cyrilzakka/clinical-trials huggingface dataset:
Vibratory Stimulation for the Treatment of Chronic Pain

The purpose of this study is to perform a first in man study with VCR stimulation of the belly and back for patients with chronic pain conditions including pelvic pain, functional abdominal pain, or low back pain. This study will also examine VCR stimulation of the temporal region for patients with migraine with or without aura. Additional goals of the study will be to determine the safety, tolerability, and acceptability of VCR stimulation for the treatment of these pain conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old.
* Diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back pain, or migraine with or without aura of at least 3 months duration.
* English speaking
* Ability and willingness to complete questionnaires and in-person assessments
* Current average daily pain score of greater than or equal to 4 on the Numeric Rating Scale of Pain (0-10 scale)
* For patients with migraine diagnosis they must report at least 2 headaches in the baseline headache diary in the 30 days preceding randomization.

Exclusion Criteria:

* Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
* Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
* Any suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9 assessing suicidal thoughts.
* Any current illicit drug or alcohol abuse.
* Any history of recurrent or unprovoked seizures.
* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days.
* Pregnancy, breast-feeding or lack of reliable contraception
* Changes in pain medications in the previous 4 weeks
* Implanted electrical stimulation device.
* Skin infection over stimulation sites.
* Any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks) Any botulinum toxin injection in the previous 3 months
* For patients with migraine diagnosis additional exclusion criteria include receipt of preventive anti-migraine treatment in the past 3 months, failure on greater than or equal to 3 well-conducted preventive drug trials, concurrent medication overuse headache diagnosis, and concurrent frequent/chronic tension type headache.

  4. Frequent/chronic tension type headache
Psychometric Properties of the Updated Module on Assessing Quality of Life of Patients With Breast Cancer

Females breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC QLG decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies.

The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ- C30 in patients diagnosed with breast cancer. Participants will be enrolled in three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). Various combinations of therapies are permissible, resulting in a total of 17 subgroups.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of breast cancer
* no previous primary or recurrent tumour
* ability to understand the language of the questionnaire
* mental fitness to complete a questionnaire
* 18 years of age or above
* written informed consent.

Exclusion Criteria:

* no histologically confirmed diagnosis of breast cancer
* previous primary or recurrent tumour
* not mentally fit to complete a questionnaire
* not able to understand the language of the questionnaire
* younger than 18
* refusal of informed consent
Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease

The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD.

The study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.


Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 18 to 75 years) who underwent allogeneic hematopoietic stem cell transplantation (HSCT) and developed gut acute Graft-versus-Host Disease (aGvHD).
* Participants have steroid-resistant or steroid-dependent gut aGvHD.
* Steroid resistant gut aGvHD is defined as cases in which gastrointestinal symptoms do not improve within 7 days after initial steroid therapy (≥1 mg/kg of methylprednisolone) or clear progression after 5 days.)
* Steroid-dependent gut aGVHD is defined as cases in which reduction of steroid dose was not possible due to exacerbation of gastrointestinal symptoms.
* Participants may have undergone allogeneic HSCT for any diagnosis at any time prior to developing aGvHD, and are not restricted to any specific conditioning regimen or by the subsequent administration of donor lymphocyte infusion.
* Participants should be able to give informed consent.

Exclusion Criteria:

* Participants may not have gut aGvHD which permits the tapering of steroid dose.
* Participants may not have ongoing, uncontrolled infection (i.e. unresolved bacteremia, uncontrolled CMV infection).
* Participants may not have ongoing enteritis primarily caused by enteropathy other than gut GvHD, excluding resistant clostridium difficile infection.
* Participants may not have acute neutrophil count \< 500 cells/µL.
* Participants may not have toxic megacolon
* Participants may not have active gastrointestinal bleeding.
* Participants may not be pregnant or lactating.
* Participants may not be unable to swallow pills.
Assesment of Knowledge,Attitude and Practice of Pregnant Women Regarding Iron,Folic Acid and Multivitamins at AlMonshah District.

Anaemia is defined as the lack of functioning red blood cells (RBCs) that leads to a decrease in the ability to carry oxygen causing a lot of complications during life time.

Iron deficiency anaemia is a main public health problem in all countries. Over 30% of the world's population had anaemia; 4.3%-20% and 30%-48% respectively in developed and developing countries are affected by iron deficiency anaemia. Globally, it is estimated that roughly 38% of pregnant females, 29% non-pregnant women, and 29% of all females of reproductive age are diagnosed to have anaemia .

WHO suggested a standard daily dose of 30 to 60 mg of iron and 400 µg of folic acid supplements to prevent anaemia in pregnancy. This dose of iron and folic acid should be taken ideally before gestation with the earliest possible time and must be continued throughout the gestational period.

During pregnancy it is important to take adequate nutrition which is essential for optimal growth of the foetus and decrease in the incidence of congenital anomalies. adequate dietary intake of proteins and energy is not enough for normal weight of the new-born, decrease in vitamins and minerals can adversely affect the weight of the new- born .

The prevalence of neural tube defects, low-birth weights, small babies for gestational age and maternal anaemia can be reduced by adequate intake of iron and folic acid supplements during pregnancy. A lot of studies show the same positive results for the intake of multivitamins ,but iron and folic acid are the most important .

A lot of studies show the importance of the relationship between iron and folic acid supplement or multivitamins intake and the socio-economic factors as age, level of education, residence, marital status, parity, economic status, prenatal circumstances. There are association between more intake of supplements during pregnancy and a higher socioeconomic levels , level of education and use of prenatal medical services in studies conducted in Finland . The detection of anaemia in pregnancy is based on the examination of haemoglobin (Hb) levels at the first antenatal care visit.

If the haemoglobin level is \<11.9%, the pregnant woman is declared anaemic and should be given supplements of 60 mg iron tablets and 0.5 mg folic acid. This supplement is taken regularly 1 tablet per day for 90 consecutive days. If the haemoglobin level is still \<11.9%, then the administration of iron tablets is continued. However, in practice, not all pregnant women take tablets regularly. This could be due to inadequate knowledge about the importance of iron tablets for pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who are resident in Almonshah district, Sohag and attend the mentioned health centers for antenatal care services.

Exclusion Criteria:

* 1- Women who refuse to participate in the study. 2- Presence of pregnancy complications. 3- Presence of psychiatric or cognitive diseases
Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid

The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.

High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.

Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.

In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).

Eligibility Criteria:
Inclusion Criteria:

* people who receive colonoscopy
* aged : 18-80
* people who sign the consent

Exclusion Criteria:

* those aged over 80 years
* the disabled
* intestinal obstruction
* severe constipation
* previous history of bowel resection
* liver cirrhosis
* heart failure or ischemic heart disease within 6 months
* inflammatory bowel disease
* pregnant women
* severe renal insufficiency
* people who refuse to sign the consent
Corticosteroid Injection Effectiveness in Carpel Tunnel Patients With Negative or Mild EMG Studies

Carpal Tunnel Syndrome (CTS) is the most common nerve entrapment syndrome worldwide. There are currently no studies examining the effectiveness of corticosteroid injections in patients with normal (negative) EMG studies. The purpose of this study is to gain a better understanding of the duration of symptom improvement post corticosteroid injection in patients with negative or mild EMG studies. The Boston Carpal Tunnel Questionnaire will be given to patients undergoing corticosteroid injections for the treatment of carpal tunnel syndrome to assess their response to the injection. Investigators will collect data retrospectively. The Boston Carpal Tunnel Questionnaire (BCTQ) is administered as per standard protocol to all patients with CTS who have a negative or mild EMG study. The BCTQ assesses the patient's self-reported symptom severity and functional status. Investigators will analyze this data with respect to demographics as well as numbness in the median n. distribution, nocturnal numbness, weakness/atrophy of the thenar musculature, Tinel's sign, Phalen's test, loss of 2-point discrimination, Quick-Dash score, and grip strength score.

The primary outcome will be the Boston Carpal Tunnel Questionnaire outcome score under the different EMG conditions.The secondary outcomes will be numbness in the median n. distribution, nocturnal numbness, weakness/atrophy of the thenar musculature, Tinel's sign, Phalen's test, loss of 2-point discrimination, QuickDash score, and grip strength score. Both outcomes will be examined in patients with negative or mild EMG readings. This information will allow orthopedic physicians to gain a better understanding of the duration of symptom improvement post-corticosteroid injection, allowing them to fine tune their treatment plans for CTS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who speak English
* Patients who are 18 years or older
* Patients who are clinically diagnosed with CTS
* Patients who have a negative or mild EMG study
* Patients who receive a corticosteroid injection after obtaining a negative or mild EMG study

Exclusion Criteria:

* Patients who do not speak English
* Patients who are younger than 18 years of age
* Patients who have experienced previous trauma to the wrist
* Patients who have had previous treatment for CTS including but not limited to corticosteroid injection or surgery
* Patients with a moderate or severe EMG study
End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)

The purpose of this research study is to see how effective bioelectric impedance analysis (BIA) is in determining body composition (the amount of fat versus muscle in the body) and nutritional status in patients with End Stage Liver Disease (ESLD)

The aim of this study is to report the validity of mBIA to determine body composition changes pre and post LVP (Large Volume Paracentesis)

* 18 years of age or older
* Cirrhotic patients with refractory ascites requiring LVP (a treatment to remove large volumes of excess fluid from the abdominal cavity)
* End Stage Liver Disease

Eligibility Criteria:
Inclusion Criteria:

* Patients with ESLD requiring LVP.
* Age over 18.
* Ability to provide written informed consent.

Exclusion Criteria:

* Organ retransplant candidates.
* Patient with use of any investigational agent within 30 days before LVP.
* Pregnant or lactating.
* Patients with non-bioprosthetic heart valves pacemakers, defibrillators, artificial joints, pins, plates, or other types of metal objects in the body.
* Amputations other than fingers or toes.
Relationship of Endoplasmic Reticulum Stress and Adenoid Diseases

Adenoid tissue is a significant organ for the performing of immune systems in children. The Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of cells. The purpose of the study was to explore the correlation among ER stress and adenoid tissue disorders and to explain the structure of diseases related to the immune system.


Eligibility Criteria:
Inclusion Criteria:

- Patients with the clinical diagnosis of chronic adenoiditis and adenoid hypertrophy.

Exclusion Criteria:

* Systemic diseases
* Other otolaryngological
Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy

BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.

OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.

METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (NAFL + isotretinoin) and triple therapy (NAFL + isotretinoin + PBT).

BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.

OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.

METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (1,565 nm non-ablative fractional laser + isotretinoin) and triple therapy (1,565 nm non-ablative fractional laser+ isotretinoin + PBT).

Eligibility Criteria:
Inclusion Criteria:

* Patients ranged in age from twenty to forty years old
* Clinically diagnosed as a facial acne patient
* The patients meet the needs of the research program of this topic

Exclusion Criteria:

* pregnancy
* liver or kidney functional abnormality
* skin ulceration with active bacteria
* fungal or viral infection or skin cancer
* coagulation disorders
* patients on drugs of agents
* systemic diseases such as cardiovascular disease
* epilepsy
* diabetes
* immunodeficiency disease
* active psoriasis
A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B

This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.


Eligibility Criteria:
Inclusion Criteria:

* 1. 18 and 65 years old ; 2. HBsAg positive at least for 6 months ; 3. HBeAg positive chronic hepatitis B, HBV DNA \> 10\^5 copies/ml; 4. Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN; 5. New diagnosed chronic hepatitis B subjects;

Exclusion Criteria:

* 1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;
The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

The study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer.

Major surgery elicits a metabolic stress response that is followed by a loss of body mass, fatigue, and an impaired physical performance including a reduced work capacity.

To perform ordinary daily activities many elderly people exert close to their maximum physical capacity, and even a small reduction of performance capacity may cause significant impairment in physical and social activity. Postoperative decline in strength and work capacity may thus cause previously independent living persons to become dependent upon assistance from others. Hence, it is important to avoid the postoperative reduction of physical performance and to minimize postoperative fatigue.

It has been shown that Erythropoietin treatment reduces the need for blood transfusions in patients undergoing planned colonic surgery. However, the effect of Erythropoietin treatment upon postoperative rehabilitation has not yet been studied.

Therefore the main hypothesis in this study is that perioperative treatment with Darbepoetin Alfa would improve the physical capacity in aspects by reducing postoperative fatigue and improve work capacity, balance and quality of life compared to placebo treatment. Furthermore, the researchers expect Darbepoetin treated patients to have fewer perioperative complications and less need for blood transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum

Exclusion Criteria:

* Psychiatric disease or dementia
* Diseases, that renders participation in the study impossible
* Thromboembolic disease within the last three months
* Dysregulated hypertension (systolic blood pressure\>175 mmHg and/or diastolic blood pressure\>105 mmHg)
* Other diseases or causes that will contraindicate treatment with Darbepoetin Alfa
* Other diseases or causes that will contraindicate further treatment with Darbepoetin Alfa
* Patients that preoperatively and/or four days postoperatively have a hemoglobin concentration \> 14 g/dl
* Former cancer disease
* Disseminated cancer disease
* Rectal cancer stage T4
A Study With OPTIVATE® in People With Von Willebrand Disease

The main objective of the study is to assess the pharmacokinetics of OPTIVATE® after a single dose of 80 IU/kg VWF:RCo. The secondary objectives of the study are to assess efficacy and safety of OPTIVATE® in long-term use over at least 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent.
2. Be aged 12 years or older.
3. Have severe VWD (VWF:RCo \<20%) of known type. Severity will be confirmed by a current VWF:RCo result of \<20%.
4. Be known or expected to require a concentrate for management of VWD.
5. Must have had at least one bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.
6. Have a known lack of, or poor response to, DDAVP.
7. Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
8. At the Baseline Visit (Visit 1), patients must have had at least 5 days since their last infusion of replacement factor concentrate or DDAVP.
9. Female patients of child-bearing potential must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study. Female patients must not be lactating.

Exclusion Criteria:

1. Have a history of inhibitor development to VWF or FVIII or a positive result at screening.
2. Actively bleeding (Note: the patient can enter the study once the bleed is controlled).
3. Presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator.
4. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
5. Have a recent history of alcohol or drug abuse.
6. Administration of a new chemical entity within the 4 months preceding enrolment.
7. Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the BPL clinical study Protocol 8VWF03.
8. In the opinion of the investigator, the patient is unlikely to comply with the study protocol.
The Indiana Myeloma Registry

This is a prospective, non-interventional, observational study. The purpose of this study is to collect data and bio-specimens that will support future research


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age at the time of informed consent
2. Has been diagnosed with or is suspected to have one of the following:

   1. Monoclonal Gammopathy of Undetermined Significance (MGUS)
   2. Smoldering Multiple Myeloma
   3. Multiple Myeloma
   4. Bony or Soft Tissue Plasmacytoma
   5. Primary Amyloidosis

Exclusion Criteria:

\< 18 years of age

Have not been diagnosed with one of the following:

Monoclonal Gammopathy of Undetermined Significance (MGUS) b.Smoldering Multiple Myeloma c.Multiple Myeloma d.Bony or Soft Tissue Plasmacytoma e.Primary Amyloidosis