linjc16/ctgov huggingface dataset:
Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.

Official Title
-----------------
Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors

Conditions
-----------------
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms

Intervention / Treatment
-----------------
* Drug: Motexafin Gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme ECOG performance status score either 0, 1, or 2 Willing and able to provide written informed consent Exclusion Criteria: Greater than two prior cytotoxic regimens Laboratory values showing adequate function of bone marrow, liver, and kidneys Uncontrolled hypertension Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin Gadolinium|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Lung Cancer, Prostate Cancer, Ovarian Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Metastatic Cancer, Advanced Cancer, Genitourinary Cancer, Glioblastoma Multiforme, Recurrent Cancer, Colon Cancer, Gastric Cancer, Stomach Cancer, Pancreatic Cancer, Esophageal Cancer, Throat Cancer, Bladder Cancer, Kidney Cancer, Renal Cancer, Cervical Cancer, Endometrial Cancer, Colorectal Cancer
Effects of Spray and Stretch on Postneedling Soreness and Sensitivity After Dry Needling of a Latent Myofascial Trigger Point.

Study Overview
=================
Brief Summary
-----------------
Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated as a method to reduce this soreness. As well, the characteristics and the different factors that influence in this pain will be described.

Conditions
-----------------
Pain After Dry Needling

Intervention / Treatment
-----------------
* Other: Spray and stretch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects presenting latent trigger points in the trapezius muscle Exclusion Criteria: Subjects with active trigger points or absence of trigger points.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spray and stretch<br> | Other: Spray and stretch<br>* Physiotherapeutic technique which consist in stretching the muscle while a cold spray is applied on the skin.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual analogue scale | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pressure pain threshold | 48 hours | 
| Psychological factors | Symptom check list revised. SCL-90-r | 72 hours after needling |
Family-Centered Diabetes Project - Sharing Wisdom

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women

Detailed Description
-----------------
Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.

Conditions
-----------------
Obesity, Overweight, Prediabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: A lifestyle educational program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Indian women Aged 18-40 years Living in Albuquerque area Not having diabetes Exclusion Criteria: Pregnancy Planning to become pregnant within 2 years Diagnosed with diabetes fasting blood glucose > 126 planning to move out of town in next 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: A lifestyle educational program|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased dietary fat intake |  |  | 
| increased vegetable consumption |  |  | 
| increased self-reported leisure physical activity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glucose |  |  | 
| HOMA |  |  | 
| serum free insulin |  |  | 
| Body Mass Index |  |  | 
| waist circumference |  |  | 
| decreased dietary intake of total sugar |  |  | 
| decreased time watching television |  |  | 
| resting blood pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, Prevention, American Indian
Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gene mutations may make prostate cancer cells unable to attach to androgens. This may permit the growth of prostate cancer. Gene testing may improve the identification of patients with advanced prostate cancer. PURPOSE: Clinical trial to study the androgen receptor gene in patients with prostate cancer that is not responsive to hormone therapy.

Detailed Description
-----------------
OBJECTIVES: the feasibility of collecting bone marrow biopsies from prostate cancer patients in a cooperative group setting the incidence of marrow invasion by prostate tumor in random bone marrow biopsy the influence of previous prostate radiation on obtaining prostate tumor the frequency and type of AR mutations and association of AR mutations with response to antiandrogen withdrawal.

Official Title
-----------------
Androgen Receptor Mutations in Hormone Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: mutation analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Histologically proven adenocarcinoma of the prostate that is refractory to hormone therapy Patients who are eligible for anticancer therapy on Protocol CLB-9480, CLB-9583, CLB-9680, or CLB-9780 are also eligible for this study if they have not started treatment on those protocols
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Source of patient samples<br>The CALGB conducted a phase III study (CALGB 9583) in which 260 men with AiPC were randomly assigned to antiandrogen withdrawal together with simultaneous ketoconazole and hydrocortisone versus antiandrogen withdrawal alone, followed by sequential ketoconazole and hydrocortisone. Metastatic disease with progression despite castrate levels of testosterone, prior antiandrogen therapy for a minimum of 4 weeks, and a minimum PSA level of 5 ng/mL were required; treatment with sequential antiandrogens was allowed. No prior chemotherapy was allowed. Bone marrow biopsies were obtained from 164 patients enrolled on CALGB 9583 and from 20 patients enrolled on CALGB chemotherapy trials (CALGB 9480, 9680, 9780). | Other: mutation analysis<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, recurrent prostate cancer
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture

Study Overview
=================
Brief Summary
-----------------
prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively

Detailed Description
-----------------
prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively Non inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale

Official Title
-----------------
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture

Conditions
-----------------
Preoperative Anxiety

Intervention / Treatment
-----------------
* Drug: Melatonin 5 MG Sublingual Tablet
* Drug: Hydroxyzine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients scheduled for hip fracture surgery Exclusion Criteria: Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery | Drug: Melatonin 5 MG Sublingual Tablet<br>* Melatonin 5 mg 12 hours and 2 hours prior to surgery<br>|
| Active Comparator: Group B<br>patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery | Drug: Hydroxyzine<br>* Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative anxiety | preoperative anxiety scale | 1 hour before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, Hydroxizin, Hip fracture
The Correlational Study of PPV in Various VT in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
Mesquida, J et al showed there was a significant linear correlation between pulse pressure variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase of severe sepsis and septic shock. No study revealed the actual relationship between various PPV under different VT. So we hypothesized that there were relationship between various PPV in different tidal volume settings. The objective of this study was to examine the relationship between various PPV.

Official Title
-----------------
The Correlational Study of Pulse Pressure Variation in Various Tidal Volume in Mechanically Ventilated Patients Under General Anaesthesia

Conditions
-----------------
Respiration, Artificial

Intervention / Treatment
-----------------
* Other: 300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal Exclusion Criteria: acute lung injure acute respiratory distress syndrome cardiovascular diseases neurological disease renal or hepatic disease diabetes mellitus BMI less than 18 kg/m2 or greater than 25 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: change respiratory parameters, volume expanding<br> | Other: 300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive arterial blood pressure as a Measure of Safety | if instability of circulation, stop the clinical trial | Day 1 |
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nebivolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients, of age 18 - 54 years Patients diagnosed with stage 1 or stage 2 essential hypertension Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant Exclusion Criteria: Secondary hypertension or severe hypertension History of Type 1 diabetes mellitus A medical contraindication to discontinuing a current antihypertensive therapy Clinically significant respiratory disease that prohibit use of a beta blocker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration | Drug: Nebivolol<br>* Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration<br>|
| Placebo Comparator: 2<br>Dose-matched placebo | Drug: Placebo<br>* Dose-match placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Diastolic Blood Pressure (DBP) | Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. | Change from Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Systolic Blood Pressure (SBP) | Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. | Change from Baseline to Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage 1, Stage 2, Hypertension
Heart Rate Variability During Sleep After Fast-track Surgery

Study Overview
=================
Brief Summary
-----------------
Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances, after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental analysis of heart rate variablity after arousals during sleep. We compared preoperative and postoperative results.

Conditions
-----------------
Heart Rate Variablity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria (for the control group): Age > 60 years Exclusion criteria: surgery within the last 2 months known sleep disorder (eg. sleep apnea) daily beta blocker treatment daily dopamine treatment This protocol only concentrates on the healthy controls for the patient described in H-2-2010-011.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>patient characteristics are specified in H-2-2010-011 | |
| controls<br>age matched to patients described in protocol H-2-2010-011 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability | heart rate variability measured 5 beats before arousel and 15 beats after arousel in different sleep stages. | 24 hours |
A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.

Detailed Description
-----------------
A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.

Official Title
-----------------
A 3 Arm, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy,Safety and Tolerability of Pagoclone for Adults With Stuttering

Conditions
-----------------
Stuttering

Intervention / Treatment
-----------------
* Drug: pagoclone
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old. Stuttering severity must be notable for > 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks. Exclusion Criteria: Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.30 mg pagoclone BID | Drug: pagoclone<br>* 0.30 mg BID, 0.60 mg BID<br>|
| Experimental: 2<br>0.60 mg pagoclone BID | Drug: pagoclone<br>* 0.30 mg BID, 0.60 mg BID<br>|
| Placebo Comparator: 3<br>placebo | Other: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo. |  | Weeks 8, 16 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores. |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stutter, stuttering, Adults with a history of stuttering