cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report

The 33-month pregnant patient was followed in the gynecology service with the complaint of shortness of breath after receiving the covid positive diagnosis and was transferred to the intensive care unit due to acute respiratory failure. She was intubated in the intensive care unit and the baby was taken by cesarean section. Pulmonary rehabilitation steps to be applied to the patient with long-term intensive care hospitalization will be examined.

After the patient was admitted to the chest diseases service, pulmonary rehabilitation was started. The patient was evaluated before starting pulmonary rehabilitation.

Evaluation parameters; vital signs, shortness of breath, oxygen support, grip force and pinchmeter, fatigue, anxiety and depression, cognitive functions. The pulmonary rehabilitation program will be implemented every day during the hospitalization. The pulmonary rehabilitation program will consist of breathing exercises, strengthening training of upper and lower extremity, exercises in bed, mobilization and reducing oxygen support. The patient will be re-evaluated before discharge.Pulmonary rehabilitation after discharge will continue 2-3 days a week.The patient will be re-evaluated at the 3rd, 6th, 9th and 12th months.

Eligibility Criteria:
Inclusion Criteria:

-pregnant and covid patient

Exclusion Criteria:
Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles

This study will evaluate the physiopathologic characteristics of dark circles in participants with various ethnicities and Fitzpatrick Skin Types and the impact of the dark circles on the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Fitzpatrick skin type I-VI
* Willingness to not wear any eye makeup on the day of the study visit prior to the study visit appointment
* Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
* Willingness to have facial exams, skin instrumentation measurements, and digital photos performed on the face.

Exclusion Criteria:

* Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test area
* Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, active hepatitis, immune deficiency, or autoimmune
* Individuals who have a pre-existing or dormant dermatologic condition (e.g. history of severe psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
* Individuals who have had a blepharoplasty procedure or any other surgery in proximity or affecting the test area
* Individuals with recent procedures/surgeries (less than 6 months) on the eye bulb
* Individuals with permanent makeup around the eye area
* Chemical peel, microdermabrasion, microneedling, or dermaplaning in the previous 4 weeks
* Latisse, Revitalash, or other lash enhancement stimulators in the previous 1 month
* Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other similar prescription drugs within the previous 3 months
* Cosmetic injections (filler and/or toxins, i.e.Juvederm, Radiesse, Botox, etc.), non- ablative laser or fractional laser resurfacing in the previous 12 months
* Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical) in the previous 12 months
* Individuals who have any planned surgeries or procedures during the study.
SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

In this observational study, 60 subjects with type 2 diabetes (T2D) and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor or a fixed dose combination of SGLT-2 inhibitor with a DPP4-inihibitor for 12 weeks. Measures will be performed at baseline and after 12 weeks of treatment, as per good clinical practice.

The day of the study patients undergo a routine clinical evaluation. Whole blood samples will be collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin).

A mid-stream first urine in the morning sample will be collected into a sterile container. 50 ml of urine will be immediately transferred into a sterile falcon and centrifugated at 4500 rpm for 10 min. After removal of the supernatant and addition of 10 ml of PBS or sterile physiological solution, the sample will be further centrifugated at 4500 rpm for 10 min. The supernatant will be removed and the pellet stored in a falcon at -80°C.

Genomic DNA will be extracted throw Qiamp DNA mini kit (QIAGEN) and quantified using spectrophotometric assay.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosis
* Hb1Ac ≥ 7% and ≤ 9%

Exclusion Criteria:

* Hb1Ac \> 9%
* current treatment with an SGLT2i or a DPP4i drugs, or in the prior 4 week
* irritating and/or obstructive urinary or genital symptoms
* menstrual cycle for women
* current antibiotic treatment or in the prior 4 weeks
* anatomical or functional abnormalities of the urinary tract (e.g. incontinence, neurological bladder, bladder prolapse).
Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.

AIM 1: To evaluate the effect of transcranial direct current stimulation (tDCS) (2mA for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the Auditory Hallucination Rating Scale (AHRS) by patients before and after stimulation. We hypothesize that tDCS will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation.

AIM 2: To evaluate the long term effects of tDCS by having patients give a rating on the AHRS after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. We hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tDCS at one month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness \>1 year.
* 18-99 years old.
* Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care .
* On current antipsychotic doses for approximately 4 weeks or more.
* Capacity to understand all relevant risks and potential benefits of the study (informed consent) OR has a legal guardian who can complete consent forms on the patients behalf
* Right handed

Exclusion Criteria:

* Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months.
* History of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae.
* Prior brain surgery.
* Any brain devices/implants, including cochlear implants and aneurysm clips.
* Co-morbid neurological condition (i.e. seizure disorder, brain tumor).
* Medical or neurological illness (unstable cardiac disease AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation.
* Non English speakers.
* Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
Gut Microbiota, PGx and INSTIs Response

This is an interventional phase IV trial enrolling HIV-infected patients treated by dolutegravir or bictegravir-based combined antiretroviral therapy, and patients with a planned shift to a dolutegravir or bictegravir-based combined antiretroviral therapy, that aims at understanding the individual response to dolutegravir and bictegravir, in terms of efficacy and toxicity.

The main objective of our research project is to better define the inter-individual variability in terms of clinical and biological response towards Integrase Strand Transfer Inhibitors, an important ARV drug class used in the treatment of HIV infection. We aim at identifying predictors of drug efficacy and toxicity, which are eagerly awaited by clinicians as INSTIs are now prescribed worldwide and concerns about previously unidentified side effects are emerging.

The specific objectives of the project are:

* To study the impact of genetic polymorphisms in selected pharmacogenes (including genes coding for biotransformation enzymes and transport proteins) on INSTIs PK parameters and biomarkers relevant for TDM, such as trough (C0) and intracellular (IC) concentrations.
* To determine whether genetic polymorphisms in selected pharmacogenes might affect INSTIs efficacy, as assessed by the measurement of the viral load.
* To address the important question of the pathophysiological mechanisms lying behind the two main side effects of INSTIs, namely neuropsychiatric adverse events and abnormal weight gain.
* To describe how INSTIs affect the gut microbiome of treated patients, and to determine in turn how and by which pathways the gut microbiome might influence the clinical response (i.e. efficacy and toxicity) to INSTIs.

Eligibility Criteria:
Inclusion will be proposed to:

* HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and currently treated by 50mg OD of DTG (n=80) or 50mg OD of BIC (n=30).
* Virally controlled immunologically functional HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and shifting from another ARV class to a treatment containing 50mg OD of DTG (n=20) or 50mg OD of BIC (n=20).
* HIV infected adult patient retrospectively identified as having stopped standard dosage of DTG (ie. 50mg OD) due to NPAE (insomnia, depression, anxiety) (n=50). Identification will be based on the interrogation of our prospective clinical database.

Exclusion Criteria:

* Pregnancy at the time of inclusion or expected pregnancy within 12 months, for patients treated by DTG or BIC during the study
* Liver failure (Child-Pugh A, B or C)
ATGAM General Investigation

The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan.

The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM.

The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe aplastic anemia who receive ATGAM

Exclusion Criteria:

* No exclusion criteria is set out in this study.
The Effect of Daily Consumption of Extra Virgin Olive Oil on Blood Glucose Among Diabetic Patients

Saudi Arabia has the highest prevalence (24%) of type 2 diabetes mellitus (T2DM) among the modern nation states in the world. In addition, majority of Saudi diabetic patient do not have their blood glucose controlled. Data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and HbA1c (glycated hemoglobin). Olive oil has been associated with weight reduction as well as improvements in lipid profile (increase in high density (HDL) and decrease in low-density lipoprotein (LDL)). No randomized controlled trial has specifically examined the effect of olive oil as a supplement on blood glucose among diabetics. The study objective is to test the effect of daily consumption (30 mL) of extra-virgin olive oil (EVOO) on HbA1c among patients with type 2 diabetes.

Problem: Saudi Arabia has the highest prevalence (24%) of type 2 diabetes mellitus (T2DM) among the modern nation states in the world. In addition, majority of Saudi diabetic patient do not have their blood glucose controlled.

Significance: Data suggests that diet, rich in olive oil and nuts, significantly reduces fasting plasma glucose and HbA1c (glycated hemoglobin). Olive oil has been associated with weight reduction as well as improvements in lipid profile (increase in high density (HDL) and decrease in low-density lipoprotein (LDL)). No randomized controlled trial has specifically examined the effect of olive oil as a supplement on blood glucose among diabetics.

Objectives: To test the effect of daily consumption (30 mL) of extra-virgin olive oil (EVOO) on HbA1c among patients with type 2 diabetes.

Methods: The study design will be an open-label randomized controlled trial with 2 groups (EVOO versus no oil). The study will include 420 patients and each patient will be followed for 3 months. Group difference in HbA1c will be compared at 3 months to determine the effect of EVOO.

Implications: Dietary supplementation of EVOO could aid Saudi diabetic patients in keeping blood glucose levels controlled.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Type 2 diabetes within 10 years of enrollment
* baseline HbA1C \> 7%,
* willing to supplement the diet with oil
* able to read and write

Exclusion Criteria:

* type 1 diabetes mellitus
* have gall-bladder or liver diseases or malabsorption or Crohn's disease
* have advanced heart disease
* have an aversion or allergy to olive oil
* already using olive oil daily as a dietary supplement
* morbidly obese (Body Mass Index \>40 kg/m2)
Pars Plana Surgical Capsulotomy for Posterior Capsular Opacification

Cataract is a leading cause of Global blindness. After cataract surgery nearly half of the people become blind due to posterior capsular opacification. The only solution for this problem is LASER capsulotomy. Laser machine is not available in remote areas especially in underdeveloped countries. The solution of this problem is surgical capsulotomy which can be performed any where.

posterior capsular opacification is treated by YAG laser capsulotomy. this require sophisticated technology ans specific environment which is not possible in underdeveloped countries. we describe a method in which posterior capsular opacification could be managed by using only a 27 Gauge needle through pars plana. opacified posterior capsule is under tension that is why a small puncture results in a large central opening

Eligibility Criteria:
Inclusion Criteria:

* Patients with Posterior capsular opacification
* Both Sexes
* All ages

Exclusion Criteria:

* Retinal disease
* Uncontrolled Glaucoma
* Corneal opacity
Effectiveness of Acupuncture Clinical Pathway

The study will be described the development and implementation of the Clinical pathway (CPW) for acupuncture treatment in the management of patients with some chronic pain conditions. The effectiveness of this CPW will be explored in this study through retrospective analysis of clinical outcomes after administration of acupuncture treatment summarised in the guidelines.

This longitudinal, observational, retrospective study included adults (\>18 years) with common chronic pain condition treated at the Son Llàtzer University Hospital Pain Clinic, in Palma de Mallorca, Spain, from January 2015 to December 2018. All patients received treatment according to the Acupuncture Clinical Pathway developed. The primary outcome measures will be a change in pain intensity measured by VAS for pain at the completion of treatment. Number of responder patients, reduction of pain medication intake, improve of quality of live scale, sleep quality index and scale of anxiety and depression after treatment are also to be included in the study.

The purpose of this study is to assess the effectiveness of integrated a clinical pathway approach for chronic pain treatment with acupuncture in a Pain Clinic.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (\>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Applying Acupuncture treatment Clinical Pathway and completed at least 50% of the medical appointments.

Exclusion Criteria:

Inclusion Criteria:

Adult patients (\>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Without applying Acupuncture treatment Clinical Pathway or not completed at least 50% of the medical appointments.
Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®

The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.

This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any ethnicity, between 18 and 99 years of age.
* No known allergies to study material.
* Able to communicate with the investigator and read, understand, and sign the informed consent form.
* Maxillary incisor, canine, or premolar with at least one Miller's Class I or II gingival recession defects that are not adjacent to one another.
* Depth of the gingival recession defects of 2mm or greater.
* No gingival surgery within the past 12 months at the defect site. No prior antibiotic use within 3 months with less than 2 weeks durations.
* Ability to maintain good oral hygiene.

Exclusion Criteria:

* Patients taking any medications known to cause gingival enlargement.
* Patients with unstable systemic diseases.
* Patients with compromised immune systems or unstable bleeding disorders.
* Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HIV, etc.).
* Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.).
* Patients taking steroid medications.
* Tobacco use or smoking within 1 year of screening visit (e.g. cigarettes, pipes, cigars, chew).
* Pregnant females or females attempting to get pregnant.
* Other conditions the investigator feels would inhibit from a good candidate for the study.
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males

To assess the safety and tolerability of ascending single oral doses of SAM-531, an investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion criteria:

* Men aged 20 to 45 years (inclusive) at the time of getting informed consent.
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥50 kg (BMI = \[weight (kg)\]/\[height (m)2).
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
* Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.
A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 12 weeks
* Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which has progressed during/after standard therapy
* Human epidermal growth factor receptor 2 (HER2)-negative among participants with breast cancer
* Negative pregnancy test or use of an adequate contraceptive method among women of childbearing potential
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Clinical evidence of central nervous system (CNS) metastases
* Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy within 2 weeks of study Day 1
* History of palmar plantar syndrome Grade 2 or worse, or any unresolved residual chemotherapy effects
* Prior HER2-active agents, continuous intravenous (IV) 5-fluorouracil, capecitabine, or other fluoropyrimidine
* Any investigational agent within 28 days of study start
* Prior cumulative doxorubicin dose greater than (\>) 360 mg/m\^2 or equivalent
* Significant cardiovascular disease
* Active/uncontrolled concurrent illness or infection-
* Major surgery or trauma within 4 weeks of study Day 1
Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population

This study aims to further define the appropriate population for Pico-Salax, a purgative used prior to colonoscopy. Patients over the age of 70 years with normal renal function scheduled for colonoscopy will receive Pico-Salax and have pre and post preparation bloodwork and electrocardiograms (ECGs).


Eligibility Criteria:
Inclusion Criteria:

* \>70 years

Exclusion Criteria:

* renal dysfunction
* congestive heart failure
* ileus