cyrilzakka/clinical-trials huggingface dataset:
Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation

This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.

The current study is prospective observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .

It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

- Age 18 to 60 years;

Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;

1. Radicular leg pain with or without back pain;
2. Symptoms persisting for at least four weeks prior to surgery;
3. Given written Informed Consent;
4. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
5. Visual Analogue Scale score at least 40/100 at baseline.

Exclusion Criteria:

1. More than one symptomatic level requiring multilevel surgical decompression
2. Stenosis any etiology at the same level;
3. Spondylolisthesis any etiology at the same level;
4. Prior lumbar spinal surgery at any level;
5. Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
6. Concurrent participation in another clinical study that may confound study results.
Bone Marrow Derived Stem Cell Transplantation in T2DM

The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.

We hypothesize that Autologous bone marrow derived stem cells which would be expanded into culture and their subsequent transplant into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(\>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that stem cell in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a micro-environment which supports beta cell/resident stem cell activation and survival.

Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes mellitus between 30 and 70 years of age.

* Failure to triple oral hypoglycemic agent and on stable doses of insulin for at least 3 months.
* On vildagliptin,pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
* HbA1c \< 7.5%.
* Insulin requirement ≥0.4 IU/kg/d.
* GAD antibody negative status.

Exclusion Criteria:

* Patients with type 1 diabetes mellitus or secondary diabetes.
* Patients with serum creatinine \> 1.5 mg/dl.
* Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
* History of cholecystitis/ cholelithiasis/ cholecystectomy
* Seropositivity for HIV, HBsAg and hepatitis C virus (HCV).
* History of myocardial infarction or unstable angina in the previous 3 months.
* History of malignancy
* Patients with active infections.
Low or High Botox Dilution for the Hemiplegic Gait?

There is debate regarding the efficiency of different dilutions of Botulin toxin type A (BTX-A) injections. Some authors believe that highly diluted BTX-A injections achieve greater neuromuscular blockade resulting in higher spasticity reduction. On the other hand, other researchers suggest that there is no difference in spasticity decrease if either high or low volume toxin is being injected. Studies on this subject lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol. In an attempt to have a better understanding, a cross over study was designed. The material will be patients with spastic hemiparesis which will be treated with Botulin toxin at different dilutions. Gait analysis will be used for the evaluation of the Botulin toxin injection on gait improvement. To the best of our knowledge such a trial hasn't been performed yet.

There is an ongoing controversy regarding the effect of different dilutions in the efficacy of Botulin toxin type A (BTX-A) injections. Some authors believe that highly diluted BTX-A injections achieve greater neuromuscular blockade resulting in higher spasticity reduction. They are arguing that BTX-A in high dilution is the optimal choice especially when bigger muscles are injected, for the large volume of fluid administered into the muscle will carry the BTX-A molecules to endplates remote from the injection site. Two animal studies suggest that increasing the volume of diluents is a potential strategy in order to achieve a more efficient and cost-effective manner of BTX-A treatment. An attempt to quantify how the location of BTX-A injection affects the drug effect was made, which revealed that injecting only 0.5 cm away from the motor endplates yielded a 50% decrease in paralysis2. A newer double-blinded study by JM Gracies et al performed on humans comes to the same conclusion, that high volume dilution provides greater neuromuscular block and spasticity reduction than a low volume dilution. On the other hand, other researchers suggest that there is no difference in spasticity decrease if either high or low volume toxin is being injected.

Previous studies lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol.

Eligibility Criteria:
Inclusion Criteria:

* equinovarus deformity
* with an average 3 on Ashworth spasticity scale
* able to walk indoors either freely or with a cane.

Exclusion Criteria:

* patients suffering from any mental illness that would disturb the gait pattern
* patients suffering from musculoskeletal diseases that overtly interfere with the gait
The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence

In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom distress and complications, which have an impact on a woman's quality of life and contribute to high health care costs. For the majority of the patients, symptom and distress can be reduced if adequate treatment is provided. This study aims to test possible differences between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in women with vulvar neoplasia after surgical treatment.

In a sequential explanatory mixed-methods project, a randomized phase II study will be followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically will participate in the randomized trial in four Swiss hospitals and one Austrian hospital. After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to standardized care and the WOMAN-PRO II program. The standardized care group will receive a set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II program group will obtain counseling sessions by specially trained gynecology-oncology nurse specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge, week twelve and week 24 after surgery. The primary outcome of this study is symptom prevalence. Secondary outcomes will be collected for explorative reasons and include symptom distress, uncertainty, quality of life, social support, resilience, quality of care, sociodemographic and medical characteristics, post-surgical complications, functional status, cost evaluation and process outcomes. Quantitative data will be collected at the counseling points of time and analyzed by using mixed linear regression analysis. Twenty interviews will be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be conducted with twelve gynecology-oncology nurse specialists in order to better understand to which degree the interventions meet individual needs as well as to identify remaining barriers and enablers for the implementation of symptom self-management. Qualitative data will be analyzed by using thematic analysis and a critical hermeneutic reflection.

This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence, patient-reported outcomes and clinical parameters, and inform the design of a possible phase III study on the clinical efficacy of the program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vulvar intraepithelial neoplasia (VIN) or vulvar cancer (primary diagnosis or recurrent neoplasia)
* Surgical treatment of VIN or vulvar cancer in one of the designated hospitals
* Age \> 18

Exclusion Criteria:

* Patients being judged by a physician or by a gynecology-oncology nurse specialist as not being capable to participate in the trial and to complete the questionnaire due to cognitive, linguistic, emotionally or physically reasons.
* Patients in concurrently psychiatric treatment
* Terminal illness
Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects

To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 55 years
* Broca ≥ -20 % and ≤ +20 %

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infection
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half life (\> 24 hours) ≤ 1 month prior to administration or during the trial
* Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (30 days prior to administration or during the trial)
* Smoker
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≤ 1 month prior to administration or during the trial)
* Excessive physical activities (≤ 5 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* Hypersensitivity to telmisartan and/or simvastatin and/or related classes of drugs

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
SAEM: A Serious Game for Emotional Regulation Problems in Adolescents

This study aims to assess the effects of an intervention to improve emotional regulation skills in adolescents with affective (anxiety and/or depression) and behavioral problems.

Emotional regulation skills and strategies are a protective factor against various problems and psychopathologies. The development and maintenance of affective symptoms are usually very harmful to the adolescent and for his/her family and social environment and can lead to other more serious psychological problems (depression, anxiety, adaptive disorders, etc.) or problems of socio-educational maladjustment.

This study aims to improve the emotional regulation of adolescents who present affective symptoms related to anxiety, depression, or behavioral problems, such as difficulties in their interpersonal relationships, impulsivity, anxiety, anger attacks, low tolerance to frustration, apathy, or sadness. The intervention program, applied through a video game, is an intervention protocol for emotional well-being that has been tested and validated in an adolescent population with emotional and behavioral problems.

Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 16 years old
* Show affective symptoms associated with depression and anxiety or behavior problems
* Show willingness to participate in the research study
* Understand written and spoken Spanish
* Show stability in treatment dosage, if taking medication.

Exclusion Criteria:

* Exhibit incapacitating neurological and/or intellectual impairment
* Have a diagnosis of severe mental disorder
* Substance abuse addiction or dependence
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.

Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.

Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.

Eligibility Criteria:
Inclusion Criteria:

* Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
* Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
* Life expectancy of at least 3 months
* Satisfactory performance status (ECOG ≤ 2);

Exclusion Criteria:

* Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
* Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
* Pregnancy
* Viral hepatitis (B or C)
* Active serious infectious process
* HIV positivity;
* Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
* Prior allogeneic transplantation
* Prior autologous transplantation within twelve months of baseline visit
* Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
* Active central nervous system (CNS) disease at baseline
* Participation in a trial with an investigational agent within 30 days prior to entry in the study
* Malignant cells in circulating peripheral blood (\> 25%)
* Other active malignant disease that would severely limit life expectancy
CPR Surface Choice on Chest Compression Quality

The objective of our randomized simulation study on mannequins with a population of Basic Life Support students is to compare the quality of chest compressions, taking depth as the main variable, in two simulated scenarios of out-of-hospital cardiac arrest on a bed: one where Cardiopulmonary Resuscitation is performed on the bed and another where the patient is transferred to the ground for Cardiopulmonary Resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Those individuals who sign the informed consent and do not meet exclusion criteria

Exclusion Criteria: Individuals with any limitation or contraindication for physical exercise:

* Arthritis
* Heart disease
* Advanced lung disease
* Severe physical disability
* Morbid obesity
* Chronic fatigue
* Pregnancy

Withdrawal Criteria:

* Those individuals who, due to limitations in physical exercise, do not reach 2 minutes of compressions
* Students who have not obtained the certificate of successfully completing the course.
Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib

The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. HER2-positive (defined as either (a) IHC3+ or (b) FISH+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. These are either new, current or completed cases from any of the following settings:

   * treated according to physician's clinical judgement in routine practice; or
   * treated in clinical trials with known allocation to lapatinib-based regimen; or
   * treated via lapatinib expanded access or named patient programs. These regimens should contain lapatinib as the only anti-HER2 agent.
2. Exposed to \< 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. These regimens should contain trastuzumab as the only anti-HER2 agent.
3. Patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. If this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-HER2 therapy.
4. Willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. If consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation.

Exclusion Criteria:

1. Patients who have been exposed to other experimental anti-HER2 therapy eg. pertuzumab, trastuzumab-DM, neratinib, ertumaxomab, AV-412, BIBW2992, CUDC-101, anti-HER2 vaccines.
2. Other primary lesions that are not of breast origin.
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis

First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
* Have a negative urine drug screen/alcohol breath test on admission to clinic
* Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 30 days following completion of dosing
* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1
* Normal BMI except liver fibrosis participants (BMI 18 to ≤35 kg/m2)
* Be in general good health
* Clinical laboratory values within normal range
* Lung fibrosis participants-a diagnosis of lung fibrosis,
* Liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration

Exclusion Criteria:

* Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol
* History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
* Blood donation or significant blood loss within 60 days prior to the first study drug administration
* Plasma donation within 7 days prior to the first study drug administration
* Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
* Females who are pregnant or lactating
* Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
* Failure to satisfy the PI of fitness to participate for any other reason
* Active infection or history of recurrent infections
* Active malignancy and history of malignancy in the past 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
* Chronic obstructive pulmonary disease
* Antibiotic treatment within 3 months
* Chronic medical condition
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia

The purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged ≥ 3 months to \< 5 years in Saudi Arabia.


Eligibility Criteria:
Inclusion Criteria:

A child will be eligible for inclusion if he/she meets the following criteria:

* Age: ≥ 3 months and \< 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
* Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
* Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
* Written informed consent obtained from parent or guardian prior to study start.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.

* Hospitalised during the diagnosis of AOM or during treatment,
* Otitis externa, or otitis media with effusion
* Presence of a transtympanic aerator
* Systemic antibiotic treatment received for a disease other than AOM in the 72 hours prior to enrolment,
* Receiving antimicrobial prophylaxis for recurrent AOM,
* Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit, prior to the sampling
* Patients on antibiotics for AOM who are clinically improving.