cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors vs TP Injection for Pain Management

The principal objective is to contribute valuable insights that hold direct implications for medical practice and patient care, with the potential to influence health policy pertaining to fibromyalgia management.

The study aims to outline distinct patient subgroups manifesting heightened responsiveness to one therapeutic intervention vis-à-vis the other, thereby facilitating the formulation of more personalized and efficacious treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* Stable on SSRIs for at least three months (for Group A)
* Age between 18 and 65 years
* Participants suffering from recent cervical pain without any pathology

Exclusion Criteria:

* Presence of any other chronic pain conditions.
* Contraindications to SSRIs or trigger point injections.
* Pregnancy or lactation.
* History of psychiatric disorders other than depression and anxiety
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse

Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.


Eligibility Criteria:
Inclusion Criteria:

* Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
* Patient who is at leat 21 years of age.
* Patient whose family is complete.
* Patient may not have uncontrolled diabetes.

Exclusion Criteria:

* Patients may not have coagulation disorders.
iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease

The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer program and those in the control group (no mentor).

The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer program and those in the control group (no mentor).

The proposed trial aims to examine the impact of the iPeer2Peer program on self-management skills of youth with IBD (mentees) as well as health outcomes of peer mentors in the program. This innovative program leverages the Internet, commonly used by youth, to improve access and acceptability of self-management interventions while fostering social engagement in youth with IBD, thereby potentially improving HRQL.

Eligibility Criteria:
Inclusion Criteria:

* males and females 12-18 years old,
* gastroenterologist-diagnosed IBD,
* able to speak and read English,
* access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet devices),
* willing and able to complete online measures.

Exclusion Criteria:

* significant cognitive impairments or
* severe co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment (e.g., psychosis, active suicidal ideation),
* participating in other peer support or self-management interventions
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).

Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication \[OAM\]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening
* Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable
* Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening
* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

* Participants who have a diagnosis of type 1 diabetes
* Participants who have previously been treated with any other glucagon-like peptide 1 (GLP-1) analog
* Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening
* Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening
* Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening
* Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
E7070 in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients with solid tumors.
* Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population.
* Propose a safe dose for phase II study.
* Assess the pharmacokinetics of this drug at different dose levels in this patient population.
* Determine any possible antitumor activity of this drug in this patient population.

OUTLINE: This is a dose escalation study.

Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed every 3 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy
* No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic:

* Bilirubin less than 1.5 mg/dL
* Liver function tests no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

* Creatinine no greater than 1.4 mg/dL OR
* Creatinine clearance at least 60 mL/min

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active bacterial infections (e.g., abscess or fistulae)
* No other nonmalignant disease that precludes protocol therapy
* No history of alcoholism, drug addiction, or psychotic disorders that preclude participation
* No glaucoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No other concurrent antitumor drugs

Endocrine therapy:

* At least 4 weeks since prior anticancer hormonal therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy)
* No concurrent radiotherapy (except localized palliative radiotherapy)

Surgery:

* Not specified

Other:

* No concurrent sulfonylurea agent for diabetes or antiarrhythmic agents
* No other concurrent investigational drugs
Platelet Antisedimentation Rate and Multiplate Exams in Patients on Antiplatelet Therapy and Controls

To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent

Exclusion Criteria:

* Declined informed consent
S9431: Studying Genes and Immune Response in Tumor Samples From Patients With Locally Advanced or Metastatic Melanoma

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma.

OBJECTIVES:

* Characterize the frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases and explore their association with clinical outcome of patients with metastatic melanoma.
* Characterize the frequency of specific genetic alterations at either the DNA, mRNA, or protein level and explore the association of these abnormalities with clinical outcome in these patients.
* Characterize the host immunologic response to metastatic melanoma by determining whether the in vivo pattern of cytokine expression is consistent with specific subsets of T helper cells within melanoma deposits and to explore whether host immunologic response varies based on the site of metastatic disease and/or correlates with clinical outcome in these patients.
* Obtain peripheral blood, sera, and paraffin embedded tumor blocks from these patients.
* Correlate the most prevalent gene copy alteration observed in metastatic disease with the risk of progression in tissue samples from patients registered on SWOG-9035 (primary melanoma).

OUTLINE: Fresh and snap frozen tumor tissue samples are obtained from biopsy or surgical procedures in the coordinated study. Specimens undergo mRNA and DNA analysis of tumor-related genes and cytokine gene expression. Peripheral blood samples are obtained and processed for sera and mononuclear cell testing. Tumor tissue samples embedded in paraffin or on unstained slides are also obtained.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 3-4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage III or IV metastatic melanoma

  * Concurrent enrollment on a SWOG-coordinated melanoma treatment study (within 56 days of registration on this study) OR
  * Previously enrolled on and eligible for at least 1 SWOG-coordinated melanoma study and scheduled to undergo biopsy/surgery for regional lymph node or disseminated metastatic disease OR
  * Concurrent enrollment on SWOG-9430 (FISH analysis)

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Not previously enrolled on SWOG-9431
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

A prospectively planned interim analysis will be performed on the double-blind data.

Eligibility Criteria:
Inclusion Criteria:

* Clear clinical and laboratory diagnosis of HAE
* Baseline plasma level of functional C1INH of less than 50% of normal
* Evidence for exacerbation or development of a severe abdominal, oro-facial/ pharyngeal/ laryngeal, genito-urinary and/or peripheral HAE attack

Exclusion Criteria:

* Acquired angioedema
* Pregnancy or breastfeeding
* Participation in another clinical study within prior 3 months
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542)

The purpose of the the study is to evaluate the ability of injections of Ji Gami(TM) C to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Able to provide informed consent after risks and benefits of the study have been explained.
* Be willing to undergo all study procedures.
* Ability to communicate effectively with study personnel.
* Have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit.
* Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Paricipation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Clinically significant dermatologic condition in donation or study areas.
* Prior surgery in the donor or study areas.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral-naive patients with HIV-1 infection
* not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
* No antidiarrheal medication within 7 days prior to entry

Exclusion Criteria:

* Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
* Bloody stools within 7 days prior to study entry
* Any unstable or severe intercurrent medical condition, including active opportunistic infections
Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

Objective from this study to compare the clinical outcomes and safety between colistin and tigecycline for multi-drug resistant gram negative bacteria.

Study will be in Beni-Suef university hospital. Group I: 66 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose in intensive care unit to treat their MDR infection and group 2 contains 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection

Eligibility Criteria:
Inclusion criteria:

Study will include

* adult patient (male, female)
* age from 18 to 70 years
* Patients admitted to intensive care unit in study period (six months) who received intravenous colistin or tigecycline as antimicrobial drug for treatment their MDR gram negative infection.

Exclusion criteria:

* Patient admitted to intensive care unit younger than 18 years or older than 70 years.
* Liver transplantation patients.
* Patients are chronic kidney disease (CKD on hemodialysis or baseline creatinine clearance (crcl) \< 10 ml/min (estimated by Cockcroft Gault equation).
* Patients received renal replacement therapy before or during admission.
* Patient is on any other nephrotoxic drug (vancomycin, aminoglycosides, NSAIDs, cyclosporine, amphotericin B, etc.).
* Pregnant and lactating women.
* Patients refused the consent of the study.
Manipulation of Dietary Protein and the Anabolic Response

In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Aged between 18-35 years
* Healthy, recreationally active
* BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Allergies to milk proteins (whey or casein)
* Vegetarians
* Diagnosed GI tract diseases
* Female
* Arthritic conditions
* A history of neuromuscular problems
* Previous participation in amino acid tracer studies
* Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.

This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study

Eligibility Criteria:
Key inclusion criteria:

* Healthy men and women, ages 18 to 49, inclusive
* Nonsmokers
* Women not pregnant or breastfeeding
* Participants who could match solutions of the same sweetness and provide consistent sweetness scores during the taste screening

Key exclusion criteria:

* Any significant acute or chronic medical illness
* Any acute or chronic condition that may have altered taste sensory perception
* Any major surgery or trauma within 4 weeks of Day 1
* Blood transfusion within 4 weeks of study participation
* Recent (within 6 months of Day 1) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse
* Positive urine drug screen
* Positive urine screen for cotinine
* Positive hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibodies
* Clinically significant elevations in results of liver function tests above normal range
Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a substance used to make specific organs, blood vessels, or tumors easier to see) that is given by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains chemical information from the tumor. During MRS, signals are detected from the chemicals (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS give extra information which is not available with the regular MRI. The regular MRI only shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels of the tumor. DW-MRI provides information related to the state of the tumor tissue with regards to the quality or condition of cells present in it and MRS gives information about the chemical makeup of the tumor.

The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can predict which patients will do well with either surgery or chemo-radiation therapy. This study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the therapy is working.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven diagnosis of head and neck cancer or patients with tumors strongly suspicious for head and neck cancer due to clinical features or FNA (fine needle aspiration) cytology assessment.
* Will undergo surgery or chemo-radiation treatment
* Patients must be 18 years or older and have the ability to give informed consent

Exclusion Criteria:

* Claustrophobia
* Known reaction to Gd-DTPA
* Pre-operative radiation to primary tumor site
* Contraindication to MRI

  1. Pacemaker
  2. Aneurysmal clips
  3. Metal implants in field of view
  4. Pregnant or nursing women
  5. Age and mental status wherein he/she is unable to cooperate for MRI study