cyrilzakka/clinical-trials huggingface dataset:
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181036 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
* Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
* Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
* Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
* Male or Female, 18 years or older
* Resolution of all acute toxicities of prior therapies
* Adequate organ function

Exclusion Criteria:

* Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
* Symptomatic central nervous system metastases
* Serious acute or chronic illness
* Current treatment on another clinical trial
* Pregnant or breastfeeding.
Study of Inflammatory Mechanisms in Epidermolysis Bullosa Simplex- Dowling Meara

Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis characterized by spontaneous or post traumatic large cutaneous blisters. No curative treatment is actually available. Some data suggest a role of inflammation in the occurrence of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in DM-EBS.

Material and methods: A first retrospective immunohistochemical study will be led on remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical multicentric prospective study will be led on 8 patients older than 1 year with severe DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In case of flare of the disease, the liquid and the top of the blisters will be took. Samples will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic analysis in association with a quantitative PCR will be made on the top of the blisters. If unknown, genotypic study will be made.

Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer new therapeutic ways.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* older than 1 year-old
* severe Dowling Meara epidermolysis bullosa (more than 2 blisters per day)
* systematic written informed consent
* child consent
* affiliated to french social security

Exclusion Criteria:

* younger than one year-old
* no consent
* non affiliated to french social security
* participation to another clinical trial within 3 months ago
* intercurrent disease justifying the withdrawal of the study
* own patient decision to stop the study, withdrawal of informed consent
Instant Message-guided Hypertension Management Intervention Among Stroke Survivors

This pilot and feasibility study aims to develop an automated instant message-delivered intervention (i.e., EMI) for hypertension management in stroke survivors, and to investigate the feasibility and effectiveness of the intervention.

Intervention group:

Participants in intervention group will receive the EMI for 4 weeks. Based on the steps of mobile message development recommended by Abroms, et al., we will develop a message content library and protocol for EMI delivery.

1. Message contents: The message content library will consist of two parts: 1. brief stroke and hypertension education messages (mandatory), and 2. lifestyle modification messages (optional).
2. Message delivery

   * Regular messages: The messages in the two parts will be sent regularly to each participant. As personalisation is a core process subject to behavioural changes, the content, frequency, and timing of the messages will be determined based on participants' preferences. To save labour and increase efficiency, we will develop a message 'scheduler' program. We will pre-set the message scheduler, which will then automatically send out content to participants according to their preferences. The development of the program is highly useful particularly in cases which participants prefer to receive messages during non-office hours.
   * Nurse-led real-time support messages (chat-type): Chat-based nurse support will be given to the participants as an extension of the regular messages. However, the participants will be informed beforehand that the nurse will only play a supportive role and will not provide formal care. The number of the chat messages will not be limited, but the nurse-led real-time support messages will only be provided during working hours (i.e., 9am-6pm) on weekdays to limit the nurse RA's workload.

Control Group:

The control group will receive one instant message about general stroke management including hypertension management from the Hospital Authority of HK SAR Government website (https://www21.ha.org.hk/smartpatient/SPW/en-US/Disease-Information/Disease/?guid=29ac1219-3d68-4378-a2bd-09e111da3650), which is open to the public.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke (ICD-10 codes: I60-I69)
* Diagnosis of hypertension and antihypertension medication
* Aged ≥18
* Able to read and communicate in Chinese (Cantonese or Putonghua)
* Able to use text messaging function on mobile phones
* MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)

Exclusion Criteria:

* Currently receiving active stroke care in acute or post-acute inpatient settings
* Has diagnosis of psychiatric disease or is currently taking psychotropic drug
Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.

PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated immunodeficiency.With the increasing number of solid organ transplantation, how to effectively treat severe PCP after solid organ transplantation has become an urgent problem to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as second-line alternatives when TMP-SMX fails to treat HIV-PCP. Therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ transplantation.

PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated immunodeficiency.With the increasing number of solid organ transplantation, how to effectively treat severe PCP after solid organ transplantation has become an urgent problem to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as second-line alternatives when TMP-SMX fails to treat HIV-PCP. More and more studies suggest that clindamycin-based alternatives play an increasingly important role in treating of PCP. Therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ transplantation.

Eligibility Criteria:
Inclusion Criteria:

* PJP after solid organ transplantation.

Exclusion Criteria:

* renal failure,heart failure,tumor recurrence
Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)

Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective in preventing GVHD and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for BMT/PBSCT from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in UBMT/UPBSCT.

GVHD prophylaxis recommendation tacrolimus (0.03 mg/kg/day i.v. by continuous infusion from day -2 and taper with an oral form until 1 year after BMT/PBSCT) methotrexate (15 mg/m2 i.v. on days 1 and 10 mg/m2 i.v. on days 3, 6, 11)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria
* and either marrow criterion.
* Peripheral blood

  1. Neutrophils \< 0.5 x 109/l
  2. Platelets \< 20 x 109/l
  3. Corrected reticulocytes \< 1%
* Bone marrow

  1. Severe hypocellularity (\< 25%)
  2. Moderate hypocellularity (25-30%) with hematopoietic cells representing \< 30% of residual cells
* No prior hematopoietic stem cell transplantation.
* Age: no limits.
* Performance status: ECOG 0-2.
* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

  1. Heart: a shortening fraction \> 30%, ejection fraction \> 45%.
  2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
  3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
* Patients must lack any active viral infections or active fungal infection.
* Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
* Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

* Pregnant or nursing women.
* Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
* Psychiatric disorder that would preclude compliance.
* Congenital aplastic anemia including Fanconi anemia.
* Manipulated bone marrow.
Complex Regional Pain Syndrome (CRPS) and the Gut-bacteria

The purpose of this study is to investigate, for the first time, whether gut bacteria composition and function of patients with CRPS differ from those of healthy adults. Samples of stool, urine and blood will be collected from patients with CRPS and from healthy adults. The type and function of bacteria of CRPS patients will be analyzed and compared to those of healthy adults to test if potential differences could explain the mechanism/s involved with the development of CRPS.


Eligibility Criteria:
Inclusion criteria:

1. Women and men over the age of 18, diagnosed with CRPS of the upper or lower limb according to the Clinical Budapest Criteria, with a duration of 6 months and over (for the 1st study group).
2. Healthy women and men over the age of 18, who share a household with a CRPS patients participating in the study (for the 1st control group).
3. Healthy women and men over the age of 18 (for the 2nd control group).
4. Be able to read and write in either French, English or Hebrew.

Exclusion criteria:

1. Any major illness (eg. malignancy, active inflammatory disease, metabolic disease, etc.)
2. Pregnancy
3. Chronic pain conditions (other than CRPS in the patients group)
4. Acute illness of any type in the preceding 1 month
5. Use of systemic antibiotics in the preceding 1 month
6. Change in any other regularly taken medications in the past 1 month
7. Substantial dietary / gastrointestinal alterations in the past 1 month.

The inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition.
Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017.

A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period.

As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.

The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use.

This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older;
* 2-month refractory pain to conservative treatment, non-surgical patients;
* Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;
* Symptomatic for at least 8 weeks despite appropriate medical treatment;
* Patient who agrees to participate in the study and who signed the informed consent form;
* Patient with social protection.

Exclusion Criteria:

* Previous surgical treatment of the studied disc(s);
* Patient with pure radicular pain;
* Sick leave of more than 12 months secondary to the symptoms;
* Patients who cannot read or write French;
* History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;
* Local or general infection, or suspicion of infection;
* Severe coagulation disorders;
* Other rheumatic inflammatory disease;
* Undercurrent serious pathology with life expectancy \< 2 years;
* Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
* Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection
* Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.
Ear Plugs Versus Acupressure for Management of Severe Gag Reflex

The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques: the ear plug technique and acupressure on the P6 point in reducing gag reflex during impression making and to assess patient's experience in terms of comfort and satisfaction.

The study will take place at the clinics of Riyadh Colleges of Dentistry and Pharmacy (RCsDP) in Riyadh, Saudi Arabia.

Patients, who on previous occasions have demonstrated difficulties in accepting the procedure of making impressions of maxillary teeth due to a severe gag reflex (GR) will be invited to participate in the study.

A Randomized single blinded clinical trial will be conducted on 30 participants who fulfill the inclusion criteria. Participants will be assigned to three separate groups. For each patient, two maxillary alginate impressions will be made; one before applying the proposed management technique and one after. Participants of Group EP (n=10) will be managed using earplugs while Group AC (n=10) will be managed using acupressure band and Group PL (n=10) will receive placebo management in forms of regular bands.

Informed consent will be obtained from all participants. All impressions will be made by one dentist that will be blinded to the gag reflex (GR) management techniques. The GR evaluation for all the participants will be performed by another calibrated dentist who is also blinded to the applied technique.

The severity of gag reflex will be assessed during making of the first impression using Dickinson \& Fiske (2005) gagging severity index (GSI).

After 20 minutes of making the first impression, participants of Group EP will be asked to place the earplugs in and wait in the waiting room for 10 minutes. Then, the second impression will be made while the participant still has the earplugs on. Group AC will have acupressure technique via sea aid bands which will be placed on the P6 points of both hand wrists. Participants will be asked to wait in the waiting room for 10 minutes then the second impression will be made. PL Group will have the placebo management via placebo bands ( with no pressure points ) which will be placed on both hand wrists. Participants will also be asked to wait in the waiting room for 10 minutes then the second impression will be made. The effectiveness of the treatment will be assessed using Dickinson \& Fiske (2005) gagging prevention index (GPI).

Participants will be asked to rate their discomfort during impression making using visual analogue scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* The individual is able to give informed consent.
* Patients with GR severity that are assigned to a gagging severity index (GSI) III-IV (for standardization of the baseline severity in between Groups).

Exclusion Criteria:

* Pregnant women
* Patients with Chronic heart diseases or cardiac pacemakers
* Patients with central or peripheral nervous system disorders
* Patients with oral lesions
* Patients with gastrointestinal disorders.
Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis

Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its closure. Children with AD who receive pharmacological treatment present more frequently than other premature children, necrotizing enterocolitis or isolated intestinal perforation.

At the present time, the conventional treatment of DA consists in the administration of intravenous ibuprofen, slow bolus in 3 daily doses 10-5-5 mg / kg / day. Recently, it has been observed that treatment with ibuprofen in continuous iv infusion for 3 days seems to be more effective in closing DA than conventional treatment for 3 days with the same dose but in slow iv bolus. This experimental treatment reduced the incidence of associated necrotizing enterocolitis. Our group demonstrated in a previous pilot trial that the guided treatment with echocardiography (EchoG) of DA with ibuprofen compared with conventional treatment, allows to reduce the number of doses to the patient. The EchoG treatment thus presents a potential reduction of side effects associated with medication, this resulted in a tendency to have a lower incidence of necrotising enterocolitis in the experimental group. This multicenter clinical trial aims to test the hypothesis that the combination of 2 experimental treatments, the use of ibuprofen in continuous perfusion and EchoG, reduces the incidence of digestive side effects (necrotising enterocolitis or isolated intestinal perforation) compared to the treatment also guided by echocardiography but slow bolus iv.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with less 33 weeks of gestational age
* DA ≥ 1.5 mm with decision to start pharmacological treatment
* Informed consent signed by the legal representative

Exclusion Criteria:

* Consent denied
* Presence of serious congenital alterations
* Congenital heart disease
* Contraindication for the administration of IB: oligoanuria (diuresis \<1cc / kg / h), bleeding severe recent intraventricular (HIV grade III or extensive periventricular hemorrhagic infarction), serum creatinine\> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
Molecular Testing to Direct Extent of Initial Thyroid Surgery

The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.

The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid nodule is \>1.5 cm
* Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer

Exclusion Criteria:

* Prior thyroid/parathyroid surgery
* Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when \<18 years old
* Recurrent laryngeal nerve dysfunction
* Diagnosis of concurrent primary hyperparathyroidism
Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related

The present investigation aims to assess the diaphragmatic thickening fraction, reflecting the diaphragmatic activity, during supine (baseline) and at 1 hour following prone position in patients assisted through non invasive ventilation due to hypoxemic acute respiratory failure related to COVID-19. Also, the impact of lung aeration and comfort were ascertained in the same setting

Primary aim is to asses the effects of body position on diaphragmatic thickening fraction (primary aim) and lung aeration and vital sign (secondary aims) in patents assisted via noninvasive ventilation (NIV) for hypoxemic acute respiratory failure (hARF) associated to COVID-19. All adult patients, admitted for hARF due to COVID-19 and requiring NIV were enrolled.

Diaphragmatic thickening fraction, lung aeration assessed through ultrasound, comfort, and grade of sedation-agitation as well as vital signs, i.e., peripheral oxygen saturation, blood pressure, and breathing pattern were monitored during noninvasive ventilation in supine and after 1 hour following the switch to prone position.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infection,
* Age \> 18 years,
* NIV application,
* ICU admission

Exclusion Criteria:

* Pregnancy,
* All the conditions contraindicating prone position and NIV
Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer

The purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation.

1. determine changes in patient pain level
2. determine changes in patient functionality
3. determine changes in patient life quality


Eligibility Criteria:
Inclusion Criteria:

* Female or male that is not younger than 60 years old.
* Patient suffers from hip fracture that will need hip arthroplasty.
* Patient that weight less than 150Kg
* Patient femur head diameter between 40mm - 50mm
* Mentally normal
* Patient that could walk before suffering from hip fracture
* Patient that willing to cooperate with the doctor
* Patient that signed on the acceptance form

Exclusion Criteria:

* Patient that does not willing to cooperate with the doctor
* Patient that is legally rejected
* Patient that suffer from cancer
* Patient that had passed amputation in is limbs
* Patient that is paralysis
* Patient that passed CVA or TIA
* Patient that still recovering from hard wounds or surgery
* Patient that suffer from infection in the hip joint