cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.


Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:

  * Negative myeloperoxidase stain
  * Phenotype T (T-ALL) or B (B-ALL)
  * No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)

PATIENT CHARACTERISTICS:

* Creatinine ≤ 2.5 mg/dL (after adequate hydration)
* SGOT and SGPT ≤ 3 times upper limit of normal
* LVEF ≥ 50%
* No severe psychiatric disorders
* No other concurrent malignant disease
* No presence of documented infections not responding to antibiotic and/or antifungal therapy
* Not pregnant

PRIOR CONCURRENT THERAPY:

* No prior steroids
* No prior antiblastic chemotherapy
* No other concurrent chemotherapy or radiotherapy
Exercise During Pregnancy and Perinatal Outcome

Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Able to communicate in spanish
* Giving birth at Torrejon Universitary Hospital

Exclusion Criteria:

* Medical or obstetric complication excluding exercise ( ACOG guideline)
* Interested in the study after 18 weeks or pregnancy
* Not availability to attend to the physical exercise program
Relevance of Sensitization to Legumes in Children Allergic to Peanut

The objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut

Allergy to legumes is more and more frequent, especially in children allergic to peanut, with some severe reactions but little is known about cross-reactivity and clinical meanings of legumes sensitization in children allergic to peanut.

All children with a confirmed peanut allergy and followed at the University Hospital of Nancy between January 1st 2017 and February 29th 2020 will be included in order to evaluate the prevalence of sensitization and allergy to other legumes in this population.

In children allergic to peanut and to at least one other legume, we will evaluate the severity of the allergy and the sIgE profiles for peanut.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed allergy to peanut

Exclusion Criteria:

* no available information regarding sensitization and tolerance to legumes
Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.

The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.

At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.

The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.

The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.

Eligibility Criteria:
Inclusion Criteria:

* subjects having only plaque induced gingival inflammation

Exclusion Criteria:

* Subjects having gingival inflammation related to underling systemic diseases
* Subjects taking medications
* Gingival inflammation related to other causes
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications

The purpose of this 9-day study is to determine if:

1. Pantoprazole modifies the steady-state plasma concentrations of orally administered psychotropic medications including valproic acid, lithium, and second-generation antipsychotics (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)
2. Serum gastrin levels change within a week of starting or stopping pantoprazole

Individuals with psychiatric diagnoses may be predisposed to gastroesophageal reflux disease because of the widespread use of alcohol, cigarettes, and certain psychotropic drugs in this population. Consequently, they are often prescribed proton pump inhibitors. To our knowledge, no studies have been conducted to determine the effects of proton pump inhibitors on plasma levels of psychotropic drugs. The present clinical study will assess the effects of pantoprazole on the pharmacokinetics of valproic acid, lithium, and second-generation antipsychotics.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be fluent in English
* Participants with a psychiatric diagnosis and currently treated with one or more of the following medications: valproic acid, lithium, or a second-generation antipsychotic (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone)
* Participants on a stable dose of valproic acid, lithium, and/or a second-generation antipsychotic for a sufficient period of time that ensures they are at steady state
* Participants with symptoms of gastroesophageal reflux disease (GERD) that would benefit from treatment with pantoprazole or participants currently treated for GERD with pantoprazole for more than 8 weeks and are currently symptom free.

Exclusion Criteria:

* Participants that are hypersensitive to pantoprazole
* Pregnant or lactating women
* Women of childbearing age not using reliable contraception
* Any postsurgical complications of the gastrointestinal tract that might impair absorption
* Clinically relevant abnormalities of laboratory parameters
* Participants treated with another acid suppressing agent (e.g., H2 receptor antagonists, antacids, alginates, etc)
* Participants treated with atazanavir, delavirdine, erlotinib, nelfinavir, and/or posaconazole
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus

The purpose of this study is:

* To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes.
* To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes

This proof of concept trial has a randomized, parallel, double-blind, placebo-controlled design with a 4-week single-blind placebo and diet run-in period. Given a ratio of 1:1, patient volunteers will be randomized into one of two parallel treatment arms, Nasulin in a combination with insulin glargine or placebo in combination with insulin glargine. The randomization period will be 6 weeks in length. The total length of individual patient volunteer participation, including screening and follow-up will be approximately 13-14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Type 2 diabetes (18 years of age or older)
* Currently treated with basal insulin and OAD(s)
* HbA1c range of 6.5 - 10.
* BMI less than 41

Exclusion Criteria:

* Multiple daily injections of mealtime insulin
* Regular use of nasal sprays
* Significant nasal pathology
* Employed in a job which required irregular shift or night work
A Clinical Trial of Mirror Treatment for Phantom Pain

A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables.

The study will be conducted in two phases: Firstly, the effects of mirror treatment (M) versus tactile treatment (T) will be compared in an open, randomized, semi-cross-over case-control design study. The second phase includes the responders from the initial treatment (M or T), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered.

Phase one: The study patients will be randomized for M or T treatment. The main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. Non-responders (NR) will be allocated for an immediate second three-weeks treatment period of combined treatment (M+T); the responders (R) of the M, T and M+T enter the second phase of the study. The M+T non-responders discontinue the study.

Phase two: The responders will be observed for a period of maximum three months. When symptoms of phantom limb pain and/or CRPS resume, the patients will undergo a second treatment period with the same treatment as during phase one. The duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. The main outcome indicators will be gathered at the start and the end of the second treatment period.

The study closes at the end of the second treatment period. For both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.

Eligibility Criteria:
Inclusion Criteria:

* Present age \>16 years.
* Unilateral trans-tibial land mine amputation more than 12 months before entering the study.
* Suffering from phantom limb pain and/or CRPS-2.

Exclusion Criteria:

* Amputation stump anomalies that require surgical reconstructions such as chronic infections, neuroma or major soft tissue deformities.
* Chronic alcoholism or drug abuse.
* Loss or deformities of limbs other than the actual amputation.
* Mental and/or cognitive disorders making self-reporting unreliable.
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast

Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast

The aim of this study is to evaluate ultrasound (US)-guided treatment of capsular contracture (CC) in patients with reconstructed/ augmented breast.

Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery with an incidence of 0.5-30% and 1-38%, respectively. In irradiated patients the incidence is higher, in the range of 30-67%. It appears most commonly in the first year but in some patients, belated capsular contracture has been noticed. The more severe forms of contraction, Baker grades 3 and 4 with a firm often deformed and painful breast, have been shown to recur as often as 67% after capsulotomy

steroid injection has been demonstrated to be effective for the treatment of this condition.

20-30 female with grade III\\IV CC will be included. Patients will be treated with peri-implant US-guided injection of Dexamethasone

The purpose of our study is to use a longer acting steroid (Dexamethasone) injected intra capsular with US-guide. By that getting a better effect on the level of fibrosis.

This Clinical study will be conducted in the tertiary academic Rabin Medical Center.

Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography

Eligibility Criteria:
Inclusion Criteria:

• female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\\ augmentation

Exclusion Criteria:

* intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
* Patients with skin atrophy of the breast
Retinal Vascular Reactivity in Subjects With Newly Diagnosed Glaucoma Before and After Selective Laser Trabeculoplasty

The purpose of this study is to assess retinal blood flow and vascular reactivity in patients with newly diagnosed primary open angle glaucoma pre- and post-primary Selective Laser Trabeculoplasty(SLT). Canon Laser Blood Flowmeter will be used for the assessment of retinal blood flow.

We previously found that vascular reactivity improved after short term treatment with dorzolamide drops. It is not clear whether this improvement was a direct effect of the medication or secondary effect of the decrease in IOP. We would like to see the change of vascular reactivity before and after SLT, which will decrease the intraocular pressure without pharmacologic effect.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-75 years (Male or Female)
2. Best corrected visual acuity of at least 20/40
3. No previous treatment for glaucoma
4. Ametropia less than ±6.0 DS and ±2.5 DC)
5. Non-smoker
6. No cardiovascular/respiratory disorders

Exclusion Criteria:

1. Past history of diabetes and cerebrovascular accident
2. Vascular occlusive disease affecting the ocular circulation such as: diabetic retinopathy, retinal vein occlusion and retinal artery occlusion
3. Previous intraocular surgery
4. Ocular media opacities limiting the use of the imaging tests
Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)

This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* ≥ 18 years of age
* Untreated non-small-cell lung cancer stage IIIB/IV
* Life expectancy \> 3 months
* Performance status ECOG 0-2

Exclusion Criteria:

* Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
* Any investigational agent(s) within 4 weeks prior to study entry
* Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
* Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care

The goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (T2DM) treated with multiple dose insulin injections (MDI).

The main question\[s\] it aims to answer are:

• Are c-peptide titers and B-cell autoimmunity useful to help the decision of suspending prandial insulin in patients with T2DM treated with MDI?

Participants will:

* Wear a continuous glucose monitor for 10-14 days
* Will be asked for a C-peptide and GAD antibody test (GADA)
* Will stop prandial insulin and switch to other diabetes treatments if needed if c-peptide is \> 0.7 mmol/L and/or C-peptide is \> 0.3 mmol/L and GADA are negative
* Will be followed-up by their GP in routine clinical practice
* Will be assessed after 6 months (CGM, HbA1c, quality of life (QoL)

An algorithm will be applied in which, depending on the presence/absence of pancreatic autoimmunity and the estimation of pancreatic reserve, the same treatment will be maintained and CGM (continuous glucose monitoring) will be initiated or the prandial insulin and the treatment will be adjusted following the main clinical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with multiple dose insulin therapy

Exclusion Criteria:

* Gestation or planning gestation in the following 12 months
* Glucocorticoid use for an acute condition
* Transient insulinisationt (less than 6 months)
* Any condition that prevents the patient or their caregiver from following up for 6 months
* Severe mental illness
* Drug or alcohol abuse
The Effect of Stress Ball Use on Stress, Sleep Quality and Comfort Levels

This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients.

The study population consisted of patients undergoing hemodialysis treatment in the hemodialysis unit of a training and research hospital located in western Türkiye between February 19, 2024, and April 19, 2024 (N=90). The study sample included a total of 60 patients (30 in the experimental group and 30 in the control group), selected through randomization from those who met the research criteria and agreed to participate. During the study, two patients from the experimental group and one patient from the control group were excluded from the study due to health issues that prevented them from using the stress ball. The study was conducted with a total of 57 patients (28 in the experimental group and 29 in the control group).

Eligibility Criteria:
Inclusion Criteria:

* participants had to be volunteers
* aged 18 years and older,
* undergoing hemodialysis treatment for at least six months,
* attending hemodialysis sessions three times a week,
* not having any conditions that would impede the use of a stress ball.

Exclusion Criteria:

* individuals who refused to participate in the study,
* those undergoing hemodialysis for less than six months,
* patients attending hemodialysis sessions twice a week,
* individuals with health problems that prevented them from using a stress ball.
Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes

Background: Remote monitoring (RM) is a new screenings- and or diagnostic tool in healthcare. In 2015, the PREMOM study (Pregnancy Remote Monitoring), in which patients with gestational hypertensive diseases did received a RM prenatal follow up, has started. The first results showed an added value of RM in the prenatal follow-up. Due to these results, a RM program for pregnant women with gestational diabetes mellitus (GDM) will be developed and evaluated.

Protocol: Women (at risk of) GDM will be included in this study. They receive a iHealth Align (a glucose monitor) and associated glycemiestrips. The app of iHealth will be downloaded on the pregnant women's Smartphone to collect the data and to send them to the researcher in the hospital.

The women is asked to perform four glycemie controls/day (sober and two hours after every mail) with the received glucose monitor. The monitor is connected via Wi-Fi and Bluetooth with the computer of the researches who controls and evaluated these data. Additionally, the pregnant women has to check daily her body weight with a weight scale of her own. They have to upload these data manually in the app on her smartphone.

When the pregnant women has an prenatal consultation, an overview with the data will be send to the responsible gynecologist. The gynecologist will also be alarmed when the pregnant women has three abnormal values at the same moment of the day (ex. Every morning after breakfast). When necessary, advice among life-style can be given or a referral to an endocrinologist can be made. The researches will not perform interventions by herself, only the responsible doctor can do this.

By analyzing the patients parameters when she's at home, a better vision can be achieved of the health of the mother and the child. This study will be conducted as a first research to get a better insight in the added value of RM in pregnancies complicated with GDM.


Eligibility Criteria:
Inclusion Criteria:

* women with confirmed GDM or at risk for this disease. Pregnancies \> 10 weeks of gestation, primipara and multipara.

Exclusion Criteria:

* pregnancies \< 10 weeks of gestation, congenital malformations of the fetus
Dietary Interventions for Muscle Mass

Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.


Eligibility Criteria:
Inclusion Criteria:

* Non-obese male subjects (BMI\<30) between the age of 65-85 years.

Exclusion Criteria:

* Type II diabetes or other known diseases, use of medication, female, other ages or BMI than indicated above, participation in any regular exercise program.
Treatment of Muscle Injuries With Physium Therapy.

Muscle injuries are currently particularly frequent among people who participate in sports.

The diagnosis is easily made with an ultrasound study and Shear Wave Elastography.

Patients of the experimental group, after diagnosis by ultrasound and Shear Wave Elastography , will receive five sessions of physium therapy at 80 millibars during one month.

The measurements of the variables visual analog scale, joint mobility through the double inclinometer device, elasticity and tissue vascularization through the ultrasound, quality of life through SF-12 questionnaire and pressure algometry will be made before, after, month and three months after the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown.

Exclusion Criteria:

* Patients who are pregnant, have pacemakers and surgically operated in the area to be treated.
Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome

The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.


Eligibility Criteria:
Inclusion Criteria-fibromyalgia syndrome:

* Being diagnosed with fibromyalgia syndrome
* Being aged 18-65
* Stable use of medication for at least 3 months or longer
* Volunteering to participate in the study

Exclusion Criteria-fibromyalgia syndrome:

* Having comorbidities that may affect physical functions
* Failure to cooperate with tests to be performed
* Presence of exercise test contraindication

Inclusion Criteria-healthy control:

* Being aged 18-65
* Volunteering to participate in the study

Exclusion Criteria-healthy control:

* Having a chronic or systemic disease
* Failure to cooperate with tests to be performed