cyrilzakka/clinical-trials huggingface dataset:
A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP

To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT). If AZT is started during the study, patients must have received = or \> 15 days of aerosol pentamidine before beginning AZT.

Prior Medication:

Allowed:

* Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or \> 15 days of AZT before beginning aerosol pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
* Toxoplasmosis.
* Cryptococcosis.
* Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
* Pulmonary Kaposi's sarcoma (KS).
* Uncontrolled asthma.
* Active therapy for tuberculosis.

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
* Toxoplasmosis.
* Cryptococcosis.
* Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
* Pulmonary Kaposi's sarcoma (KS).
* Uncontrolled asthma.

Prior Medication:

Excluded within 30 days of study entry:

* Antiretroviral agents other than zidovudine (AZT).
* Immunomodulating agents.
* Corticosteroids.

Active therapy for tuberculosis.

Patients must:

* Have AIDS and recovered from their first episode of Pneumocystis carinii pneumonia (PCP).
* Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
* Have positive antibody to HIV by a Government-approved ELISA test kit, or confirmed Western blot test.
* Adequate pulmonary function (vital capacity = or \> 80 percent of predicted; forced expiratory volume (FEV), 1 s = or \> 65 percent of total FEV; and corrected pulmonary diffusion capacity \> 60 percent of predicted).
* Free of acute medical problems.

Active substance abuse.
Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

This pilot study aimed to assess the feasibility of using an instant messenger to monitor drug intake in tuberculosis patients and to assess cash incentive to improve adherence to drug intake

At the initial visit, the inclusion criteria are cross-checked, the subject is informed of the study procedures, and an informed consent form is signed by subjects willing to participate.

For the participants from the intervention group, the research team will provide a smartphone with the WhatsApp application to each participant. At the initial visit, the research team will explain to the participants how to use the phone and the instant messenger application for the study. Briefly, the subject is filmed while taking the drug. This can be via a "selfie" or by a family member. The video is then sent to the study phone contact.

Once the video is received by an investigator, a message will be sent back to the participant's mobile phone acknowledging receipt of the video. An investigator trained on the DOT protocol, will review the video clips to assess if the drug was taken correctly or not. A daily log is filled in to keep track of drug intake for each participant.

Participants from both the control and intervention group are seen once per month in person for follow-ups and getting new drugs. At these time points information on drug intake is gathered.

Eligibility Criteria:
Inclusion Criteria:

Older than 18 years

* Signed informed consent form
* Living in an area with mobile phone coverage
* Have at least 3 months of treatment remaining

Exclusion Criteria:

• Not being able to use a smartphone and unlikely to learn how to
JAK2 Mutation May Predict Response and Guide First Line Treatment in Rheumatoid Arthritis

This study included 76 newly diagnosed RA patients and 50 matched controls. Basal JAK2 mutation was assessed by PCR in blood samples, TNF-α and IL 6 were measured by ELISA in serum of patients and controls. All patients started therapy with conventional synthetic DMARDs (including methotrexate). Response assessment at 3rd month was evaluated by DAS28 and ACR response criteria. JAK2 mutation was correlated with different clinical and laboratory parameters of patients.

PCR detection of the JAK-2 V617F mutation using ASO specific PCR Genetic marker:

The detection of jak2 V617F mutation were done by using the following primers (JAK2 Reverse: 5' CTGAATAGTCCTACAGTGTTTTCAGTTTCA 3', JAK2 Forward (specific): 5' AGCATTTGGTTTTAAATTATGGAGTATATT 3' and JAK2 Forward (internal control): 5' ATCTATAGTCATGCTGAAAGTAGGAGAAAG 3'). Cycling conditions were 35 cycles with annealing temperature 58.5oC flowed by agarose gel 2% electrophoresis for bands detections.

All patients started treatment by conventional synthetic DMARDs (including methotrexate). Response assessment at 3rd month was evaluated by DAS28 and ACR response criteria. JAK2 mutation was correlated with different clinical and laboratory parameters of patients.

The Disease Activity Score (DAS) and the DAS28 have been developed to measure disease activity in RA both in daily clinical practice as well as in clinical trials on a group as well as individual level. The DAS/DAS28 is a continuous measure of RA disease activity that combines information from swollen joints, tender joints, acute phase response and general health The DAS28 is a measure of disease activity in rheumatoid arthritis (RA). DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. questionnaires (e.g. the HAQ which assesses function), X-rays, and newer imaging techniques such as ultrasound and MRI.

The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.

Eligibility Criteria:
Inclusion Criteria:

* New case RA patients
* good liver and renal function

Exclusion Criteria:

* Other autoimmune diss
* Malignancy
* Active viral infection
* pregnancy and lactation
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.


Eligibility Criteria:
Inclusion:

* Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
* In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
* Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide

Exclusion:

* Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
* Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
* Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception
Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes

The purpose of this study is to evaluate the intraocular stability and safety of secondary iris-fixated IOLs in aphakic patients.

18 eyes of 16 patients received secondary anteriorly iris-fixated intraocular lenses (IOLs) to correct for aphakia without capsular support, partly combined with anterior or complete pars plana vitrectomy. Primary outcome measurements included visual acuity (6m Snellen charts), central endothelium cell count (cECC) and postoperative intraocular position of the IOL assessed with anterior segment optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* Patients with aphakia due to complicated cataract surgery, weakness in lens support (capsula, zonulae) Marfans´s syndrome

Exclusion Criteria:

* Aphakia due to preexisting corneal, retinal o uveal disease, low endothelial cell count
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
* Body mass index in the range 22-40
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* History of type 1 diabetes
* Evidence of significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of C-reactive Protein Level in the Group of Patient With Pain Form of Temporomandibular Joint Dysfunction

Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures.

The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.

Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures.

The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.

Material and methods The research material consisted of 72 patients who reported to the prosthetic treatment because of temporomandibular joint dysfunction. The study group included 36 patients with pain form of dysfunction, and control group - 36 patients with painless form of disorder. Each patient underwent specialized examination of functional disorders, in order to diagnose the type of dysfunction and commissioned to carry out a study of the blood test concern with evaluation of the C-reactive protein (CRP) level in the same analytical laboratory.

The results of the investigation were subjected to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Factors of inclusion in the study are: pain form of temporomandibular joints dysfunction, the required age range, a good general state of health (particularly with regard to cardiac and metabolic disorders).

Exclusion Criteria:

* Factors for exclusion from the research include: the will of the patient, the emergence of general diseases, trauma, or local inflammation.
Flossing Technique With Neuromuscular Reeducation Exercises in Trained Subjects

Introduction. A deficit of dorsiflexion and motor control can limit the performance of a squat. Neuromuscular reeducation exercises, mobility and elasticity are used in the neuromuscular control and mobility of the kinetic chain. The Flossing technique is applied to improve ankle mobility and the perception of effort.

Objective. To compare the efficacy of a protocol for neuromuscular reeducation exercises, mobility and elasticity, and the Flossing technique in ankle mobility and perception of effort when performing squats.

Study design. Randomized, multicenter, single-blind clinical study with a follow-up period.

Methodology. 40 weightlifters included in the study will be assigned randomly to the study groups: experimental (protocol of reeducation exercises plus the application of the Flossing technique) and control (protocol of reeducation exercises). The intervention will last 4 weeks, with two weekly sessions of 15 minutes each. The variables of the study will be the range of movement of ankle dorsiflexion (Weight Bearing Lunge Test) and the perception of the effort during the squat (Borg scale). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. The distribution of the sample will be analyzed using the Kolmogorov-Smirnof test. In case of homogeneity, parametric tests will be used to calculate changes after each evaluation (t-student) and the intra- and intersubject effect (repeated measures ANOVA).

Expected results. Improvement in dorsiflexion of the ankle and decrease in the perception of effort during the squat.


Eligibility Criteria:
Inclusion Criteria:

* From 18 to 24 years old
* Male
* That they be weight lifters with at least one year of experience
* That they do not present musculoskeletal injury or pathology in the three months prior to the beginning of the study

Exclusion Criteria:

* Can not be present during the 6 weeks of the intervention and the evaluations will be excluded
* Under pharmacological treatment
* Who are performing another physiotherapy study
* Not sign the informed consent document.
A Weight Loss RCT Comparing Keyto vs Weight Watchers

Very low-carbohydrate ketogenic diet may have beneficial metabolic and weight loss effects, however, adhering to this diet may be challenging. Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote dietary change and weight loss. The purpose of this research is to test the Keyto self-monitoring + app intervention against a "standard of care" weight loss dietary app (Weight Watchers). 144 participants will be recruited through Facebook ads, provide online consent, and will be randomized to one of the two conditions. Weight loss after 12 weeks will be assessed as the primary outcome, with weight loss at 24 and 48 weeks being secondary outcomes. Blood samples will be collected at baseline and 12 weeks with optional blood samples at 48 weeks follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* Living in the State of California
* Body mass index (BMI) 27-43
* Must speak, read, and comprehend English
* Access to reliable internet and wi-fi
* Must have a valid email address and phone number
* Must have an Apple iPhone (iPhone 7 or later, iOS 11 or later) with cellular data plan
* Must have a kitchen and be willing to cook
* Willingness to reduce carbohydrate intake to less than 30g/day
* Willingness to restrict intake of added sugar, bread, grain, rice, pasta, sweets, most fruits, pastries, and other carbohydrates
* Willingness to comply with a strict diet for 12 months
* Willingness to eat a diet that is primarily plant and fish-based
* Interest in losing weight

Exclusion Criteria:

* HIV or immunocompromised
* Current or past cancer diagnosis
* Pregnant, breastfeeding, or planned pregnancy in next 12 months
* Beginning or ending hormonal contraception in next 12 months
* Current diagnosis of diabetes
* History of heart attack or stent
* Currently taking glucose-lowering drugs, statins, or oral steroids
* History of gastric bypass surgery or any other weight-loss surgery
* History of anorexia or bulimia
* History of mental illness
* Current smoker or smoked cigarettes within past 12 months
* Currently eating fewer than 50 g carbohydrates per day
* Have tried a low-carb, high fat (ketogenic diet) within the past 3 months
* Recent weight loss or gain of more than 5% body weight in past 6 months
* Previous experience with the Weight Watchers diet app
* Experience with a low-carbohydrate of ketogenic diet within past 6 months
Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients

Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes.

This trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in Hemoglobin A1C)

The study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with DM2 and unbalanced in their glycemic values (HbA1c above 7%). The patient were sent via email , once every other week, a link to web-based pages which provides information on changing DM2 related such as general DM2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more.

Furthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to.

Each participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages.

During the course of the study, information regarding the patients' glycemic control (in the form of HgA1c levels) was collected.

Additional variables (age, sex, BMI, time passed since diagnosed with DM2) were collected and used for statistical comparison.

Eligibility Criteria:
Inclusion Criteria:

1. Previous diabetes specialist follow
2. Age over 18.
3. Diagnosis of diabetes type 2.
4. HbA1c over 7%
5. Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.
6. Able to read Hebrew
7. Uses Email account that is actively read at least twice weekly.

Exclusion Criteria:

* Patients who did not the inclusion criteria
Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards

Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus \> 3 months
* Age≥18 years old
* Receiving glucose-lowering therapy for at least 90 days
* Blood glucose:7.8-22.2 mmol/L
* Length of proposed hospitalisation ≥5 days

Exclusion Criteria:

* Type 1 diabetes mellitus, other special types of diabetes mellitus.
* BG\>22.2 mmol/L, or acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar state.
* History of severe or repeated hypoglycaemia
* BMI≥45 kg/m2
* Pregnant and lactating women
* Clinically relevant liver disease (established cirrhosis and portal hypertension);
* Presence of severe renal disease (serum creatinine ≥3.0 mg/dL or estimated glomerular filtration rate \<30 ml/min/1.73 m2);
* Severe cardiac insufficiency;
* Patients on cortisol-based hormone therapy (equivalent to a prednisone dose \>5 mg/day);
* Psychiatric abnormalities or impaired cognitive function;
* Patients with severe oedema, infection, or peripheral blood circulation disorder;
* Patients with severe illness or patients to be transferred to ICU for treatment;
* Surgery of the heart or abdomen that may have a significant impact on the test is planned during hospitalisation.
Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED

The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.

Non-invasive positive pressure ventilation (NIMV) is a life-saving procedure for patients with hypoxic and/or hypercapnic respiratory failure. AVAPS (average volume assured pressure support) is a noninvasive ventilation mode which has been developed to assure volume and pressure controlled respiratory support. AVAPS can ensure a constant tidal air volume to the patient with variable pressure support. Thus the positive features of the volume and pressure controlled support, which have a positive impact on the healing and recovery processes are combined.

This study aims to compare, in a randomized order, BPAP ST/T and BPAP ST / T Mode with AVAPS, in patients with hypercapnic respiratory failure in the emergency department.

Subjects: One hundred and two patients with hypercapnic respiratory failure will be included.

Primary outcome; decrease in the PaCO2 values

Secondary outcomes are stated as; Failure of treatment options, or change of the NIMV mode due to patient noncompliance or the patient's need for intubation and length of hospital stay (length of stay in the hospital from the emergency department).

Eligibility Criteria:
Inclusion Criteria:

PaCO2 \> 45mmHg and any of the following

* SaO2 \<90% on air
* SaO2 \<93% on \>6 Litres O2/min
* Inability to speak in sentences due to respiratory distress
* Respiratory rate \> 24/min
* Altered mental status
* The use of accessory muscles of respiration

Exclusion Criteria:

* Respiratory arrest or unstable cardiorespiratory status
* Suspected Pneumothorax
* Urgent need for intubation
* Systolic blood pressure \< 90 mmHg
* Inability to protect airway
* Facial deformity
* Facial, esophageal, or gastric surgery history
* All trauma patients
* Acute myocardial infarction
* Severe arrythmias
* Refractory nausea and vomiting