cyrilzakka/clinical-trials huggingface dataset:
Bed Rest for Threatened Preterm Labor. Pilot Study

The aim of the pilot trial is to assess at what extend women with arrested threatened preterm labor change their activity patterns at home in response to bed rest prescription.

An area of concern for the design of a trial is the strength of health provider's recommendation to change women's behaviors, and their compliance with bed rest recommendations. The study was a randomized parallel design. The intervention group consisted of total bed rest for four days (with allowance to go to the toilet). The control group consisted in the restriction of activities during four days.


Eligibility Criteria:
Inclusion Criteria:

* Every woman admitted to hospital during the antenatal period because of an episode of TPL. If the attending physician decides that the woman is ready for hospital discharge the woman will be eligible for the study.

Exclusion criteria:

* Multiple pregnancy
* Premature rupture of membranes
* Cervical cerclage and whenever the attendant physician considers that the woman is not eligible to be randomized to bed rest or activity restriction.
A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer

A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.

This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer.

In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791.

If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.

Participants will be followed up longterm, so that survival can be measured.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma.
* The subject must be aged 18 years or above.
* The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
* Subjects will have measurable disease.
* The subject must be able to understand the information provided to them and to give written informed consent.
* Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator.
* Male subjects must be using a method of contraception judged reliable by the Investigator.

Exclusion Criteria:

* Subjects with squamous cell lung carcinoma.
* Subjects with lung lesions located centrally in the chest that involve major blood vessels.
* Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
* Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
* Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2.
* Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).

Exclusion Criteria:
CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes

Neuropathies are a major cause of moderate to severe impairments in cancer patients.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.

Neuropathies are a major cause of moderate to severe impairments in cancer patients .

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.

There are six main substance groups that cause damage to neurons developing CIPN: platinum-based antineoplastic agents, vinca alkaloids, epothilones (ixabepilone), taxanes, proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide).

Platinum-based chemotherapeutics (oxaliplatin, cisplatin and carboplatin) have the highest prevalence rates of CIPN, affecting \~ 70% of patients, often complicated by coasting Acute oxaliplatin-induced peripheral neuropathy (OIPN) can result in prolonged infusion times (\~ 22%), dose reduction (15-43%) and treatment cessation (6-21.4%) Taxane-induced peripheral neuropathy (TIPN) (paclitaxel, Docitaxel and Cabazitaxel ) is the most common non-haematological adverse event of treatment,however, docetaxel is generally considered to be less neurotoxic than paclitaxel.

CIPN occurs in a dose-dependent manner usually ,duration of exposure, scheduling and combination therapies are also potential risk factors.

diabetes mellitus and increasing age (≥75 years) have been proposed as strong independent risk factors(9). In addition to ,alcohol abuse, renal insufficiency, hypothyroidism, infections like (HIV) and smoking.

The severity of neuropathies can be graded by (Grading scales of CIPN includes; National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Most commonly used , WHO grading system ,self-assessment by patients is preferable due to consistent underrating by healtcare professionals.

symptoms of CIPN in hands and feet, such as tingling, numbness, cramps can cause problems with regular daily activities , standing and walking , Patients became limited in their daily activities and number of them stated that they became more dependent on others.

Treatment strategies depends on discontinuation or lowering the dose . Persistent neuropathic pain can be treated with anti-seizure medications, antidepressants, or analgesics . In severe painful conditions patients may be referred to the Chronic Pain Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \<75 .
* Sex : Male or female
* Adjuvant or metastatic
* Receiving neurotoxic agents " platinum and taxanes "
* No documentation of any other causes of neuropathy in their medical records as : congenital and DM

Exclusion Criteria:

* Pt not receiving any neurotoxic CTH.
* Detected other causes of neuropathy.
Early Levothyroxine Post Radioactive Iodine

The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low thyroid hormone levels).


Eligibility Criteria:
Inclusion criteria:

-all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD

Exclusion criteria:

* clinically manifest Graves' ophthalmopathy (GO)
* recent (\<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
* preexistent cardiomyopathy
* malnutrition
* psychiatric history that could get worse if patient remains persistently hyperthyroid
* unlikely to return for the planned follow-up visits
* unlikely to comply with the blood drawing schedule
* unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires
Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk factors and that persistent viral infection including residual HIV is linked to HIV COPD.

The study is a multicenter, prospective observational study of pathogenesis of HIV pulmonary disease. We will determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in HIV+ subjects. We will build on our existing longitudinal cohorts while adjusting for important co-variates such as antiretroviral therapy (ART), smoking history, co-infections, and illicit drug use. Evaluations will be scheduled at baseline, 18 months, and 36 months. (6, 12, 18 and 36 months for ART initiators at the UCSF). Study visits will consist of blood draw, questionnaires, pulmonary function testing, 6-minute walk test, CT of the chest at visit two. Oral specimen collection and glycocalyx and echocardiogram (visit two) at the Pittsburgh site only.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, documented in medical record at any time prior to study entry.
* Men and women age 18 to 80.
* Ability and willingness to complete all tests.
* Participant in HLRC studies, MACS, Women's Interagency Health Study, and local HIV clinics.
* For UCSF only, new ART initiators from Women's Interagency Health Study or the HIV clinic

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
* Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
* Hospitalization within 4 weeks prior to study entry (excluding mental health).
* Uncontrolled hypertension at screening visit (systolic \> 180 mm Hg or diastolic \> 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
* Active cancer requiring systemic chemotherapy or radiation.
* Active infection of lungs, brain, or abdomen.
* Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator
GALLANT 22 Tesaglitazar vs. Placebo

This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
* Drug-naïve (ie, no use of antidiabetic drug\[s\], for at least 24 weeks prior to visit 1).

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration

We will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .

Given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation

A research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups:

Unrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and Restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) Women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. Interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. Rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.

Eligibility Criteria:
Inclusion Criteria

* Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.
* Expressed an intention to breast feed exclusively their infant for at least 3 -months
* Possibility of contact by telephone
* Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier
* Primiparous single birth
* Mother´s age 18 years or more

Exclusion Criteria:

* Maternal risk factors for lactation

  * Lack of noticeable breast enlargement during pregnancy
  * Flat or inverted nipples
  * Variation in breast appearance (marked asymmetry, hypoplastic, tubular)
  * Any previous breast surgery, including plastics procedure
* Psychosocial problems (eg, depression, poor or negative support of breastfeeding
* Mother with a chronic condition that could influence development , including feeding ability
* Mother with eating or mental disorder.
* Mothers who smoke during pregnancy
Comparison Between High-speed Drilling With Irrigation and Low-speed Drilling With Irrigation

A randomized controlled clinical trial was conducted in the Oral Surgery Unit, Faculty of Medicine and Dentistry, University of Valencia. The research was carried out following the principles described in the Helsinki Declaration and the study was approved by the Institutional Review Board of the Ethics Committee of the University of Valencia (1937615).

Fifty patients were included in the study according to the selection criteria.The osteotomies were randomized in two groups: the control group was performed under the high-speed drilling (800 rpm) with irrigation technique and the study group under the low-speed drilling without irrigation technique (50 rpm). The randomization tool was www.randomization.com.

Before the intervention, a preoperative orthopantomography and CBCT (Cone Beam Computerized Tomography) were taken for all the patients. Every patient was submitted a prophylactic hygiene 7 days before the intervention and 2 g of oral amoxicillin tablet 1 hour before the intervention (Clamoxyl®, GlaxoSmithKline, Madrid, Spain) was prescribed as a prophylaxis medication.

All the surgeries were performed by the same experienced operator (JCBM). The interventions were conducted under local anesthesia (4% articaine with 1: 100,000 adrenaline (Inibsa®, Lliça de Vall, Barcelona, Spain). The IPX® implant model (Nueva Galimplant S.L, Sarria, Galicia, Spain) was placed in the present study.

Surgical drills with stop (K Fres Stop ®, Nueva Galimplant S.L, Sarria, Spain) were used to prepare the osteotomies. The drilling sequence used will be: initial lance drill, followed by conical drills of 2.0 mm, 2.6 mm, 3.2 mm and 3.6 mm. The implants were apico-coronally situated at 4 mm to the mucosal margin with a torque of 35 Ncm.

The placed implants were IPX Model (Nueva Galimplant S.L., Sarria, Spain) with a 2-mm height anti-rotational abutment of one piece (Nueva Galimplant S.L, Sarria, Spain). The healing was non-submerged.

As postoperative medication 1 g of paracetamol (Bexistar®, Bacino Laboratory, Barcelona, Spain) on demand maximum every 8 hours were prescribed. Postoperative hygiene and oral care instructions were explained to the patient. A mouthwash of 0.12% chlorhexidine (GUM®, John O. Butler / Sunstar, Chicago, IL, USA) twice daily for two weeks was recommended too. The sutures were removed 7 days after surgery. Prosthetic loading will be performed 10 weeks after implant placement.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults, plaque and bleeding index less than 25%, sufficient bone height and width for implant placement, vestibular keratinized gingiva of at least 2 mm and stable occlusion and healthy periodontium.

Exclusion Criteria:

* any edentulous area requiring bone grafting procedures, medical conditions that contraindicate implant surgery such as severe bruxism or poor hygiene, pregnant or lactating patients, bisphosphonate therapy, patients receiving chemotherapy and radiotherapy to the head and neck, patients non-collaborators, incomplete data collection or lack of control assistance.
A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.

The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.

About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.

All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.

Biopsies will be classified using the Updated Sydney system of classification of gastritis

The patients will be randomized (closed envelopes) into one of two groups:

1. patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
2. patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.

H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients who presented with epigastric pain and dyspeptic symptoms

Exclusion Criteria:

1. Patients recently (within 6 months) treated with anti-H. pylori therapy.
2. Allergy to any drugs used in our protocol
3. Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
4. Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
5. Presence of GI malignancy.
6. Pregnancy or lactating women.
7. Unable or refuse to give consent. -
Antiplatelet Therapies in Patients With Depression and Coronary Disease

Depression after an acute coronary syndrome (ACS) but also at any time after CAD diagnosis, is highly associated with death, and it predicts mortality more than any other risk factor, comorbidity or follow-up events, suggesting that the standard medical therapy may not be sufficient to prevent the poor prognosis in these patients.

This study aims to assess whether depression might affect the response to dual antiplatelet therapy (DAPT) as recommended in coronary artery disease (CAD) patients.

Specific aims:

* to evaluate whether depression affects the antithrombotic response during Aspirin (ASA) plus clopidogrel (CLP) therapy in CAD patients.
* to assess the antithrombotic effects of ASA plus ticagrelor or prasugrel (TCG/PSG) therapy in CAD patients with depression by evaluating pro-thrombotic phenotype in CAD patients with and without depression during ASA+TCG/PSG.
* to assess whether there is or not the reactivation of pro-thrombotic profile after cessation of dual antiplatelet therapy in CAD patients with or without depression in single antiplatelet therapy after TCG/PSG cessation.

This study is a multicentre, prospective, observational, case-control, and cross-sectional study. It is planned to enrol 400 patients/subjects (300 patients at Centro Cardiologico Monzino and 100 subjects at IRCCS National Neurological Institute "C. Mondino" Foundation).

Pharmacological treatments in progress will be recorded, administration of Beck Depression Inventory-II (BDI-II), and a fasting blood venous sample (from ante-cubital vein) will be carried out for the haematochemical analyses and for research samples. First morning-urine will be collected for oxidative stress evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Centro Cardiologico Monzino: Patients/subjects of both sexes, aged between 18 and 85 years with or without depression, with CAD:

   * Group 1: CAD patients in ASA+CLP (100mg+75mg/daily) therapy with the absence of acute coronary symptoms for at least 5 months.
   * Group 2: CAD patients in ASA+TCG/PSG (TCG:90mg/b.i.d or PSG:10mg/daily) therapy, at least 6 months after ACS.
   * Group 3: CAD patients during ASA treatment alone at least 1 month after TCG/PSG cessation.
2. IRCCS National Neurological Institute "C. Mondino" Foundation:

   * Group 1: Patients/subjects of both sexes, aged between 18 and 85 years with or without depression, without CAD.

Exclusion Criteria:

* severe chronic heart failure (NYHA class III/IV)
* severe concomitant valvular disease
* infectious pathologies
* autoimmune diseases
* haematological diseases
* serious kidney or liver failure
* positive anamnesis for current or previous neoplasia in the 5 years prior to enrolment
* positive anamnesis for major traumas and/or surgery in the 6 months prior to enrolment
* taking immunosuppressive drugs
* taking of anti-inflammatory drugs
* taking of antidepressant drugs
* presence of dementia and psychiatric disorders other than depression
* Coronavirus disease-19 (COVID-19) swab positive