cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions

The aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vien occlusion that are being studied include central (CVRO), hemi-retinal (HRVO),and branch (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide) a B-vitamin, has lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the Niacin is taking effect.

A spontaneous improvement was noted in some patients who were experiencing deteriorating retinal vein occlusions. A chart review and questioning of the patients revealed that the addition of Niacin by the Internist seemed to be the factor that was bringing about the vision improvement.

The Niacin has vasodilating properties, and it is postulated that as the Niacin dilates the retinal vessels, it will encourage earlier collateral vessel formation that will bypass the venous obstruction, and restore venous outflow. The prednisolone steroid eye drops will hopefully reduce the macular edema in the eye.

This is a retrospective study conducted by chart review of up to 45 patients who have undergone treatment with 1500 mg per day of oral Niacin (Nicotinic acid) with or without topical steroid eye drops, Prednisolone acetate (Pred Forte) for the treatment of retinal vein occlusion central (CRVO), hemi-retinal (HRVO), branch (BRVO). The retrospective chart review of patients seen by Dr. Michael Gaynon will go back to 1998 and will continue through the present time. All patients with vision impairment caused by deteriorating retinal vein occlusion, and who were or will be prescribed the Niacin with or without Pred Forte treatment will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.

Exclusion Criteria:

* Patients with active gout or high levels of uric acid.
The Study of Delay Discounting Among Beneficiaries of the Pé-de-Meia Program

The aim of this observational study is to explore how the "Pé-de-Meia" Program, a policy of the Brazilian Federal Government designed to encourage the retention and completion of studies by students from low-income families, affects both the students' tendency towards delay discounting and their academic performance. The study seeks to answer the following questions:

How does the "Pé-de-Meia" Program affect the students' propensity for delay discounting? Is there a relationship between the level of delay discounting among students, their academic performance, and school attendance? Participants in the study, high school students enrolled in the "Pé-de-Meia" Program, will undergo assessments to measure their level of delay discounting. The academic performance and school attendance of the participants will be monitored and analyzed in relation to their propensity for delay discounting


Eligibility Criteria:
Inclusion Criteria:

High school students, Students from public schools; Students from low-income families. -

Exclusion Criteria:

Students with a formal psychological report; students with a formal psychiatric report.

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Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged ≥6 to \<12 years
2. Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
4. A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Exclusion Criteria:

1. Females of childbearing potential or pregnant
2. Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
3. History of anaphylaxis and/or other severe local reaction(s) to skin testing
4. History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
5. Subjects with an active pulmonary disorder or infection.
6. Subjects with posterior subcapsular cataracts or glaucoma
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.


Eligibility Criteria:
Inclusion Criteria:

* for children with Severe Acute Malnutrition (SAM): MUAC \< 115 mm and/or WLZ \< -3 and/or mild (+) or moderate (++) edema
* for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \< 125 mm and/or -3 ≤ WHZ \< -2
* Caregiver providing informed consent

Exclusion Criteria:

* Medical complications requiring inpatient treatment, as identified by the national protocol
* Not eating/lack of appetite (as informed by appetite test and investigator judgement)
* Re-admission into the program within 2 months of previous default
* for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)
* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
* Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community
A Multi-center Prospective Study on the Oncological and Reproductive Outcomes and Quality of Life in Young Woman After Fertility-sparing Treatment of Endometrial Cancer and Endometrial Intraepithelial Hyperplasia

We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia

A multi-center prospective study on the oncological and reproductive outcomes and quality of life in young woman after fertility-sparing treatment of endometrial cancer and endometrial intraepithelial hyperplasia

Eligibility Criteria:
Inclusion Criteria:

* Fertility sparing treatment of EC and EIN.
* 18-45 Years old
* From start study (Jan 2025 - end study Jan 2028)
* All centras in Sweden

Exclusion Criteria:

* Not English och Swedish speaking
Prevention of Arthritis-Related Work Disability

People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study will look at whether vocational rehabilitation (VR) will improve the ability of employed people with arthritis to keep their jobs. Job retention VR services target key factors that increase the risk of job loss. They aim to modify jobs to reduce barriers caused by functional limitations and disease symptoms, future career planning, and establish a partnership with a VR counselor for ongoing help.

We will conduct the study among patients with rheumatic disorders recruited in eastern Massachusetts. We will give 120 study participants job retention services provided by VR counselors. We will give another 120 participants literature about employment- related resources. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in preventing job loss in people with rheumatic disorders.

Job loss commonly occurs among people with rheumatic disorders. This study will determine whether vocational rehabilitation (VR) provided to employed people with rheumatic disorders will improve their ability to remain employed. VR is applied primarily to people who have already lost their jobs. However, using job retention VR services may prevent, or delay, the onset of employment work loss among people with rheumatic disorders. Job retention VR services target important employment-loss risk factors. They do so by modifying jobs to reduce barriers posed by functional limitations and symptoms, promoting future career planning, and establishing an alliance with a VR counselor for ongoing assistance.

The study is a randomized, controlled trial conducted among patients with rheumatic disorders recruited from the practices of rheumatologists in eastern Massachusetts.

We will randomly assign 120 study participants to receive job-retention services provided by VR counselors and 120 participants (controls) to receive literature about employment-related resources. We will assess intermediate outcome variables (self-efficacy, work limitations, and job accommodation-seeking behaviors) and the endpoint outcome variable, work instability (a measure that includes employment loss), immediately prior to the interventions and at 6-month intervals over a 24-month period after the interventions are carried out. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in forestalling work instability in this population.

Eligibility Criteria:
Inclusion Criteria:

* Must currently be employed full or part time
* Must live in selected communities in eastern Massachusetts

Exclusion Criteria:

* Plans to move from area
* Plans to have joint replacement surgery in next 6 months
* Plans to retire or go on disability within next 2 years
Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block

Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).

This is a comparative, prospective, Unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included.

This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.

Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).

The primary study objective is to determine the HDPA diagnosed by using diaphragmatic thickness index in Ultrasound (US) after Low Volume (10 mL) versus Standard Volume (20 mL) of Levobupivacaine 0,25% for IBPB. Secondary end-points are 1) HDPA diagnosed by using FVC and FEV1 in spirometry, 2) HDPA diagnosed by using diaphragmatic excursion in US, 3) postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total consumption of Patient-controlled analgesia (PCA) pump of Morphine IV and (4) postoperative harms between two trial-arms.

This study is a comparative, prospective, Unicenter, double-blind and two-arm RCT. 48 patients will be included.

This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years.
* ASA I-III.
* Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block.

Exclusion Criteria:

* Age \<18 and \>80 years.
* Pregnancy.
* Exclusión to perform IBPB or spirometry.
* Allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs.
* Background of Pulmonary diseases (chronic obstructive pulmonary disease (COPD) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral Morphine 1 mg 1-month).
* Coagulation disorders (INR\>3, TTPA \> 35 y AP \<50%).
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)

This study has two parts.

Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents.

Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types.

In Part 2, the same participants will continue to receive pexidartinib twice daily.

Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.


Eligibility Criteria:
Inclusion Criteria:

* Is the age of majority in country of residence
* Has a diagnosis of:

  1. tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations and for whom surgery is not an option (prior pexidartinib is permitted for TGCT patients unless ineffective or not tolerated and there has been a washout period of at least 4 weeks)
  2. KIT-mutant tumor, including melanoma or gastrointestinal stromal tumor (GIST), for which there is no standard systemic therapy, or
  3. other solid tumors (all comers) for which there is no standard systemic therapy and there is a rationale for use of pexidartinib at the Investigator's discretion
* If a female of childbearing potential, had a negative serum pregnancy test within 14 days before enrollment, or within 72 hours before enrollment where required
* Is a non-sterile male or female willing to use of one of the protocol-defined highly effective contraception methods:

  1. intra-uterine device (nonhormonal or hormonal)
  2. sexual abstinence (only if this is in line with the patient's current lifestyle)
  3. barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation
* Is a surgically sterile male or female, or is postmenopausal for at least 1 year, at least 50 years of age, with a follicle-stimulating hormone level \> 40 milli-International units per mL (mIU/mL)
* Has adequate hematologic, hepatic, and renal function as defined by the protocol
* Is able and willing to follow all study procedures
* Has provided a signed informed consent

Exclusion Criteria:

* Is pregnant or breastfeeding
* Is unable to swallow oral medication
* Is unable to follow study procedures
* Is taking or has taken any medications or therapies outside of protocol-defined parameters
* Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:

  1. safety and well-being of the participant or offspring
  2. safety of study staff
  3. analysis of results
Surgical Approach for Acute External Thrombosed Hemorrhoidal Disease

Acute external thrombosed hemorrhoidal disease (AETHH) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. Although surgical excision is recommended in the treatment of AETHH in the guidelines of the American Society of Colorectal Surgeons (ASCRS) and the European Society of Coloproctology (ESCP), the level of evidence is low and it is emphasized that additional studies are needed. Therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of AETHH.

Hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. External hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain.

While internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. Acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (AETHD). It appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. The severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. The pain is quite severe in the first 72-96 hours. Afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind.

AETHD can be treated with surgical excision or conservative approaches. Conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. Also, phlebotonic drugs can be added. In the ASCRS and ESCP guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2C). Guidelines highlight the lack of controlled studies of AETHD treatment .

In this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of AETHD.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids
* Patients with the onset of the complaint before 96 hours

Exclusion Criteria:

Patients under the age of 18 and patients over the age of 70

* Mentally retarded patients
* Pregnant patients
* Patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.)

Those with a history of proctology surgery

* Patients with grade 3-4 internal hemorrhoids
* Patients using anticoagulant drugs
* Patients whose complaint has passed 96 hours after onset
A Descriptive Study on Patients With Bipolar Disorder in Rwanda

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda for patients with bipolar disorder.

Knowing about the barriers to treatment, risk and protective factors as well as the current treatment offered for patients with bipolar disorder is essential for the development of therapeutic approaches and improvement in access to care. Up to now, no data on characteristics of patients with bipolar disorder in Rwanda and related risk and protective factors is available. For this purpose, all outpatients with bipolar disorder in Rwanda age \> 18 years, will over a 1-year period be invited to participate in a survey on their experience living with bipolar disorder in Rwanda. Moreover, patients and relatives will be invited for in-depth interviews to explore their perceptions and experiences with the mental health system. Health care providers will meet for focus discussions on to assess the experience, knowledge and practice of caregiving for individuals with bipolar disorder.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
* Age ≥ 18 years

Exclusion Criteria:

* None
Early, Integrated, Specialized Palliative Rehabilitation

The purpose of this study is to identify whether patients with newly diagnosed advanced cancer benefit from a 12-week palliative rehabilitation program integrated with standard oncology treatment.

300 patients with newly diagnosed advanced cancer are planned to be enrolled. They wil be randomized at a 1:1 ratio to standard oncology treatment or standard oncology treatment plus a 12-week individually customized palliative rehabilitation program.

The intervention takes place in a specialized palliative setting and is planned after an individual consultation with the patient and his relatives. It can be adjusted during the 12 weeks according to the patient's symptoms and needs. All or part of the palliative rehabilitation program is organized as weekly group sessions at the hospital. The group sessions consist of lectures and debates followed by physical training. Professionals involved in the group sessions are doctors, nurses, physiotherapists, psychologists, occupational therapists, social workers, dietitians, and a priest.

If needed, the patient and/or his relatives can also be offered individual sessions.

All contacts with the patients or his relatives during the 12 weeks are registered in order to document the intervention retrospectively.

The intervention is evaluated using questionnaires. All participants receive a questionnaire at baseline and after 6 and 12 weeks. The questionnaire consists of EORTC-QLQ-C30 (a validated questionnaire developed to assess the quality of life of cancer patients) and HADS (the validated Hospital Anxiety and Depression Scale). At baseline the questionnaire is extended with the question: "Which of the following problems/ symptoms do you need help with the most?". The patients can choose between 12 defined problems matching 12 of the scales of EORTC-QLQ-C30 or "none of the above". The answer given by the patient is labeled "The Primary Problem".

Eligibility Criteria:
Inclusion Criteria:

Participants must:

* be diagnosed with non-resectable cancer less than 8 weeks before inclusion. For patients with prostate cancer they must be refered to systemic oncology treatment for the first time less than 8 weeks before inclusion.
* be fit to receive standard oncology treatment and accepting treatment
* read and understand Danish
* sign informed consent

Exclusion Criteria:

* contact with a specialized palliative unit within the last year before inclusion
* unability to cooperate in the study
* missing informed consent