vulnerable persons as defined in Articles L. 1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (e.g. persons deprived of liberty, minors, adults protected, etc.),
* Participants with a medical contraindication to sports practice,
* Cardiovascular, respiratory, neuromuscular and/or significant metabolic,
* Participants with declared pathology or medical treatment,
* Smoking or drug use,
* Significant chronic drug treatment,
* Lack of consent.
* Refusal to cooperate
* Recent rhino-bronchial infection (within last 4 weeks)
* Mental disability
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with critical lower limb ischemia,
* Ruhtherford 3 or higher,
* with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,
* with a maximum extension of 10 cm stenosis.
* The popliteal artery and at least one leg artery must be patent.

Exclusion Criteria:

* Pregnancy,
* thrombophilia,
* coagulation disorders,
* presence of active or recent bleeding,
* severe allergy to iodinated contrast,
* renal or hepatic disease,
* acute limb ischemia,
* prior surgical bypass or angioplasty (with or without stent) on the target artery,
* obstructive disease (stenosis\> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)
Temporomandibular Joint Dysfunction in Patients With Traumatic Brain Injury

Trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury.

The aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury.

Participants (traumatic brain injury patients and healthy volunteers) will be evaluated once for temporomandibular joint dysfunction.

Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler.

Exclusion criteria; communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of traumatic brain injury not receiving treatment for temporomandibular joint dysfunction

Exclusion Criteria:

communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression

The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Another goal of the study is to learn if SP-624 improves memory and learning in adults with major depression. The study will also provide additional information on the safety of SP-624 and how well it is tolerated in adult healthy volunteers and adults with major depression.

Researchers will compare SP-624 to a placebo (a look-alike substance that contains no drug) to see if SP-624 has any effect on study tests.

Study participants will:

Take capsules of study drug (SP-624 or a placebo) once daily for 2 weeks; visit the clinic at Screening, Day 1 (first dose of study drug), and Day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on Day 7 and about 1 week after the last dose of study drug.


Eligibility Criteria:
Key Inclusion Criteria:

* In generally good health
* Body mass index (BMI) between 18.0 and 40.0 kg/m2
* Willing to comply with the requirements of the study
* For participants with depression: must meet study criteria for moderate to severe major depressive disorder

Key Exclusion Criteria:

* Female who is pregnant or breastfeeding.
* Clinically significant health condition or clinically significant abnormal results on screening health tests
* For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.

Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.


Eligibility Criteria:
Inclusion Criteria:

* Over 1 year old and less than 20 years old
* Pathologically or cytologically diagnosed germ cell tumor
* Germ cell tumor which has not been treated previously
* Higher than stage II (stage I should be excluded)
* Pathologic type

  1. embryonal carcinoma
  2. choriocarcinoma
  3. yolk sac tumor
  4. teratoma with malignant germ cell tumor elements
* High risk definition

  1. More than 11 years old, male or female
  2. Less than 11 years old, male or female

     1. Extragonodal germ cell tumor, stage III
     2. Extragonodal germ cell tumor, stage IV
     3. Ovarian germ cell tumor, stage IV
* More than 8 weeks of life expectancy
* performance level : ECOG Performance score 0, 1, or 2
* informed consent should be obtained

Exclusion Criteria:

* pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
* previously reported allergy or hypersensitivity to trial chemotherapeutic agent
* severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
* Acceptable organ functions

  1. Bone marrow : Absolute neutrophil count \>=1000/µL , platelet \>= 100000/µL
  2. Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  3. Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
  4. Cardiac Function : Ejection fraction ≥ 50%
  5. Uncontrolled infection
  6. Uncontrolled urinary obstruction
  7. Uncontrolled cystitis
* Followings will be excluded

  1. Mature teratoma
  2. Gliomatosis Peritonei
  3. Low Risk Germ Cell Tumor
  4. testicular stage I
  5. ovarian stage I
  6. recurrent, refractory tumor
* Concomitant other trial agent beside the agents in this trial
* Concomitant chemotherapeutic agents besides the agents in this trial

  1. Concomitant tumor other than germ cell tumor
  2. Other trial agents
  3. Other chemotherapeutic agents
Patient Education in Gastroesophageal Reflux Disease

Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).


Eligibility Criteria:
Inclusion Criteria:

* heartburn and acid regurgitation the dominant symptom
* needing relief at least 5 days/ week when symptoms were at their worst
* disease history at least 3 months
* ability to give informed consent

Exclusion Criteria:

* current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc
* continuous need of proton pump inhibitors or NSAIDs
* wish for surgical treatment
* earlier surgical treatment in the GI-tract
* pregnancy
* alcohol or drug abuse
Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder

This study will test a version of cognitive behavioral therapy for generalized anxiety disorders that incorporates interpersonal and emotional processing techniques.

Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) to be an effective treatment for GAD, but only half of people treated with CBT for GAD experience treatment benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not address interpersonal and emotional processing problems. This study will determine the efficacy of a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing among adults with GAD.

Participation in this study will include 14 weeks of treatment and 2 years of follow-up visits. All participants will receive 14 weekly, 2-hour, individual therapy sessions and one maintenance session scheduled after completing treatment. During the first hour of each session, all participants will receive standard CBT. Participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. Participants may continue taking their current medications if they maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment.

In-depth study assessments will take place at baseline and after completing the 14 weeks of therapy. Assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. Questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. The physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. Brief psychological assessments will also follow each therapy session. Follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.

Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers
* Clinician's Severity Rating for GAD of 4 (moderate) or greater

Exclusion Criteria:

* Concurrent psychosocial therapy or past adequate dosage of CBT
* Any medical contributions to anxiety
* Current substance abuse, psychosis, or organic brain syndrome
Bone, Endocrine and Lifestyle Longitudinal Study

The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle factors on bone health in young women over a 20-year time period. It is our primary hypothesis that premenopausal women with irregular periods or endocrine issues related to estrogen will have significantly poorer low back and hip bone health when compared to regularly menstruating women. It is our secondary hypothesis that long-term assessment of changes in endocrine function and lifestyle behaviors will assist in establishing risk factors for osteoporosis in young women. This study will include 1000 premenopausal women. The women will participate in the collection of a blood sample, bone scan, body fat measures, and lifestyle questionnaires. In addition, we hope to use this initial study to develop a group of women to follow throughout menopause, with additional visits occurring every 5 years over the course of their life.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years of age
* free from any uncontrolled chronic disease that may affect bone mass
* Not pregnant

Exclusion Criteria:

* Women recently diagnosed with uncontrolled chronic disease(s) at time of enrollment known to affect bone mass, including but not limited to metabolic and endocrine diseases (specifically, diseases of the thyroid and parathyroid glands), osteoporosis, and those women who have taken prophylactic bone density agents, such as Fosamax.