cyrilzakka/clinical-trials huggingface dataset:
Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.

Eligibility Criteria:
Inclusion Criteria:

* All patients incoming for inguinal hernia repair

Exclusion Criteria:

* Preoperative abuse of analgesics
Control and Treatment of Outpatient Children with Asthma

The aim of this study is to comprehensively understand the disease control and management status of children with asthma in China, as well as the types of airway inflammation. The findings of this survey will help improve the asthma control level in Chinese children, facilitate future patient education, and guide rational medication use. Moreover, it will provide important evidence for health decision-making departments to better allocate and utilize medical resources.

Bronchial asthma (hereinafter referred to as asthma) is the most common chronic respiratory disease in children. It severely affects the physical and mental health of children and imposes a huge economic burden on families and society, consuming a large amount of medical and health resources. In recent years, the prevalence of asthma in children worldwide has generally continued to rise. Data from the Global Burden of Disease database in 2019 showed that the prevalence of asthma in children aged 0-9 years was 4.21%, in children aged 10-14 years was 4.10%, and in adolescents aged 15-19 years was 3.00%. In China, over the past 20 years, the prevalence of asthma in children has also shown an overall upward trend, increasing from 0.91% in 1990 to 1.54% in 2000, and then to 3.02% in 2010. Thanks to the continuous efforts of several generations of pediatricians, the level of standardized diagnosis and treatment of childhood asthma has significantly improved. However, the control of asthma in children still faces many challenges.

The purpose of this study is to comprehensively understand the disease control and management status of children with asthma in China, as well as the types of airway inflammation. The findings of this survey will help improve the asthma control level in Chinese children, facilitate future patient education, guide rational medication use, and provide important evidence for health decision-making departments to better allocate and utilize medical resources.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 16 years old；Children who have been diagnosed with asthma for more than 3 months;Children who have had asthma symptoms or asthma treatment within the past 12 months.

Exclusion Criteria:

* Children diagnosed with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, and pneumonia; Children who have participated in any interventional clinical studies related to asthma within the 3 months prior to enrollment in this study; Children whose parents, legal representatives, or guardians do not agree to participate in this study.
Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section

To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section


Eligibility Criteria:
Inclusion Criteria:

* Participants on early puerperium period having constipation and willing to participate.
* Primigravida
* Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria:

* Laxatives-induced patients
* History of chronic constipation
* Post cesarean abdominal suture infection.
* People with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision.
* Participants with inability to tolerate the binder.
* Participants who show unwillingness to participate in the study
Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study

The objective of this study is to determine whether bilateral sacral nerve stimulation with First stage tined lead placement test is more effective than unilateral stimulation, among patients with non obstructive urinary retention.


Eligibility Criteria:
Inclusion Criteria:

* Patients who signed the informed consent
* Patients (male and female), aged between 18-70 years, with non obstructive urinary retention.

Two specific subcategories of retention are included

1. Incomplete voiding or incomplete retention (\>100 cc residual) such as hesitancy or intermittency, that are due to an acontractile detrusor or due to urethral sphincter overactivity. The overactivity of the sphincter may occur in absence of detrusor contraction and may be the cause of the lack of detrusor activity.
2. Complete retention. These individuals are completely unable to void.

All patients must have the potential for storing an adequate volume of urine:

i.e., at least 100 ml

Exclusion Criteria:

* Known psychiatric disorders
* Current or plans of pregnancy
* Known neurologic diseases or impairment; including DM (severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement), spinal cord injury, MS
* Reiter's syndrome
* Concomitant medical conditions that would limit the success of the procedure such as: active degenerative disc disease, spinal cord injury\< 6 months old, bleeding complications, CVA\< 6 months old etc.
* Extra urethral incontinence
* Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/ diagnosis.
* Anatomic obstructive voiding disorders
* Current urinary tract infection
* Malignancy of urinary tract
* Severe grade III/ IV pelvic prolapse, cystocele, urethrocele, enterocele
* Proven interstitial cystitis or clinical symptoms of interstitial cystitis
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.
* Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
* Adequate organ function (bone marrow, hepatic, renal, cardiac).

Exclusion Criteria:

* Prior anthracyclines as part of prior anticancer therapy.
* Concurrent antitumor therapy.
* Second primary malignancy.
* Serious concomitant systemic disorder.
* Pre-existing sensorial or motor neuropathy

  * Grade 1.
Predict Adverse Events by Covid-19 Nephritis

This non-interventional, observational study retrospectively (and in parts prospectively) investigates, if a Covid-19 associated Nephritis, diagnosed by Urine-dipstick and further Urine-analyses on addmission, can help to predict later complications, adverse outcomes and later need for ICU-capacity in Covid-19 patients as well as can guide preventive strategies.

Parameters predicting risks for Covid-19 patients are urgently sought. The current study investigates, if Covid-19 associated nephritis indicating systemic cappillary leak syndrome/severe nephrotic syndrome could be the major driver for complications, predictor for respiratory failure and later need for ICU, and death.

This study intends to generate an algorithm for University hospitals, which allows early detection of Covid-19 associated nephritis and to classify the risk for respiratory decompensation by quantification of severity of nephrotic syndrome.

The rationale of the observational study can be explained by the hypothesis that Covid-19 causes Nephritis: Podocytes express high levels of ACE2, which makes the glomerulus to a target for Covid-19. Other zoonoses, such as Hanta-virus, are a well described cause of nephrotic syndrome inducing cardiopulmonary syndrome. Life-threatening complications of severe nephrotic syndrome are well known as are preventive therapies.

Covid-19 ICU patients with nephritis have

1. pulmonary interstitial edema, possibly also due to capillary leak/ nephrotic syndrome;
2. immune-incompetence, due to renal loss of immunoglobulins;
3. circulatory insufficiency, due to hypalbuminemia (which might explain sudden deaths in the geriatric population);
4. less response to some medications caused by impaired plasma protein binding of drugs due to hypalbuminemia and renal loss;
5. thromboembolic events, due to antithrombin-deficiency (which might explain lethality in oligo-symptomatic young patients).

In conclusion, ACE2 in the respiratory tract is the gateway for Covid-19 for infection, however, the study postulates that Covid-19 associated nephritis and severe cappillary leak/nephrotic syndrome is a major driver of adverse outcome. If confirmed by others, these findings and algorithm would allow early prediction of later need for ICU-capacity, better allocation of patients for clinical trials, and preventive strategies focused on the nephrotic syndrome including treatment, which can save lives. Same might apply for risk-evaluation of outpatients.

Eligibility Criteria:
Inclusion Criteria:

1. approved Covid-19 diagnosis (by PCR or CT-scan);
2. urine status during hospital stay
3. Patient expressed willingness to participate in observational studies during hospital admission.

Exclusion Criteria:

1) Patient expressed unwillingness to participate in observational studies during hospital admission.
Arimidex in McCune Albright Syndrome

The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
* females less than or equal to 10 years of age
* diagnosed with McCune-Albright Syndrome
* have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

* any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
* concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
* liver function tests at screening visit (AST, ALT) \> or = 3x the upper limit of the reference range for age
* known hypersensitivity to any component of study medication
Parathyroid Allo-transplantation With a New Technique

Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.

Hypoparathyroidism is a clinical problem which is associated with hypocalcemia, hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a complication of thyroid surgery . Direct injury, ischemia or unintended excision of parathyroid tissue are the most common mechanisms that cause temporary or permanent hypoparathyroidism. Temporary hypoparathyroidism (\<6 months) develops at 10% of cases after thyroid surgery and nearly half of them develops permanent hypoparathyroidism (\>6 months) (3-5). Due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy and neck dissection is performed more frequently than before that yields increase in frequency of permanent hypoparathyroidism.

As a current standard treatment, oral or intravenous calcium preparations and active vitamin-D3 are used in the treatment of hypocalcemia which was developed due to permanent hypoparathyroidism (PH). However, this approach is a symptomatic treatment, must continue a lifetime, the cost is high and is only intended to correct hypocalcemia. Besides, it has no beneficial effect on metabolic problems due to PH.

For these reasons, less costly and effective treatments have been searched over 30 years and parathyroid allo-transplantation (PA-t) was introduced as a treatment alternative. Nonetheless, it did not meet the expectations completely. The main problem in PA-t is the development of immune and inflammatory response against graft tissue which shortens its life and impairs the efficacy of the treatment. Various kinds of treatment methods such as immunosuppression, microencapsulation and cultivation were tried to overcome this problem. Despite these treatment options, convincing results have not yet been achieved . In literature, PA-t cases are often presented as case reports, only a few clinical series are available .

In this study, we aimed to present the results of our new PA-t technique that is performed on 10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no benefit from standard medical therapy

Eligibility Criteria:
Inclusion Criteria:

* patients who have permanent hypocalcemia
* Patients who accept to participate to study

Exclusion Criteria:

-Patients who don't accept to participate to study
The Effects of Two Education Strategies About Insulin on Patient Preferences and Perceptions About Insulin Therapy

This study compared the impact of two educational strategies (an education program versus a pamphlet) on participants preferences for insulin and their perceptions about insulin and injections after attending an educational session with a diabetes educator about insulin.

Main research question: Among adults with type 2 diabetes who are potential candidates for insulin therapy, does an education strategy that involves a personal letter from the family physician, a presentation about insulin, and information about giving an injection, versus a pamphlet education strategy, effect: preference to accept insulin therapy; perceptions about insulin therapy; or perception about the injection?

Many people with type 2 diabetes who need insulin therapy are often reluctant to start using insulin to manage their diabetes. This may be because they are worried about giving an injection and do not know enough about insulin to make an informed choice. This research is important because it will help researchers and health care providers better understand the feelings and educational support that patients need when they are thinking about starting insulin. This can help health care providers to better tailor the care they give to patients.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Have a diagnosis of type 2 diabetes mellitus in their medical chart
* Have suboptimal glycosylated hemoglobin (HgA1c \> 7.5%) recorded in their chart as the most recent lab result
* Currently perform self-monitoring of blood glucose
* Able to understand written and spoken English

Exclusion Criteria:

* Are currently using, or have previously used insulin
* Have cognitive, visual, hearing or other medical impairment
* Have terminal malignancies or dementia
* Have psychiatric illness not controlled with medications
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.

This was an open-label, multi-center, single arm study with flexible dosing allowing both dose adjustment and one drug holiday per patient.

The study design consisted of 3 parts:

* Screening Epoch (0 - 2 weeks): required for all patients to assess initial eligibility. Eligible patients came from study CAMG334ADE01 (NCT03828539).
* Open-label Treatment Epoch (128 weeks): Individual patients were treated for 128 weeks. In this open-label treatment phase, the erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit. Additionally, a voluntary single treatment interruption ('drug holiday') of up to 24 weeks (approximately six months) could be introduced after at least 12 weeks of treatment in the open-label Treatment Epoch.
* Follow-up Epoch (4 weeks): A Follow-Up Visit 4 weeks after the last regular study visit (8 weeks after last investigational medicinal product \[IMP\] application) was required as part of routine safety monitoring.

Eligibility Criteria:
The study population consisted of patients with a documented history of episodic (4 - 14 baseline migraine days) or chronic migraine (≥15 baseline headache days), who had been successfully randomized to clinical trial CAMG334ADE01.

Key inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study
* Patient is capable of understanding the nature, significance and implications of the clinical trial.
* Adults ≥18 years of age upon entry into screening

Key exclusion Criteria:

* Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01
* Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.
Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects

Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state


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
* Chronic or relevant acute infections
* History of hypersensitivity to Asasantin ER and any of the excipients
* 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 (\< 1 month prior to administration or during the trial)
* Known alcohol abuse
* Known drug abuse
* Blood donation (\< 1 month prior to administration)
* Excessive physical activities (\< 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforating or bleeding
* History of bronchial asthma
* Any laboratory value outside the normal range of clinical relevance

Female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket.

ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.

The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, adult or child
* Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature)
* Signed informed consent
* In France only :Patient affiliated to a Health Insurance Scheme ("sécurité sociale")

Exclusion Criteria:

* Spreading infection in the alveolar socket
* Placement of Alveogyl done immediately after tooth extraction
* Multiple post-extraction dry sockets
* Patient treated with cervico-facial radiotherapy
* Immunodeficiency related to any diseases or current treatments
* Psychiatric patient or patient unable to assess his/her pain via the study Pain VAS
* Patient with history of hypersensitivity to one of the components
* Patient on post extraction of deciduous teeth
* Participation in another clinical investigation
Multiple CoolSculpting Treatment Study

To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.

The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,

Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \> 18 years of age.
* Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:

  1. Lower Abdomen - One 60 minute cycle with CoolMax,
  2. Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously.
* Subject has not had weight change exceeding 10 pounds in the preceding month.
* Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
* Subject agrees to not making any major changes in their diet or lifestyle during the course of the study.
* Subject has read and signed a written informed consent form.

Exclusion Criteria

* Subject has had an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
* Subject has a history of hernia in the area(s) to be treated.
* Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
* Subject is lactating or has been lactating during the past 3 months.
* Subject is unable or unwilling to comply with the study requirements, such as blood draw.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* Subject has a history of lipodosis or other confounding metabolic diseases.
* Subject is taking or has taken medication within the past 3 months which may affect the metabolic function.
* Patient has a history of diabetes.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.