cyrilzakka/clinical-trials huggingface dataset:
Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section

Spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. Hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. Various methods and agents have been tried in order to address this problem. However, this calamity is far from over.

Perfusion index is one such attempt to address the problem of hypotension by predicting which group of parturient may develop hypotension. This is a type of non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ration of pulsatile versus the non-pulsatile component of the blood flow. During normal physiological changes in pregnancy, there is relative loss of vascular tone which predisposes this group of patient to sudden development of hypotension after the sympathetic block due to spinal anesthesia.

Thus, the aim of the study is to use the non-invasive perfusion index data to predict the occurrence of hypotension in a parturient so that helps us to guide fluid and other drug therapy to address the problem of hypotension.


Eligibility Criteria:
Inclusion Criteria:

1. ASA II physical status.
2. Planned for elective LSCS
3. Gestational age \>36 weeks and \<41 weeks

Exclusion Criteria:

1. Patient's refusal.
2. Emergency LSCS.
3. Patient's with contraindications to spinal anesthesia
4. Patient with BMI \>40, preeclampsia, placenta praevia.
5. Patients with comorbidities like cerebrovascular or cardiovascular disease, and gestational diabetes.
Bone Mineral Content in Healthy Children

The primary purpose of this study is to determine the effects of early diet on bone health.


Eligibility Criteria:
Inclusion Criteria:

* Current or past participation in the Beginnings study (IRB#07180)
* Age 5-7 years

Exclusion Criteria:

* Growth or bone disorders
* Non-removal metal on participant
* Any other conditions that may affect the outcome of interest as determined by the PI.
Clinical Trial of Hydroquinone Versus Miconazol in Melasma

Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face.The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%), and the other group topical miconazole. Miconazol has antimelanotic properties and can be used as treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 30. The purpose of this study is determine if there is a difference in the effectiveness of these two agents. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.

Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment with depigmenting compounds such as hydroquinone, are still the gold standard in this condition. Miconazol has depigmented properties that could be used as part of the treatment in melasma patients. This effect is exerted by inhibiting the tyrosinase enzyme. So, the primary objective of this study is to compare the depigmenting activity of miconazole against hydroquinone.

Patients who are included in the study will be randomly assigned to receive one of the treatments, which should use for 12 weeks. The medications should be applied in the affected regions twice a day.

The evaluation of clinical improvement will be done in a blinded modality by means of the MASI score, the Global Physician Assessment, as well as colorimetry and histological melanin content. Evaluations will be held on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.

At the end of the study, data will be compared concerning the former parameters. All side effects will be recorded and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Mexican women over 18 years of age
* Dermatologic diagnostic of melasma
* Phototype III or more

Exclusion Criteria:

* Pregnant or breastfeeding
* Postbirth, abortion in the past 6 months
* Having an endocrine or autoimmune disease
* Under hormonal therapy of any kind including contraceptives or it´s use in the past 6 months
* Currently under treatment for melasma including sunblock
* Currently under radiation therapy, chemotherapy, immunosuppressants of any kind or phototherapy or it´s use in the past 6 months
* Having used or are consuming photosensitizing substances, oral or topical
Ultrasound of Supraspinatus Muscle Tears

The supraspinatus is a relatively small muscle of the upper back that runs from the supraspinatus fossa superior portion of the scapula to the greater tubercle of the humerus. It is one of the four rotator cuff muscles and also abducts the arm at the shoulder. A supraspinatus tear is a tear or rupture of the tendon of the supraspinatus muscle.

Many pathological conditions as trauma (whether acute or chronic), inflammation or instability may cause supraspinatus muscle disease which is one of the commonest cause of shoulder pain and malfunction.

Supraspinatus muscle failure usually results from tendinopathy that transforms from partial to full thickness tears.

Basically shoulder impingement is a clinical diagnosis. The role of imaging in such condition is to identify the causal factors as well as to detect the involvement of tendon injuries and its extension as tears of the cuff muscles is difficult to be identified clinically.

The decision making in the treatment of the supraspinatus muscle tears relies mainly upon the correct diagnosis of the type and extent of the tear. According to the diagnosis whether conservative or surgical treatment is chosen, even the type of the surgical intervention (open or arthroscopic) would differ according to the diagnosis.

In addition identifying the extent of tendons retraction and the condition of the ruptured edges, as well as the quality of the muscle itself influences the management policy.

To evaluate the painful shoulder a variety of imaging tests have been used; yet, for diagnosing a supraspinatus muscle tear the standard imaging modalities such as unenhanced magnetic resonance imaging, indirect and direct magnetic resonant arthrography, and ultrasound are used.

US of the shoulder is utilized increasingly in healthcare settings to assess the integrity of the supraspinatus muscle. It is a non-invasive examination with practically no side effects. It is beneficial in the dynamic examination of the tendon during movement of the shoulder .

Eligibility Criteria:
Inclusion Criteria:

* patients of different age groups presented with clinical diagnosis department of shoulder impingement and diagnosed by magnetic resonance imaging as supraspinatus

Exclusion Criteria:

* patients with previous shoulder surgery
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
* HbA1c \>or = 7% and \< or = 10%
* Fasting c-peptide \> or = 1.0 umol
* Body Mass Index \< or = 41 kg/m2
* Mean serum triglycerides \< or = 600 mg/dl
Adjust-Unlikely PE

The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.

The pilot study objectives are to:

1. Determine study recruitment rate, per site, per month
2. Determine study 90-day loss to follow up rate
3. Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
4. Estimate of the Adjust-Unlikely algorithm efficiency
5. Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.

The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.


Eligibility Criteria:
Inclusion Criteria:

* Emergency physician decides to test for PE

Exclusion Criteria:

* Tested for PE without using the Adjust-Unlikely algorithm
* D-dimer level is known before Adjust-Unlikely assessment
* A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant
* Declines participation
* Is inaccessible for follow-up
* Has previously participated in this study
High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia

The purpose of this study is to determine whether the addition of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve insomnia symptoms based on changes in the Insomnia Severity Index at two months following completion of the intervention, compared to placebo plus usual care.

Insomnia is the most prevalent sleep disorder and is associated with significant psychosocial and somatic pathology. Effective noninvasive interventions for insomnia are lacking. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), is a noninvasive, brain feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time. An open label, randomized, crossover pilot trial showed that HIRREM was safe and effective, with significant benefits for individuals with moderate to severe insomnia, based on differential change with symptoms of insomnia (Insomnia Severity Index, ISI). This study will extend those results in a larger cohort using a single blind, placebo controlled study design.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe clinical insomnia (Insomnia Severity Index score of 15 or higher)

Exclusion Criteria:

* Unable, unwilling, or incompetent to provide informed consent
* Physically unable to come to the study visits
* Known obstructive sleep apnea
* Diagnosed periodic limb movement disorder or known restless legs syndrome
* Known seizure disorder
* Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
* Severe hearing impairment
* Known, or suspected diagnosis of post-traumatic stress disorder (PTSD)
* Known, relevant traumatic brain injury (TBI)
* Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclics, and sleep medications such as zolpidem or eszopiclone
* Anticipated and ongoing use of recreational drugs or alcohol
* Lack of internet or smart phone access
Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus

The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.

Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs
* visual analogue scale (VAS) equal or more than 4

Exclusion Criteria:

* Liver disease
* Respiratory disease
* Dermatological disease
* Hemoglobin less than 10
* Cholestasis
* Malignancies
A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers

This is a single center, randomized, open-label, three-way crossover, single dose, pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (of non-childbearing potential only) between 18 and 55 years of age.
* Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:

  1. hysteroscopic sterilization;
  2. bilateral tubal ligation or bilateral salpingectomy;
  3. hysterectomy;
  4. bilateral oophorectomy, or;
  5. be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment.
* Male subjects must use reliable forms of contraception from screening to 30 days after the end of dosing.
* Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.

Exclusion Criteria:

* History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
* pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 60-100 beats/min.
* 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS \>= 110 milliseconds (msec), QT/QTcF interval of \> 450 msec for men or \>470 msec for women, or PR \> 200 msec.
* Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)

This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Woman with at least 50 moderate to very severe hot flash episodes per week
* Postmenopausal
* Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
* Not receiving hormone therapy
* Has had both a normal mammogram and a normal Pap test in the past 6 months
* Generally healthy

Exclusion Criteria:

* A history of cancer, except for certain skin cancers
* Undiagnosed vaginal bleeding or any uterine endometrial disorder
* Currently uses tobacco products, or has used them in the last 6 months
* Has human immunodeficiency virus (HIV)
Intracuff Pressure During One-lung Ventilation in Infants and Children

The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients 0-18 yars old.
* Patients requiring intubation with a cuffed specialized endotracheal tube or bronchial blocker.
* Patients having thoracic surgery.
* Patients that require one-lung ventilation (OLV).

Exclusion Criteria:

* Patients that do not require to have cuffed specialized endotracheal tube or bronchial blocker.
* Patients not requiring one-lung ventilation.
* Patients not having thoracic surgery.
Oxygen Wound Therapy Feasibility Study

Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hard to heal lower leg wounds as determined by the treating clinician.
* Patient has a wound area greater than the area of the interface
* Aged 16 years and over
* Able to provide informed consent

Exclusion Criteria:

* Lower limb wounds with bone or tendon exposed
* Infected wounds which require treatment with antibiotics
* Wounds with critical bioburden requiring a medicated dressing
* Wounds that require dressing changes more than every second day, for example high exudating wounds
* Wounds with slough covering more than 30% of the wound surface
Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.


Eligibility Criteria:
Inclusion Criteria:

1. Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage \< 30IU);
2. The anti-diabetic therapy is stable within 3 months before study screening;
3. Age: 25-65years, both gender, BMI: 20-35kg/m2;
4. Good compliance with the follow-up
5. Signed informed consent
6. HbA1c ≥ 8.0 % and ≤ 12%

Exclusion Criteria:

1. Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
2. For once daily insulin therapy: daily dose insulin therapy dosage \> 30IU
3. Having the history of using GLP-1 for therapy within 3 months before screening
4. Women in pregnancy or under breast feeding
5. Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
6. Allergic to study drugs
7. Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR \< 60ml/min)
8. Other severe conditions which will put the patients in high risk during the study
9. Recently drug or alcohol abuse
Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Endoscopically confirmed GERD (Los Angeles classification A-D)
* Patients whose compliance is expected to be high with respect to the completion of the questionnaires

Main Exclusion Criteria:

* Other gastrointestinal diseases
* Severe concomitant diseases
* Proton pump inhibitors (PPIs) during last 14 days before start
* H2 receptor antagonists, prokinetics during last 7 days before study start
* Helicobacter pylori (H. pylori) eradication during last 28 days before study start
Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow

The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are:

* Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration?
* What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.

Participants will:

* Receive guided bone regeneration around implant
* Visit the clinic after 2,7,14 days for detection any signs of flap dehiscence
* Bone gain and bone density will be assessed after 6 months

Twenty sites with ridge defects will be recruited for this study. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for clinical approval. The purpose of the present study will be explained to the patients and informed consents will be obtained . Sites were randomly divided into 2 treatment groups .10 sites will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide \&amp; 10 sites will receive the same treatment except it will be guided using digitally designed guide. Membranes in both groups will be stabilized by tacks. Following clinical parameters will be recorded: the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2, 7 and 14 days, flap dehiscence. Also, bone gain and bone density will be assessed using cone beam computed tomography (CBCT) at baseline and 6 months post-surgery. The collected data was statistically analyzed at the different follow up periods.

Eligibility Criteria:
Inclusion Criteria:

* medium horizontal ridge defect according to clone classification
* must have a general health showing no contraindications for surgery
* must be at least 35 years old
* patients also have adequate soft tissue thickness and width of keratinized gingiva

Exclusion Criteria:

* no sign of uncontrolled systemic diseases
* non smoker
* not pregnant
* sever ridge deficient
* patients below 18 years old