cyrilzakka/clinical-trials huggingface dataset:
Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life.

The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes.

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.

Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.

The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Muscle cramps( ≥3 cramps per week )

Exclusion Criteria:

* Allergy to baclofen
* Renal impairment
* Pregnant and lactating women
* Peripheral vascular disease
* Peripheral neuropathy
* Medications as calcium channel blockers, conjugated estrogens and naproxen.
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema

Retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone 0.7mg.

This retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) approved by the Institutional Review Board of Hospital Oftalmológico de Sorocaba/SP, and adhered to the tenets of the Declaration of Helsinki. Were included patients older than 18 years, treated between April 2014 and July 2015, diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg (Avastin; Genentech, South San Francisco, CA) and intravitreal implant of dexamethasone 0.7mg (Ozurdex; Allergan, Inc, Irvine, CA).

Eligibility Criteria:
Inclusion Criteria:

* central macular thickness \> 300 µm on optical coherence tomography (OCT)
* macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions

Exclusion Criteria:

* intravitreal anti-VEGF within 6 weeks
* treatment with laser or intravitreal corticosteroids within 3 months of study entry.
Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals

The proposed project is a Randomized Controlled study design. Seniors (age \>65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria:

1. able to stand independently 90 seconds
2. able to walk 10 meters (with cane if necessary)
3. able to understand verbal instructions.

The exclusion criteria will be:

1. Serious visual impairment
2. Inability to ambulate independently (cane acceptable, walker not).
3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
4. Persons with impaired communication capabilities.

The whole project will be conducted over a period of 24 months. The proposed study is a randomized experimental intervention/ control group design. A total of 60 elderly volunteer subjects will be randomly assigned to two groups, exercise group (30) and control group (30). Twelve training periods will be performed with 8 subjects participating in training during each period (4 exercise groups). The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week).

Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques

1. Medical background variables.
2. Berg Balance Scale.
3. Late life Function and Disability Instrument.
4. Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
5. Fall Efficacy Scale
6. Fall incidence and fall severity.
7. 6-minute walk test. The control group will not perform any specific balance training during the 12 week period.

These individuals from control will participate in a separate exercise program after the training period.

The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.


Eligibility Criteria:
Inclusion Criteria:

1. able to stand independently 90 seconds;
2. able to walk 10 meters (with cane if necessary);
3. able to understand verbal instructions.

Exclusion Criteria:

1. Serious visual impairment;
2. Inability to ambulate independently (cane acceptable, walker not).
3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
4. Persons with impaired communication capabilities.
A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease

The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.

This is an open-label, non-comparative, randomized, single center, 24-week study. Patients are stratified into 3 groups (8 patients in each group) based on kidney function:

Group 1: Serum creatine less than 2 mg/dL. Group 2: Serum creatine 2-5 mg/dL. Group 3: Serum creatine greater than 5 mg/dL.

All 24 patients are randomized 1:1 to receive 1 of 2 study regimens:

Arm A: Saquinavir SGC plus d4T plus 3TC. Arm B: Saquinavir SGC plus nelfinavir plus d4T. Patients are seen at Weeks 4, 8, 12, and 24. At Week 24, a kidney biopsy is performed with patient consent.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Detectable HIV-1 RNA by Amplicor assay.
* Biopsy-proven nephropathy.

Exclusion Criteria

Prior Medication:

Excluded:

* Saquinavir and nelfinavir.
* d4T or 3TC within the past 4 months.

Required:

Stable antiretroviral therapy for more than 4 weeks.
Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.

Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.


Eligibility Criteria:
Inclusion Criteria:

* General practitioners (GPs):

  • All GPs settled in the 2 departments of Loire-Atlantique and Vendée with more than 100 patients in the year before baseline, will be eligible.
* Patients:

  * aged over 18 years
  * affiliated to the French health insurance system (CPAM)
  * treated with PPI with more than 300 DDD/year in the year before baseline, estimated with reimbursement databases.
  * whose GP is included in the study

Exclusion Criteria:

* General practitioners (GPs):

  • Participation refusal
* Patients :

  * Participation refusal
  * Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors
Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System

TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality

Once people with TBI and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with TBI, and discover their own services and supports. Inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. Once home, the person with TBI's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. Community health workers (CHWs) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address TBI care partners' needs, particularly those from low income and/or traditionally underserved minority groups. CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be adults (age 18 or older).
* Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
* The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
* If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
* Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.

Exclusion Criteria:

* Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.

The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.

On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.


Eligibility Criteria:
Inclusion Criteria:

* Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
* Menopausal women with age \> 55 years
* Tumor size \<= 15 mm by ultrasonography
* Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis \& Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
* Good lesion boundary with ultrasonography and MRI
* Minimal distance of 5 mm between the skin and the tumor
* Performance Status 0-1
* Ability to understand and willingness to sign a written informed consent document
* Covered by a medical insurance
* Signed informed consent

Exclusion Criteria:

* Invasive lobular carcinoma
* Tumor with retro-nipple location
* Extended microcalcifications (\> 15 mm) with mammography
* Xylocaine allergy
* Patient deprived of freedom
Intrauterine Device Insertion and Felt Pain

The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.

The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.

Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).

In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.

In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study
* Preferring an intrauterine device for the contraceptive method

Exclusion Criteria:

* Patients with uterine leiomyoma
* Patients with endometriosis
* Patients with chronic pelvic pain
* Patients with familial mediterranean fever
* Patients who experienced complications during the procedure
* Patients who developed vasovagal reactions
* Patients who had previously used an IUD for any reason
* Patients with uterine anomalies
Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples

Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory suggests that most tumors undergo a process of differentiation through which a relatively rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result of this cellular diversity, one or more cells within the tumor are likely to be resistant to therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the original intervention. The cellular programs driving the uncontrolled proliferation of many solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs will be effective in the treatment of cancer. The investigators' research program focuses on the elucidation of signaling mechanisms, control of cellular processes and discovery of small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental to CSCs. Our preliminary results identified a novel Notch associated protein NACK that functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human solid tumors and is required for cell survival and tumor growth in notch -dependent tumor cells. The investigators' aim is to further interrogate the link between Notch and Nack.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a primary cancer tumor scheduled for a surgery to remove it.

Exclusion Criteria:

* Patients not diagnosed with a primary cancer scheduled for a standard of care (SOC) surgery.
Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery

"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.

In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS"


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing in Cardiac Surgery like, CABG, univalve, bivalve and trivalve.

Exclusion Criteria:

* Valve and CABG surgery combined with other cardiac surgery like percutaneous valve replacement.
* Cognitive disorder of the heart.
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).


Eligibility Criteria:
Inclusion Criteria:

* Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
* Suspected bacterial infection at time of surgery in at least 1 ear.
* Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
* Legally Authorized Representative (LAR) must read and sign the informed consent.
* Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
* Middle ear pathology in either ear other than otitis media.
* Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
* Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
* Other protocol-specified exclusion criteria may apply.
Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Cross-Sectional Observational Study

Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival. However, living with an ICD may pose several challenges and affect quality of life (QoL). This prospective cross-sectional observational cohort studies will provide detailed insights in patient-reported QoL. The aim is to study the QoL perspective of patients who have an ICD, including physical and emotional health; ICD acceptance; concerns of ICD patients with regard to physical and sexual activity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Patients with any type of ICD followed in UZ Leuven
* Willing and able to provide signed written informed consent

Exclusion Criteria:

* Patients who are hospitalized
* Patients with a mental disability
* Patients already included in another interventional study
MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study

This study evaluates adherence to the oral chaperone therapy migalastat in patients with Fabry disease.

Fabry disease is a rare disease and part of the group of lysosomal storage disorders. Since 2016, chaperone therapy as a new therapeutic approach is available.

This study is a prospective cohort study and observes patients under therapy with migalastat. This study is suggested to help estimating the adherence of the oral therapy.

All patients in treatment with migalastat in the Fabry Center Wuerzburg (FAZiT) and selected patients of other cooperating Fabry Centers are included in this study if informed consent is provided.

Eligibility Criteria:
Inclusion Criteria:

* Fabry disease (genetically confirmed)
* Signed informed consent
* 18 years and older

Exclusion Criteria:

* No informed consent
* Withdrawal of informed consent