cyrilzakka/clinical-trials huggingface dataset:
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome

To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.

Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
* Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).

Patients must have:

* Documented HIV infection.
* Wasting syndrome.
* Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
* No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
* Life expectancy of at least 6 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Chronic diarrhea (five or more unformed stools per day).
* Peripheral neuropathy of grade 2 or worse.
* Requirement for tube feeding or intravenous feeding.
* Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
* Inability to ingest at least a maintenance diet based on present weight.
* Any condition that precludes study participation.
* Not under the care of a primary physician.

Concurrent Medication:

Excluded:

* Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).

Concurrent Treatment:

Excluded:

* Radiotherapy.

Patients with the following prior conditions are excluded:

* Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry.
* Prior intolerance to thalidomide.

Prior Medication:

Excluded:

* ddC within 1 month prior to study entry.
* Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.
* Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry.

Prior Treatment:

Excluded:

* Radiotherapy within 6 weeks prior to study entry.

Required ONLY IF patient is on antiretroviral therapy:

* Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.
Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.

Exclusion Criteria:

* Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.
* Significant risk of suicide based on clinical judgment.
* Use of prohibited treatments
A Phase 2 Study With CC-220 in Skin Sarcoidosis

This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, sequential, dose-ascending, safety and tolerability study in subjects with chronic cutaneous sarcoidosis.

Two dose cohorts of CC-220 (Cohort 1: 0.3 mg by mouth (PO) every day (QD) or matching placebo and Cohort 2: 0.6 mg PO QD or matching placebo) will be evaluated using a sequential, dose-ascending design

Eligibility Criteria:
Inclusion Criteria:

Males or females aged ≥ 18 years at the time of consent.

* Have chronic cutaneous sacrcoidosis (CCS) prior to consent
* Have active cutaneous sarcoidosis lesion(s) at screening
* Forced vital capacity of ≥ 45% of predicted normal value at screening.
* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min.
* Females of childbearing potential must have negative pregnancy tests prior to starting study therapy and agree to either commit to true abstinence or use effective contraception.
* Male subjects must practice true abstinence or agree to use a condom even if he has undergone a successful vasectomy

Exclusion Criteria:

* Positive tuberculosis test at screening.
* History of inadequately treated tuberculosis
* History of Human Immunodeficiency Virus (HIV) and/or Common Variable Immunodeficiency Disease.
* History of alcohol or drug abuse
* History or current peripheral neuropathy
* Current uveitis or any other clinically significant ophthalmological finding
* Currently require therapy for precapillary pulmonary hypertension.
Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients

The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged more than 18 years old.
2. Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)
3. Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:

   * ACEi (angiotensin converting enzyme inhibitor)
   * ARB (angiotensin receptor blocker)
   * ARNI in place of ACEi OR ARB
   * Beta blocker
   * (MRA) Mineralocorticoid receptor antagonists
   * Diuretics as needed.
4. All patients signed the informed consent.

Exclusion Criteria:

1. Patients suffering from conditions like acute CVS illness and severe sepsis that raise inflammatory markers and may lead to cardiac dysfunction as opposed to heart failure.
2. Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.
3. Female patients during pregnancy or lactation
4. Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR \<20 mL/min/1.73 m²).
5. Individuals suffering from verbal communication disorders or psychic cognitive impairment.
Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we predict associations between subjective effects/alterations in emotion processing tests and functional imaging (fMRI) activity.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 50 years.
2. Sufficient understanding of the German language
3. Subjects understand the procedures and the risks associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session. Women and men must agree to use an effective form of birth control (double-barrier method).
9. Body mass index 18-29 kg/m2.

Exclusion Criteria:

1. Chronic or acute medical condition
2. Hypertension (\>140/90 mmHg) or Hypotension (SBP\<85 mmHg)
3. Current or previous major psychiatric disorder
4. Psychotic disorder in first-degree relatives
5. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
6. Pregnant or nursing women.
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medications that may interfere with the effects of the study medications (any psychiatric medications).
9. fMRI related criteria including: metal implants (clips from operations, cochlea, large red/yellow tattoos in the neck area)
10. Tobacco smoking (\>10 cigarettes/day)
11. Consumption of alcoholic drinks (\>10/week)
Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance

Determine the force required to occlude the esophagus with a left paratracheal pressure


Eligibility Criteria:
Inclusion Criteria:

* Physical status score 1 or 2
* No contre indication to Left Paratracheal pressure

Exclusion Criteria:

* Obese patients
* Physical status score 3, 4 or 5
* Contre indication to Left Paratracheal pressure
Removable Partial Dentures Made of PEEK

As part of the clinical study, 25 patients each were provided with removable partial dentures with clasps made of PEEK in two centres (University Hospital Heidelberg, Department of Prosthodontics and University Hospital for Dental Prosthetics Innsbruck). The patients were examined over a period of 3 years for the number and type of technical or biological complications and questioned about their oral health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a clasp-anchored removable partial denture

Exclusion Criteria:

* Minors and adults unable to give consent
* Pregnancy or breastfeeding
* Severe general illnesses
* Allergies or other intolerances to one of the materials used (PEEK, PMMA)
* Suspicion of lack of compliance
Corneal Crosslinking Treatment Study

Three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.

Riboflavin does not penetrate the intact corneal epithelium. Corneal cross linking (CXL) is typically performed using the so-called "Dresden protocol". The Dresden protocol states 30 minutes of UVA-radiation (3mW/cm2) but a 10 minute irradiation protocol (9mW/cm2) is frequently used. Both of the protocols involve mechanical removal of the epithelium over the central 8 mm of the corneal surface. The first days after treatment therefore involves some degree of pain, often intense, and the presence of a healing epithelial defect may be associated with development of infiltrates in the cornea. A number of approaches have been evaluated in order to promote riboflavin penetration through the intact epithelium, of which iontophoresis appears most promising. Keratoconic corneas are thin at the cone location and sometimes it is difficult to maintain the safety margin of 400 microns during corneal crosslinking. Instead of using isotonic standard riboflavin, a swelling effect of the cornea can be obtained by using hypotonic riboflavin. However, the latter has been indicated as less effective in the process of inducing cross links.

Eighty-one of 81 patients of various degrees of keratoconus will be randomised to one of the following groups: 1) CXL (UVA 9mW/cm2) using isotonic riboflavin, or 2) CXL (UVA 9mW/cm2) using hypotonic riboflavin or 3) Iontophoresis with Ricrolin with following CXL (UVA 9mW/cm2).

Hypothesis:

i) CXL with hypotonic riboflavin or CXL with Ricrolin administered by iontophoresis or CXL with isotonic riboflavin is non-inferior compared to standard CXL with isotonic riboflavin.

ii) The morphological structure post-CXL in the three different groups will be similar without any significant differences.

The iontophoresis-assisted treatment arm has been interrupted due to low efficacy in halting disease progression. The results have been published.

Eligibility Criteria:
Inclusion Criteria:

* Progress in keratoconic eye. We define progress as an increase in Kmax of 1.0 diopter in 1 year or 0.5 diopter in 6 months. This increase in Kmax will be accepted as progression if concomitant changes tomographic parameters.

Exclusion Criteria:

* Concurrent ocular infection or corneal disease other than keratoconus.
* Pregnancy.
* Treatment with Isotretinoin.
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years.

Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).


Eligibility Criteria:
Key Inclusion Criteria:

Part A:

* Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Documented confirmation by a physician of the diagnosis of at least one of the following conditions:

  1. Coronary artery disease and/or congestive heart failure.
  2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
  3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.

Part B:

* Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.

Parts A and B:

- Able to comply with study requirements.

Key Exclusion Criteria:

Part A:

* Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary.
* History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
* Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1.
* History of myocarditis, pericarditis, or myopericarditis.

Part B:

* Previous treatment with alemtuzumab or rituximab within 2 years prior to Day 1.
* Previous treatment with plasmapheresis within 30 days prior to Day 1.
* A history of complications of immunosuppression.
* A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment.

Note: Other protocol-defined inclusion/exclusion criteria apply
Characterization of Bleeding Disorders in EDS

Ehlers-Danlos Syndrome (EDS) is a disease that weakens the connective tissues (i.e. tendons and ligaments) in the human body. EDS can make the joints loose and alter skin and wound healing. It can also weaken blood vessels and organs. Many EDS patients are referred for investigation of bleeding symptoms. Although most patients will have mild symptoms such as bruising, many will experience significant bleeding that can be life-threatening. The physiological reason behind this has not been identified and therefore, treating this is challenging. In addition, patients with EDS frequently require major surgery due to complications from their connective tissue disease. These surgery carries a significant risk of catastrophic bleeding which is further magnified in this group of patients. The specific reason of clinical bleeding in patients with EDS is likely multifactorial, including skin and blood vessel fragility leading to increased bruising and poor wound healing, coagulopathies related to factor deficiency, acquired vonWillebrand disease (VWD), and notable platelet dysfunction.

Despite compelling preliminary evidence, there is limited data on the diagnosis and management of platelet dysfunction in EDS patients. Therefore, in this study we will characterize hemostasis, the medical term which refers to the process of stopping blood flow, across the three most common subtypes of EDS.we will also determine the burden of illness of pathologic bleeding in patients with Ehlers-Danlos Syndrome (EDS) using validated patient reported tools.


Eligibility Criteria:
Inclusion Criteria:

* Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.

Exclusion Criteria:

* Subtypes of Ehlers Danlos Syndrome which are not Classical, Hypermobile, or Vascular.
* Unable or unwilling to consent for the study
Prospective Study to Investigate the Frequency of Possible Bacterial Entry Into the Bloodstream (Bacteremia) and Infectious Complications Associated With the Use of the Spyglass Cholangioscopy System During ERCP (Endoscopic Retrograde Cholangiopancreatography).

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.

Rates of bacteremia (bacterial seeding of the blood) following ERCP's range from 6.4% to 18.0%. However, infectious complications of cholangitis/sepsis occur in only 0.5%- 3.0% of patients undergoing this procedure. The Spyglass Direct Visualization System allows cholangioscopy with direct visualization of the bile duct during ERCP by using a specialized small caliber endoscope. During the Spyglass portion of the procedure, saline is introduced into the bile duct to to irrigate the biliary system, in order to distend the biliary ducts and to improve visualization by clearing contrast, pus and stone debris. Saline irrigation may increase intrabiliary pressures and may therefore theoretically increase the risk for bacteremia and infection.

The effect of Spyglass cholangioscopy and biliary irrigation on the frequency of bacteremia/post cholangioscopy infections is unknown and has not previously been studied.

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass system.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80
2. Biliary disease such as large stones necessitating electrohydraulic lithotripsy;
3. Biliary strictures needing tissue acquisition through cholangioscopic directed biopsies
4. Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies
5. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18, \> 80
2. Potentially vulnerable subjects including pregnant women, homeless people, employees and students.
3. Patients who have a clear indication for pre-procedure antibiotics based on current ASGE guidelines
4. Patients who had received antibiotics for any reason within the prior 7 days
5. Patients who had evidence of systemic infection at time of the ERCP
6. Patients in whom additional venous access for blood cultures cannot be established.
7. Participation in another investigational study within the previous 90 days
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

* Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
* History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening