cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Hyperbaric Oxygen Therapy in Adults

The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.

The main questions it aims to answer are:

1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?
2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?

Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35;
* Healthy, physically active men;
* Subject who is knowingly willing to participate in the study;
* Subject able to read, understand and sign an informed consent to participate.

Exclusion Criteria:

* Inability to attend scheduled visits and/or follow study protocol;
* Use of HBOT prior to study inclusion;
* Severe or unstable physical impairment or severe cognitive deficits at study entry;
* Pressure-sensitive chest diseases (including moderate or severe asthma) or pressure-sensitive ear or sinus diseases;
* Active smoking;
* Having suffered an injury within 3 months up to the date of the study;
* Taking pre- and/or probiotics in the last 3 months before the study;
* Inpatient hospital or emergency room stay in the last 4 weeks prior to study entry;
* Travel to tropical countries during the last 4 weeks prior to the study;
* Taking antibiotics, steroids and steroid-anabolic agents during the last 4 weeks before the study
"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol

To evaluate the safety and anti-HBV efficacy of γδT cells.

In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.

Eligibility Criteria:
Inclusion Criteria:

* 1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads\>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.

Exclusion Criteria:

* 1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment
Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe plaque-type psoriasis
* A candidate for systemic therapy or phototherapy
* Not using prescription systemic therapies for psoriasis prior to starting the study
* Not using efalizumab within 3 months prior to starting the study

We are seeking adults who:

* Have moderate to severe plaque-type psoriasis
* Are generally healthy
* Are not hypersensitive to Raptiva® (efalizumab) or any of its components.
* Are not pregnant or lactating women

You will:

* Be interviewed and examined
* Have blood drawn
* Be injecting the study medication

Exclusion Criteria:

* Hypersensitivity to Raptiva or any of its components
* Pregnant or lactating women
* History of liver disease or abnormal liver enzymes
* History of chronic infection or malignancy
* History of significant hematologic abnormalities
Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia

The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.

The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. One subject for the control group, one for the study group (I), then the other for study group (II), and so on, distributed the participants into three equivalent groups as fellow:

Control Group: Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.

Study Group (I): Consisted of 30 neonates who will receive Vimala massage. The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.

Study Group (II): Consisted of 30 neonates who will receive hydrotherapy. It will be applied two times per day before feeding, each lasting 5-10 min.

Eligibility Criteria:
Inclusion Criteria:

full-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute Apgar score of seven or above. Furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal

Exclusion Criteria:

* major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby).
Real-time Location System Feasibility Study

The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.

In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.


Eligibility Criteria:
Inclusion criteria

* Male or female patients between the ages of 18 and 90.
* Admitted to the Surgical Ward.
* Recovering from surgery.
* Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.
* Ability to understand and complete the study survey instruments in English.

Exclusion criteria

* Non-surgical patient.
* Emergency surgical procedure.
* Anticipated discharge less than 24 hour.
* Unable to ambulate or ambulation not permitted by treating provider.
* Unable to understand and complete the study survey instruments in English.
* Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.
Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of selenium and vitamin E may stop cancer from growing or coming back.

PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E to see how well it works compared with a placebo in preventing cancer progression and recurrence in patients with early-stage bladder cancer.

OBJECTIVES:

* To investigate whether selenium and/or vitamin E (α-tocopherol) supplementation reduces the risk of recurrence and progression.

OUTLINE: This is a multicenter study. Patients are stratified by recurrence risk group (high vs intermediate) and treatment center and randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral selenium tablet and oral vitamin E capsule once daily.
* Arm II: Patients receive oral selenium tablet and oral placebo capsule once daily.
* Arm III: Patients receive oral placebo tablet and oral vitamin E capsule once daily.
* Arm IV: Patients receive oral placebo tablet and oral placebo capsule once daily.

In all arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed every 6 months for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (\< pT2)

  * Newly diagnosed disease
* Able to be randomized within twelve months of diagnostic transurethral resection bladder tumor/biopsy
* Must meet 1 of the following recurrence risk criteria:

  * Intermediate risk

    * Multiple G1 pTa (\> 1)
    * Solitary G1 pTa (≥ 3 cm)
    * G2 pTa
    * G1 pT1
    * G2 pT1 (1 or 2 tumors)
  * High risk

    * G3 pTa
    * G3 pT1
    * Cis
    * Multiple G2 pT1 (3 or more foci)
  * Low risk

    * Solitary G1 pTa \< 3 cm

PATIENT CHARACTERISTICS:

* Not pregnant or breast feeding
* No HIV infection
* No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives

PRIOR CONCURRENT THERAPY:

* No concurrent immunosuppressive therapy after organ transplantation
* No concurrent cyclosporine
* Those who currently use or have used selenium and/or vitamin E supplements will not be excluded, however, they must agree not to take supplements containing selenium and vitamin E above a pre-specified dosage
A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy

Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New therapeutic strategies are required in platinum-refractory disease. Inhibition of growth signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established antiestrogen tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum refractory to platinum- and taxane-based chemotherapy measurable or non-measurable disease written informed consent aged 18 years or older Karnofsky performance status \> 60%

Exclusion Criteria:

complete bowel obstruction symptomatic brain metastases known hypersensitivity to evaluated drugs inadequate kidney function inadequate hepatic function evidence of clinically active interstitial lung disease history of congestive heart failure \> NYHA 2
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.

This trial will prospectively evaluate screw deviation from pre-planned trajectory using the standard of care Mazor X robotic system. Patients undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation at previously uninstrumented levels for degenerative conditions, spinal deformity, spinal infection, trauma, or neoplastic processes between T2-S1 will be asked to participate in this prospective cohort study.

This single centered study will enroll up to 50 patients to achieve a total number of 250 screws for assessment. Subjects will be followed till discharge following surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for posterior thoracolumbar arthrodesis surgery.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Degenerative conditions, spinal deformity, spinal infection, traumatic injuries, or neoplastic processes between T2-S1 necessitating placement of pedicle screw instrumentation.
* Surgery performed at The Ohio State University Wexner Medical Center (OSUWMC) via one of the study investigators

Exclusion Criteria:

* Current or previous spinal tumor
* Severe co-morbidities (e.g., heart, respiratory, or renal disease)
* Concurrent involvement in another investigational drug or device study that could confound study data
* Subjects who are pregnant
* Prisoner
* Subjects who do not speak English Relative Exclusion Criteria
* Prior pedicle screw instrumentation at that level (i.e. prior L4-5 instrumentation, now undergoing an L4-S1 fusion, only new S1 screw accuracy would be evaluated in this patient)
Core Strengthening for DRA in Postpartum Women

This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate and clarify the association between IRD and low back pain.

DRA is a separation of the abdominal wall muscles that commonly occurs during pregnancy and is caused by the stretching of the linea alba to accommodate a growing fetus. Separation of core muscles is thought to be factor in postpartum low back pain, stress urinary incontinence, and core strength, as well as being cosmetically undesirable. This study will evaluate the effect of a core strengthening program on shortening the IRD and improving the connectivity and strength of abdominal wall muscles in postpartum women with a DRA. It will also investigate the relationship between IRD and low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women who have given birth within the last 36 months but are at least 12 weeks postpartum
* Not currently pregnant
* Current DRA diagnosed using ultrasound with an IRD of at least 2.0 cm

Exclusion Criteria:

* History of ventral/umbilical hernia prior to pregnancy
* \>36 months postpartum
* Currently pregnant
* Beighton's score \>5/9
* Unable to participate in a regular core strengthening program
* Unable to attend the three data collection sessions
Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.

The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of ovarian cancer
* Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel)
* At least 18 years of age
* Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
* Karnofsky performance status of at least 70%
* Estimated life expectancy of at least 12 weeks
* Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
* Subject must be able to comply with study procedures and follow-up examinations.
* Signed written informed consent
* Lab Values (obtained ≤ 7 days prior to study enrollment):
* ANC at least 1.5x10e9/L,
* Platelet count at least 100x10e9/L,
* Hemoglobin at least 8.5 g/dL,
* Creatinine within 2 times upper limit of normal
* AST and ALT within 3 times upper limit of normal
* Bilirubin within 1.5 times upper limit of normal
* Albumin great than 2.5 g/dL
* INR \< 1.5 for subjects without anticoagulants

Exclusion Criteria

* Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
* NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \<50%, or acute anginal symptoms
* Patients who have received any investigational agent within 4 weeks of enrollment
* Patients who are pregnant or breast-feeding
* History of prior malignancy other than ovarian cancer within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* History of central nervous system metastases or carcinomatous meningitis
* Major surgery within 4 weeks of enrollment
Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia

The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)

1. 18 Years to 80 Years (Adult, Senior);
2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
3. Patient meets at least one of the following diagnostic criteria for the index limb:

   1. ABI\<0.7mmHg
   2. TcpO2 \<40 mm Hg
   3. Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization;
4. Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;
5. Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;
6. Unlikelihood of major amputation of the leg during the next 12 months;
7. Expected life span more than 2 years.

Exclusion Criteria:

1. Pregnant or lactating;
2. Diabetics with poorly controlled blood glucose levels (defined as HbA1c\>7% and/or proliferative retinopathy);
3. Patients with decompensated cardiac, renal or liver disease;
4. Patients with confirmed malignant tumor;
5. Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation;
6. Known or suspected disease of the immune system or osteomyelitis;
7. Inability to sign informed consent form and to comply with the schedule of the study;
8. There has reason to suspect that the patient is forced to join the study;
9. Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.
Oral Curcumin for Radiation Dermatitis

The purpose of the study is to determine whether curcumin, an ingredient of some foods, can prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues..

Radiation is a toxic agent and a widely accepted form of treatment for various types of cancer. Approximately half of all women with breast cancer receive radiation therapy. Despite advances in medical technology, radiation therapy still causes severe skin effects. Radiation dermatitis occurs in approximately 90% of patients and ranges in severity from mild redness to more severe skin changes. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it; currently, there is no standard treatment for the prevention of radiation-induced dermatitis. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of non-inflammatory breast adenocarcinoma (including in situ and bilateral)
* scheduled to begin radiotherapy without concurrent chemotherapy; concurrent hormone or Herceptin® (trastuzumab)treatment is okay
* can have been treated by lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment
* can have had breast reconstruction
* scheduled to receive 25-35 radiation treatment sessions (1 session per day) using standard irradiation fractionation (1.8-2.0 Gy per sessions) OR 16-20 radiation treatment sessions (1 session per day) using Canadian irradiation fractionation (2.2-3.0 Gy per session)(100, 101).
* able to swallow medication.
* three weeks must have elapsed after chemotherapy and surgery before the patient can begin the study
* able to understand English

Exclusion Criteria:

* inflammatory breast cancer
* previous radiation therapy to the breast or chest
* concurrent chemotherapy treatment
* concurrent treatment with anti-coagulants (e.g., coumadin®, warfarin®), or anti-EGFR (human epidermal growth factor receptor) drugs (e.g. Iressa® (gefitinib), Erbitux® (cetuximab, C225); aspirin is allowed
* known radiosensitivity syndromes (e.g., Ataxia-telangiectasia)
* collagen vascular disease, unhealed surgical sites, or breast infections
Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism

It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)

All subjects were followed up on a yearly basis collection with clinical data (weight, sex, age, comorbidities, treatment), biological (VS, CRP, ACPA, lipid balance, cross laps), radiology (hand and foot radiographs and ultrasonography ), BMO Measure

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years
* Rheumatoid arthritis meeting ACR criteria Spondyloarthritis meeting ASAS criteria

Exclusion Criteria:

* Patient under guardianship