cyrilzakka/clinical-trials huggingface dataset:
Frequency of Sexual Intercourse,Women With Fibromyalgia

Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?


Eligibility Criteria:
Inclusion Criteria:

\* Female patient with fibromyalgia

Exclusion Criteria:

* Uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological),
* Major psychiatric disease,
* Endocrine disease,
* Pregnancy
* Menopausal status,
* Antihypertensive, antidepressant, anxiolytic, antiepileptic drugs use
Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19

The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.

Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.

Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.

Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing.

110 patients, 90 adults and 20 children, were recruited. The lung function included LCI, FEV1, FVC and DLCO (Hb corrected). Additionally we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the test.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 Infection, non-hospitalized during infection

Exclusion Criteria:

* Smoking, existing lung disease (COPD, Asthma bronchiale)
Overcoming Barriers and Obstacles to Adopting Diabetes Devices

This study will create a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with type 1 diabetes (T1D) the skills to maximize benefit and minimize daily interference from barriers associated with continuous glucose monitoring (CGM) and increase readiness for closed loop.

The proposed research will create and refine the ONBOARD intervention for CGM use. Participants will be tracked using metrics of A1c, time in glucose target range, number of days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress, and technology attitudes. The investigators will examine whether ONBOARD leads to improved diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of CGM and increase readiness for closed loop adoption.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is age 18-50 years at time of screening
2. Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the past 6 months
3. Subject has a clinical diagnosis of type 1 diabetes
4. Subject comprehends spoken and written English

Exclusion Criteria:

1. Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
2. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer

The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation
* Expected survival \> 12 months.
* Patients having provided written informed consent.
* Patients mentally fit for completing a questionnaire.

Exclusion Criteria:

* Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.
* Patients who already have been treated with a GnRH analogue within the last year.
* Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients.
* Patients with a contraindication according to SmPC.
Lung and Diaphragm-Protective Ventilation by Means of Assessing Respiratory Work

This study is designed to test a proposed strategy for lung- and diaphragm-protective ventilation (LDPV) in patients with acute hypoxemic respiratory failure. Ventilation and sedation will be titrated to evaluate whether it is feasible and safe within this patient population.

Lung injury and diaphragm injury incurred by mechanical ventilation have very serious adverse effects on patients with acute respiratory failure. Lung injury results from excessive mechanical stress and strain applied to the lung by the ventilator and/or respiratory muscles, while diaphragm injury results from either insufficient or excessive inspiratory effort.

The objective of this study is to investigate a new LDPV strategy designed to prevent both disuse-mediated and load-induced diaphragm injury, while also preventing excess global and regional mechanical stress and strain in the injured lung. To achieve these goals, the following specific targets to be met are: (1) respiratory muscle effort similar to that of healthy subjects breathing at rest, (2) lung stress within safe limits, and (3) clinically acceptable gas exchange.

Targets are assessed through measurements of global lung stress, tidal recruitment, inspiratory effort, diaphragm contractile effort and adequacy of respiratory muscle and systemic tissue perfusion. Measurements commence at enrollment and continue for 24 hours consecutively.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute hypoxemic respiratory failure
* PaO2:FiO2 ratio less than or equal to 300 mm Hg at time of screening
* Oral endotracheal intubation and mechanical ventilation
* Bilateral airspace opacities on chest radiograph or chest CT scan

Exclusion Criteria:

* Liberation from mechanical ventilation is anticipated within 24 hours
* Intubated for traumatic brain injury or stroke
* Contraindication to esophageal catheterization
* Intracranial hypertension
The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus

The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Abnormal anatomy of tracheobronchial tree
* Intraluminal lesion in the left or right mainstem bronchus
* Anticipated difficult intubation
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review.

The secondary objectives of the study are:

* To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including:
* Major pathologic response (mPR) rate per independent central pathology review
* pCR rate and mPR rate per local pathology review
* ORR prior to surgery, according to local assessment using RECIST 1.1
* To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)
* To evaluate the safety profile of neoadjuvant cemiplimab
* To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review
* To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review


Eligibility Criteria:
Key Inclusion Criteria

* Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
* At least 1 lesion that is measurable by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria

* Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia \[CLL\]) at any time
* Distant metastatic disease (M1), visceral and/or distant nodal
* Prior radiation therapy for CSCC
* Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
* Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
* History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
* Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply
GUM Remote Testing v4.0

Capillary blood sample results are compared to venous blood results

Capillary blood samples can be taken by patients from their own finger without requiring a healthcare professional to take a blood sample. Samples taken this way can be posted from home. This crucially avoids visits to the clinic or hospital to have blood samples taken. It would reduce the burden on healthcare professionals and is often preferred by patients. It is important to demonstrate that the results of an analysis performed on capillary blood samples are equivalent to the analysis of a standard venous sample.

This study aims to collect, in parallel to a standard venous blood sample, a capillary blood sample taken by the participant which is then added to specially designed filter paper (dried plasma spot sample) or other collection devices. Parallel analysis of paired samples will then allow the investigators to assess if results measured in samples taken using the two methods are similar.

The investigators will recruit 40 participants for each collection device to this study. It is important to obtain a range of positive and negative results from the study participants, and from stored samples and quality control material.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Able and willing to provide informed consent.
* Already having a venous blood sample for clinical care

Exclusion Criteria:

* Failure to consent
Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged of 18 to 60 years old;
* Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
* untreated.

Exclusion Criteria:

* Pregnancy or lactation women;
* Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
* Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
* Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
* Obviously poor compliance.
Incentive Spirometer and Inspiratory Muscle Trainer

Patients suffering from parkinsonism have respiratory function abnormalities. This study compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary functions in patients with parkinsonism.

The participants were recruited according to the inclusion and exclusion criteria. Participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. These trainings were performed for 6 weeks duration. Several outcome measures related to pulmonary function tests were measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having Parkinsonism Disease by the Neuro physician.
* Duration of Parkinson's Disease ≥ 5 years.
* Patients with the age of 65 to 80 years.
* Hoen and Yahr classification within 1 to 3.
* Both males and females were included.
* Patients who were able to comprehend the commands.
* Patients who were willing to participate.

Exclusion Criteria:

* Patients having any cardiovascular and pulmonary disorders.
* History of smoking currently or in the past.
* Psychological Impairment.
* Insufficient verbal/intellectual understanding.
* Patients with unstable vital parameters.
* Those unable to perform pulmonary function tests (PFT) because of anatomical abnormalities or clinical signs of dementia.
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.
* Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
* Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4.
* Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.

Exclusion Criteria:

* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* History of an organ transplant which requires continued immunosuppression.
Safety and Immunogenicity of a Naked DNA-based Vaccine Therapy in Patients With Chronic Hepatitis B

The purpose of this study was to investigate whether HBV-DNA vaccination is safe and could restore immune responses in patients with chronic hepatitis B non responder to available therapies.

* Despite the availability of effective hepatitis B vaccines for many years, over 370 million people remain persistently infected with hepatitis B virus (HBV). Persistent infection is associated with chronic liver disease that can lead to the development of cirrhosis and hepatocellular carcinoma in some patients. Viral persistence is thought to be related to poor HBV-specific immune responses.
* Interferon (IFN)-alpha treatment significantly decreases HBV replication in only one third of patients with hepatitis B e antigen (HBeAg)-positive chronic active hepatitis B. Nucleoside analogues, such as lamivudine and adefovir dipivoxil, inhibit HBV replication and improve histological signs of liver disease,but their use is limited by the risk of relapse after treatment discontinuation and the emergence of drug-resistant viral variants.
* Patients with acute self-limited hepatitis B display detectable polyclonal and multispecific cytotoxic T lymphocyte and T helper (Th) responses to viral antigens,whereas these responses are weak or absent in chronic HBV carriers.
* Increasing the strength of HBV-specific T-cell responses to the levels found in patients recovering from infection is therefore a goal in the treatment of patients with chronic hepatitis.
* Immunization with a nucleic acid vaccine (DNA vaccine) usually elicits antibody responses and T lymphocytes with a Th1 cytokine profile. In animal models of chronic hepatitis B infection, including nonhuman primates, intramuscular injection of a plasmid encoding HBV envelope proteins induces rapid, strong, and sustained humoral and cell-mediated immune responses. Clinical trials of DNA vaccines for hepatitis B conducted in healthy adult volunteers using a plasmid encoding hepatitis B surface antigen and the gene gun as a delivery system showed good tolerance.
* We carried out a phase I trial of a HBV DNA vaccine in patients with chronic active viral hepatitis, aiming to restore HBV-specific immune responses and to assess safety regarding liver disease.

Eligibility Criteria:
Inclusion Criteria:

* chronic HBV carriers
* biopsy proven chronic hepatitis
* active HBV replication for \> 6 months
* non responding to Interferon-alpha or lamivudine treatment

Exclusion Criteria:

* co-infection with HIV, HCV, delta hepatitis virus
* alcohol consumption\> 40g/day
* decompensated liver disease
* HLA DR2
BE of Torrent's Esomeprazole Mg DR Capsules

Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days.

An open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Mg DR Capsule containing Esomeprazole Mg 40 mg \[ Test Formulation, Torrent Pharmaceutical Ltd., India\] Versus Nexium 40 mg DR Capsule containing Esomeprazole 40 mg \[Reference Formulation, AastraZeneca LP, USA\] Under administered as the contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* Inability to communicate or co-operate.
* Administration of any study drug in the period 0 to 3 months before entry to the study,
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of pre-existing bleeding disorder.
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* HIV, HCV, HBsAg positive volunteers.
* History of alcohol or drug abuse.
* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
* Positive to Breath alcohol test.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°F or more than 98.6°F.
* Respiratory rate less than 12/minute or more than 20/minute.
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* Recent History of kidney or liver dysfunction.
* Volunteers suffering from any psychiatric (acute or chronic) disorder.
* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.